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OMB Control No. 0910-0601
Expiration Date: 09-30-2022
TABLE OF CONTENTS
Introduction ..................................................................................................................................... 2
Background ..................................................................................................................................... 4
Definitions ...................................................................................................................................... 6
Standard No. 1 - Regulatory Foundation ...................................................................................... 11
Standard No. 2 - Training Program .............................................................................................. 13
Standard No. 3 - Inspection Program............................................................................................ 20
Standard No. 4 - Inspection Audit Program ................................................................................. 26
Standard No. 5 - Food-Related Illness, Outbreak, and Hazards Response ................................... 29
Standard No. 6 - Compliance and Enforcement Program ............................................................ 32
Standard No. 7 - Industry and Community Relations ................................................................... 34
Standard No. 8 - Program Resources ............................................................................................ 36
Standard No. 9 - Program Assessment ......................................................................................... 37
Standard No. 10 - Laboratory Support.......................................................................................... 39
Appendix 1: Self-Assessment Worksheet..................................................................................... 44
Appendix 2.1: Self-Assessment Worksheet.................................................................................. 54
Appendix 2.2: Inspector Training Record Summary .................................................................... 57
Appendix 2.3: Inspector Training Record .................................................................................... 58
Appendix 2.4: Curriculum Example Basic Food Inspector Training ........................................... 63
Appendix 3.1: Self-Assessment Worksheet.................................................................................. 65
Appendix 3.2: Risk Classification Criteria for Food Plants ......................................................... 70
Appendix 4.1: Self-Assessment Worksheet.................................................................................. 72
Appendix 4.2: Performance Rating for the Field inspection Audits............................................. 74
Appendix 4.2a: Summary of Field Inspection Audit Findings ..................................................... 76
Appendix 4.3: Performance Rating for Inspection Report Audits................................................ 77
Appendix 4.3a: Summary of Inspection Report Audit Findings .................................................. 79
Appendix 4.4: Performance Rating for the Sample Report Audits .............................................. 80
Appendix 4.4a: Summary of Sample Report Audit Findings ....................................................... 82
Appendix 4.5: Contract Audit Form (FDA 3610) ........................................................................ 83
Appendix 4.5a: Guidance for Completing the Contract Audit Form (FDA 3610) ....................... 89
Appendix 4.6: Inspection Report Audit Form .............................................................................. 96
Appendix 4.7: Sample Report Audit Form ................................................................................... 99
Appendix 4.8: Corrective Action Plan ........................................................................................ 103
Appendix 5.1: Self-Assessment Worksheet................................................................................ 104
Appendix 6.1: Self-Assessment Worksheet................................................................................ 107
Appendix 6.2: Calculation of the Level of Conformance to Compliance Procedures ............... 108
Appendix 6.2a: Performance Review of Enforcement Actions .................................................. 110
Appendix 7.1: Self-Assessment Worksheet............................................................................... 111
Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet .................................. 112
Appendix 8.1: Self-Assessment Worksheet................................................................................ 113
Appendix 8.1a: Self-Assessment Worksheet Instructions .......................................................... 114
Appendix 8.2: Calculation for Determining a Required Number of Inspectors ....................... 1142
Appendix 8.3: Inspection Equipment ......................................................................................... 116
Appendix 9.1: Self-Assessment Summary Report ..................................................................... 117
Appendix 10.1: Self-Assessment Worksheet.............................................................................. 121
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INTRODUCTION
The Food Safety Modernization Act (FSMA) mandates that the Food and Drug Administration
(FDA) establish an Integrated Food Safety System (IFSS). An IFSS requires partnerships
between federal, state, local, and tribal agencies to collaborate and leverage resources to ensure
the protection of public health.
The Manufactured Food Regulatory Program Standards (MFRPS) is a critical component in
establishing FDA’s IFSS. The MFRPS (henceforth also referred to as (“program standards”)
establishes a uniform foundation for regulatory agencies responsible for oversight of food
manufacturing plants. When fully implemented, the program standards define a set of best
practices of a regulatory system.
Conformance with the program standards requires a regulatory agency to continuously assess,
evaluate, and take necessary corrective actions to address gaps. MFRPS conformance will
facilitate a system of mutual reliance between the FDA and other regulatory agencies and
support continued improvements in regulatory manufactured food programs throughout the
nation.
The program standards are comprised of ten standards that establish requirements for the critical
elements of a regulatory program designed to protect the public from foodborne illness and
injury. These elements include the program’s regulatory foundation, staff training, inspection,
quality assurance, food defense preparedness and response, foodborne illness and incident
investigation, enforcement, education and outreach, resource management, laboratory resources,
and program assessment. Each standard contains a purpose statement, requirement summary,
description of program elements, projected outcomes, and a list of required documentation. The
program standards have corresponding self-assessment and supplemental worksheets designed to
assist the regulatory program in achieving and sustaining conformance.
FDA will use the program standards as a tool to continuously improve manufactured food
contracts and promote the development of a high-quality state manufactured food regulatory
program which includes a process for continuous improvement based upon quality management
systems. The program standards will assist both FDA and the states in fulfilling their regulatory
obligations. States will be expected to develop and implement improvement plans to demonstrate
that they are moving toward full implementation and to participate in FDA audits to determine
level of conformance. States are encouraged to build sustainable systems including sustainability
strategies and plans that will result in the standards being maintained in conformance.
The goal of the MFRPS is to implement a nationally integrated, risk-based, food safety system
focused on protecting public health. The program standards establish a uniform basis for
measuring and improving the performance of prevention, intervention, and response activities of
manufactured food regulatory programs in the United States. The development and
implementation of these program standards will help federal and state programs better direct
their regulatory activities toward reducing foodborne illness hazards in food plants.
Consequently, the safety and security of the United States food supply will improve as greater
focus is placed on prevention.
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The collection of information is approved by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995. The OMB control number is 0910-0601.
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BACKGROUND
The food safety regulatory system in the United States is a tiered system that involves Federal,
state, and local governments. The Food and Drug Administration (FDA) is responsible for
ensuring that all foods moving in interstate commerce, except those under United States
Department of Agriculture jurisdiction, are safe, wholesome, and labeled properly. State
agencies conduct inspection and regulatory activities that help ensure food produced, processed,
or sold within their jurisdictions is safe. Many state agencies also conduct food plant inspections
under contract with the FDA. These inspections either are performed under the states’ laws and
authorities or the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or both.
To maximize the use of resources among the FDA and the states, particularly when their
jurisdictions overlap, their inspection programs should be equivalent in effect.
In June 2000, the Department of Health and Human Services’, Office of the Inspector General
(OIG) released a report of FDA’s oversight of state contracts. In this report, the OIG
recommended that [FDA] take steps to promote “equivalency among Federal and State food
safety standards, inspection programs, and enforcement practices. 1 In response to their findings,
FDA established a committee to develop a set of quality standards for manufactured food
regulatory programs. The committee was comprised of officials from FDA and state agencies
responsible for regulating manufactured food plants 2. The result of the committee was the first
edition of the program standards published by FDA in 2007.
In January 2011, FSMA gave the FDA authority to develop a framework to build the capacity of
state and local regulatory agencies to support the IFSS model. In 2012, the FDA created the
Standards Implementation Staff to give assistance, support and guidance to state programs
enrolled in the MFRPS. Additionally, FDA helped establish the Manufactured Food Regulatory
Program Standards (MFRPS) Alliance to create a network of state programs and assist with
further development and revisions of the program standards.
In December 2011, the OIG released “Vulnerabilities in FDA’s Oversight of State Food Facility
Inspections”. In response, the FDA stated, “Collaboration with our state partners is critical to an
integrated national food safety system and is also mandated under the FDA Food Safety
Modernization Act (FSMA). 3 Over the last decade, the FDA has worked to develop and
implement the MFRPS which will strengthen states’ food safety programs. These program
standards reflect an effort in which FDA has been engaged in for many years of partnering,
1
Office of Inspector General, FDA Oversight of State Food Firm Inspections: OEI-01-98-00400 (Department of Health and Human
Services, 2000), p. 5.
2
A building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food
as defined by 21 CFR Part 110.3 (k) . Manufactured
3
Office of Inspector General, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections: OEI-02-09-00430 (Department of
Health and Human Services, 2011), p. 34.
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leveraging and empowering agencies to move the vision of a nationally integrated food safety
system.
It should be noted that in the 2019 revised version of the MFRPS, definitions have been used and
slightly modified from the Field Management Directive 76 titled State Contracts - Evaluation of
Inspectional Performance.
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DEFINITIONS
1. Assessment: means a systematic, independent, and documented process for obtaining
objective evidence and evaluating it to determine the extent to which a requirement is
met. The MFRPS assessments are conducted by FDA at approximately 18, 36, and 60
months after enrollment. Assessments after 60 months will be conducted every two years.
The FDA will determine IMPLEMENTATION during each assessment. The FDA will
determine CONFORMANCE at 60 months. The FDA may determine CONFORMANCE at 18
and 36 months when a standard is found to be fully implemented.
2. Conformance or Conformity: means the fulfillment of a requirement, specifically a
State program is using and can demonstrate the use of a particular element, system, or
program listed in the MFRPS.
3. Consumer Complaints: are complaints made by the public regarding food products,
facility, practices, labeling, and any other related activities.
4. Contact Hour: an inspector qualifies for one contact hour of continuing education for
each clock hour of participation. Contact hours for a specified presentation, course, or
training activity will be recognized only one time within a 3-year continuing education
period.
5. Critical Violations: are violations which are directly linked to public health risk, food
adulteration, and/or known contributors to foodborne illness unless otherwise defined by
the State.
6. Current and Fit-for-Use: “current” indicates that documentation is signed and dated in
accordance with program policies and procedures that meet criteria in the most current
standard. “Fit-for-use” is a quality term used to indicate that a product or service fits the
customer’s defined purpose for that product or service. Documentation may be electronic
or hard copy.
7. Current Experienced Staff: defined by the State program in their training plan.
8. Document Control: document control ensures that documents are reviewed for
adequacy, approved for release by authorized personnel and distributed to and used at the
location where the prescribed activity is performed.
9. Environmental Assessment (Also called “Environmental Health Assessment”):
means an on‐site food product investigation, conducted in conjunction with investigations
(e.g., traceback) as needed to assess and rule out the potential that the contaminant of
concern was introduced at a particular point in the distribution or production system. This
is achieved by identifying contributing factors and environmental antecedents.
10. Equivalent: means that the State law directly references the relevant provision or
regulation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 Code of
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Federal Regulations (CFR). The State program specifies the Federal statute or regulation
that is incorporated into the State law, including the revision date of the State statutory
provision or regulation, the date the Federal statutory provision or regulation was
incorporated into the State law, and whether that statutory or regulatory provision is
included in whole, in part, or modified from the original.
11. Equivalent in Effect: means that the State law has the same regulatory effect as the
relevant FD&C Act provision or CFR regulation. A State law may have the same
regulatory effect as the Federal law or regulation if either a single State law or rule has
the same regulatory effect as the Federal law or regulation, or when multiple laws of that
State are combined and deemed equivalent to a single Federal law or regulation. In
conducting such self-assessment, the State program may need to consult with its legal
counsel when a provision is determined to be Equivalent in effect.
12. Evaluation: means an inspection in which the ability of an inspector is assessed to
determine if they are competent to complete independent inspections. Evaluations are
required for GMP and each specialized inspections. The evaluation should assess an
inspector’s ability to:
• Prepare for an inspection
• Conduct an inspection
• Follow procedures identified by the State for the specific type of inspection
• Communicate during the inspection and on the inspection report; and
• Assess specialized processes (as applicable).
Appendix 4.5 Field Audit Form, a modified version of the Conference for Food
Protection Audit form, or an original form created by the State which evaluates the
elements listed above may be used. It is recommended that new inspectors complete
evaluations and independent inspections before entering the audit cycle. However, if
States use the Appendix 4.5 – Field Audit Form, the evaluations may be counted toward
the total audits for that year.
13. Field Inspection Audit: means an inspection in which a state inspector is accompanied
by a QUALIFIED AUDITOR (either FDA or State) for the purpose of assessing the quality
and performance of inspections either contract or state. These inspections may be counted
under 2.3.2.3 and 2.3.3.2 Field Training as evaluations and also under 4.3.2 Field
Inspection Audit if Appendix 4.5 is used.
14. Food-Related Incident: means an unintentional or deliberate contamination, threatened
or actual, of food that may occur at any point in the production system (e.g., pre‐harvest
production, processing, distribution) and may cause food-related illness, injury, outbreaks
and HAZARDS. Examples of food related incidents include but are not limited to
foodborne illness outbreaks and food tampering.
15. Hazard: means any biological, chemical, or physical agent in food that is reasonably
likely to cause illness or injury in the absence of its control.
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16. Highly Susceptible Population: include immuno-compromised persons, preschool age
children, or older adults; and persons who obtain food at a facility that provides services
such as custodial care, health care, assisted living, a child or adult day care center, kidney
dialysis centers, hospital or nursing home, or nutritional or socialization services (senior
citizen centers)
17. Implementation: means a State program has a particular element, system, or program as
required in the Program Elements and documentation requirements for MFRPS.
18. Industry Complaints: are complaints made by Industry about inspections or inspectors.
19. Joint Field Training Inspection: means an inspection conducted jointly by the FDA
and/or state personnel for the purposes of training or enforcement. A joint inspection may
be used to provide training to a state inspector during an inspection of a firm and may
either be trainer led or trainee led.
20. Newly Hired Experienced Staff: staff with manufactured food regulatory experience
received outside the manufactured food safety program to which they are currently
employed.
21. Not Equivalent: means there is no State law equivalent to the relevant Federal law or
regulation, there is such a State law but it does not apply to the State’s food plant or
manufacturing establishment program, or the Federal and State laws address the same
matter but are inconsistent and do not have the same regulatory effect.
22. Outreach Activity Event: means an outreach activity which the State program hosts, cohosts or is an invited presenter such as seminars, workshops, conferences, trainings, or
meetings that relate to food protection topics and that support communication and
information exchange among regulators, industry, academia, and consumer
representatives.
23. Primary Servicing Laboratory: means any laboratory used by the State program for
ongoing or routine testing.
24. Qualified Field Inspection Auditor: means an individual who is recognized by the
regulatory jurisdiction’s food safety program manager as having field experience and
communication skills necessary to audit other inspectors/investigators and who has:
• Demonstrated the competency for basic food inspection auditing to the food
safety program manager;
• Successfully completed advanced food inspection training coursework and field
training in any areas where the auditor performs advanced auditing, such as low
acid foods, acidified foods, seafood HACCP, or juice inspections;
• Been assigned this auditing responsibility; and
• Completed the required audit training per the State program requirements.
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25. Qualified Date: qualified date begins when an inspector has completed all basic course
and field elements and has been signed off to do independent inspections. This date is
used to calculate the start of the continuing education hours in 2.3.4.
26. Qualified Field Inspection Trainer: means an individual who is recognized by the
regulatory jurisdiction’s food safety program manager as having field experience and
communication skills necessary to train or supervise other inspectors/investigators and
who has:
• Demonstrated the competency for basic food inspection training to the food safety
program manager;
• Successfully completed advanced food inspection training coursework and field
training in any areas where the trainer performs advanced training, such as low
acid foods, acidified foods, seafood HACCP, or juice inspections; and
• Been assigned this training responsibility.
• State program includes a definition of “qualified trainer” within their training
plan.
27. Recall Audit Checks: are conducted by the State Agency to verify that the firm’s recall
was successful as defined by the State’s recall procedures.
28. Regulatory Foundation: means laws, regulations, rules, ordinances, or other regulatory
requirements that govern the operation of a food plant or manufacturing establishment.
29. Sampling Program: means a program in which the state collects samples as part of their
manufactured food program in one or more of the sampling types as defined in the
Partnership for Food Protection’s Food/Feed Testing Laboratories Best Practices
Manual 4 (Draft) (Final Draft 11/1/2013). The program can be based on state defined
sampling frequency and does not have to be continuous or routine.
30. Start Date: date of newly hired into the manufactured food program or newly reassigned
into the manufacturing food program as the start time for training timelines for
employees.
31. Strategic Improvement Plan: means a type of improvement plan that includes the
following information: (1) the individual element or documentation requirement of the
standard that was not met, (2) improvements needed to meet the program element or
documentation requirement of the standard, (3) projected completion dates for each task,
(4) personnel responsible, and (5) date completed.
32. Traceback: [a] The method used to determine the source and scope of the
product/processes associated with an outbreak and document the distribution and
production chain of the product that has been implicated in a foodborne illness or
4
Reference: PFP Food/Feed Testing Laboratories Best Practices Manual can be found:
http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404716.pdf
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outbreak. 5 and [b] The process by which the origin or source of a cluster of contaminated
food is identified. 6
33. Traceforward: [a] once the source of an implicated food item is established,
investigators may do a "traceforward" to document the distribution of all implicated lots
of food from the source. This can help epidemiologists with case finding and can be used
to test hypotheses about the outbreak. Traceforwards should only be used when there is a
reasonable degree of confidence that the traceback correctly identified the source of the
implicated product. A product recall also involves a traceforward to determine the
suppliers that received the product. [b] Tracking a recalled product from the origin or
source through the distribution system. 6
34. Verification Audit Inspection: means an inspection in which a qualified FDA or State
auditor observes a State qualified auditor performing an audit of a State inspector
conducting an inspection.
5
Reference: Multistate Foodborne Outbreak Investigations Guidelines for Improving Coordination and Communications. Glossary can be found
at: http://www.cifor.us/clearinghouse/tooldetail.cfm?id=212
6
Reference: Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response, 2009.
Appendix 1: Glossary which can be found at: http://www.cifor.us/documents/CIFORGuidelinesAppendices.pdf
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STANDARD No. 1
Regulatory Foundation
1.1
Purpose
This standard describes the elements of the REGULATORY FOUNDATION used by a State program
to regulate food plants.
1.2
Requirement Summary
The State program evaluates the scope of its legal authority and regulatory provisions to ensure
the protection of manufactured food within its jurisdiction. The State program’s evaluation
includes a determination of how the State’s REGULATORY FOUNDATION corresponds to the U.S.
FDA’s REGULATORY FOUNDATION.
1.3
Program Elements
1.3.1
Written Procedure for Evaluation of Legal Authority
The State program has a written procedure to evaluate the legal authority and regulatory
provisions to inspect and investigate food plants, gather evidence, collect and analyze
samples, and take enforcement actions. The written procedure must:
1.3.1.1
1.3.1.2
1.3.1.3
Include timeframes for a REGULATORY FOUNDATION assessment;
Describe the REGULATORY FOUNDATION assessment process, to include
whenever significant changes are made to applicable Federal and/or
state laws and regulations; and
Address the statutes, regulations, rules, ordinances, and other
prevailing regulatory requirements that:
1.3.1.3.1
1.3.1.3.2
1.3.1.3.3
1.3.1.3.4
1.3.2
Apply to the regulation of manufactured food;
Delegate authority to the State program;
Describe the State program’s administrative procedures
for rulemaking to protect public health; and
Identifies and lists other State or Federal agencies that
have authority for any area of the REGULATORY
FOUNDATION that the State program lacks.
REGULATORY FOUNDATION Assessment
1.3.2.1
The State program must complete Appendix 1.2 or equivalent
form. The State program conducts a baseline self-assessment to
determine if they are EQUIVALENT, EQUIVALENT IN EFFECT, or
NOT EQUIVALENT to sections of the current Federal Food, Drug,
and Cosmetic Act (FD&C Act) and Code of Federal Regulations
(CFR) Title 21 specified in Appendix 1.2.
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1.3.2.2
If the State program has not adopted the current version of a CFR
provision the State must provide the revision date of the CFR
that was adopted for each regulation.
Note: If the State program has laws and regulations pertinent to the regulation of manufactured
food, for which there are no Federal provisions, these laws and regulations can also be listed in
Appendix 1.2 or equivalent form.
Note: In conducting a self-assessment, the State program may need to consult with legal counsel
when regarding whether a provision is EQUIVALENT IN EFFECT.
1.4
Outcome
The State program has the legal authority and regulatory provisions to protect the public health
by ensuring the safety and security of the manufactured food supply within its jurisdiction. For
any part of the REGULATORY FOUNDATION that the State program lacks, the State program
identifies another State or Federal program with that regulatory authority to protect public health.
1.5
Documentation
The State program maintains the records listed here.
1.5.1 Written procedure for evaluation for legal authority
1.5.2 State program’s written REGULATORY FOUNDATION assessment process
1.5.3 The statutes, regulations, rules, ordinances, and other prevailing regulatory
requirements that: (1) apply to the regulation of manufactured food, (2) delegate
authority to the State agency, and (3) describe the State agency’s administrative
procedures for rulemaking to protect public health
1.5.4 Appendix 1.1 – SelfAssessment Worksheet
1.5.5 Appendix 1 - Self-Assessment Worksheet or equivalent form
1.5.6 If applicable, review by legal counsel
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STANDARD No. 2
Training Program
2.1
Purpose
This standard defines the essential elements of a training program for inspectors.
2.2
Requirement Summary
The State program uses a written training plan that promotes development and demonstrates that
all inspectors who will conduct manufactured food inspections complete course curriculums,
field training, and continuing education to adequately perform their work.
2.3
Program Elements
2.3.1
Training Plan and Training Records
2.3.1.1
2.3.1.2
2.3.1.3
2.3.1.4
2.3.1.5
2.3.2
The State program uses a written training plan that ensures all
inspectors receive training required to adequately perform their work
assignments. The training plan includes course curriculums which
provides for basic and advanced food inspection training as well as
continuing education.
Appendix 2.2 or equivalent form must be used to document and
summarize all training provided to inspectors.
The State program maintains a training history for active inspectors.
The training history for all inactive inspectors must be kept for three
years or per the state’s record retention policy.
Appendix 2.3 or equivalent form must be used to document training
for each inspector.
The State training record summary and individual training records
must include the inspector’s START DATE. Equivalent forms including
electronic records may be used for required appendices.
Basic Food Inspection Training
The State program requires that each inspector complete a basic food inspection training
curriculum that consists of coursework and field training described here.
2.3.2.1
Timeframe
The Basic Food Inspection Training course curriculum shall be successfully
completed within 24 months of the inspector’s START DATE with the manufactured
food program.
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2.3.2.2
Course Curriculum:
The Basic Food Inspection Training consists of coursework in the subject areas
listed in this section.
2.3.2.2.1
2.3.2.2.2
2.3.2.2.3
2.3.2.2.4
2.3.2.2.5
2.3.2.2.6
2.3.2.2.7
2.3.2.2.8
2.3.2.2.9
2.3.2.2.10
2.3.2.2.11
Prevailing statutes, regulations, and ordinances
Public health principles
Emergency management
Communications skills
Microbiology
Epidemiology
Basics of HACCP
Allergen management
Basic food labeling
Food defense awareness training
Sampling technique and preparation
Note: States may further subdivide their basic training by identifying courses required for
inspectors who only inspect non high risk warehouses. These courses must be clearly defined in
the state training plan.
Note: Appendix 2.4 provides a list of available Basic Food Inspection Training Coursework that
may be used to satisfy the requirements in 2.3.2.2.
2.3.2.3
Field training
2.3.2.3.1
2.3.2.3.2
Each inspector who will inspect general manufactured
food firms must complete:
2.3.2.3.1.1
Ten JOINT FIELD TRAINING INSPECTION,
FIELD INSPECTION AUDITS, or
EVALUATIONS with a QUALIFIED FIELD
INSPECTION TRAINER; and
2.3.2.3.1.2
Of the ten, two must be acceptable FIELD
INSPECTION AUDITS or EVALUATIONS by
a QUALIFIED FIELD INSPECTION TRAINER
or QUALIFIED FIELD INSPECTION
AUDITOR.
Each inspector who will only inspect non high risk food
warehouses must complete:
2.3.2.3.2.1
Five JOINT FIELD TRAINING INSPECTION,
FIELD INSPECTION AUDITS, or
EVALUATIONS with a QUALIFIED FIELD
INSPECTION TRAINER; and
2.3.2.3.2.2
Of the five, two must be acceptable
FIELD INSPECTION AUDITS or
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EVALUATIONS by a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR.
2.3.2.3.3
2.3.2.3.4
2.3.3
Inspectors who meet 2.3.2.3.2 and advance to conduct
general manufactured food firms must complete:
2.3.2.3.3.1
Five additional JOINT FIELD TRAINING
INSPECTIONS, FIELD INSPECTION AUDITS,
or EVALUATIONS to fulfill requirements
identified in 2.3.2.3.1; and
2.3.2.3.3.2
Of the five, two must be acceptable
FIELD INSPECTION AUDITS or
EVALUATIONS by a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR.
JOINT FIELD TRAINING INSPECTION or FIELD INSPECTION
AUDITS/EVALUATIONS are conducted in firms that are
representative of the firms to be inspected by the
inspector. Each inspector will complete the minimum
field training requirements prior to conducting
independent inspections.
Advanced Food Inspection Training
The State program requires each inspector who will conduct specialized food inspections
to complete an advanced inspection training curriculum which consists of relevant
coursework and field training as described here.
2.3.3.1
Coursework
The state program requires each inspector who will perform specialized food
inspections to successfully complete the coursework specific to the type of
specialized food inspections they will be performing. Specialized food inspection
courses include, but not limited to:
2.3.3.1.1
2.3.3.1.2
2.3.3.1.3
2.3.3.1.4
2.3.3.1.5
2.3.3.1.6
2.3.3.2
7
Acidified foods
Low acid canned foods
Juice HACCP
Seafood HACCP
Traceback Investigations 7
Foodborne Illness Investigations7
Field training
These advanced food inspection training courses are not subject to 2.3.3.2 Field Training requirements.
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The State program requires that each inspector successfully complete the
following before performing independent specialized food inspections.
2.3.3.2.1
2.3.3.2.2
Participate in two JOINT FIELD TRAINING INSPECTIONS;
After successful completion of the course participate in
one EVALUATION or FIELD INSPECTION AUDIT that is
found to be acceptable by a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD INSPECTION
AUDITOR prior to conducting independent inspections;
and
Within one year after being released to do specialized
food inspections complete a second EVALUATION or
FIELD INSPECTION AUDIT that is found to be acceptable
by QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED
FIELD INSPECTION AUDITOR in the area of specialty.
2.3.3.2.3
2.3.4
Experienced Inspectors
The criterion for conducting a minimum of 10 JOINT FIELD TRAINING INSPECTIONS and/or
required coursework is intended for new employees or employees new to the food safety
program. For CURRENT EXPERIENCED STAFF or NEWLY HIRED EXPERIENCED STAFF, a State
program’s training plan shall include the following unless the state determines in their
training plan that all staff will be required to complete the program elements in 2.3.2 and
2.3.3:
2.3.4.1
CURRENT EXPERIENCED STAFF
Missing Record
2.3.4.1.1
JOINT FIELD
TRAINING
INSPECTIONS
2.3.4.1.2
Basic Course
Work
2.3.4.1.3
Specialized
Food Inspection
Course Work
Certificates
Documentation in Employee Training
File
Statement or affidavit explaining the
background or experience that justifies
a waiver of the basic or specialized
JOINT FIELD TRAINING INSPECTIONS.
Document training records available.
Create a statement or affidavit
explaining the background or
experience that justifies a waiver of the
missing Basic Course Work.
Statement or affidavit explaining the
date and location that they have
successfully completed the specialized
training.
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2.3.4.2
NEWLY EXPERIENCED STAFF
Missing Record
2.3.5
2.3.4.2.1
JOINT FIELD
TRAINING
INSPECTIONS
2.3.4.2.2
Basic Course
Work
2.3.4.2.3
Specialized Food
Inspection
Course Work
Certificates
Documentation in Employee Training
File
Statement or affidavit explaining the
background or experience that justifies
a waiver of some or all of the basic or
specialized JOINT FIELD TRAINING
INSPECTIONS. Conduct two successful
EVALUATION or FIELD INSPECTION
AUDIT within 6 months of the
Inspector’s QUALIFIED DATE.
Document training records available.
Statement or affidavit explaining the
background or experience that justifies
a waiver of the Basic Course Work.
Statement or affidavit explaining the
date and location that they have
successfully completed the specialized
training.
Continuing education
Within the scope of this standard, the goal of continuing education and training is to
enhance the inspector’s knowledge, skills, and ability to perform manufactured food
inspections. The objective is to build upon the inspector’s knowledge base.
2.3.5.1
2.3.5.2
2.3.5.3
2.3.5.4
Each inspector must accumulate 20 CONTACT HOURS of continuing
education in food safety every 36 months.
The 36-month continuing education interval starts at the QUALIFIED
DATE, when the basic training cycle is completed.
The program may establish an alternate timeframe to track continuing
education as long as the alternate timeframe and how that timeframe
still meets or exceeds the intent of the standard (at least 20 CONTACT
HOURS every 36 months) are clearly identified in program procedures.
The inspector qualifies for CONTACT HOURS for participation in any of
the following activities that are related specifically to manufactured
food safety or manufactured food inspectional work:
• Attendance at national or regional seminars / technical
conferences;
• Professional symposiums / college courses;
• Food-related training provided by government agencies (e.g.,
USDA, State, local);
• Food safety related conferences and workshops;
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2.3.5.5
2.3.5.6
2.3.5.7
• Distance learning opportunities that pertain to food safety; or
• Training approved by a QUALIFIED FIELD INSPECTION TRAINER.
Of the accumulated 20 CONTACT HOURS of continuing education, a
maximum of ten (10) CONTACT HOURS may be accrued from the
following activities:
• Delivering presentations at professional conferences;
• Providing classroom and/or field training to newly hired
inspectors, or being a course instructor in food safety; or
• Publishing an original article in a peer-reviewed professional or
trade association journal/periodical.
Of the accumulated 20 CONTACT HOURS of continuing education, a
maximum of four (4) CONTACT HOURS may be accrued for reading
technical publications related to manufactured food safety.
Documentation must accompany each activity submitted for
continuing education credit. Examples of acceptable documentation
may include:
•
•
•
•
•
•
2.3.6
Certificates of completion indicating the course date(s) and
number of hours attended or CE credits granted;
Transcripts from a college or university;
A letter from the administrator of the continuing education
program attended;
A copy of the peer-reviewed article or presentation made at a
professional conference; or documentation to verify technical
publications related to food safety have been read including
completion of self-assessment quizzes that accompany journal
articles, written summaries of key points/findings presented in
technical publications, and/or written book reports; and
An agenda and attendance roster.
Documentation approved by the QUALIFIED FIELD INSPECTION
TRAINER.
Coursework Sources
Basic, advanced, and continuing education coursework must be obtained from one of the
sources listed here:
2.3.6.1
2.3.6.2
8
Training provided by a government agency (including in house
training);
Distance learning, for example, satellite downlinks or web-based
training 8;
FDA/ORA U classroom and long distance learning courses are listed at: http://www.fda.gov/ora/training/course_ora.html
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2.3.6.3
2.3.6.4
2.4
Colleges, schools, research centers, and institutes;
Food Safety Alliances recognized by FDA.
Outcome
The State program has trained inspectors with the knowledge, skills, and abilities to competently
inspect, conduct investigations, gather evidence, collect samples, and take enforcement actions
with manufactured food plants.
2.5
Documentation
The State program maintains the records listed here.
2.5.1
2.5.2
2.5.3
2.5.4
2.5.5
2.5.6
2.5.7
2.5.8
2.5.9
Appendix 2.1 Self-Assessment Worksheet
Appendix 2.2 State Training Record Summary
Appendix 2.3 Individual training record
Documents verifying successful completion of required courses
Course description or agendas for non-FDA courses
Signed statements for experienced inspectors
EVALUATIONS or FIELD INSPECTION AUDITS
Documentation for continuing education credit
Written Training Plan
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STANDARD No. 3
Inspection Program
3.1
Purpose
This standard describes the elements of an effective inspection program for manufactured food
establishments.
3.2
Requirement Summary
The State program has a manufactured food inspection system. This system provides the
foundation for inspecting food firms to determine compliance with the laws administered by
Federal, State, and local governments. In addition, the State program has: (1) a risk based
inspection program, (2) an inspection procedure, (3) an inspection report procedure, (4) a system
to respond to CONSUMER COMPLAINTS, (5) a system to resolve INDUSTRY COMPLAINTS about
inspections, (6) a recall system, and (7) a sampling procedure.
3.3
Program Elements
3.3.1
Risk-based Inspection Program
The State program has an inventory of food establishments for which the State has
regulatory oversight. The inventory is categorized by the risk associated with the
likelihood that a food related incident will occur.
3.3.1.1
3.3.1.2
3.3.2
Inspections are prioritized and frequencies assigned based on
established risk categories. The State program has written procedure
documenting their classification criteria and inspection frequencies.
The state program must use the risk factors and classification criteria
as described in:
• Appendix 3.2; or
• FD&C Act, Section 421 (a)(1); or
• Develop its own risk factor and classification criteria. If the state
chooses to develop its own risk factor and classification criteria a
written rationale must be provided that demonstrates how public
health is protected.
Inspection Procedure
The State program has a written procedure for inspecting food plants that require the
inspectors to:
3.3.2.1
Review the previous inspection report and CONSUMER COMPLAINTS.
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Manufactured Food Regulatory Program Standards
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3.3.2.2
3.3.2.3
3.3.2.4
3.3.2.5
3.3.2.6
3.3.2.7
3.3.2.8
3.3.2.9
3.3.2.10
3.3.2.11
3.3.2.12
3.3.2.13
3.3.2.14
3.3.2.15
3.3.2.16
3.3.2.17
3.3.2.18
3.3.2.19
3.3.2.20
9
Have appropriate equipment 9 and forms (if necessary). Equipment
must be verified and maintained as defined by the State’s standard
operating procedures or manufacture’s recommendations.
Make appropriate introductions, and explain the purpose and scope of
the inspection.
Establish jurisdiction.
Select an appropriate product for the inspection and, if necessary,
make appropriate adjustments based on what the plant is producing.
Assess employee practices critical to the safe and sanitary production
and storage of food.
Properly evaluate the likelihood that conditions, practices,
components, and/or labeling could cause the product to be adulterated
or misbranded or otherwise in violation of applicable law.
Recognize significant violative conditions or practices, if present, and
record findings consistent with State program procedures.
Distinguish between significant and insignificant observations, and
isolated incidents versus trends.
Review and evaluate the appropriate records and procedures for the
establishment’s operation and effectively apply the information
obtained from this review [during the inspection].
Collect adequate evidence and documentation to support inspection
observations in accordance with State program procedures.
Verify correction of deficiencies identified during the previous
inspection.
Behave professionally and demonstrate proper sanitary practices
during the inspection.
Use current versions of applicable hazard guides or other guidance, to
identify and evaluate the HAZARDS associated with product(s) and
process(es) when conducting inspections of specialized food and
processes.
Assess the firm’s implementation of sanitation monitoring for the
applicable eight key areas of sanitation when required by regulation.
When appropriate review the firm’s: scheduled process; HACCP plan
or necessary process controls in the absence of a HACCP plan; food
safety control plan and applicable monitoring, verification and
deviation or corrective action records, including those related to
sanitation.
Recognize deficiencies in the firm’s monitoring controls and sanitation
procedures through in-plant observations.
Use suitable interviewing techniques.
Explain findings clearly and adequately throughout the inspection.
Alert the firm’s person in charge when an immediate corrective action
is necessary.
Standard number 8, Appendix 8.3 Inspection Equipment
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Manufactured Food Regulatory Program Standards
September 2019
3.3.2.21
3.3.2.22
3.3.3
Answer questions and provide information in an appropriate manner.
Write findings accurately, clearly, and concisely on the State
document and provide a copy to the firm’s person in charge.
Inspection Report
The State program has a written inspection report procedure that requires inspectors to:
3.3.3.1
3.3.3.2
3.3.3.3
3.3.3.4
3.3.4
Submit the inspection report within designated timeframes;
Complete the inspection report form completely and accurately;
Document violations and observations clearly, legibly, and concisely;
and
Follow up with corrective action, compliance and enforcement.
Food Recalls 10
The State program has a food recall system with written recall procedures for:
3.3.4.1
3.3.4.2
3.3.4.3
3.3.5
Sharing information about recalls with relevant agencies;
Ensuring recalled products are removed promptly from the market;
and
Performing RECALL AUDIT CHECKS.
Consumer Complaints
The State program has a system for handling CONSUMER COMPLAINTS. The system
contains written procedures for:
3.3.5.1
3.3.5.2
3.3.5.3
3.3.5.4
3.3.5.5
3.3.6
Receiving;
Tracking;
Evaluating;
Responding to; and
Closing CONSUMER COMPLAINTS.
Complaints Resulting from State Program Inspection Activities
The State program has a system for handling INDUSTRY COMPLAINTS about inspections.
The system contains written procedures for:
3.3.6.1
3.3.6.2
3.3.6.3
Receiving;
Evaluating; and
Responding to INDUSTRY COMPLAINTS.
10
Reference: PFP Best Practices for Improving FDA and State Communication During Recalls can be found:
http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM460013.pdf?source
=govdelivery&utm_medium=email&utm_source=govdelivery
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3.3.7
Sampling Procedure 11
The State program has a written sampling procedure to ensure its SAMPLING PROGRAM is
carried out in a manner that is consistent with state procedure. The sampling procedures
must be reflective of the types of food and samples that the state collects and must
include:
3.3.7.1
Procedures that require sample collectors to:
3.3.7.1.1
3.3.7.1.2
3.3.7.1.3
3.3.7.1.4
3.3.7.2
Use the appropriate method and equipment to collect
the sample.
Record sample chain of custody per state procedure.
Handle, package, and ship sample using procedures
appropriate to prevent compromising condition of the
sample and ensuring security of the sample.
Deliver or ship sample to the appropriate laboratory
program within prescribed timeframes.
Instructions for documenting the sample collection must include the
following elements when applicable the State’s SAMPLING PROGRAM:
3.3.7.2.1
3.3.7.2.2
3.3.7.2.3
3.3.7.2.4
3.3.7.2.5
3.3.7.2.6
3.3.7.2.7
3.3.7.2.8
3.3.7.2.9
Date of Sample Collection
Product Identification Including:
3.3.7.2.2.1
Name of Product
3.3.7.2.2.2
Unique Manufacturing Identification
references
Description of the product
Collection information including:
3.3.7.2.4.1
Method of Collection
3.3.7.2.4.2
Lot Sampled
3.3.7.2.4.3
Lot Size
3.3.7.2.4.4
Special Sample techniques if used to
collect the sample
Location where sample was collected.
Name and address of responsible party, guarantor,
possessor, or distributor.
Sample type
Analysis requested if applicable.
Product labels or specific labeling information that is
collected or reproduced per state policies.
11
Reference: PFP Food/Feed Testing Laboratories Best Practices Manual can be found:
http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404716.pdf
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3.3.7.2.10
3.3.7.3
3.3.8
Identification of the sample with the sample number
assigned by the sampler at the time of collection.
State programs are not required to have a written sampling procedure
unless they collect samples. However, these programs must have a
statement in lieu of sampling procedures that explains why a
SAMPLING PROGRAM is not supported and how the public health is
protected in the absence of such a program. An example may include:
Stating that public health is protected because another state or federal
agency collects samples and fulfills this need. The statement should
include the name of the agency and the type of samples that it collects.
Records Retention
The State program must maintain records as required under Section 9.3.2.2 for the
following:
3.3.8.1
3.3.8.2
3.3.8.3
3.3.8.4
3.3.8.5
3.4
Inspection reports which includes follow up activities;
Essential recall information;
CONSUMER COMPLAINTS;
INDUSTRY COMPLAINTS about inspections 12; and
Documentation associated with sample collection.
Outcome
The State program is based on an inspection program that reduces the occurrence of foodborne
illness, injury, or allergic reaction.
3.5
Documentation
The State program maintains the records listed here.
3.5.1
3.5.2
3.5.3
3.5.4
3.5.5
3.5.6
12
Appendix 3.1 Self-Assessment Worksheet
An inventory of food plants for which the state has regulatory oversight 13
Written procedure documenting the classification criteria and inspection
frequencies
Written rationale of the risk factor and classification criteria if a State program
develops its own risk factor and classification criteria
Written procedures for inspecting food plants.
Written inspection reports procedure
Records dealing with personnel actions are not subject to review during an ASSESSMENT.
13
Refer to PFP Document Data Elements and Definitions for recommended but not required data elements for each food plant.
http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404717.pdf
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Manufactured Food Regulatory Program Standards
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3.5.7
3.5.8
3.5.9
3.5.10
3.5.11
3.5.12
3.5.13
3.5.14
Written inspection reports, which includes follow-up activities
Written procedures for food recalls
Essential recall information
Written procedures for CONSUMER COMPLAINTS
CONSUMER COMPLAINTS
Written procedures for INDUSTRY COMPLAINTS
INDUSTRY COMPLAINTS about inspections 14
about inspections
Written procedures for sampling or, in the absence of any SAMPLING PROGRAM, a
statement stating how public health is protected
3.5.15 Sample collection reports
3.5.16 Documentation associated with sample collection
14
Records dealing with personnel actions are not subject to review during an ASSESSMENT.
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STANDARD No. 4
Inspection Audit Program
4.1
Purpose
This standard describes the Quality Assurance Program (QAP) and auditing procedures
necessary for a State program to (1) evaluate the effectiveness and accuracy of the inspection
program, inspection records, and sampling records; and (2) identify best practices used to
achieve quality inspections and sample collections.
4.2
Requirement Summary
The State program has a Quality Assurance Program that conducts audits to assess the
effectiveness and accuracy of its inspections and sample collections. The QAP has two
components: (1) a FIELD INSPECTION AUDIT component, which is an on-site performance
EVALUATION of inspections and (2) a desk audit component, which is a performance review of
the written reports of inspections and sample collections.
4.3
Program Elements
4.3.1
Quality Assurance Program
The State program has a written Quality Assurance Program that contains written
procedures for:
4.3.1.1
4.3.1.2
4.3.1.3
4.3.1.4
4.3.2
Conducting field inspection audits as described in section 4.3.2; and
Conducting inspection report audits as described in section 4.3.3; and
Conducting sample report audits as described in section 4.3.4; and
A corrective action plan as described in section 4.3.5.
Field Inspection Audit
QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR conducts
FIELD INSPECTION AUDITS or VERIFICATION AUDIT INSPECTIONS to verify that inspections
are consistently performed according to the State’s written procedures described in
Standard 3.
4.3.2.1
Frequency. The QAP requires a minimum of two FIELD INSPECTION
of each inspector be conducted every 36 months. Inspections
selected for audits should include the highest risk firms that the
inspector is trained for including specialized food inspections.
Performance is documented on Appendix 4.2 or equivalent form and
Appendix 4.5 or a State audit form that meets the program elements in
Standard 3, Program Element 3.3.2.
AUDITS
4.3.2.2
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4.3.3
Inspection Report Audit
The QAP requires periodic review of inspection reports to verify that inspectional
findings are obtained and reported according to established written procedure. The
quality of each inspection report is audited using the performance factors listed in
Appendix 4.6. An overall inspection report rating is calculated using Appendix 4.3.
4.3.3.1
The State program will review a random selection of inspection reports
based on the number of inspections completed in the last 12 months
using the table below:
Number of
Inspections in 12
Months
Less than 40
reports
40 – 800 reports
More than 800
reports
4.3.3.2
4.3.3.3
4.3.4
Minimum Number
of Reports
Required
Maximum
Number of
Reports Required
All
All
40
40
5% of reports
70
Seven percent (7%) of the inspection reports reviewed must be taken
from inspections that were audited.
Performance is documented on Appendices 4.6 and 4.3 or equivalent
forms.
Sample Report Audit
If the samples are collected in conjunction with the manufactured food program, the QAP
requires periodic review of sample reports. This review is to verify that samples were
properly collected, identified, recorded and submitted according to established written
procedure. The quality of each sample report is audited using the performance factors
listed in Appendix 4.7. An overall sample report rating is calculated using Appendix 4.4.
4.3.4.1
The State program will review a random selection of sample reports
based on the number of samples collected in the last 12 months using
the table below:
Number of
samples in 12
Months
Less than 40
reports
40 – 800 reports
Minimum Number
of Reports
Required
Maximum Number
of Reports
Required
All
All
40
40
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Manufactured Food Regulatory Program Standards
September 2019
More than 800
reports
4.3.4.2
4.3.5
5% of reports
70
Performance is documented on Appendices 4.7 and 4.4 or equivalent
forms.
Corrective Action Plan
The state program has a written corrective action plan (Appendix 4.8 or equivalent form) for
the inspection, sampling, and FIELD INSPECTION AUDITS that addresses action to be taken
when one or more of the conditions below are met:
4.3.5.1
4.3.5.2
4.3.5.3
4.4
An individual receives an overall rating of “needs improvement”;
A single performance factor for the program falls below 80%;
An overall rating for the program falls below 80%.
Outcome
The State program systematically evaluates and improves its inspection and sample collection
systems to ensure that activities and information are accurate, complete, and comply with the
jurisdiction’s procedures and policies.
4.5
Documentation
The State program maintains the records listed here.
4.5.1
4.5.2
4.5.3
4.5.4
4.5.5
4.5.6
4.5.7
4.5.8
4.5.9
Written procedures that describe the Quality Assurance Program
Appendix 4.1 Self-Assessment Worksheet
Appendix 4.2 Summary of FIELD INSPECTION AUDIT Findings
Appendix 4.3 Summary of Inspection Report Audit Findings
Appendix 4.4 Summary of Sample Report Audit Findings
Appendix 4.5 FIELD INSPECTION AUDIT form or a State audit form that meets the
program elements in Standard 3, Program Element 3.3.2
Appendix 4.6 Inspection Report Audit Form, or equivalent form
Appendix 4.7 Sample Report Audit Form, or equivalent form
Appendix 4.8 Corrective Action Plan or equivalent form.
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Manufactured Food Regulatory Program Standards
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STANDARD No. 5
Food-related Illness, Outbreak and Hazards Response
5.1
Purpose
This standard describes the food emergency response functions and related activities necessary to
investigate FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS that are likely to
result in a foodborne illness, injury or outbreak.
5.2
Requirement Summary
The State program has a written food emergency response program. The program describes
surveillance, investigation, control measures and post response activities in collaboration with
other agencies and jurisdictions for responding to reports of food-related illness, injury,
outbreaks and HAZARDS, whether unintentional or deliberate, and for generating
recommendations for foodborne illness prevention.
5.3
Program Elements
5.3.1
Coordination of Food-related Illness, Outbreak and Hazards Response Activities
with Other Authorities
5.3.1.1
5.3.1.2
Memorandum of understanding with other state agencies: If the
responsibility for state food-related illness and outbreak investigations
is assigned to another state agency, a memorandum of understanding
with this agency is required to fulfill the requirements of this standard.
The State program has a written procedure that:
5.3.1.2.1
5.3.1.2.2
5.3.1.2.3
5.3.1.2.4
5.3.1.2.5
5.3.1.2.6
Identifies and describes the roles, duties, and
responsibilities of each program for the requirements in
5.3.2-5.3.5;
Describes agency collaboration as necessary with FDA
and other appropriate local, state and federal authorities
in multi-jurisdictional FOOD-RELATED INCIDENTS;
Designates response coordinator(s) to guide program
investigation efforts in collaboration with all agencies
involved;
Describes how all relevant agencies are notified in case
of FOOD-RELATED INCIDENTS;
Provides guidance for notification of appropriate law
enforcement agencies when intentional food
contamination is suspected or threatened;
Describes the maintenance of a list(s) of relevant
agencies and emergency contacts that is updated at least
yearly.
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Manufactured Food Regulatory Program Standards
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5.3.2
Surveillance
The State program:
5.3.2.1
5.3.2.2
5.3.3
Uses epidemiological information from local, state, or federal agencies
to detect incidents or outbreaks of foodborne illness or injury.
Maintains notifications of FOOD-RELATED INCIDENTS that are reported
to the program, in a log(s) or database(s).
Investigation/Environmental Assessment
The State program:
5.3.3.1
5.3.3.2
5.3.3.3
5.3.3.4
5.3.3.5
5.3.4
Uses established procedures with recommended timeframes to
investigate reports of FOOD-RELATED INCIDENTS.
Collects environmental data using established procedures similar to
those found in the most current versions of “International Association
for Food Protection Procedures to Investigate a Foodborne Illnesses"
and the CIFOR “Guidelines for Foodborne Disease Outbreak
Response.” 15 .
Coordinates the TRACEBACK and TRACEFORWARD of food implicated
in an illness, injury, outbreak or found to contain a HAZARD in
accordance with written procedures.
Has access to laboratory support 16 for investigation of reports of FOODRELATED INCIDENTS.
Correlates and analyze ENVIRONMENTAL ASSESSMENT data to identify
contributing factors and antecedents that led to food contamination or
adulteration causing illness, injury, or outbreak.
Control Measures
The State program:
5.3.4.1
5.3.4.2
Mitigates and contains food-related illness, injury and HAZARDS
through strategies that include industry education, enforcement and
public awareness activities.
Maintains a written procedure with criteria for releasing prevention
guidance and information to the public (includes identifying a media
person and developing guidelines for coordinating media information
with other jurisdictions).
15
Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response. Atlanta: Council of State
and Territorial Epidemiologists available http://cifor.us/ .
16
Specific requirements for laboratory support are contained in Standard 10.
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5.3.5
Post Response
The State program:
5.3.5.1
5.3.5.2
5.3.5.3
5.4
Maintains program investigation and ENVIRONMENTAL ASSESSMENT
findings and reports.
Distributes final program investigation report(s), including an
ENVIRONMENTAL ASSESSMENT if completed to relevant agencies
responsible for reporting contributing factors and antecedents to CDC.
Distributes recommendations, when available, from investigation and
ENVIRONMENTAL ASSESSMENT findings and reports to relevant
agencies and stakeholders responsible for prevention, education and
outreach.
Outcome
The State program uses a systematic approach for the detection, investigation, mitigation,
documentation and analysis of FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS
that are likely to result in a foodborne illness, injury or outbreak.
5.5
Documentation
The program maintains the records listed here:
5.5.1
5.5.2
5.5.3
Appendix 5.1 Self-Assessment Worksheet
A Memorandum of Understanding, if applicable
Written procedures for coordination, surveillance, ENVIRONMENTAL ASSESSMENT,
control measures, and post response.
5.5.4 Records associated with coordination, surveillance, ENVIRONMENTAL
ASSESSMENT, control measures, and post response.
5.5.5 A log(s) or database(s) that tracks notification of FOOD-RELATED INCIDENTS
5.5.6 Investigation/ ENVIRONMENTAL ASSESSMENT, reports and summaries
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STANDARD No. 6
Compliance and Enforcement Program
6.1
Purpose
This standard describes the State agency’s strategies, procedures, and actions to enforce the laws
and regulations to achieve compliance and to evaluate the effectiveness of its compliance and
enforcement program.
6.2
Requirement Summary
The State program has a written compliance and enforcement program, which describes its
compliance strategy and procedures. The compliance and enforcement program conducts an
annual review and records those actions on appendix 6.2. The State calculates an overall rating
which is used to determine if compliance and enforcement procedures were followed. Results of
the review are used to identify improvements and modify procedures.
6.3
Program Elements
6.3.1
Compliance and Enforcement Program
The State program has a written compliance and enforcement program that:
6.3.1.1
6.3.1.2
6.3.1.3
6.3.1.4
6.3.1.5
Contains compliance and enforcement strategies;
Describes the procedure to monitor
6.3.1.2.1
CRITICAL VIOLATIONS;
6.3.1.2.2
chronic violations; and
6.3.1.2.3
chronic violators;
Uses a risk-based process to determine when a directed investigation,
follow-up, or re-inspection is needed;
Establishes a framework for compliance and enforcement progressive
actions 17; and
Has a system to communicate policy and guidance to managerial and
non-managerial staff.
6.3.2 Performance Review
The State program conducts a performance review of compliance and enforcement actions as
defined by the State program. The State program will conduct a performance review:
17
Compliance and Enforcement Progressive Actions may include, but are not limited to:
•
Preventive actions such as promoting voluntary compliance through education program and consultation;
•
Field actions such as verbal warnings, documented warnings, re-inspections, and product embargos;
•
Supervisory/management actions such as warning letters or informal hearings;
•
Administrative actions such as complaints and evidentiary hearings to suspend or revoke a business license; and
•
Civil or criminal sanctions.
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6.3.2.1
6.3.2.2
6.3.2.3
6.3.2.4
6.4
Annually;
Document on Appendix 6.2 or equivalent form to evaluate if internal
compliance and enforcement actions are followed;
Use results of the review to identify improvements and modify
procedures; and
Require a corrective action if performance ratings fall below 80
percent.
Outcome
The State program has a compliance and enforcement program that has written procedures to
ensure that compliance actions are supported by sound judgment, adequate evidence, and
appropriate documentation that is submitted in program-prescribed formats.
6.5
Documentation
The State program maintains the records listed here.
6.5.1
6.5.2
6.5.3
Appendix 6.1 Self-Assessment Worksheet
Written Compliance and Enforcement Program
Appendix 6.2 Performance Review of Enforcement Actions or equivalent form
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STANDARD No. 7
Industry and Community Relations
7.1
Purpose
This standard describes the elements of industry and community outreach activities or OUTREACH
ACTIVITY EVENTS developed and accomplished by the State program.
7.2
Requirement Summary
The State program participates in activities that support communication and information
exchange among regulators, industry, academia, and consumer representatives. It also
coordinates or participates in outreach activities or OUTREACH ACTIVITY EVENTS that provide
educational information about food protection topics
7.3
Program Elements
The State program has a written procedure of the methods that will be used for communication
with the food industry stakeholders and consumers. The written procedure includes how the State
program will:
7.3.1
Identify the methods for communication with the food industry stakeholders and
consumers.
7.3.2 Interact with industry and consumers by sponsoring or actively participating in
meetings such as task forces, advisory boards, or advisory committees.
7.3.3 Tailor outreach efforts to a target population, which may include dissemination of
information using electronic sources and traditional methods such as mailings.
Topics of outreach efforts may include food defense, investigation strategies,
regulatory requirements, violation trends, and emerging issues regarding
manufactured foods. Representatives from affected food industries, consumers,
academia, and other Federal, State, and local food protection agencies are invited
to these meetings.
7.3.4 Document and evaluate OUTREACH ACTIVITY EVENTS using Appendix 7.2 or
equivalent form. Include documents such as agendas and meeting summaries and
program evaluations.
7.4
Outcome
The State program uses outreach activities or OUTREACH ACTIVITY EVENTS to inform varied
populations about food protection-related issues.
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7.5
Documentation
The State program maintains the records listed here.
7.5.1
Written procedure for methods used to communicate with food industry
stakeholders and consumers
7.5.2 Appendix 7.1 Self-Assessment Worksheet
7.5.3 Appendix 7.2 or equivalent documentation for each OUTREACH ACTIVITY EVENT
7.5.4 Meeting summaries, agendas, or other records documenting interaction with food
industry stakeholders s and consumers
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STANDARD No. 8
Program Resources
8.1
Purpose
This standard describes the elements for assessing the resources (staff, equipment, and funding)
needed to support a manufactured food regulatory program.
8.2
Requirement Summary
The State program conducts an assessment of resource needs for staffing, equipment, and
funding for the manufactured food regulatory program.
8.3
8.4
Program Elements
8.3.1
Program Assessment
The State program completes the self-assessment to assess staffing, funding, and
equipment using Appendix 8.1 or equivalent form. The administrative functions
needed to support all program areas should be considered when determining
program resources.
8.3.2
Staffing
The State program conducts a calculation for determining a required number of
inspectors and documents on Appendix 8.2 or equivalent form. The State program
has staff to inspect food plants in its establishment inventory at a frequency that is
based on the plant’s risk classification and the necessary inspection and travel
time.
8.3.3
Equipment
A list of the equipment required for inspections and sample collections must be
established and maintained by the State program using Appendix 8.3 or
equivalent form.
Outcome
The State program assesses and allocates resources needed to support a manufactured food
regulatory program.
8.5
Documentation
The State program maintains the records listed here:
8.5.1
8.5.2
8.5.3
Appendix 8.1 Self-Assessment Worksheet
Appendix 8.2 or equivalent form.
Appendix 8.3 or equivalent form.
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STANDARD No. 9
Program Assessment
9.1
Purpose
This standard describes the process a State program uses to assess and demonstrate its
CONFORMANCE with each of the program standards.
9.2
Requirement Summary
Managers conduct periodic self-assessments of the manufactured food regulatory program
against the criteria established in each program standard. These self-assessments are designed to
identify the strengths and weaknesses of the State programs by using the program standards.
The results of the self-assessments are used to determine areas or functions of the State program
that need improvement. The results of the baseline self-assessment are used to develop a
STRATEGIC IMPROVEMENT PLAN and establish timeframes for making improvements. Subsequent
self-assessments are used to track progress toward meeting and maintaining CONFORMANCE with
the program standards.
9.3
Program Elements
9.3.1
In the first year the State program conducts a baseline self-assessment to
determine if the program meets the elements of each standard. The State program
uses the Appendices and Worksheets contained herein or equivalent forms. The
State program uses the results of its self-assessments to complete the SelfAssessment Summary Report (also known as Appendix 9.1).
9.3.2
The State program must:
9.3.2.1 Have a written DOCUMENT CONTROL procedure that ensures that all
guidance, procedures, documents, and forms required by the standards are
CURRENT AND FIT-FOR-USE.
9.3.2.1.1 All of the documents subject to this procedure can demonstrate
they are CURRENT AND FIT-FOR-USE through maintenance of a
master document list or other system that shows:
9.3.2.1.1.1 Documents are reviewed for accuracy.
9.3.2.1.1.2 Documents are approved for release by authorized
Personnel and signed/dated with an approval or revision date.
9.3.2.1.1.3 Documents are distributed to and used at the location
Where the prescribed activity is performed.
9.3.2.1
9.3.2.2 Retain records or procedures required under x.5 of each
standard for the three previous years, or per the State program’s record
retention policy, whichever is longer. Records or procedures can be
maintained either electronically or in hardcopy.
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9.3.3
If the State program fails to meet any of the program elements and documentation
requirements of a standard, it develops a written STRATEGIC IMPROVEMENT PLAN
that includes the following information:
9.3.3.1
9.3.3.2
9.3.3.3
9.3.3.4
9.3.3.5
9.4
The individual element or documentation requirement of the standard
that was not met;
Improvements needed to meet the program element or documentation
requirement of the standard;
Projected completion dates for each task;
Personnel responsible, and
Date completed for each task.
9.3.4
The State program shall review and update self-assessment appendices and its
STRATEGIC IMPROVEMENT PLAN at least annually.
9.3.5
The State program participates in FDA ASSESSMENTS to determine
IMPLEMENTATION and CONFORMANCE to the standards. The State program
addresses FDA ASSESSMENT observations and incorporates corrective actions as
needed into its STRATEGIC IMPROVEMENT PLAN.
Outcome
The State program conforms to the program standards through well-defined and written
evaluation activities and a process for continuous improvement.
9.5
Documentation
The State program maintains records listed here.
9.5.1 Appendix 9.1 Self-Assessment Summary Report
9.5.2 STRATEGIC IMPROVEMENT PLAN
9.5.3 DOCUMENT CONTROL procedure
9.5.4 Record retention rules, policies or procedures
9.5.5 FDA ASSESSMENT reports
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STANDARD No. 10
Laboratory Support
10.1
Purpose
This standard describes the elements of laboratory support for a manufactured food regulatory
program.
10.2
Requirement Summary
The State program has access to the laboratory services needed to support program functions and
documents its laboratory capabilities including agreements with external laboratories.
10.3
Program Elements
10.3.1 Laboratory Support
10.3.1.1
10.3.1.2
10.3.1.3
The State program has access to a laboratory that is capable of
analyzing a variety of samples including food, environmental, and
clinical samples.
The State program maintains a list of services for routine and nonroutine analyses such as biological HAZARD determinations.
The State program has a contract or written agreement with each
PRIMARY SERVICING LABORATORY unless under the same
administrative agency. If not, the contract or written agreement must
be documented such as a memorandum of understanding, e-mail, or
any written format but must contain the components below:
10.3.1.3.1
10.3.1.3.2
10.3.1.4
Define the responsibilities of each party;
Describe the types of testing services to be performed;
and
10.3.1.3.3
Describe how exceptions to planned work will be
communicated.
When a program uses a laboratory service from a non-primary
servicing laboratory, there shall be documentation of the service
provided; the documentation can be in a simplified format.
10.3.2 ISO Accredited Laboratories
The State program utilizes laboratories that have a current accreditation to the ISO/IEC
17025:2005 or ISO/IEC 17025:2017 standards to analyze food and environmental
samples. The accreditation body of the laboratory must be a full member of the
International Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC
Mutual Recognition Arrangement (MRA).
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10.3.3 Non-ISO Accredited Laboratories
If state programs do not use laboratories holding accreditation to ISO/IEC 17025:2005 or
ISO/IEC 17025:2017 for the analysis of food and environmental samples, then the
program must utilize laboratories that have in place a quality system which incorporates
the following management and technical requirements of ISO/IEC 17025:2005* or
ISO/IEC 17025:2017 at a minimum:
*Note ISO/IEC 17025:2005 will be invalid after November 30, 2020 per ILAC. Future
versions of the ISO/IEC 17025 standard shall be evaluated and incorporated into
Standard 10, as applicable.
10.3.3.1
A documented quality system which incorporates management and
technical requirements of ISO/IEC 17025:2005 or ISO/IEC
17025:2017 and associated procedures, that include but ae not limited
to:
10.3.3.1.1
10.3.3.1.2
10.3.3.1.3
10.3.3.1.4
10.3.3.1.5
10.3.3.1.6
10.3.3.2
10.3.3.3
10.3.3.4
10.3.3.5
Calibration and maintenance of equipment;
Analyses are performed using validated and verified
test procedures;
Documentation of sample traceability;
Documentation of analytical results and analysts
performing work;
Analysts that are trained and authorized to perform
technical procedures; and
Periodic audits.
A procedure that defines the activities necessary when non-conforming
work occurs. The documented process must describe how quality
control data are assessed to assure that test results from nonconforming work are not released. The documented process must
describe how cause analysis and problem resolution are recorded.
A document control procedure that assures documents issued to
personnel are current, suitable, and reviewed and approved by
authorized personnel prior to release. The procedure must also assure
that obsolete documents are removed from use.
A documented record keeping process that assures that records of
original observations and data collection are maintained and sufficient
to establish traceability of test results to sample handling and storage,
to sample analysis including data collection, to equipment calibration
and maintenance, and to the review of test results prior to release.
A documented process to assure that reference materials and reference
cultures used are fit for purpose, are not outdated, and are traceable to
a lot number or other unique identifier.
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10.3.3.6
10.4
A documented process to assure that the laboratory participates in
relevant and available proficiency testing activities.
Outcome
The State program has access to laboratory services described in this standard.
10.5
Documentation
The State program maintains records listed here.
10.5.1
10.5.2
10.5.3
10.5.4
Appendix 10.1 Self-assessment worksheet
Contracts or written agreements with PRIMARY SERVICING LABORATORIES
A list of laboratories used by the state that are non-primary servicing laboratories.
Documentation of services provided by PRIMARY SERVICING LABORATORIES and
non-primary servicing laboratories.
10.5.5 ISO Accredited Laboratory: ISO/IEC 17025:2005 or ISO/IEC 17025:2017
Certificate and Scope of Accreditation
10.5.6 Non-ISO Accredited Laboratory Documents:
10.5.6.1 Documented Quality System
10.5.6.2 Corrective Action
10.5.6.3 Document Control
10.5.6.4 Record Keeping
10.5.6.5 Process for Ensuring Validity of Results (including but not limited to
Reference Materials and or Proficiency Testing)
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Appendix 1.1: Self-Assessment Worksheet
State Agency:
Program Elements
Yes/No
If No, please explain why element is
not met
1.3.1 Written Procedure for Evaluation of Legal Authority
Does the State Program’s written procedure:
1. Describe the REGULATORY FOUNDATION assessment
process?
2. Include timeframes for conducting a REGULATORY
FOUNDATION assessment; including whenever
significant changes are made to applicable Federal
and/or State laws and regulations?
3. Address statutes, regulations, rules, ordinances, and
other prevailing regulatory requirements that:
a. Apply to the regulation of manufactured food?
b. Delegate authority to the State’s program?
c. Describe the State administrative procedures for
rulemaking to protect public health?
d. Identify and list other State and Federal agencies that
have authority for any area of the REGULATORY
FOUNDATION the State program lacks?
1.3.2 REGULATORY FOUNDATION Assessment
Does the State’s REGULATORY FOUNDATION
assessment include:
1. A baseline self-assessment using Appendix 1.2 or
equivalent to determine if the State is EQUIVALENT,
EQUIVALENT IN EFFECT, or NOT EQUIVALENT to
sections of the FD&C act and CFR as specified in
Appendix 1.2?
2. Revision date of the CFR that was adopted for each
regulation if the State Program has not adopted the
current version of a CFR provision.
Assessment completed by:
Date______________
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Appendix 1: Statutes and Regulations Worksheet
Instructions: Determine if State laws and regulations are “EQUIVALENT,” “EQUIVALENT IN EFFECT,” or “NOT EQUIVALENT” to Federal
statutes and regulations. If there is no State law or regulation that is EQUIVALENT or EQUIVALENT IN EFFECT, mark the NOT EQUIVALENT
box; otherwise list the State law or regulation citation and complete the columns for either EQUIVALENT or EQUIVALENT IN EFFECT as
appropriate. The Notes section shall be used in part to detail differences between State and Federal laws and regulations. If regulatory
responsibility for a FD&C-CFR falls under the jurisdiction of another agency, that particular FD&C-CFR row should be left blank – with
documentation provided in the notes section of which agency has the jurisdiction. Please note that to the extent that any federal statutes or
regulations guided below reference FDA regulated products other than food (i.e. tobacco), such references are not intended to be within the
scope of this self-assessment which relates only to human food.
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
Federal Food, Drug & Cosmetic Act
201
Definitions (f), (k), (m),
and (ff)
301
Prohibited acts (a), (b),
(c), (d), (e), (f), (k), and
(v)
303*
Penalties
304**
Seizure
401
Definitions and standards
for food
402
Adulterated food
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
403
Misbranded food (a)-(s)
413
New dietary ingredients
701
Regulations and hearings
703***
704
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Notes
Review Date
Records of interstate
shipments
Factory inspection
*Penalties may vary from Federal statute.
**Although the State program may not have authority for seizure, the State program could have legal authority to stop adulterated and misbranded products from moving in commerce, for example,
detention, stop-sale orders, withdrawal from distribution, and embargoes.
*** This section covers records in interstate commerce. State laws should include intrastate records.
Title 21 Code of Federal Regulations: Food and Drugs
1
7
General enforcement
regulations
(§ 1.20-1.24)
and (Subpart O § 1.9001.934)
Enforcement policy
(ONLY § 7.1-7.13 and §
7.40-7.59)
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EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
70
Color additives
(ONLY § 70.20-70.25)
73
Listing of colors exempt
from certification (ONLY
§ 73.1-§ 73.615)
74
Listing of color additives
subject to certification
(ONLY § 74.101-706)
81
General Restrictions for
Provisional Color
Additives for Use in
Foods, Drugs, and
Cosmetics
82
Listing of certified
provisionally listed colors
and specifications (ONLY
§ 82.3-§ 82.706)
100
General (ONLY §
100.155)
101
Food labeling (EXCEPT
§ 101.69 and § 101.108)
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
102
Common or usual name
for nonstandardized foods
(EXCEPT § 102.19)
104
Nutritional quality
guidelines for foods
105
Foods for special dietary
use
106
Infant formula quality
control procedures
(EXCEPT § 106.120)
107
Infant formula (EXCEPT
§ 107.200-§ 107.280)
108
Emergency permit control
(ONLY § 108.25-§
108.35)
109
Unavoidable
contaminants in food for
human consumption and
food- packaging materials
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Notes
Review Date
Current good
manufacturing practice in
manufacturing, packing,
or holding human food
110 18
111
Current good
manufacturing practice
for dietary supplements
113
Thermally processed lowacid foods packaged in
hermetically sealed
containers
114
Acidified foods
115
Shell eggs
117
Current Good
Manufacturing Practice
and Hazard Analysis and
Risk-Based Preventive
Controls for Human Food
18
Part 110 was modernized and codified in Part 117 by the current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventative Controls for
Human Food Rule (21 CFR Part 117).
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EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
118
Production, Storage, And
Transportation of Shell
Eggs
120
Hazard Analysis and
Critical Control Point
(HACCP) systems
123
Fish and fishery products
129
Processing and bottling of
bottled drinking water
130
Food standards: general
(EXCEPT § 130.5-6 and
§ 130.17)
131
Milk and cream
133
Cheeses and related
cheese products
135
Frozen desserts
136
Bakery products
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
137
Cereal flours and related
products
139
Macaroni and noodle
products
145
Canned fruits
146
Canned fruit juices
150
Fruit butters, jellies,
preserves, and related
products
152
Fruit pies
155
Canned vegetables
156
Vegetable juices
158
Frozen vegetables
160
Eggs and egg products
161
Fish and shellfish
163
Cacao products
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
164
Tree nut and peanut
products
165
Beverages
166
Margarine
168
Sweeteners and table
syrups
169
Food dressings and
flavorings
170
Food additives
EXCEPT § 170.6, §
170.15, and § 170.17)
172
Food additives permitted
for direct addition to food
for human consumption
173
Secondary direct food
additives permitted in
food for human
consumption
174
Indirect food additives:
general
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
175
Indirect food additives:
adhesives and
components of coatings
176
Indirect food additives:
paper and paperboard
components
177
Indirect food additives:
polymers
178
Indirect food additives:
adjuvants, production
aids, and sanitizers
180
Food additives permitted
in food or in contact with
food on an interim basis
pending additional study
181
Prior-sanctioned food
ingredients
182
Substances generally
recognized as safe
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Review Date
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Notes
EQUIVALENT
IN EFFECT
EQUIVALENT
State Citation
184
Direct food substances
affirmed as generally
recognized as safe
186
Indirect food substances
affirmed as generally
recognized as safe
189
Substances prohibited
from use in human food
190
Dietary supplements
Revision Date of
Federal
Law/Regulation
Date
Incorporated
into State Law
NOT EQUIVALENT
Partial
or Full
Notes
Review Date
State law and regulations:
State laws and regulations used by the program to address regulatory responsibilities outside of FDA jurisdiction are listed below.
Assessment completed by:_______________________________________________________________________________________________
(NAME)
(DATE)
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Appendix 2.1: Self-Assessment Worksheet
State agency: __________________________________________________________________
Program Elements
Yes/No If no, please explain why element is not met
2.3.1. Training Plan and Training Records
Does the State program:
1. Have a written training plan that ensures all inspectors
receive training required to adequately perform their
work assignments?
2. Maintain a training history for active inspectors?
3. Maintain a history for all inactive inspectors for three
years or per the state’s record retention policy?
4. Use Appendix 2.2 or equivalent form to document and
summarize all training provided to inspectors?
5. Use Appendix 2.3 or equivalent form to document
training for each inspector?
6. Training record summary and individual training
records include the inspector’s START DATE?
2.3.2. Basic Food Inspection Training
Does the State program require that each inspector:
1. Complete all Basic Food Inspection Training
coursework within 24 months of START DATE with
manufactured food program?
2. Complete the basic course curriculum in the subject
areas listed in 2.3.2.2.1 – 2.3.2.2.11?
3. Who will inspect general food manufactured food
firms complete ten JOINT FIELD TRAINING INSPECTION
or FIELD INSPECTION AUDITS or EVALUATIONS with a
QUALIFIED FIELD INSPECTION TRAINER?
4. Who will inspect general food manufactured food
firms complete two acceptable FIELD INSPECTION
AUDITS or EVALUATIONS by a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD INSPECTION
AUDITOR?
5. Who will inspect non high risk food warehouses
complete five JOINT FIELD TRAINING INSPECTION,
FIELD INSPECTION AUDITS, or EVALUATIONS with a
QUALIFIED FIELD INSPECTION TRAINER?
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Program Elements
Yes/No If no, please explain why element is not met
6. Who will inspect non high risk food warehouses
complete two acceptable FIELD INSPECTION AUDITS, or
EVALUATIONS with a QUALIFIED FIELD INSPECTION
TRAINER?
7. Who advances to conduct general food manufacturing
firms from non-high risk food warehouses complete
five additional JOINT FIELD TRAINING INSPECTIONS,
FIELD INSPECTION AUDITS, or EVALUATIONS to fulfill
requirements identified in 2.3.2.3.1, of which, two are
representative of the general manufactured food
firms?
8. Who advances to conduct general food manufacturing
firms from non-high risk food warehouses complete
two additional acceptable FIELD INSPECTION AUDITS,
or EVALUATIONS with a QUALIFIED FIELD INSPECTION
TRAINER?
9. Complete the minimum field training requirements
prior to conducting independent inspections?
2.3.3. Advanced Food Inspection Training
Does the State program require each inspector:
1. Who performs specialized food inspections to
complete the coursework specific to the type of
specialized food inspection they will be performing?
2. Who performs specialized food inspections to
participate in two JOINT FIELD TRAINING
INSPECTIONS?
3. After successful completion of the course; participate
in one EVALUATION or FIELD INSPECTION AUDIT with
a QUALIFIED FIELD INSPECTION TRAINER or
QUALIFIED FIELD INSPECTION AUDITOR prior to
conducting independent inspections?
4. Within one year after being released to do specialized
food inspections complete a second EVALUATION or
FIELD INSPECTION AUDIT with a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD INSPECTION
AUDITOR in the area of specialty?
2.3.4 Experienced Inspectors
For CURRENT EXPERIENCED STAFF or NEWLY HIRED
EXPERIENCED STAFF a State program’s training plan shall
include the following unless the state determines in their
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Program Elements
Yes/No If no, please explain why element is not met
training plan that all staff will be required to complete the
program elements in 2.3.2 and 2.3.3:
1. Missing basic course work, does the State program
have a statement or affidavit that explains the
background or experience that justifies the waiver?
2. Missing JOINT FIELD TRAINING INSPECTIONS, does the
State program have a Statement or affidavit explaining
the background or experience that justifies a waiver of
the basic or specialized JOINT FIELD TRAINING
INSPECTIONS?
3. Who is newly hired who had JOINT FIELD TRAINING
INSPECTIONS waived, were two successful
EVALUATIONS or FIELD INSPECTION AUDITS
completed within 6 months of the inspector’s
QUALIFIED DATE?
4. Missing specialized coursework, does the State
program have a statement or affidavit explaining the
date and location that the specialized training was
completed?
2.3.5 Continuing Education and Training
1. Does each inspector conducting manufactured food
inspections accumulate 20 CONTACT HOURS of
continuing education every 36 months from the start
of the QUALIFIED DATE?
2. Does the state program maintain documentation for
continuing education credit as outlined in 2.3.5.7?
2.3.6 Coursework Sources
Is all basic, advanced, and continuing education
coursework obtained from sources listed in 2.3.5.1 –
2.3.5.4?
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
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Appendix 2.2: Inspector Training Record Summary
Instructions: This Appendix is used to document and track inspectors’ training status. Enter the name of all active inspectors. Include the START
of employment, and record the date the inspector completed the coursework and field training for the basic and advanced curriculums.
For continuing education, indicate the QUALIFIED DATE and number of CONTACT HOURS completed.
DATE
Employee name
START DATE
Basic Food Inspection
Curriculum
Course
Field
work
work
Advanced Food Inspection Curriculum
Area of Specialty
Course
work
Continuing Education
Field
work
QUALIFIED
DATE
CONTACT
HOURS
Assessment completed by:_______________________________________________________________________________________________
(NAME)
(DATE)
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Appendix 2.3: Inspector Training Record
State Agency: _________________________________________________________________
Name of Inspector _______________________________________ START DATE _________
Basic Food Inspection Curriculum
Coursework
Course
Please provide the course name and location for each subject area
Date completed
Course Documentation
Available for Review (Y/N)
Prevailing statutes, regulations, and ordinances
Public health principles
Emergency Management
Communication skills
Microbiology
Epidemiology
Basics of HACCP
Allergen Management
Basic food labeling
Food defense awareness training
Sampling Techniques and preparation
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Appendix 2.3: Inspector Training Record (continued)
Inspector Name_______________________________________________________________________
Basic Food Inspection Curriculum
Fieldwork
JOINT FIELD TRAINING INSPECTION or FIELD
INSPECTION AUDITS
Date
Completed
EVALUATION/AUDIT
Acceptable
(Y/N)
Documentation
Available for
Review
(Y/N)
Please provide the name of the food plant and identification
number.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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Appendix 2.3: Inspector Training Record (continued)
Inspector Name_______________________________________________________________________
Advanced Food Inspection Curriculum Coursework
Course
Please provide the name and location of the course.
Completion Date
Course Documentation
Available For Review
(Y/N)
Acidified food
Low acid canned food
Juice HACCP
Seafood HACCP
Traceback Investigations
Foodborne Illness Investigations
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Appendix 2.3: Inspector Training Record (continued)
Inspector Name_______________________________________________________________________
Instructions: Identify and record the type of specialized food inspection conducted for the JOINT FIELD
TRAINING INSPECTION or FIELD INSPECTION AUDITS, such as acidified foods, low acid canned foods, juice
HACCP, or seafood HACCP.
Advanced Food Inspection Curriculum Fieldwork
Specialized food inspection
JOINT FIELD TRAINING INSPECTION or FIELD
INSPECTION AUDITS
Completion Date
EVALUATION/AUDIT
Acceptable
(Y/N)
Documentation
Available for
Review
(Y/N)
Completion Date
EVALUATION/AUDIT
Acceptable
(Y/N)
Documentation
Available for
Review (Y/N)
Please provide the name of the food plant and
identification number.
1.
2.
3.
Specialized food inspection
JOINT FIELD TRAINING INSPECTION or FIELD
INSPECTION AUDITS
Please provide the name of the food plant and
identification number.
1.
2.
3.
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Appendix 2.3: Inspector Training Record (continued)
Name of Inspector _____________________________________ QUALIFIED DATE _________
CONTINUING EDUCATION COURSEWORK
A total of 20 CONTACT HOURS required every 36 months
Activities in Program Element 2.3.4.4
Maximum of 20 CONTACT HOURS
Date
Documentation Available
Type of Activity
Completed
for Review (Y/N)
(Provide Title and Brief Description
CONTACT HOURS
Earned
Subtotal
Presenting, Training, or Publishing (Program Element 2.3.4.5)
Maximum of 10 CONTACT HOURS
Date
Documentation Available
Type of Activity
Completed
for Review (Y/N)
(Provide Title and Brief Description
CONTACT HOURS
Earned
Subtotal
Reading Technical Publications (Program Element 2.3.4.6)
Maximum of 4 CONTACT HOURS
Date
Documentation Available
Type of Activity
Completed
for Review (Y/N)
(Provide Title and Brief Description
CONTACT HOURS
Earned
Subtotal
Total CONTACT HOURS Earned
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Appendix 2.4: Curriculum Example Basic Food Inspector Training
Standard 2 requires a State program to have a documented training plan that ensures all inspectors
receive training to adequately perform their work assignments. Additionally, Standard 2 identifies
thirteen coursework areas for basic food inspection training and allows for coursework to be obtained
from distance learning, for example satellite downlinks or web-based training such as those available
from FDA Office of Regulatory Affairs University (ORAU).
The list below is an example of the basic food inspection training coursework that could be used to meet
section 2.3.2 Basic Food Inspection Training coursework requirements. Unless indicated below, the
majority of FDA courses are available through
http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm119016.htm
PREVAILING STATUTES, REGULATIONS, ORDINANCES
1. Basic Food Law for State Regulators (60) FDA35
2. Basics of Inspection: Beginning an Inspection (90) FDA38
3. Basics of Inspection: Issues & Observations (90) FDA39
4. An Introduction to Food Security Awareness (60) FD251 (ORA U internet site)
5. Food & Drug Law: FDA Jurisdictions, FDA01
6. Food & Drug Law: Prohibited Actions, FDA02
7. Food & Drug Law: Judicial Actions, FDA03
8. Food & Drug Law: Criminal Actions Violations, FDA04
9. Food & Drug Law: Imports & Exports, FDA05
10. Recalls of FDA Regulated Products, FDA24
NOTE: Specific state/local laws & regulations to be addressed by each jurisdiction
PUBLIC HEALTH PRINCIPLES
1. Public Health Principles (90) FDA36
EMERGENCY MANAGEMENT
FEMA – Incident Command System and National Incident Management System: Course available from
FEMA web link. – http://training.fema.gov/IS/NIMS.asp
1. IS-100.a, Introduction to Incident Command System, (180) ICS-100 or IS-100 for FDA
2. IS-200.a, ICS for Single Resources and Initial Action, Incidents, (180) ICS-200
3. IS-700.a, NIMS an Introduction, (180) ICS 700
4. IS-800.b, National Response Framework – An Introduction, ICS 800
COMMUNICATION SKILLS
1. Communication Skills for Regulators (Course can be accessed through
https://ifpti.absorbtraining.com/#/purchase/category/49067)
FOOD MICROBIOLOGICAL CONTROL (SERIES):
1. Overview of Microbiology (60) MIC01
2. Gram-Negative Rods (60) MIC02
3. Gram-Positive Rods & Cocci (90) MIC03
4. Foodborne Viruses (60) MIC04
5. Foodborne Parasites (90) MIC05
6. Mid-Series Exam (30) MIC16
7. Controlling Growth Factors (90) MIC06
8. Control by Refrigeration & Freezing (60) MIC07
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Appendix 2.4: Curriculum Example Basic Food Inspector Training (continued)
FOOD MICROBIOLOGICAL CONTROL (SERIES):
9. Control by Thermal Processing (90) MIC08
10. Control by Pasteurization (90) MIC09
11. Control by Retorting (90) MIC10
12. Technology-Based Food Processes (120) MIC11
13. Natural Toxins (90) MIC12
14. Aseptic Sampling (90) MIC13
15. Cleaning & Sanitizing (90) MIC15
EPIDEMIOLOGY: Foodborne Illness Investigations (series):
1. Collecting Surveillance Data (90) FI01
2. Beginning the Investigation (90) FI02
3. Expanding the Investigation (90) FI03
4. Conducting a Food Hazard Review (90) FI04
5. Epidemiological Statistics (90) FI05
6. Final Report (30) FI06
HACCP: Basics of HACCP (series):
1. Overview of HACCP (60) FDA16
2. Prerequisite Programs & Preliminary Steps (60) FDA17
3. The Principles (60) FDA18
ALLERGEN MANAGEMENT
1. Food Allergens (60) FD252
BASIC LABELING
1. Food Labeling (60) FDA45 (Course can be accessed through
https://ifpti.absorbtraining.com/#/purchase/category/49067)
FOOD DEFENSE
1. ALERT: Food Defense Awareness Training
SAMPLING TECHNIQUE
1. Aseptic Sampling (90) MIC13
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Appendix 3.1: Self-Assessment Worksheet
State agency: __________________________________________________________________
Program Elements
Yes/No If no, please explain why element is not met
3.3.1 Risk-based inspection program
1. Does the State program maintain an inventory of food
plants for which the State has regulatory oversight?
2. Does the State program have a written procedure
documenting the classification criteria and inspection
frequencies?
3. Is the inventory categorized by the degree of risk
associated with the likelihood that a food safety or
defense incident will occur?
4. Does the State program use the risk factors and
classification criteria as described in 3.3.1.2?
3.3.2 Inspection procedure
Does the State program’s inspection procedure require
inspectors to:
1. Review the previous inspection report and CONSUMER
COMPLAINTS?
2. Have appropriate forms (if necessary) and
equipment 19 that has been verified and maintained as
defined by the state’s standard operating procedures
or manufacturer’s recommendations?
3. Make appropriate introductions, and explain the
purpose and scope of the inspection?
4. Establish jurisdiction?
5. Select appropriate product/process for the inspection
(high risk products and processes)?
6. Assess employee practices critical to the safe and
sanitary production and storage of food?
7. Properly evaluate the likelihood that conditions,
practices, components, and/or labeling could cause the
product to be adulterated or misbranded?
19
Manufactured Food Regulatory Programs Standard 8: Program Resources and appendix 8.3 Inspection Equipment
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Program Elements
Yes/No If no, please explain why element is not met
8. Recognize significant violative conditions or
practices, and record findings consistent with program
procedures?
9. Distinguish between significant and insignificant
observations, and isolated incidents versus trends?
10. Review and evaluate the appropriate operational
records and procedures and apply the information
obtained from this review?
11. Collect adequate evidence and documentation in
accordance with program procedures to support the
inspectional observations?
12. Verify correction of deficiencies from a previous
inspection?
13. Behave professionally and demonstrate proper
sanitary practices during the inspection?
14. Use current versions of applicable hazard guides or
other guidance, to identify and evaluate the HAZARDS
associated with product(s) and process(es) when
conducting inspections of specialized food and
processes?
15. Assess the firm’s implementation of sanitation
monitoring for the applicable eight key areas of
sanitation when required by regulation?
16. When appropriate review the firm’s: scheduled
process; HACCP plan or necessary process controls in
the absence of a HACCP plan; food safety control
plan and applicable monitoring, verification and
deviation or corrective action records, including those
related to sanitation.
17. Recognize deficiencies in the firm’s monitoring
controls and sanitation procedures through in-plant
observations?
18. Use suitable interviewing techniques?
19. Explain findings clearly and adequately throughout
the inspection?
20. Alert the firm’s person in charge when an immediate
corrective action is necessary?
21. Answer questions and provide information in an
appropriate manner?
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Program Elements
Yes/No If no, please explain why element is not met
22. Write findings accurately, clearly, and concisely on
the State document and provide a copy to firm’s
person in charge?
3.3.3 Inspection reports
Does the State program have written inspection report
procedures that require inspectors to:
1. Submit inspection report in a timely manner?
2. Complete the inspection report form completely and
accurately?
3. Document violations and observations clearly, legibly,
and concisely?
4. Follow up with corrective action, compliance and
enforcement?
3.3.4 Food recalls
Does the State program have a food recall system that has
written procedures for:
1. Sharing information about recalls with relevant
agencies?
2. Ensuring recalled products are removed promptly
from the market?
3. Performing RECALL AUDIT CHECKS?
3.3.5 CONSUMER COMPLAINTS
Does the program have procedures for receiving,
tracking, evaluating, responding to, and closing
CONSUMER COMPLAINTS?
3.3.6 Industry complaints about inspections
Does the program have procedures for receiving,
evaluating, and responding to food INDUSTRY
COMPLAINTS about inspections?
3.3.7 Sampling procedure
Does the State program’s sampling procedure include:
1. Use of appropriate method & equipment to collect the
sample?
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Program Elements
Yes/No If no, please explain why element is not met
2. Record sample chain of custody per State
procedures?
3. Appropriately handle, package, and ship sample
according to procedures to prevent compromising
conditions and ensure security of the sample?
4. Deliver or ship sample to the appropriate laboratory
within acceptable timeframes?
5. Instructions for documenting the applicable sample
collection information?
a. Date of sample collection?
b. Product identification which includes name of
product and unique manufacturing identification
reference?
c. Description of product?
d. Collection information which includes method
of collection, lot sampled, lot size, and any
special sampling techniques used?
e. Location where sample was collected?
f.
Name and address of responsible party,
guarantor, processor or distributor?
g. Sample type?
h. Analysis requested (when applicable)?
i.
Product labeling or labeling information?
j.
Identification of the sample with a sample
number assigned at the time of collection?
6. For states that do not have a SAMPLING PROGRAM, is
there a statement that explains why a SAMPLING
PROGRAM is not supported and how public health is
protected in the absence of such a program?
3.3.8 Records Retention
Does the State program maintain records as required
under 9.3.2.2 for the following:
1. Inspection reports which include follow up activities?
2. Essential recall information?
3. CONSUMER COMPLAINTS?
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Program Elements
Yes/No If no, please explain why element is not met
4. INDUSTRY COMPLAINTS about inspections 20
5. Documentation associated with sample collection?
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
20
Records dealing with personnel actions are not subject to review during an ASSESSMENT.
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Appendix 3.2: Risk Classification Criteria for Food Plants
Risk management is prioritizing opportunities to reduce risk and allocate food safety efforts and
resources. Policymakers must consider the entire production-to-consumption chain and all of the
participants (regulators, industry, researchers, health care providers, and consumers) when deciding how
to best utilize resources to maximize food safety and reduce costs.
Standard number 3 focuses on one segment of the total food safety system – inspection of food plants.
Although this standard does not prescribe a classification scheme or inspection frequency, frequencies
could be established through: (1) risk-based assessment of foodborne hazards, (2) ranking the public
health impacts of specific hazards, (3) measurement and valuation of the benefits of reducing risk, (4)
evaluation of the effectiveness and cost of risk reduction intervention options, and (5) integration of these
analyses to allocate resources.
When categorizing establishments by risk, State programs may consider several factors including: (1) the
type of food and ingredients, (2) processing requirements, (3) volume of product manufactured or
distributed, (4) intended consumer, and (5) compliance history of the food plant. The factors may be
assigned numerical values that are tabulated to rank the food plants and prioritize inspections.
Foods with microbial hazards, especially those that require stringent temperature controls, are usually
deemed high risk. Other foods such as unpasteurized juices may be classified as high risk based on
epidemiologic implication in foodborne disease outbreaks. In addition to microbial hazards, chemical
hazards should also be evaluated.
Complex manufacturing processes with many critical control points such as commercial sterilization,
acidification, dehydration, formulation control, or mandatory HACCP systems are generally considered
high risk. These operations must be properly controlled to prevent, eliminate, or reduce food safety
hazards to acceptable levels. Reconditioning operations including food salvage are often ranked as high
risk because improper reconditioning could result in distribution of adulterated or misbranded products to
consumers.
High volume manufacturers and distributors have the potential to expose more consumers to food safety
hazards if product or process controls fail. When combined with other factors, they may be classified as
high risk.
Many classification schemes prioritize products intended for use by HIGHLY-SUSCEPTIBLE POPULATIONS
because these populations are more likely to experience foodborne illnesses compared to the general
population.
Inspection or compliance history is commonly considered when establishing inspection frequencies. It is
reasonable to expect those firms with a history of compliance to be inspected less frequently than those
firms with a history of non-compliance. Some State programs factor the compliance history directly into
the risk ranking while others use performance criteria to adjust the inspection frequency from a baseline
established by other criteria.
Standard number 3 requires a State program to categorize food plants based on risk and to allocate
resources and establish inspection frequencies based on that categorization. Standard number 3 does not
prescribe how this must be done. State programs should document their classification system and
inspection frequencies. Differences between agencies will exist for many reasons including variable
resources, legislative mandates, localized industries and practices, and competing priorities.
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Appendix 3.2: Risk Classification Criteria for Food Plants (continued)
The risk classification criteria listed is intended solely to assist State programs with establishing their own
classification system.
Risk
Type of processing
High
Canning low acid foods, acidifying foods, vacuum packaging, salvaging, smoking for
preservation, curing
Medium
Cooking, cooling, holding under controlled temperatures, pasteurization
Low
Temperature control not required
Risk
Type of foods
High
Potentially hazardous foods frequently implicated in foodborne illness (sprouts,
unpasteurized juices, raw shellfish, cream-filled pastries, filled macaroni products)
Medium
Potentially hazardous foods not typically implicated in foodborne illness
Low
Non-potentially hazardous foods
Risk
Volume of product manufactured/distributed
Higher
High volume operations with broad distribution
Lower
Low volume operations or operations with localized distribution
Risk
Target population
Higher
Foods consumed by HIGHLY-SUSCEPTIBLE POPULATIONS
Lower
Foods consumed solely or primarily by the general population
Risk
Compliance History
Higher
Businesses with an inconsistent or poor history of compliance with food safety
requirements
Lower
Businesses routinely in compliance with food safety requirements
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Appendix 4.1: Self-Assessment Worksheet
State agency: ______________________________________________________
Program Elements
Yes/No If no, please explain why element is not met
4.3.1 Quality Assurance
The State program has a written Quality Assurance
Program (QAP) that contains written procedures:
1. Conducting FIELD INSPECTION AUDITS as described in
section 4.3.2?
2. Conducting inspection report audits as described in
section 4.3.3?
3. Conducting sample report audits as described in
section 4.3.4?
4. A corrective action plan as described in section 4.3.5?
4.3.2 FIELD INSPECTION AUDITS
Does the State program:
1. Use a QUALIFIED TRAINER or QUALIFIED AUDITOR
conduct FIELD INSPECTION AUDITS or VERIFICATION
AUDIT INSPECTIONS to verify that inspections are
consistently performed according State program’s
written inspection procedures described in Standard
3?
2. Conduct a minimum of two FIELD INSPECTION AUDITS
per inspector conducted every 36 months?
3. Select inspections for FIELD INSPECTION AUDITS that
include the highest risk firms that the inspector is
trained for including specialized food inspections?
4. Complete Appendix 4.5 or equivalent form be used to
document FIELD INSPECTION AUDITS?
5. Complete Appendix 4.2 or equivalent form document
overall rating calculations of FIELD INSPECTION
AUDITS?
4.3.3 Inspection Report Audits
Does the State program:
1. Conduct a periodic review of inspection reports to
verify that inspectional findings are obtained and
reported according to established written procedure?
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Program Elements
Yes/No If no, please explain why element is not met
2. Use a random selection of inspection reports based on
the number of inspections completed in the last 12
months using the table in 4.3.3.1?
3. Take seven percent (7%) of inspection reports
reviewed from inspections that were FIELD
INSPECTION AUDITS?
4. Complete Appendix 4.6 or equivalent form to
document inspection report audits?
5. Complete Appendix 4.3 or equivalent form to
document overall rating calculations of inspection
report audits?
4.3.4 Sample Report Audits
Does the State program:
1. Conduct a periodic review of sample reports to verify
that samples were collected, identified, recorded, and
submitted according to established written procedure?
2. Use a random selection of sample reports based on the
number of samples collected in the last 12 months
using the table in 4.3.4.1?
3. Complete Appendix 4.7 or equivalent form to
document sample report audits?
4. Complete Appendix 4.4 or equivalent form to
document overall rating calculations of sample report
audits?
4.3.5 Corrective Action Plan
Does the State program have a written corrective action
plan (Appendix 4.8 or equivalent form) that addresses
actions when one or more of the conditions below are met:
1. An individual receives a rating of “needs
improvement”?
2. An individual performance factor for the program falls
below 80%?
3. An overall rating for the program falls below 80%?
Assessment completed by:_____________________________________________________________
(NAME)
(DATE)
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Appendix 4.2: Performance rating for the field inspection audits
State agency: _____________________________________________________________________________
Performance period: ______________________________
Performance rating (4): ___________
Reviewed by:
Office:
Date:
Auditor’s initials and date of audit (1)
At
(3)
Performance
factors (5)
Performance ratings (2)
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
IIA.1
IIA.2
IIA.3
IIA.4
III.1
III.2
III.3
III.4
III.5
III.6
Subtotal
Total
Enter the sum of the totals from all continuation sheets.
Enter the final sums (subtotal + sums of (3) on this form).
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
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NIt
(3)
Appendix 4.2: Performance rating or the field inspection audits (continued)
State agency: __________________________________________________________
Performance period: ______________________________
Auditor’s initials and date of audit (1)
At
(3)
Performance
factors (5)
Performance ratings (2)
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
IIA.1
IIA.2
IIA.3
IIA.4
III.1
III.2
III.3
III.4
III.5
III.6
Total
Enter the sums of (3).
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
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NIt
(3)
Appendix 4.2a: Summary of Field Inspection Audit Findings
The summary of the performance factor ratings for all FIELD INSPECTION AUDITS allows FDA and the
State program to recognize trends in inspectional coverage and identify specific areas in the inspection
program that may need improvement.
Appendix 4.2 is used to calculate an overall rating for the performance period and identify single
performance factors rated as “needs improvement” in multiple audits. The performance factors are
described in appendix 4.5. A rating below 80 percent indicates a need for improvement and requires
corrective action.
INSTRUCTIONS:
(1) For each field inspection audited, record the auditor’s initials and date of
audit in the box.
(2) For each field inspection audited, record the rating for each performance
factor listed in appendix 4.5.
A = acceptable; NI = needs improvement.
(3) Record the At and NIt for each performance factor.
At = horizontal total of acceptable ratings.
NIt = horizontal total of needs improvement ratings.
(4) Calculate the overall rating for the FIELD INSPECTION AUDITS.
Record the rating in the space provided in the box located at the top of
Appendix 4.2.
FORMULA:
FIELD INSPECTION AUDIT performance rating =
[ ∑ At / ( ∑ At + ∑ NIt )] x 100
NOTE: ∑ is the statistical symbol for the sum of all numbers.
∑ At = vertical sum of acceptable ratings.
∑ NIt = vertical sum of needs improvement ratings.
(5) Evaluate audit ratings for a single performance factor. Use the space at the
bottom of Appendix 4.2 to identify and make notes about single performance
factors rated as “needs improvement” in multiple audits.
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Appendix 4.3: Performance rating for inspection report audits
State agency: _____________________________________________________________________________
Performance period: ______________________________
Performance rating (4): ___________
Reviewed by: _______________________________________________
Office: _________________________________________
Date: ______________
Firm identification number and date of inspection (1)
Performance
factors (5)
Performance ratings (2)
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
Subtotal
Total
Enter the sum of the totals from all continuation sheets.
Enter the final sums (subtotal + sums of (3) on this form).
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
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At
NIt
(3)
(3)
Appendix 4.3: Performance rating for inspection report audits (continued)
State agency: ____________________________________________________
Performance period: ______________________________
Firm identification number and date of inspection (1)
Performance
factors (5)
Performance ratings (2)
I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
I.9
I.10
Subtotal
Total
Enter the sum of the totals from all continuation sheets.
Enter the final sums (subtotal + sums of (3) on this form).
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
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At
NIt
(3)
(3)
Appendix 4.3a: Summary of inspection report audit findings
The summary of the performance factor ratings for all inspection report audits allows FDA and the State
program to recognize trends in inspectional coverage and identify specific areas in the inspection program
that may need improvement.
Appendix 4.3 is used to calculate an overall rating for the performance period and identify single
performance factors rated as “needs improvement” in multiple audits. The performance factors are
described in appendix 4.6. A rating below 80 percent indicates a need for improvement and requires
corrective action.
INSTRUCTIONS:
(1) For each inspection report audited, record the firm identification number and
date of the inspection in the box.
(2) For each inspection report audited, record the rating for each performance
factor listed in appendix 4.6.
A = acceptable; NI = needs improvement.
(3) Record the At and NIt for each performance factor.
At = horizontal total of acceptable ratings.
NIt = horizontal total of needs improvement ratings.
(4) Calculate the overall rating for the inspection report audits.
Record the rating in the space provided in the box located at the top of
Appendix 4.3.
FORMULA:
Inspection report audit performance rating =
[ ∑ At / ( ∑ At + ∑ NIt ) ] x 100
NOTE: ∑ is the statistical symbol for the sum of all numbers.
∑ At = vertical sum of acceptable ratings.
∑ NIt = vertical sum of needs improvement ratings.
(5) Evaluate audit ratings for a single performance factor. Use the blank page of
Appendix 4.3 to identify and make notes about single performance factors rated
as “needs improvement” in multiple audits.
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Appendix 4.4: Performance rating for the sample report audits
State agency: _____________________________________________________________________________
Performance period: ______________________________
Performance rating (4): ___________
Reviewed by: _______________________________________________
Office: _________________________________________ Date: ______________
Sample report identification number and date of sample collection (1)
Performance
factors (5)
Performance ratings (2)
I.1
I.2
I.3
I.4
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
Subtotal
Total
Enter the sum of the totals from all continuation sheets.
Enter the final sums (subtotal + sums of (3) on this form).
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
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At
NIt
(3)
(3)
Appendix 4.4: Performance rating for the sample report audits (continued)
State agency: _________________________________________________________________
Performance period: ______________________________
Sample report identification number and date of sample collection (1)
Performance
factors (5)
Performance ratings (2)
I.1
I.2
I.3
I.4
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
Total
Enter the sums of (3).
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
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At
NIt
(3)
(3)
Appendix 4.4a: Summary of sample report audit findings
The summary of the performance factor ratings for all sample report audits allows FDA and the State
program to recognize trends in inspectional coverage and identify specific areas in the inspection program
that may need improvement.
Appendix 4.4 is used to calculate an overall rating for the performance period and identify single
performance factors rated as “needs improvement” in multiple audits. The performance factors are
described in appendix 4.7. A rating below 80 percent indicates a need for improvement and requires
corrective action.
INSTRUCTIONS:
(1) For each sample report audited, record the sample report identification
number and date of sample collection in the box.
(2) For each sample report audited, record the rating for each performance factor
listed in appendix 4.7.
A = acceptable; NI = needs improvement.
(3) Record the At and NIt for each performance factor.
At = horizontal total of acceptable ratings.
NIt = horizontal total of needs improvement ratings.
(4) Calculate the overall rating for the sample report audits.
Record the rating in the space provided in the box located at the top of
Appendix 4.4.
FORMULA:
Sample report audit performance rating =
[ ∑ At / ( ∑ At + ∑ NIt ) ] x 100
NOTE: ∑ is the statistical symbol for the sum of all numbers.
∑ At = vertical sum of acceptable ratings.
∑ NIt = vertical sum of needs improvement ratings.
(5) Evaluate audit ratings for a single performance factor. Use the space at the
bottom of Appendix 4.4 to identify and make notes about single performance
factors rated as “needs improvement” in multiple audits.
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Appendix 4.5: Contract Audit Form (FDA 3610)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CONTRACT AUDIT
FDA AUDITOR
STATE INSPECTOR
FIRM
CFN / FEI NUMBER
FIRM ADDRESS
PRODUCT(S) COVERED
TIME IN
TIME OUT
OVERALL RATING
Acceptable
Needs Improvement
NOTE: EVERY ITEM MARKED "NEEDS IMPROVEMENT" MUST BE ACCOMPANIED
BY AN EXPLANATION OF WHY THE ITEM WAS JUDGED AS NEEDING
IMPROVEMENT.
Overall Rating:
If three or less items are marked "needs improvement," the overall rating is "acceptable." If four or
more items are marked "needs improvement," the overall rating is "needs improvement." The overall
rating must be marked in the space provided in the header on the first page.
All questions must be answered "acceptable" or "needs improvement," except for section II.A.
Inspection Observations and Performance for ’HACCP-Regulated’ firms. If the establishment is not
subject to Seafood or Juice HACCP regulations, leave the scoring for these four questions blank.
If four or more evaluated items are marked as "needs improvement," the state program manager must
be notified by the appropriate FDA liaison that additional training or other performance improvement
measures for then inspector being audited should be initiated. All contract inspectors who receive an
overall audit score of "needs improvement" shall receive remedial training in deficient areas or as
agreed upon by the FDA Project and Co-Project Officers prior to resuming contract inspection duties.
I. Preinspection Assessment
1. DID THE INSPECTOR REVIEW THE STATE’S ESTABLISHMENT FILE FOR THE PREVIOUS INSPECTION
REPORT AND POSSIBLE COMPLAINTS OR ACCESS OTHER AVAILABLE RESOURCES IN PREPARATION
FOR THE INSPECTION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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2. DID THE INSPECTOR HAVE THE APPROPRIATE EQUIPMENT AND FORMS TO PROPERLY CONDUCT THE
INSPECTION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
II. Inspection Observations and Performance
1. WAS FDA JURISDICTION ESTABLISHED?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. DID THE INSPECTOR SELECT AN APPROPRIATE PRODUCT FOR THE INSPECTION AND, IF NECESSARY,
MAKE APPROPRIATE ADJUSTMENTS BASED ON WHAT THE FIRM WAS PRODUCING?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
3. DID THE INSPECTOR ASSESS THE EMPLOYEE PRACTICES CRITICAL TO THE SAFE PRODUCTION AND
STORAGE OF FOOD?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
4. DID THE INSPECTOR PROPERLY EVALUATE THE LIKELIHOOD THAT CONDITIONS, PRACTICES,
COMPONENTS, AND/OR LABELING COULD CAUSE THE PRODUCT TO BE ADULTERATED OR
MISBRANDED?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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5. DID THE INSPECTOR RECOGNIZE SIGNIFICANT VIOLATIVE CONDITIONS OR PRACTICES IF PRESENT
AND RECORD FINDINGS CONSISTENT WITH STATE PROCEDURES?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
6. DID THE INSPECTOR DEMONSTRATE THE ABILITY TO DISTINGUISH BETWEEN SIGNIFICANT VERSUS
INSIGNIFICANT OBSERVATIONS AND ISOLATED INCIDENTS VERSUS TRENDS?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
7. DID THE INSPECTOR REVIEW AND EVALUATE THE APPROPRIATE RECORDS AND PROCEDURES FOR
THIS ESTABLISHMENT’S OPERATION AND EFFECTIVELY APPLY THE INFORMATION OBTAINED FROM
THIS REVIEW?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
8. DID THE INSPECTOR COLLECT ADEQUATE EVIDENCE AND DOCUMENTATION IN ACCORDANCE WITH
STATE PROCEDURES GIVEN THE NATURE OF THE INSPECTIONAL FINDINGS?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
9. DID THE INSPECTOR VERIFY CORRECTION OF DEFICIENCIES IDENTIFIED DURING THE PREVIOUS
STATE INSPECTION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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10. DID THE INSPECTOR ACT IN A PROFESSIONAL MANNER AND DEMONSTRATE PROPER SANITARY
PRACTICES DURING THE INSPECTION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
II. A. Inspection Observations and Performance for ‘HACCP-regulated’ Facilities
Note to Auditor: These four questions apply to only firms subject to HACCP regulations. These
four questions should be left blank for firms not subject to HACCP regulations.
1. DID THE INSPECTOR USE THE "FISH AND FISHER PRODUCTS HAZARDS AND CONTROLS GUIDE" OR THE
"JUICE HACCP HAZARDS AND CONTROLS GUIDE," AS APPROPRIATE, TO IDENTIFY AND EVALUATE
THE HAZARDS ASSOCIATED WITH THE PRODUCT AND PROCESS?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. DID THE INSPECTOR ASSESS THE FIRM’S IMPLEMENTATION OF SANITATION MONITORING FOR THE
APPLICABLE EIGHT KEY AREAS OF SANITATION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
3. DID THE INSPECTOR REVIEW THE FIRM’S HACCP PLAN (OR NECESSARY PROCESS CONTROLS IN THE
ABSENCE OF A HACCP PLAN) AND APPLICABLE MONITORING, VERIFICATION AND CORRECTIVE
ACTION RECORDS, INCLUDING THOSE RELATED TO SANITATION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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4. DID THE INSPECTOR RECOGNIZED EFFICIENCIES IN THE FIRM’S MONITORING AND SANITATION
PROCEDURES THROUGH IN-PLANT OBSERVATIONS?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
II. Oral and Written Communication
1. DID THE INSPECTOR IDENTIFY HIMSELF/HERSELF AND MAKE APPROPRIATE INTRODUCTIONS, WHICH
INCLUDE EXPLAINING THE PURPOSE AND SCOPE OF THE INSPECTION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. DID THE INSPECTOR USE SUITABLE INTERVIEWING TECHNIQUES?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
3. DID THE INSPECTOR EXPLAIN FINDINGS CLEARLY AND ADEQUATELY THROUGHOUT THE
INSPECTION?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
4. DID THE INSPECTOR ALERT THE FIRM’S APPROPRIATE MANAGEMENT WHEN AN IMMEDIATE
CORRECTIVE ACTION WAS NECESSARY?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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5. DID THE INSPECTOR ANSWER QUESTIONS AND PROVIDE INFORMATION IN AN APPROPRIATE
MANNER?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
6. DID THE INSPECTOR WRITE THEIR FINDINGS ACCURATELY, CLEARLY AND CONCISELY ON THE
STATE FORM/DOCUMENT LEFT WITH THE FIRM?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
ADDITIONAL COMMENTS
SIGNATURE OF FDA AUDITOR
DATE
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610)
This document provides guidance on assigning ratings during an audit for each of the performance
factors listed on the Contract Audit Form. For each performance factor examples of actions and
observations that would likely result in a “needs improvement” rating are provided.
I. PRE INSPECTION ASSESSMENT
1. Did the inspector review the State’s establishment file for the previous inspection report and
possible complaints or access other available resources in preparation for the inspection?
References:
• State program’s establishment files
• FDA compliance programs referenced in the contract
Examples of a “needs improvement” rating:
a. The inspector does not review the State’s previous inspection report and follow-up on previously
cited deficiencies.
b. The inspector does not review a firm’s response letter that promised corrective actions after the
last inspection, which was conducted by the State.
c. The inspector does not verify the firm’s normal days of operation or seasonal hours.
d. The inspector does not follow-up on a consumer complaint contained in the State's establishment
file.
2. Did the inspector have the appropriate equipment and forms to properly conduct the
inspection?
References:
• FDA compliance programs referenced in the contract
• FDA inspection guides
Examples of a “needs improvement” rating:
a. During an inspection of a cream-filled pie manufacturer, the inspector does not have a calibrated
thermometer to check the temperature of the pie.
b. During an inspection of a cooked, ready-to-eat food processor, the inspector does not have a
method to test the concentration of iodine sanitizer in the hand dip station. During the inspection,
the inspector does not have a flashlight to examine poorly lit raw material storage areas.
II. INSPECTION OBSERVATIONS AND PERFORMANCE
1. Was FDA jurisdiction established?
References:
• FDA Investigations Operations Manual (IOM), subchapter 432 - Documenting Interstate
Shipments
• IOM, subchapter 701 – Statutory Authority
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610) (continued)
Examples of a “needs improvement” rating:
a. The inspector fails to confirm interstate movement of a product or ingredients.
b. The inspector conducts an inspection of a candy manufacturer assigned under FDA contract.
He/she fails to discover that the manufacturer has not shipped product in interstate commerce in
the past 24 months. This manufacturer has no ingredients or packaging components shipped
interstate.
2. Did the inspector select an appropriate product for the inspection and, if necessary, make
appropriate adjustments based on what the firm was producing?
References:
• FDA compliance programs referenced in the contract
Examples of a “needs improvement” rating:
a. The inspector covers only a low-risk product while the firm is producing a high-risk product on
the day of the inspection.
b. The inspector does not cover a small ready-to-eat sandwich operation in a large frozen dinner
processing plant.
c. While inspecting a beverage bottling plant whose primary product is institutional-sized root beer
syrup, the inspector ignores a bottled water processing operation at that site.
3. Did the inspector assess the employee practices critical to the safe production and storage of
food?
Examples of a “needs improvement” rating:
a. The inspector fails to evaluate the hygienic practices of employees working in a food processing
area.
b. The inspector is unaware of the need for employees who are processing cooked, ready-to-eat
foods to wash and sanitize their hands every time they touch an unclean surface.
c. The inspector notices that the firm has a trash bin and a reclaim bin in the same area. He/she does
not, however, recognize the potential hazard. Consequently, the inspector misses an employee
placing trash in the reclaim bin that contains product reintroduced into the manufacturing process.
4. Did the inspector properly evaluate the likelihood that conditions, practices, components,
and/or labeling could cause the product to be adulterated or misbranded?
References:
• FDA compliance programs referenced in the contract
• NLEA inspection guide
Examples of a “needs improvement” rating:
a. The inspector fails to recognize when a firm’s finished product labeling does not contain a sulfite
declaration, even though the raw material does contain a sulfite declaration.
b. The inspector fails to note the significance of “back hauling” raw eggs in a tanker used to carry
pasteurized ice cream mix.
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610) (continued)
c. During an inspection of a baby food manufacturer, the inspector notices a rapid moving belt is
causing glass jars to rattle and shards of glass are on the belt. The inspector fails to relate that
observation to a recent increase in complaints about glass in baby food.
d. The inspector fails to recognize the addition of an allergen during the production of a breaded
product and fails to follow-up on the label review.
5. Did the inspector recognize significant violative conditions or practices, if present, and record
findings consistent with State procedures?
Examples of a “needs improvement” rating:
a. The inspector fails to recognize that the food residues and mold growth on food contact surfaces
are violations.
b. The inspector does not recognize that employees handling cooked, ready-to-eat product with
soiled hands is a deficiency.
c. The inspector doesn’t notice that machine parts over food contact surfaces are lubricated with
automobile oil.
d. The inspector fails to recognize that condensate dripping from a freezer onto finished product
may cause cross contamination.
6. Did the inspector demonstrate the ability to distinguish between significant versus insignificant
observations and isolated incidents versus trends?
References:
• FDA compliance programs referenced in the contract
Examples of a “needs improvement” rating:
a. The inspector notes minor deficiencies such as chewing gum and nail polish while failing to note
places where cross contamination of cooked and raw product might occur.
b. The inspector identifies record keeping deficiencies in records that are two months old. The
inspector objects to these deficiencies without appropriately considering that the firm’s weekly
management review of the records has identified the deficiencies, which have not been repeated
within the last seven weeks.
c. During an inspection of a ready-to-eat salad processor, the inspector focuses primarily on filthy,
non-food contact surfaces.
d. During the inspection of a warehouse, the inspector focuses on products stored against the wall
but doesn’t notice several pallets of rice infested with moths.
7. Did the inspector review and evaluate the appropriate records and procedures for this
establishment’s operation and effectively apply the information obtained from this review?
Examples of a “needs improvement” rating:
a. During a review of the processing records, the inspector fails to detect that cooking times are
outside the scheduled process.
b. The inspector fails to detect possible evidence of record falsification such as inconsistencies
among different types of records, unrealistic and repetitive data, and inconsistencies in signatures.
c. Can teardown records are reviewed, but the inspector didn’t realize teardown measurements were
not done at appropriate intervals.
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610) (continued)
8. Did the inspector collect adequate evidence and documentation in accordance with State
procedures given the nature of the inspectional findings?
Examples of a “needs improvement” rating:
a. The inspector fails to adequately document findings according to State requirements when
violations are found in the firm.
b. The inspector fails to follow State requirements when collecting samples of processed food
necessary to document violative conditions.
c. In an acidified food processing plant, the pH of the final product is questionable. The inspector
does not, however, collect a sample of the product for pH determination.
9. Did the inspector verify correction of deficiencies identified during the previous State
inspection?
Examples of a “needs improvement” rating:
a. Although significant time-temperature abuse of coconut cream pies was identified during the
previous inspection, the inspector does not determine if the deficiencies were corrected.
b. In the previous inspection, the inspector reported that a private well was not equipped with a
sanitary seal. During the current inspection, the manager tells the inspector that the well was
repaired, and the lab results were acceptable. The inspector reviews the microbiological lab
results, but does not go to the well to verify that the sanitary seal was installed.
c. The inspector fails to follow up on deficiencies from the previous inspection for cooked, readyto-eat product because that product was not being made at the time of the inspection. Nor does the
inspector review process records for the product to determine if the firm took appropriate
corrective actions.
10. Did the inspector act in a professional manner and demonstrate proper sanitary practices
during the inspection?
Examples of a “needs improvement” rating:
a. The inspector does not use the boot bath when entering in the firm's processing areas.
b. The inspector fails to sanitize his/her thermometer prior to probing product.
c. The inspector fails to wear protective clothing when entering an aseptic processing area.
d. The inspector wears dangling earrings, bracelets, and necklaces in the food processing areas of a
baby food manufacturer.
II. A. INSPECTION OBSERVATION AND PERFORMANCE FOR ‘HACCP-REQUIRED’
FACILITIES
Note: Questions 1-4 are rated only when the firm is required by regulation to have a HACCP plan.
References:
• FDA compliance programs referenced in the contract
• Title 21 Code of Federal Regulations (21 CFR) parts 110, 120, 123, and 1240
•
•
•
Fish and Fishery Products Hazards & Controls Guide
HACCP Regulation for Fish & Fishery Products: Questions and Answers
Juice HACCP Hazards and Controls Guide
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610) (continued)
1. Did the inspector use the “Fish and Fishery Products Hazards and Controls Guide” and the
“Juice HACCP Hazards and Controls Guide”, as appropriate, to identify and evaluate the
hazards associated with the product and process?
Examples of a “needs improvement” rating:
a. In a tuna processing plant, the inspector fails to identify histamine as a hazard inherent to the
incoming raw material and fails to question its absence in the firm’s HACCP plan. (Failure to
identify a hazard reasonably likely to occur.)
b. A firm is producing fresh, raw, refrigerated fish in Cryovac packaging. The inspector is not aware
that C. botulinum is a significant hazard.
c. An inspector incorrectly identifies aquaculture drugs as a significant hazard for a secondary
processor of a product that it receives from the primary processor. (Identification of a hazard not
reasonably likely to occur.)
d. The inspector fails to recognize that a batter tank in a breaded shrimp processing operation is a
possible CCP. (Failure to recognize an appropriate CCP.)
2.
Did the inspector assess the firm’s implementation of sanitation monitoring for the applicable
eight key areas of sanitation?
Examples of a “needs improvement” rating:
a. The inspector insisted the firm perform medical check-ups for crabmeat pickers.
b. The inspector cannot determine which of the eight areas of sanitation are relevant to the
firm’s operations.
c. The inspector fails to inquire about the firms SSOPs and monitoring practices.
3.
Did the inspector review firm’s HACCP plan (or necessary process controls in the absence of
a HACCP plan) and applicable monitoring, verification, and corrective action records,
including those related to sanitation?
Examples of a “needs improvement” rating:
a. The inspection reveals that the firm is processing a product that requires a HACCP plan. The
inspector cites the firm’s failure to have a HACCP plan, but the inspector does not determine
if the necessary controls were put into place without a HACCP plan.
b. Although the inspector is told that the firm uses well water, not potable water, as its source
for ice, the inspector does not verify that the firm has the water tested for coliforms to ensure
its safety.
c. The inspector does not ask the plant manager for records of pest control after learning that the
service is contracted to a private company.
d. The inspector does not accompany the firm’s sanitarian on a routine pre-operation inspection
that would have given him an indicated that the sanitation and/or sanitation monitoring may
be inadequate.
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610) (continued)
4.
Did the inspector recognize deficiencies in the firm’s monitoring and sanitation procedures
through in-plant observations?
Examples of a “needs improvement” rating:
a. The inspector fails to recognize that cumulative times and temperatures for cooling, holding,
and picking of cooked crabs were substantially above such times and temperatures specified
in the firm’s HACCP plan.
b. The inspector fails to recognize that a firm’s finished product labeling does not contain a
sulfite declaration even though an ingredient contains a sulfite declaration.
c. The inspector fails to recognize that the presence of food residues and mold growth on
processing equipment immediately prior to processing is evidence of unsanitary conditions.
d. The inspector does not recognize that food-contact surfaces are being sanitized with a product
that is not approved for use on food contact surfaces.
III. ORAL AND WRITTEN COMMUNICATION
1. Did the inspector identify himself/herself and make appropriate introductions, which include
explaining the purpose and scope of the inspection?
Examples of a “needs improvement” rating:
a. The inspector fails to explain why he/she is at the firm.
b. The inspector enters through the back door and begins examining a storage area without
notifying anyone at the firm.
2. Did the inspector use suitable interviewing techniques?
Examples of a “needs improvement” rating:
a. The inspector requests for information are vague; consequently, the firm provides documents that
are unrelated to the inspection.
b. The firm manager is unable to respond to a request for information, because the inspector spoke
in unfamiliar and confusing jargon.
c. When the plant manager’s responses are evasive, the inspector does not ask follow-up questions
to obtain the necessary information. Consequently, the answers to the questions are incomplete.
3. Did the inspector explain findings clearly and adequately throughout the inspection?
Examples of a “needs improvement” rating:
a. The inspector does not discuss a significant observation at the close-out meeting.
b. The inspector does not discuss with the general manager a significant deficiency observed in the
processing area before going to the packing area of the cannery.
c. The inspector is vague during his discussion with the managers at the end of the inspection.
Therefore, the managers are unaware of the significance of the observations and that corrective
actions are needed.
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Appendix 4.5a: Guidance for completing the contract audit form (FDA 3610) (continued)
4. Did the inspector alert the firm’s appropriate management when an immediate corrective
action was necessary?
Examples of a “needs improvement” rating:
a. The inspector fails to alert the appropriate manager that food containing undeclared FD&C
Yellow #5 is being packaged, and, if shipped, could result in a health hazard.
b. The inspector didn’t notify the plant manager when he saw blood dripping from boxes of
boneless beef onto raw carrots.
c. The inspector documented condensate dripping from bins of ready-to-eat salad not packaged.
5. Did the inspector answer questions and provide information in an appropriate manner?
Examples of a “needs improvement” rating:
a. The inspector discusses specific information about a pending compliance action against a
competitor with an employee on the processing line.
b. The inspector gives a competitor’s product formula to a friendly plant manager.
c. The inspector fabricates an answer to a policy question that could lead the firm to take an
inappropriate corrective action.
d. The inspector dictates an inappropriate corrective action for a deficiency.
6. Did the inspector write their findings accurately, clearly, and concisely on the State
form/document left with the firm?
References:
• FDA compliance programs referenced in the contract
Examples of a “needs improvement” rating:
a. The inspector fails to write that the firm has a significant process deviation on the list of findings.
b. The inspector fails to write on the list of findings that he/she observed excreta pellets in bags of
rice.
c. The list of findings shows that the “Firm did not control hazards” with no further explanation.
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Appendix 4.6: Inspection Report Audit Form
MANUFACTURED FOOD REGULATORY PROGRAM STANDARDS
INSPECTION REPORT AUDIT FORM
AUDITOR:
DATE OF AUDIT:
DATE OF INSPECTION:
FIRM NAME:
Type of Inspection:
FIRM ADDRESS:
TOTAL NUMBER:
General Food
Seafood HACCP
Juice HACCP
LACF
Acidified
Other:
AUDIT RATING:
Acceptable
Acceptable
Needs Improvement
Needs Improvement
Audit Score:
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated ‘Acceptable’ or ‘Needs Improvement.’ The total number of
‘Acceptable’ and ‘Needs Improvement,’ as well as the audit score and audit rating, must be recorded in the
space above.
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x 100.
If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement.’
I. Organization and Records of Findings
1. THE INSPECTOR SUBMITTED THE REPORT WITHIN DESIGNATED TIMEFRAMES.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. ALL REQUIRED FIELDS ON INSPECTION REPORT OR RELATED REPORT FORMS ARE COMPLETED.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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3. WRITTEN OBSERVATIONS WERE CLEAR AND CONCISE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
4. THE INSPECTOR FOLLOWED ALL CURRENT AND APPLICABLE STATE REPORT WRITING AND INSPECTIONAL
DOCUMENTATION PROCEDURES.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
5. THE INSPECTOR IDENTIFIES VIOLATIONS BASED ON STATE AND/OR FEDERAL REGULATIONS.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
6. THE INSPECTOR REVIEWS PAST INSPECTION FINDINGS AND ACTS ON REPEATED OR UNRESOLVED
VIOLATIONS.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
7. THE INSPECTOR RECORDED SIGNIFICANT FINDINGS.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
8. THE INSPECTOR RECORDED THE COLLECTION OF ALL SAMPLES, EXHIBITS, PHOTOGRAPHS, OR
PHOTOCOPIES TO SUPPORT FINDINGS.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
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9. OBTAINS AND DOCUMENTS ON-SITE CORRECTIVE ACTION AT THE TIME OF INSPECTION AS APPROPRIATE
TO THE TYPE OF VIOLATION.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
10. THE INSPECTOR FOLLOWED THROUGH AND DOCUMENTED COMPLIANCE ACTIVITIES PER STATE POLICY.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
General Comments
Enter any general comments or recommendations as a result of this audit.
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Appendix 4.7: Sample Report Audit Form
MANUFACTURED FOOD REGULATORY PROGRAM STANDARDS
SAMPLE REPORT AUDIT FORM
AUDITOR:
DATE OF AUDIT:
DATE OF INSPECTION:
FIRM NAME:
DATE OF COLLECTION:
FIRM ADDRESS:
SAMPLE ID #:
TOTAL NUMBER:
AUDIT RATING:
Acceptable
Acceptable
Needs Improvement
Needs Improvement
Audit Score:
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated ‘Acceptable’ or ‘Needs Improvement.’ The total number of ‘Acceptable’
and ‘Needs Improvement,’ as well as the audit score and audit rating, must be recorded in the space above.
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x 100.
If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement.’
I. Sample Observations and Performance
1. METHOD OF COLLECTION WAS APPROPRIATE FOR TYPE OF PRODUCT.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
2. RECORD SAMPLE CHAIN OF CUSTODY PER STATE PROCEDURE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
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3. SAMPLE WAS HANDLED, PACKAGED, AND SHIPPED TO PREVENT COMPROMISING THE CONDITION OR
INTEGRITY OF THE SAMPLE, AS EVIDENCED BY ACCEPTANCE AND TESTING BY THE RECEIVING
LABORATORY.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
4. SAMPLE WAS SUBMITTED WITHIN PRESCRIBED TIMEFRAMES.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
II. Sample Collection
1. DATE OF SAMPLE COLLECTION
Acceptable
Needs improvement
Comments (required for Needs Improvement)
2. PRODUCT IDENTIFICATION INCLUDING NAME AND MANUFACTURING REFERENCE INFORMATION WAS
RECORDED. FOR ENVIRONMENTAL SAMPLES A DESCRIPTION OF THE COLLECTION POINT IS ACCEPTABLE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
3. DESCRIPTION OF PRODUCT INCLUDING SAMPLE SIZE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
4. COLLECTION INFORMATION, INCLUDING METHOD OF COLLECTION, LOT SAMPLED, LOT SIZE, AND ANY
SPECIAL TECHNIQUES USED TO COLLECT THE SAMPLE WAS RECORDED.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
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5. LOCATION WHERE SAMPLE WAS COLLECTED IS RECORDED.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
6. NAME AND ADDRESS OF MANUFACTURER, RESPONSIBLE PARTY, GUARANTOR, PROCESSOR, OR
DISTRIBUTOR WERE RECORDED. FOR ENVIRONMENTAL SAMPLES THE PHYSICAL LOCATION OF THE
COLLECTION SITE AND RESPONSIBLE PARTY IS ACCEPTABLE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
7. SAMPLE TYPE (SURVEILLANCE, COMPLIANCE, INVESTIGATIONAL, OR REGULATORY) WAS RECORDED.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
8. THE TYPE OF ANALYSIS REQUESTED WAS RECORDED IF APPLICABLE. IF THE TYPE OF ANALYSIS IS NOT
REQUIRED ON SAMPLE REPORT PER STATE PROCEDURES THIS ITEM IS ACCEPTABLE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
9. PRODUCT LABELS OR LABELING INFORMATION INCLUDING IS COLLECTED OR REPRODUCED IF REQUIRED BY
STATE PROCEDURES. FOR ENVIRONMENTAL SAMPLES THE DESCRIPTION OF THE LOCATION OF THE SAMPLE
COLLECTION POINT IS ACCEPTABLE.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
10. THE SAMPLE IDENTIFICATION ASSIGNED BY THE SAMPLER AT THE TIME OF COLLECTION WAS REPORTED.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
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General Comments
Enter any general comments or recommendations as a result of this audit.
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Appendix 4.8: Corrective Action Plan
The corrective action for each deficiency reported during an audit should be described in the table below. Supporting documents should be
referenced and maintained by the State program.
State agency: _________________________________________________________________________________________________________
Assessment Completed by: ______________________________________________________________________________________________
(NAME)
Type of audit:
(DATE)
FIELD INSPECTION
Performance factor
(record number from
audit form)
INSPECTION REPORT
Description of deficiency
Corrective action(s)
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SAMPLE REPORT
Date of
next audit
Appendix 5.1: Self-Assessment Worksheet
State agency: ________________________________________________________________
Program Elements
Yes/No
If no, please explain why element is not met
5.3.1 Coordination with Other Authorities
Does the State program:
1. Have an MOU for foodborne illness outbreak
investigations, if required?
2. Have a written procedure that identifies and
describes the roles, responsibilities and duties of
each program responsible for supporting
foodborne illness outbreak response in
requirements 5.3.1-5.3.4?
3. Have a written procedure that describes
collaborate with FDA and other agencies in
multi-jurisdictional FOOD-RELATED INCIDENTS?
4. Have a written procedure that designates a
response coordinator(s) to guide program
investigation efforts in collaboration with all
agencies involved?
5. Have a written procedure that notifies all relevant
agencies of FOOD-RELATED INCIDENTS?
6. Have written procedure that provides guidance
for notification of appropriate law enforcement
agencies when intentional food contamination is
suspected or threatened?
7. Have a written procedure that describes the
maintenance of a list(s) relevant agencies and
emergency contacts that is updated at least
yearly?
5.3.2 Surveillance
Does the State program:
1. Use epidemiological information from local,
state, or federal agencies to detect incidents or
outbreaks of foodborne illness or injury?
2. Maintain notifications of FOOD-RELATED
INCIDENTS that are reported to the program, in a
log or database?
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Program Elements
Yes/No
If no, please explain why element is not met
5.3.3 Investigation/Environmental Assessment
Does the State program:
1. Use established procedures with recommended
timeframes to investigate reports of FOODRELATED INCIDENTS?
2. Collect ENVIRONMENTAL ASSESSMENT data
using established procedures similar to those
found in IAFP and CIFOR?
3. Coordinate the TRACEBACK and TRACEFORWARD
of food implicated in an illness, injury, outbreak
or found to contain a HAZARD?
4. Have access to laboratory support for
investigation of reports of FOOD-RELATED
INCIDENTS?
5. Correlate and analyze ENVIRONMENTAL
ASSESSMENT data to identify contributing factors
and antecedents?
5.3.4 Control Measures
Does the State program:
1. Mitigate and contain food-related illness, injury
and HAZARDS through strategies that include
industry education, enforcement and public
awareness activities?
2. Maintain a written media procedure with criteria
for releasing prevention guidance and
information to the public?
5.3.5 Post Response
Does the State program:
1. Maintain written program investigation and
ENVIRONMENTAL ASSESSMENT findings and
reports?
2. Distribute final program investigation report,
including an ENVIRONMENTAL ASSESSMENT, if
completed, of illness or injury implicating food to
relevant agencies responsible for reporting
contributing factors and antecedents to CDC?
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Program Elements
Yes/No
If no, please explain why element is not met
3. Distributes recommendations, when available,
from investigation and ENVIRONMENTAL
ASSESSMENT findings and reports to relevant
agencies and stakeholders responsible for
prevention, education and outreach.
Assessment completed by: ______________________________________________________________
(NAME)
(DATE)
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Appendix 6.1: Self-Assessment Worksheet
State agency: ________________________________________________________________________
Program Elements
Yes/No If no, please explain why element is not met
6.3.1 Compliance and Enforcement Program
Does the state have a written compliance and
enforcement program that:
1. Contains written compliance and
enforcement strategies?
2. Describes the procedure to monitor:
CRITICAL VIOLATIONS, chronic violations and
chronic violators?
3. Uses a risk-based process to determine when
a directed investigation, follow-up, or reinspection is needed?
4. Establishes a framework for compliance and
enforcement progressive actions?
5. Has a system to communicate policy and
guidance to managerial and non-managerial
staff?
6.3.2 Performance Review
Does the State program conduct a performance
review:
1. Annually?
2. Document on Appendix 6.2, or equivalent
form to evaluate if internal compliance and
enforcement actions are followed?
3. Use results of the review to identify
improvements and modify procedures?
4. Require a corrective action if performance
ratings fall below 80 percent?
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
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Appendix 6.2: Calculation of the level of conformance to compliance procedures
State agency: _______________________________________________________________
Rating for conformance to compliance procedures (4):
Food firm
identification
number (1)
Subtotal
Total
Enforcement action
recommended (1)
Compliance
procedures
followed? (2)
Enter the sum of the
totals from all
continuation sheets.
At =
NIt =
Enter the final sums -subtotal + sums of (2) - on this form.
At =
NIt =
USE THIS SPACE TO EXPLAIN
IMPROVEMENTS NEEDED TO
FOLLOW COMPLIANCE
PROCEDURES
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
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Appendix 6.2: Calculation of the level of conformance to compliance procedures
(continued)
Food firm
identification
number (1)
Total
Enforcement action
recommended (1)
Enter the sums of (2).
Compliance
procedures
followed? (2)
At =
USE THIS SPACE TO EXPLAIN
IMPROVEMENTS NEEDED TO
FOLLOW COMPLIANCE
PROCEDURES
NIt =
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Appendix 6.2a: Performance Review of Enforcement Actions
Appendix 6.2 is used to record the enforcement actions recommended in the past 12 months and to
calculate the State agency’s rating for conformance to compliance procedures. Supporting documents
should be referenced and maintained by the State agency. Please indicate if an action was taken because
voluntary compliance was not achieved.
It is recommended that all cases be reviewed; otherwise, a statistical approach should be used to
determine a representative number of cases. Use continuation sheets as necessary.
INSTRUCTIONS:
(1) Record the food firm identification number and the recommended
enforcement action.
(2) For each type of enforcement action, record the level of conformance to
compliance procedures.
A = acceptable; NI = needs improvement
(3) Record the At and NIt .
At = vertical sum of acceptable ratings.
NIt = vertical sum of needs improvement ratings.
(4) Calculate the overall rating for the State agency’s conformance to
compliance procedures. Record the rating in the box located at the top of
Appendix 6.2.
FORMULA:
Performance factor rating = [ At / ( At + NIt )] x 100
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Appendix 7.1: Self-Assessment Worksheet
State agency: ________________________________________________________________________
Program Elements
Yes/No If no, please explain why element is not met
7.3 Outreach Methods
Does the State program have a written procedure
that includes how the program will:
1. Identify the methods that will be used for
communication with the food industry
stakeholders and consumers?
2. Interact with industry and consumers by
sponsoring or actively participating in meetings
such as task forces, advisory boards, or advisory
committees?
3. Tailor outreach efforts to a target population and
may include dissemination of information using
electronic sources and traditional methods such
as mailings?
4. Document and OUTREACH ACTIVITY EVENT
using Appendix 7.2 or equivalent form? Include
documents such as agendas and meeting
summaries and program evaluations.
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
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Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet
State program:
This worksheet is completed by the State program to document OUTREACH ACTIVITY EVENTS. Attach
verifying documents such as agendas and meeting summaries and program evaluations to this form.
Section I. Overview of Outreach Activity
a. Type of OUTREACH ACTIVITY EVENT (check one):
Seminar
Workshop
Training course
Other: _____________________________________________
b. Subject or name of OUTREACH ACTIVITY EVENT:
c. Date of OUTREACH ACTIVITY EVENT:
d. Host organization:
Section II. Self-Evaluation of OUTREACH ACTIVITY EVENTS
Program Elements
Yes/No
If no, please explain.
a. The purpose and objectives were clearly defined
b. The content of the OUTREACH ACTIVITY EVENT was
consistent with the objectives
c. The activity was tailored to a target population
Identify target population:
d. An evaluation was completed by attendees
e. State program addressed comments from attendees in
Section III of this form.
Section III. Critique of OUTREACH ACTIVITY EVENT
Discuss what went well, what could be done better, and what more could be done to improve the
OUTREACH ACTIVITY EVENT. Address comments from attendees, if available.
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
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Appendix 8.1: Self-Assessment Worksheet
State agency: _________________________________________________________________________________________________________
Assessment completed by:_______________________________________________________________________________________________
(NAME)
(DATE)
Does the State program have sufficient funds, staff, equipment, and resources necessary to meet the program standards? Answer yes or no in each
block. If no, please explain. Use additional pages as needed
Standard
1
Regulatory
Foundation
2
Training Program
3
Inspection Program
4
Inspection Audit
Program
5
Food-related Illness
…Outbreaks…Food
Defense
6
Compliance and
Enforcement
7
Industry and
Community Relations
8
Program Resources
9
Program Assessment
10
Laboratory Support
Funding
Staffing
Equipment
Other resources needed
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Appendix 8.1a: Self-Assessment Worksheet Instructions
The Appendix 8.1 Self-Assessment Worksheet summarizes the State program’s assessment of their
resources for all ten Standards.
Instructions:
For each Standard, the State program conducts an assessment of resource needs for staffing, equipment,
and funding for the manufactured food regulatory program. Answer yes or no in each block. If the
response is no, please explain the additional resources needed. Use additional pages as needed.
When completing Appendix 8.1 the State program should consider the following items:
•
Regulatory Foundation (Standard 1). The State program has resources to evaluate the scope of its
legal authority and regulatory provisions to ensure the protection of manufactured food within its
jurisdiction.
•
Training Program (Standard 2). The State program has resources to implement a training plan that
ensures all inspectors conducting manufactured food inspections complete course curriculums,
field training, and continuing education to adequately perform their work.
•
Inspection Program (Standard 3). The State program has resources to implement a risk based
inspection program that reduces the occurrence of foodborne illness, injury, or allergic reactions.
•
Inspection Audit Program (Standard 4). The State program has resources to administer and
monitor the quality of its inspections and sample collections.
•
Food-related Illness and Outbreaks and Food Defense Preparedness and Response (Standard 5).
The State program has the resources necessary to detect, investigate, mitigate, document and
analyze the FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS that are likely to
result in a foodborne illness, injury or outbreak.
•
Compliance and Enforcement Program (Standard 6). The State program has resources to
administer and monitor a compliance and enforcement program.
•
Industry and Community Relations (Standard 7). The State program has resources that allow
participation and assessment of outreach activities and OUTREACH ACTIVITY EVENTS.
•
Program Resources (Standard 8).The State program has resources to conduct an assessment of
resource needs for staffing, equipment, and funding to support a manufactured food regulatory
program.
•
Program Assessment (Standard 9). The State program has the resources to conduct selfassessments and develop and manage a STRATEGIC IMPROVEMENT PLAN resulting in conformance
with the Manufactured Food Regulatory Program Standards and a process for continuous
improvement.
•
Laboratory Support (Standard 10). The State program has resources to assess laboratory services
needed to support program functions.
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Appendix 8.2: Calculation for determining a required number of inspectors
This appendix is an example of how to calculate the number of field staff required to conduct
inspections 21 of food plants. The data in the following table will vary significantly based on local or
regional conditions. The State program may use the risk categories and inspection frequencies found in
the statement of work for the food contract as a basis for determining the required number of inspectors.
Risk
category
High
Medium
Low
Number in
inventory
1,000
2,000
1,000
Inspection
frequency
12 months
18 months
24 months
Average inspection time
(includes travel) 22
7.2 hours
5.7 hours
4.2 hours
Reinspection
frequency
10%
10%
10%
1. Calculate available annual inspection time per full time equivalent (FTE).
For example, the State agency determines that after allowances for annual leave, sick leave, holidays,
training, administrative time, and other activities each State program FTE has 1200 hours available for
conducting inspections.
2. Calculate the number of hours required to inspect establishments in each risk category.
Formula for high risk establishment inspection time:
1000 firms x 100% coverage = 1000 inspections + 10% reinspection = 1100 total inspections per year x
7.2 hours = 7920 hours
Formula for medium risk establishment inspection time:
2000 firms x 66.6% coverage = 1333 inspections + 10% reinspection = 1466 total inspections per year
x 5.7 hours = 8356 hours
Formula for low risk establishment inspection time:
1000 firms x 50% coverage = 500 inspections + 10% reinspection = 550 inspection total inspections x 4.2
hours = 2320 hours
3. Calculate the number of FTE’s required.
Formula:
7920 hours for high risk + 8356 hours for medium risk + 2320 hours for low risk = 18596 inspection
hours required / 1200 inspection hours available per FTE = 15.5 FTEs
21
Includes routine surveillance, reinspections, complaint or outbreak investigations, compliance follow-up investigations, risk assessment
reviews, process reviews, and other direct establishment contact time such as on-site training.
22
Inspection times based on calculations presented in “DHHS Office of Inspector General’s FDA Oversight of State Food Firm Inspections”
dated June 2000.
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Appendix 8.3: Inspection Equipment
State agency: ________________________________________________________________________
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
The State program should develop a list of equipment needed to conduct inspections and sample
collections. Please add and remove equipment from the table. Then indicate if the equipment is assigned,
available, or a “wish list” item. Also indicate in the verified column if the equipment item is to be verified
and maintained. Items checked as “verified” will need to have a written verification and maintenance
procedure as required in Standard 3, 3.3.2.2. “Wish list” items include equipment requested by
inspectors but not available.
EQUIPMENT
ASSIGNED AVAILABLE WISH LIST VERIFIED
Computer and printer
Camera
Credentials
Important phone numbers
(supervisor and servicing laboratory)
Regulation and policies
Paper, pen, masking tape, and permanent marker
Clipboard
Required forms (attached)
Alcohol swabs and wipes
Flashlight and holder
Blacklight
Light meter
Thermometer
Infrared thermometer
Exacto knife and scissors
Putty knife and scraper
Sampling devices (sieves, triers, and swabs)
Sampling equipment (sterile containers and
scoops)
Coolant (ice and freezer paks)
Shipping containers
Appropriate sanitizer test strips
Official seals
Protective clothing(lab coat, gloves, and boots)
Eye protection
Hair restraint
Hearing protection
Hard hat
Safety shoes
Respirator
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Appendix 9.1: Self-Assessment Summary Report
State agency: _________________________________________________________________________
Report completed by:__________________________________________________________________
(NAME)
(DATE)
Standard
Self Assessment
Complete
1. Regulatory
Foundation
Full
Partial
____
Complete
Full
Incomplete
Partial
Hours used
____
Complete
3. Inspection
Program
Full
Incomplete
Partial
Hours used
____
Complete
4. Inspection Audit
Program
Full
Incomplete
Partial
Hours used
5. Food-related
Illness,
Outbreak, and
Hazards
Response
____
Complete
Full
Incomplete
Partial
Hours used
____
Complete
6. Compliance and
Enforcement
Full
Incomplete
Partial
Hours used
____
Complete
7. Industry and
Community
Relations
Explain improvements needed to fully IMPLEMENT standards
(required for incomplete self-assessment and partial
IMPLEMENTATION)
Incomplete
Hours used
2. Training
Program
IMPLEMENTATION
Full
Incomplete
Partial
Hours used
____
Appendix 9.1: Self-Assessment Summary Report (continued)
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State agency: _________________________________________________________________________
Report completed by:_________________________________________________________________
(NAME)
(DATE)
Standard
Self-Assessment
Complete
8. Program
Resources
Full
Partial
____
Complete
Full
Incomplete
Partial
Hours used
____
Full
Complete
10. Laboratory
Support
Explain improvements needed to fully IMPLEMENT standards
(required for incomplete self-assessment and partial
IMPLEMENTATION)
Incomplete
Hours used
9. Program
Assessment
IMPLEMENTATION
Incomplete
Partial
Hours used
____
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Standard 9: Appendix 9.1 Self-Assessment Summary Report Instructions
Appendix 9.1 is the Self-Assessment Summary Report. This summary report shows the implementation
status of each standard and a brief description of needed improvements. Appendix 9.1 can be used to
develop the STRATEGIC IMPROVEMENT PLAN (SIP). Standards that are “Incomplete” or “Partial”
implementation must be addressed in the SIP.
Instructions: Complete Appendix 9.1 for each Standard. Each row has four sections that must be
completed. The sections are described below:
1. Self-Assessment – Complete versus Incomplete Section:
• Check “Complete” if you have conducted the appropriate self-assessment worksheets or equivalent
forms in each respective standard. Otherwise, check “Incomplete.”
2. Self-Assessment – Hours Used Section:
• FDA must provide a cost estimate to the Office of Management Bureau (OMB) on the MFRPS burden
of work (approximate hours per year) to develop and maintain MFRPS paperwork in accordance with
the Paperwork Reduction Act (PRA)i. Programs shall include all hours used to develop, implement and
conform to the MFRPS each year whether the hours were funded through Cooperative Agreement funds
or State funds. Programs should include time associated with the following types of activities:
•
•
•
•
•
•
•
•
•
•
Completing Standards Assessments
Standard 2 Training Coordination
Staff Auditing/Evaluation
Standard Operating Procedure Development/Revision
Review/Update of Operational Manuals
Equipment Verification/Calibration
Outreach Activities
Strategic Improvement Plan Development/Monitoring
Resource Allocation/Budgeting
Laboratory Coordination/Maintenance of Methods, Analysis Lists, Etc.
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•
•
•
•
•
Meeting with DSI/Participation in MFRPA Meetings
MFRPA Workgroup Activities, Projects, or Surveys
Tracking/Trend Analysis
MFRPS Standards Coordinator Activities
Subject Matter Expert Activities Associated with the Standards
Time associated with conducting inspections, enforcement actions, foodborne illness outbreak
investigations and complaint investigations should not be included in the calculation of hours.
3. Implementation - Full versus Partial Section:
• Check “Full” if the state program has all of the required elements listed in the Program Elements and
Documentation sections of that Standard.
• Check “Partial” if the state program is missing any of the requirements of that Standard.
Note: The state program must update Appendix 9.1 based upon the results of the Audit Staff Audit
Report. The state program must document corrective actions necessary to achieve “Full”
IMPLEMENTATION on the SIP.
4. Explain Improvements Needed to Fully Implement Standard Section:
This section is used to describe program elements that need to be developed or modified to achieve
“Full” IMPLEMENTATION. Brief descriptions may include:
• No documented process for annual review of REGULATORY FOUNDATION
• Continuing education credits are not captured
• No documented sampling protocol
• Inspection Report Audits are not included in the Quality Assurance Program
• The Compliance and Enforcement Program is not applied throughout the state
• Memorandum of Understanding for foodborne illness and outbreak response is in draft form or
unsigned
Appendix 9.1 and other Self-Assessments are used to develop the STRATEGIC IMPROVEMENT PLAN
(SIP). Each task on the SIP must include details for what individual element or documentation was not
met, what improvements are needed, projected completion dates, the responsible personnel, and the
completion date. Appendix 9.1 and the SIP must be updated at least annually.
State programs should work closely with their FDA Office of Partnerships, Standards Implementation
Staff (SIS) specialist to ensure accurate completion of MFRPS documents. Programs receiving
Cooperative Agreement funds must participate in periodic ASSESSMENTS conducted by the FDA Office
of Operations, Audit Staff (AS). The AS are responsible for verifying the accuracy of the self-assessments,
and determine IMPLEMENTATION and CONFORMANCE.
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Appendix 10.1: Self-Assessment Worksheet
State agency:
Program Elements
____
Yes/No If no, please explain why element is not met
10.3.1 Laboratory Support
Does the State program:
1. Have access to a laboratory that is capable of
analyzing a variety of samples including food,
environmental, and clinical samples?
2. Maintains a list of services for routine and nonroutine analyses such as biological HAZARD
determinations?
3. Have a contract or written agreement with each
PRIMARY SERVICING LABORATORY unless under the
same administrative agency? The contract or
written agreement can be a memorandum of
understanding, e-mail, or any written format but
must contain the components below:
1) Define the responsibilities of each party;
2) Describe the types of testing services to be
performed; and
3) Describe how exceptions to planned work will
be communicated.
4. Have documentation of the services provided, if
services are provided from a non- PRIMARY
SERVICING LABORATORY?
10.3.2 ISO Accredited Laboratories
Does the state program:
Use laboratories that have a current accreditation to the
ISO/IEC 17025:2005 or ISO/IEC 17025:2017 standards
to analyze food and environmental samples?
10.3.3 Non-ISO Accredited Laboratories
If not using laboratories holding accreditation to
ISO/IEC 17025:2005 or ISO/IEC 17025:2017 for the
analysis of food and environmental samples, is the
program using laboratories that have in place a quality
system which incorporates the following management
and technical requirements at a minimum:
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Program Elements
Yes/No If no, please explain why element is not met
1. A quality system that is documented and includes
items 10.3.3.1.1 through 10.3.3.1.6.
2. A procedure that defines the activities necessary to
take corrective action when non-conforming work
occurs
3. A document control procedure that assures
documents issued to personnel are current, suitable,
and reviewed and approved by authorized personnel
prior to release.
4. A documented record keeping process that assures
that records of original observations and data
collection are maintained and sufficient to establish
traceability of test results to sample handling and
storage, to sample analysis including data
collection, to equipment calibration and
maintenance, and to the review of test results prior
to release
5. A documented process to assure that reference
materials and reference cultures used are fit for
purpose, are not outdated, and are traceable to a lot
number or other unique identifier.
6. A documented process to assure that the laboratory
participates in relevant and available proficiency
testing activities.
Assessment completed by:______________________________________________________________
(NAME)
(DATE)
122
Manufactured Food Regulatory Program Standards
September 2019
| File Type | application/pdf |
| Author | Delius, Guy |
| File Modified | 2019-08-12 |
| File Created | 2019-06-24 |