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pdfManufactured Food Regulatory Program Standards
September 2010
The collection of information has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 and has been assigned OMB control number 0910-0601.
To request a copy of the standards go to:
http://www.fda.gov/ora/fed_state/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
OMB Control No. 0910-0601
Expiration Date: 09-30-2013
Table of Contents
Introduction ...................................................................................................................................... 1
Background ...................................................................................................................................... 2
Standard No. 1 Regulatory Foundation ........................................................................................ 3
Standard No. 2 Training Program................................................................................................. 5
Standard No. 3 Inspection Program .............................................................................................. 8
Standard No. 4 Inspection Audit Program ................................................................................. 11
Standard No. 5 Food-related Illness and Outbreaks and Response .................. ……….……. 15
Standard No. 6 Compliance and Enforcement Program........................................................... 18
Standard No. 7 Industry and Community Relations ................................................................. 20
Standard No. 8 Program Resources ............................................................................................ 21
Standard No. 9 Program Assessment .......................................................................................... 24
Standard No. 10 Laboratory Support ........................................................................................... 26
Appendix 1
Appendix 2.1
Appendix 2.2
Appendix 3.1
Appendix 3.2
Appendix 4.1
Appendix 4.2
Worksheet 4.2
Appendix 4.3
Worksheet 4.3
Appendix 4.4
Worksheet 4.4
Appendix 4.5
Appendix 4.5a
Appendix 4.6
Appendix 4.7
Appendix 4.8
Appendix 5.1
Appendix 5.2
Appendix 6.1
Appendix 6.2
Worksheet 6.2
Appendix 7
Appendix 8.1
Appendix 8.2
Appendix 8.3
Worksheet 9
Appendix 10
Self-Assessment Worksheet -- Standard No. 1................................................. 28
Self-Assessment Worksheet -- Standard No. 2................................................ 32
Individual Training Record............................................................................... 33
Self-Assessment Worksheet -- Standard No. 3................................................. 38
Risk Classification Criteria for Food Plants .................................................... 41
Self-Assessment Worksheet -- Standard No. 4................................................. 44
Summary of Field Inspection Audit Findings.................................................. 45
Calculation of the performance ratings for the field inspection audits......................46
Summary of Inspection Report Audit Findings .............................................. 48
Calculation of the performance rating for the inspection report audits ....................49
Summary of Sample Report Audit Findings.................................................... 52
Calculation of the performance rating for the sample report audits .........................53
Contract Audit – FDA Form 3610 .................................................................... 55
Guidance for Completing the Contract Audit Form....................................... 64
Inspection Report Audit Form .......................................................................... 74
Sample Report Audit Form ............................................................................... 79
Corrective Action Plan....................................................................................... 81
Self-Assessment Worksheet -- Standard No. 5................................................. 82
Memorandum of understanding between the department of health
and the department of agriculture concerning the investigation of foodborne
illnesses associate with food service establishments
and food plants.................................................................................................... 84
Self-Assessment Worksheet -- Standard No. 6................................................. 87
Performance Review of Enforcement Actions ................................................. 88
Calculation of the level of conformance to compliance procedures ...........................89
Self-Assessment Worksheet -- Standard No. 7................................................. 91
Self-Assessment Worksheet -- Standard No. 8................................................. 92
Calculation for determining a required number of inspectors ...................... 93
Inspection Equipment ........................................................................................ 94
Self-Assessment and Improvement Tracking...............................................................95
Self-Assessment Worksheet -- Standard No. 10............................................... 97
Manufactured Food Regulatory Program Standards
September 2010
INTRODUCTION
The Manufactured Food Regulatory Program Standards (program standards) establish a
uniform foundation for the design and management of State programs 1 responsible for
the regulation of food plants. The elements of the program standards describe best
practices of a high-quality regulatory program. Achieving conformance with them will
require comprehensive self-assessment on the part of a State program and will encourage
continuous improvement and innovation.
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 has
corresponding self-assessment worksheets and certain standards have supplemental
worksheets and forms for determining a level of conformance with such standards. The
State program is not required to use the forms and worksheets contained herein; however,
alternate forms should be comparable to the forms and worksheets for program standards.
These program standards do not address the performance appraisal processes that a State
agency may use to evaluate individual employee performance.
FDA will use the program standards as a tool to improve contracts with States. The
program standards will assist both FDA and the States in fulfilling their regulatory
obligations. The implementation of the program standards will be negotiated as an option
for payment under the State contract. States that are awarded this option will be expected
to implement the program standards to evaluate and improve their manufactured food
program. FDA recognizes that full use and implementation of the program standards by
those States will take several years. Such States will, however, be expected to implement
improvement plans to demonstrate that they are moving toward full implementation.
The goal is to implement a risk-based food safety program by establishing a uniform
basis for measuring and improving the performance 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.
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.
1
Program defined as an operational unit(s) that is responsible for the regulatory oversight of food plants.
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September 2010
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 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. 2 ” 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 from State agencies responsible for the regulation and inspection
of food plants 3 .
2
Office of Inspector General, FDA Oversight of State Food Firm Inspections: OEI-01-98-00400 (Department of Health and Human
Services, 2000), p. 5.
3
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) .
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September 2010
STANDARD No. 1
Regulatory Foundation
1.1
Purpose
This standard describes the elements of the regulatory foundation 4 used by a State
program to regulate food plants.
1.2
Requirement Summary
The State program has the legal authority and regulatory provisions to perform
inspections and investigations, gather evidence, collect samples, and take enforcement
actions under Federal and State laws. If the State adopts FDA laws and regulations by
reference, the terms of adoption must be clearly defined.
NOTE: When State code does not provide for adopting FDA laws and
regulations by reference, which includes subsequent amendments and
editions of the Title 21 Code of Federal Regulations (CFR), a legal review
by the State agency’s counsel to determine if State laws and regulations are
equivalent in effect to the current Federal laws and regulations listed in
appendix 1 is needed. If it has not adopted the current version of the CFR,
the State must provide the revision date of the CFR that was adopted for
each regulation in the box under “State citation or alternate provision” of
appendix 1.
1.3
Program Elements
a. The State program has the legal authority to inspect food plants, gather evidence,
collect and analyze samples, and take enforcement actions for adulteration or
misbranding of foods equivalent in effect to sections of the current FD&C Act
specified in appendix 1.
b. The State program enforces regulatory provisions equivalent in effect to the Federal
regulations specified in appendix 1. In the absence of a corresponding law or
regulation, a legal review by the State agency’s counsel to determine if State laws
and regulations are equivalent in effect to the current Federal laws and regulations
listed in appendix 1 is needed.
c. The State program uses its laws and regulations to broaden its scope of regulatory
authority.
4
Laws, regulations, rules, ordinances, or other regulatory requirements that govern the operation of a food plant or manufacturing
establishment.
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September 2010
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 food supply.
1.5
Documentation
The State program maintains the records listed here.
•
•
Appendix 1 Self-assessment worksheet
The statutes, regulations, rules, ordinances, and other prevailing regulatory
requirements that: (1) apply to the operation of food plants, (2) delegate authority
to the State agency, and (3) describe the process by which the State agency
establishes its authority and adopts rules by reference, for example, the
administrative rulemaking process
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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 has a training plan that ensures all inspectors receive training required
to adequately perform their work assignments. The plan provides for basic and advanced
food inspection training as well as continued training for professional development in the
field of food processing.
The State program has written basic and advanced food inspection training programs that
include course curriculums. ORA-U offers courses that the State program should
consider when developing basic and advanced training curriculums.
2.3
Program Elements
The State program maintains a history of the training provided to all inspectors.
Appendix 2.1 may be used to document all training provided to inspectors. Or, the
training history may be recorded and retained electronically.
The State program provides, or otherwise makes available, inspection training for all
inspectors. A training record similar to appendix 2.2 is maintained for all inspectors.
The individual training record should have the inspector’s start date.
NOTE: All required basic and advanced courses must be listed on the
inspector’s training record. Documentation to verify that an inspector has
successfully completed a course must be retained.
a. 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.
Coursework
The State program requires each inspector to complete coursework in the following areas
within 24 months of his or her start date with the State program.
•
•
•
•
Prevailing statutes, regulations, and ordinances
Public health principles
Food defense awareness training
Communications skills
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•
•
•
•
•
•
Microbiology
Epidemiology
Basics of HACCP
Basic labeling
Control of allergens (when available)
Sampling technique and preparation
Coursework is obtained from sources listed here.
•
•
•
In-house training provided by a government agency
Distance learning, for example, satellite downlinks or web-based training 5
Colleges, schools, and research centers
Field training
The State program requires that each inspector participate in a minimum of ten joint or
audit inspections with a qualified trainer and receive a minimum of two acceptable
evaluations from the trainer. Joint or audit inspections are conducted in firms that are
representative of the food plants in the State program’s establishment inventory. Each
inspector will complete the minimum field training requirements within 18 months of his
or her start date with the State program and prior to conducting independent inspections.
b. Advanced Food Inspection Training
The State program requires each inspector who will conduct specialized food inspections
to complete an advanced inspection training curriculum that consists of relevant
coursework and field training as described here.
Coursework
The State program requires each inspector who will perform specialized food inspections
to complete coursework listed here.
•
•
•
•
•
•
•
•
5
Applications of epidemiology & foodborne illness investigations
Traceback investigations
National Incident Management System (incident command system)
Nutrition labeling
Acidified foods
Low acid canned foods
Juice HACCP
Seafood HACCP
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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Field training
The State program requires that each inspector who will conduct specialized food
inspections participate in three joint inspections with a qualified trainer and receive a
minimum of two acceptable evaluations from the trainer. The joint inspections are
conducted in food plants representative of the specialty area. The inspector will complete
the minimum field training requirements prior to performing independent inspections.
c. Continuing education
The State program requires that each inspector participate in continuing education that
includes coursework and inspections. Every 36-month interval, each inspector is
required to receive 36 contact hours of classroom training and participate in at least two
joint or audit inspections with a qualified trainer. These joint inspections are intended to
assist the inspector with applying what was learned in the classroom to what should be
covered during an inspection.
[Note: The 36-month continuing education interval starts when the basic training cycle is
complete -- 24 months after the employee’s start date.]
One contact hour is earned for each hour of participation in the continuing education
activities from sources described in Section 2.3a.
.
2.4
Outcome
The State program has trained inspectors with the knowledge, skills, and abilities to
competently inspect food plants.
2.5
Documentation
The State program maintains the records listed here.
•
•
•
•
•
•
Appendix 2.1 Self-assessment worksheet
Appendix 2.2 Individual training record
Documents verifying successful completion of required courses
Course description, if necessary
Field training and evaluations
Continuing education certificates
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STANDARD No. 3
Inspection Program
3.1
Purpose
This standard describes the elements of an effective inspection program for food plants.
3.2
Requirement Summary
The State program has an inspection system. This system provides the foundation for
inspecting food plants to determine compliance with the laws administered by Federal,
State, and local governments. In addition, the State program has: (1) an established recall
system, (2) a system to respond appropriately to consumer complaints, (3) a system to
resolve industry complaints about inspections, and (4) a recordkeeping system for all
elements of the inspection program.
3.3
Program Elements
a. Risk-based inspection program
The State program updates its inventory of food plants. The inventory is categorized by
the degree of risk associated with the likelihood that a food safety or defense incident will
occur. Inspections are prioritized, frequencies assigned, and resources allocated based on
risk categories assigned to a food plant or product, the manufacturing processes, and the
inspection history of the food plant. Appendix 3.2 provides factors that may be
considered when defining risk categories.
b. Inspection protocol
The State program has written policies and procedures for inspecting food plants that
require the inspectors to:
1.
2.
3.
4.
Review the previous inspection report and consumer complaints
Have appropriate equipment 6 and forms needed to conduct inspections
Establish [FDA] jurisdiction
Select an appropriate product for the inspection and, if necessary, make
appropriate adjustments based on what the plant is producing
5. Assess employee activities critical to the safe and sanitary production and storage
of food
6. Properly evaluate the likelihood that conditions, practices, components, and/or
labeling could cause the product to be adulterated or misbranded
7. Recognize significant violative conditions or practices if present and record
findings consistent with State program procedures
6
Standard number 8, appendix 8.3 Inspection Equipment
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8. Distinguish between significant and insignificant observations, and isolated
incidents versus trends
9. 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]
10. Collect adequate evidence and documentation to support inspection observations
in accordance with State program procedures
11. Verify correction of deficiencies identified during the previous inspection
12. Behave professionally and demonstrate proper sanitary practices during the
inspection
As appropriate for seafood and juice processors subject to HACCP regulations:
13. Use the Fish and Fishery Products Hazards and Controls Guide or the Juice
HACCP Hazards and Controls Guide, when and as appropriate, to identify and
evaluate the hazards associated with the product and process
14. Assess the firm’s implementation of sanitation monitoring for the applicable eight
key areas of sanitation
15. 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
16. Recognize deficiencies in the firm’s monitoring and sanitation procedures through
in-plant observations
17. Make appropriate introductions, and explain the purpose and scope of the
inspection
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
22. Write findings accurately, clearly, and concisely on the State document and
provide a copy to the firm’s person in charge
c. Food recalls
The State program has a food recall system.
The State program has written recall procedures for:
1.
2.
3.
4.
Sharing information about recalls with affected government agencies
Promptly removing recalled food products from the market
Performing recall audit checks
Identifying and maintaining records about essential recall information
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d. Consumer complaints
The State program has a system for handling consumer complaints. The system contains
written procedures for receiving, tracking, evaluating, answering, closing, and
maintaining records of consumer complaints.
e. Food industry inspection complaints
The State program has a system to resolve complaints from industry about inspections.
The system contains written procedures for receiving, evaluating, answering, and
maintaining records of industry complaints about inspections.
3.4
Outcome
The State program has an inspection program that reduces the occurrence of foodborne
illness, injury, or allergic reaction by:
1. Focusing inspection resources on high risk plants, products, and processes
2. Obtaining immediate corrections and long-term improvements from
manufactured food processors
3. Responding efficiently to prevent unsafe products from reaching consumers or
to remove unsafe food from the human food system
3.5
Documentation
The State program maintains the records listed here.
•
•
•
•
•
•
Appendix 3.1 Self-assessment worksheet
An official establishment inventory of food plants
Written procedures and rationale used for grouping establishments based on food
safety risk, including the inspection frequency assigned to each defined risk-based
establishment category
Inspection policies and procedures including guidelines for performing
inspections that require immediate corrective action and re-inspection
Written procedures for food recalls, consumer complaints, and industry
complaints about inspections
Records for the three previous years including inspection reports and reports
pertaining to food recalls and follow-up activities, consumer complaints, and
industry complaints about inspections
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STANDARD No. 4
Inspection Audit Program
4.1 Purpose
This standard describes the basic quality assurance reviews necessary to: (1) evaluate the
effectiveness of the inspection program, (2) recognize trends in inspectional coverage,
and (3) identify best practices used to achieve quality inspections and sample collections.
4.2 Requirement Summary
The State program conducts quality assurance reviews to assess the effectiveness of its
inspections and sample collections. The data used to determine such performance is
obtained from observing an inspector conducting an inspection and the inspector’s
written reports. This standard is not intended, however, to evaluate individual
performance.
4.3 Program Elements
The State program implements a quality assurance program (QAP) that identifies
elements of its inspection and sample collection processes that need improvement.
The QAP has two components: (1) a field 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.
Worksheets 4.2, 4.3, and 4.4 will be used to: (1) calculate an overall audit rating for
each review (field inspection performance and written reports of inspections and
samples collections) and (2) evaluate ratings for a single performance factor.
Managers use the ratings to identify specific aspects of its inspection program that
need improvement. When performance ratings fall below 80 percent, a corrective
action plan (appendix 4.8 or comparable form) is required.
The State program compiles and summarizes the results of the field and desk audits
annually and determines an overall performance rating, which is reported on the selfassessment worksheet (appendix 4.1). The results of the audits are evaluated every
12 months to: (1) determine the effectiveness of the food inspection program,
(2) recognize trends in inspectional coverage, and (3) identify best practices used to
achieve quality inspections and sample collections.
The worksheets contained in appendices 4.1-4.4 are used to record and summarize audit
findings. Or, the State program may use comparable worksheets to record audit findings.
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Manufactured Food Regulatory Program Standards
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a. Field Inspection Audit
Supervisory inspector, senior inspector, or team leader conducts field inspection
audits to verify that inspections are consistently performed according to the
established policies and procedures. The quality of each inspection is audited
using the performance factors identified on appendix 4.5 and follows the process
described in FDA’s Field Management Directive No. 76. An overall rating for
field inspection performance is calculated using worksheet 4.2.
Frequency
The QAP requires a minimum of two field inspection audits
of each inspector be conducted every 36 months.
Inspections selected for audit should include high-risk food
firms such as seafood facilities, juice processors, and lowacid canned food operations.
Performance
Documentation
Appendices 4.5 and 4.2 (including worksheet 4.2)
Performance
Factors
Inspection procedures and policies described in
standard number 3 and appendix 4.5
b. Inspection Report Audit
The QAP requires periodic review of inspection reports to verify that inspectional
findings are obtained and reported according to established procedures and policies.
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 worksheet 4.3.
Frequency
The State program determines the number of reports for
review based on its inventory of food plants and the number
of inspections completed in the past 12 months. At least
75 reports, including inspection reports from field
inspection audit, are randomly selected across inspectors
and supervisors, and geographical locations. If less than
75 inspections were conducted; all inspection reports will be
reviewed. Seven percent of the inspection reports reviewed
should be taken from inspections that were audited.
Performance
Documentation
Appendices 4.6 and 4.3 (including worksheet 4.3)
Performance
Factors
Performance factors listed on appendix 4.6, and policies
and procedures established by the State program.
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c. Sample Report Audit
The QAP requires periodic review of sample reports to verify that samples were
properly collected, identified, and submitted according to established procedures and
policies and that appropriate information was recorded. 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 worksheet 4.4.
Frequency
The State program determines the number of reports for
review based on the number of samples collected in the past
12 months. At least 75 reports are randomly selected across
inspectors and supervisors, and according to sample type,
for example, microbiology, aflatoxin, or low-acid canned
foods. If less than 75 samples were collected, all reports
will be reviewed.
Performance
Documentation
Appendices 4.7 and 4.4 (including worksheet 4.4)
Performance
Factors
Performance factors listed in appendix 4.7, and
policies and procedures established by the State program.
d. Corrective Action Plan
A corrective action plan is required when an overall audit rating falls below
80 percent or when an individual performance factor is rated as “needs
improvement.” Appendix 4.8 is used to document how the deficiency was corrected.
4.4
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.
•
•
•
•
Written procedures that describe the quality assurance program
Appendix 4.1 Self-assessment worksheet
Appendix 4.2 Summary of field inspection audit findings
(includes worksheet 4.2)
Appendix 4.3 Summary of inspection report audit findings
(includes worksheet 4.3)
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•
•
•
•
•
•
Appendix 4.4 Summary of sample report audit findings
(includes worksheet 4.4)
Appendix 4.5 Contract Audit - FDA Form 3610
Appendix 4.5a Guidance for completing contract audit form
Appendix 4.6 Inspection report audit form
Appendix 4.7 Sample report audit form
Appendix 4.8 Corrective action plan (includes table 4.8)
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STANDARD No. 5
Food-related Illness and Outbreak Response
5.1 Purpose
This standard describes the functions and related activities necessary to investigate foodrelated illnesses, outbreaks, and hazards as well as coordinating roles and responsibilities
with other jurisdictions and notifying the public.
5.2 Requirement Summary
The State program establishes systems to:
a. Use epidemiological information from local, State, or Federal agencies
to detect incidents or outbreaks of foodborne illness or injury
b. Investigate reports of illness, injury, and suspected outbreaks
c. Correlate and analyze data
d. Rapidly notify customers and consumers
e. Share outbreak reports and surveillance summaries with other agencies
f. Disseminate current guidance to industry on food defense
g. Provide guidance for immediate notification of law enforcement agencies when
intentional food contamination or terrorism is suspected or threatened
h. Collaborate as necessary with FDA and other Federal authorities under conditions of
increased threat of intentional contamination
5.3 Program Elements
The State program has procedures for investigating food-related illnesses and outbreaks
that include coordinating roles and responsibilities with other authorities and notifying
the public. If the responsibility for food-related illness and outbreak investigations is
assigned to another agency, a memorandum of understanding with this agency is needed
to fulfill the requirements of this standard. Appendix 5.2 is an example of a
memorandum of understanding between the department of health and the department of
agriculture.
If a State program contracts for support of foodborne illness or injury investigations, it
will:
a. Develop and coordinate the operation of written support service agreements between
the food program and the epidemiology support program.
b. Ensure the support service contract or agreement identifies and describes the roles,
duties, and responsibilities of each program for: (1) receiving reports of foodborne
illness or injury, (2) performing investigational activities to identify the source of the
problem, (3) reporting and recording the results of the investigations, (4) containing
or mitigating the incident, and (5) preventing recurrence.
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Manufactured Food Regulatory Program Standards
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Whether foodborne illness support activities are performed by the State program or under
a contractual agreement, it must have [or contract for] a system to:
a. Conduct illness or injury investigations and collect information using established
epidemiology procedures similar to those found in the “International Association for
Food Protection Procedures to Investigate a Foodborne Illnesses, Fifth Edition" and
the “Guidelines for Foodborne Disease Outbreak Response.” 7
b. Provide laboratory support 8 for investigations of illness, injury, or outbreaks
c. Maintain a current list of relevant agencies and emergency contacts
d. Coordinate the traceback and trace-forward of food implicated in an illness, injury, or
outbreak
e. Identify contributing factors for reports of illness, injury, or incidents implicating
food
f. Maintain investigational findings
g. Distribute the final report of illness or injury implicating food to relevant agencies,
e.g. the State epidemiologist and Centers for Disease Control
h. Immediately notify all relevant agencies if intentional contamination is suspected or
threatened, e.g. tampering or terrorism
i. Establish criteria for releasing information to the public (includes identifying a media
person and developing guidelines for coordinating media information with other
jurisdictions)
j. Mitigate and contain food-related illness and injury using enforcement activities and
public awareness programs
k. Provide guidance to prevent or reduce the incidence of food-related illness, injury,
and intentional contamination, e.g. tampering or terrorism
l. Collaborate as necessary with FDA and other Federal authorities under conditions of
increased threat or intentional contamination
5.4 Outcome
The State program has written procedures for documenting and investigating alleged
food-related illnesses, injuries, and unintentional or deliberate food. Additionally, the
State program must have a rapid response system and team that is capable of detecting
and distinguishing between outbreaks of foodborne disease and possible intentional
contamination.
5.5 Documentation
The program maintains the records listed here.
•
Appendix 5.1 Self-assessment worksheet- Food-related Illness and Outbreak
Response
7
Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response. Atlanta:
Council of State and Territorial Epidemiologists, 2009.
8
Specific requirements for laboratory support are contained in standard number 10.
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Manufactured Food Regulatory Program Standards
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•
•
•
•
•
•
•
•
•
9
A written description of epidemiology support or an agreement that defines
epidemiology support similar to appendix 5.2
A complaint log or database
Up-to-date emergency contact list for all relevant jurisdictions
Procedure and contact person for releasing information to the public
Documented timeframes for responding to complaints
The illness, injury, or outbreak response procedures and the data collection forms
Policies and procedures for handling incidents and threats of deliberate
contamination and for collaborations with FDA and other jurisdictions under
conditions of increased threat or intentional contamination
Written agreements that identify and describe sources of supplemental laboratory
capacity and expertise including laboratory support 9 to detect contaminants not
normally found in food
Investigation reports and summaries
Standard number 10 describes the elements of laboratory support for a manufactured food regulatory program.
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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 compliance and enforcement program, which describes its
compliance strategy and procedures. The compliance and enforcement program conducts
an annual review of its enforcement actions. The State program records the enforcement
actions on appendix 6.2 and calculates an overall rating used to interpret compliance and
enforcement procedures were followed. Results of the review are used to identify
improvements, modify procedures, and develop enforcement strategies.
6.3
Program Elements
The State program has a compliance and enforcement program that: (1) contains written
enforcement strategies, (2) tracks critical and chronic violations and violators, (3) uses a
risk-based system to determine when a directed investigation, follow-up, or re-inspection
is needed, (4) establishes a timeline for progressive actions, and (5) has a system to
communicate verbal and written policy and guidance to managerial and non-managerial
staff. Appendix 6.1 is a framework for explaining the compliance and enforcement
program required by this standard. This outline is a means through which the State
should describe its program. Other aspects that may be pertinent to the State’s program
that have not been included in the outline should be added.
The State program conducts a performance review of enforcement actions. Enforcement
actions 10 are recorded on appendix 6.2 and an overall rating is calculated to determine if
internal procedures for enforcement and compliance actions (which include licensing and
permitting procedures) are followed. Performance ratings that fall below 80 percent
indicate a need for improvement and require corrective action.
10
Actions in the enforcement strategy 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.
18
Manufactured Food Regulatory Program Standards
September 2010
Frequency
The performance review is conducted every
12 months. Results of the review are used to
identify improvements, modify procedures, and
develop enforcement strategies.
Performance
Documentation
Appendix 6.2 (including worksheet 6.2) or
equivalent form
Written description of compliance and enforcement
program (refer to appendix 6.1)
Performance
Factors
6.4
Performance factors listed in appendix 6.1
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
and timeframes.
6.5
Documentation
The State program maintains the records listed here.
•
•
•
Written description of compliance and enforcement program (refer to
appendix 6.1)
Appendix 6.2 Performance Review of Enforcement Actions
(includes worksheet 6.2)
Applicable laws, regulations, and guidance documents referenced in
standard number 1
19
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September 2010
STANDARD No. 7
Industry and Community Relations
7.1
Purpose
This standard describes the elements of industry and community outreach activities
developed and accomplished by the State program.
7.2
Requirement Summary
The State program participates in activities that foster communication and information
exchange among the regulators, industry, academia, and consumer representatives. It
also coordinates or participates in outreach activities that provide educational information
on food safety and defense issues. Outreach activities are documented on Appendix 7.
7.3
Program Elements
The State program interacts with industry and consumers by sponsoring or actively
participating in meetings such as task forces, advisory boards, or advisory committees.
Appendix 7 is completed for each outreach activity.
Outreach efforts are tailored to a target population and may include dissemination of
information using electronic sources and traditional methods such as mailings. Topics at
outreach efforts may include food defense, investigation strategies, and regulatory
requirements. Representatives from affected food industries, consumers, academia, and
other Federal, State, and local food protection agencies are invited to these meetings.
7.4
Outcome
The State program uses outreach activities to inform varied populations about foodrelated issues.
7.5
Documentation
The State program maintains the records listed here.
•
•
Appendix 7 Self-assessment worksheet for each outreach activity
Meeting summaries, agendas, or other records documenting interaction with food
industries and consumers
20
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September 2010
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
Staff, equipment, and funding are managed to accomplish the elements detailed in these
standards.
8.3 Program Elements
Staffing
a. General Administration and Management
The State program has adequate staff to provide the direction, support, and oversight
needed to implement the program standards. Capability may be needed in program
management and direction, general administration, clerical support, office services,
and coordination with laboratories.
b. Training Program (standard number 2)
The State program has adequate staff to coordinate a training curriculum and ensure it
is properly delivered and tracked.
c. Inspection Program (standard number 3)
The State program has adequate staff to inspect food plants in its establishment
inventory at an adequate frequency that is based on the plant’s risk classification and
the necessary inspection and travel time. The risk categories and inspection
frequencies found in the statement of work for the food contracts should be
considered.
Appendix 8.2 is only an example of how to calculate the number of field staff needed
to conduct inspections of food plants. State programs should use verifiable data to
determine the required number of inspectors.
d. Inspection Audit Program (standard number 4)
The State program has adequate staff to administer and monitor its inspection quality
assurance program.
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Manufactured Food Regulatory Program Standards
September 2010
e. Food-related Illness and Outbreaks and Food Defense Preparedness and Response
(standard number 5)
The State program has adequate staff to prepare for and respond to emergency
situations.
f. Compliance and Enforcement Program (standard number 6)
The State program has adequate staff to implement compliance and enforcement
strategies.
g. Industry and Community Relations (standard number 7)
The State program has adequate staff to participate in outreach and education
activities.
h. Program Assessment (standard number 9)
The State program has adequate staff to conduct self-assessments of the manufactured
food regulatory program.
Equipment
a. Calibration and Repair
Equipment including thermometers is calibrated as required by the State’s standard
operating procedures or industry recommendation. Government-owned vehicles are
maintained and repaired following manufacturer’s recommendations.
b. Program administration and recordkeeping
The State program has computers, software, and equipment necessary to maintain and
secure records.
c. Communication systems and equipment
The State program has equipment needed for routine and emergency communications.
d. Inspections
The State program provides inspectors with equipment needed to conduct quality
inspections. Appendix 8.3 is a list of inspection equipment.
Program funding
The State program is adequately funded to cover the following expenses:
a. Salary and benefits
b. Training costs
c. Travel-related expenses
d. Equipment and supplies
22
Manufactured Food Regulatory Program Standards
September 2010
e. Industry and community outreach expenses
f. Laboratory expenses
g. Legal services fees
h. Indirect costs
i. Overhead costs
8.4 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.
•
•
•
•
Appendix 8.1 Self-assessment worksheet
Document showing the calculations used to determine an adequate number of
inspectors such as appendix 8.2
Inventory of assigned and available inspection equipment similar to appendix 8.3
Document containing the number and function of administrative support staff
23
Manufactured Food Regulatory Program Standards
September 2010
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 its 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 program by determining
the level of conformance with 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 an 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
In the first year of implementing the program standards, the State program conducts a
baseline self-assessment to determine if they meet the elements of each standard. The
State program should use the worksheets and forms contained herein; however it can use
alternate forms that are equivalent.
The State program maintains the documents required by each standard and records of all
self-assessments, improvement plans, and program assessment validation audits.
The information contained in the documents must be current and fit-for-use.
The State program uses the results of its self-assessments to complete the
Self-Assessment and Improvement Plan Report (also known as Worksheet 9).
The State program should update this worksheet each year.
If the State program fails to meet all program elements and documentation requirements
of a standard, it develops a written strategic 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, and (3) projected completion dates for each task.
After the State has completed their baseline self-assessment and improvement plan,
24
Manufactured Food Regulatory Program Standards
September 2010
FDA conducts a program assessment validation audit (hereafter known as validation
audit). The validation audit should occur within 18 months. A subsequent validation
audit will be conducted at 36 months to evaluate the State’s progress toward fully
implementing the standards. Then, at 60 months, FDA will conduct a comprehensive
program audit. As part of the program audit, the auditor reviews the records and
supporting documents required by the criteria in each standard to determine if the selfassessment and improvement plan accurately reflect the State program’s level of
conformance with each of the standards.
9.4
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 the records listed here.
•
•
•
•
Worksheet 9 Self Assessment and Improvement Plan Report
Completed appendices 1, 2.1 – 6.1, 7, 8.1, 10
Documents required under Section x.5 of each standard
Records and supporting documents required in the elements for each standard
25
Manufactured Food Regulatory Program Standards
September 2010
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
a. The State program has access to a laboratory that is capable of analyzing a variety of
samples including food, environmental, and clinical samples.
b. The State program maintains a list of services for routine and non-routine analyses
such as biological hazard determinations.
c. The State program has a contract or written agreement with its primary servicing
laboratories 11 .
d. The State program utilizes laboratories that have a current A2LA 12 accreditation.
e. Or, the State program utilizes laboratories that have quality assurance programs that
incorporate management and technical requirements found in ISO/IEC 17025:2005.
10.4 Outcome
The State program has access to laboratory services described in this standard.
11
Primary laboratory is a laboratory that analyzes more than 51 percent of the samples collected by the State program. State
programs are not required to have written agreements with FDA laboratories.
12
American Association for Laboratory Accreditation
26
Manufactured Food Regulatory Program Standards
September 2010
10.5 Documentation
The State program maintains records listed here.
•
•
•
Appendix 10 Self-assessment worksheet
Contracts or written agreements with primary servicing laboratories
A list of all servicing laboratories used by the State program
27
Manufactured Food Regulatory Program Standards
September 2010
Appendix 1
Self-Assessment Worksheet
The State program describes how equivalency is accomplished when it lacks authority to enforce the sections of
the current FD&C Act and the parts of the CFR listed in the following tables and subsequent final rules.
For example, the State program may comply with standard number 1 either by identifying its equivalent State
authorities or by describing how equivalency is attained through alternative procedures or agreements.
a. Federal Food, Drug, and Cosmetic Act (FD&C Act)
The State law must be equivalent in effect to the sections of the current FD&C Act. The language used does not
have to be identical if the same outcome is achieved. If the provisions contained in the relevant sections of your
food laws and codes are not the same as those contain the corresponding Federal citations, please identify the
difference between the two.
Section
Title
State citation or
alternate provision
Differences with
Federal law
201
Definitions (f), (k), (m), and (ff)
Prohibited acts (a), (b), (c), (d), (e),
301
(f), (k), and (v)
303* Penalties
304** Seizure
401
Definitions and standards for food
402
Adulterated food
403
Misbranded food (a)-(s)
413
New dietary ingredients
701
Regulations and hearings
703*** Records of interstate shipments
704
Factory inspection
*Penalties may vary from Federal statute.
**Seizure authority is not required under this standard. The agency, however, should have legal authority to stop adulterated and
misbranded products from moving in commerce, for example, detention, stop-sale orders, and embargoes.
***This section covers records in interstate commerce. State law should include intrastate records.
b. Code of Federal Regulations (CFR)
The State regulation must be equivalent in effect to the sections listed in the current CFR. The language used
does not have to be identical if the same outcome is achieved. States may have more stringent regulations
unless preempted. If a specific version of the CFR is adopted, please provide the date of the CFR.
If the provisions contained in the relevant sections of your food regulations differ from the corresponding
Federal citations found in the current CFR, please report the difference between the two. Differences between
the CFR adopted by the State and the current CFR should be reported.
Part
1
Title
State citation or
alternate provision
Differences with
Federal code
General enforcement regulations
(ONLY § 1.20-1.24)
28
Manufactured Food Regulatory Program Standards
September 2010
Appendix 1
Part
7
70
73
74
81
82
100
101
102
104
105
106
107
108
109
110
111
113
114
Title
State citation or
alternate provision
Differences with
Federal code
Enforcement policy
(ONLY § 7.1-7.13 and § 7.40-7.59)
Color additives (ONLY § 70.2070.25)
Listing of colors exempt from
certification
(ONLY § 73.1- § 73.615)
Listing of color additives subject to
certification
(ONLY § 74.101-706)
General Restrictions for Provisional
Color Additives for Use in Foods,
Drugs, and Cosmetics
Listing of certified provisionally
listed colors and specifications
(ONLY § 82.3- § 82.706)
General
(ONLY § 100.155)
Food labeling
(EXCEPT § 101.69 and § 101.108)
Common or usual name for
nonstandardized foods
(EXCEPT § 102.19)
Nutritional quality guidelines for
foods
Foods for special dietary use
Infant formula quality control
procedures
(EXCEPT § 106.120)
Infant formula
(EXCEPT § 107.200- § 107.280)
Emergency permit control
(ONLY § 108.25- § 108.35)
Unavoidable contaminants in food
for human consumption and foodpackaging materials
Current good manufacturing practice
in manufacturing, packing, or
holding human food
Current good manufacturing practice
for dietary supplements
Thermally processed low-acid foods
packaged in hermetically sealed
containers
Acidified foods
29
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September 2010
Appendix 1
Part
Title
115
Shell eggs
Production, Storage, And
Transportation of Shell Eggs
Hazard Analysis and Critical Control
Point (HACCP) systems
Fish and fishery products
Processing and bottling of bottled
drinking water
Food standards: general
(EXCEPT § 130.5-6 and § 130.17)
Milk and cream
Cheeses and related cheese products
Frozen desserts
Bakery products
Cereal flours and related products
Macaroni and noodle products
Canned fruits
Canned fruit juices
Fruit butters, jellies, preserves, and
related products
Fruit pies
Canned vegetables
Vegetable juices
Frozen vegetables
Eggs and egg products
Fish and shellfish
Cacao products
Tree nut and peanut products
Beverages
Margarine
Sweeteners and table syrups
Food dressings and flavorings
Food additives (EXCEPT § 170.6,
§ 170.15, and § 170.17)
Food additives permitted for direct
addition to food for human
consumption
Secondary direct food additives
permitted in food for human
consumption
Indirect food additives: general
Indirect food additives: adhesives
and components of coatings
118
120
123
129
130
131
133
135
136
137
139
145
146
150
152
155
156
158
160
161
163
164
165
166
168
169
170
172
173
174
175
Part
Title
State citation or
alternate provision
Differences with
Federal code
State citation or
alternate provision
Differences with
Federal code
30
Manufactured Food Regulatory Program Standards
September 2010
Appendix 1
176
177
178
180
181
182
184
186
189
190
Indirect food additives: paper and
paperboard components
Indirect food additives: polymers
Indirect food additives: adjuvants,
production aids, and sanitizers
Food additives permitted in food or
in contact with food on an interim
basis pending additional study
Prior-sanctioned food ingredients
Substances generally recognized as
safe
Direct food substances affirmed as
generally recognized as safe
Indirect food substances affirmed as
generally recognized as safe
Substances prohibited from use in
human food
Dietary supplements
c. State law and regulations
State laws and regulations used by the program to broaden its scope of regulatory authority are listed below.
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
Assessment completed by:
___________________________________________________________________________________
(NAME)
(DATE)
31
Manufactured Food Regulatory Program Standards
September 2010
Manufactured Food Regulatory Program Standards
Appendix 2.1
Self-Assessment Worksheet
State agency: ______________________________________________________________________________
Year _______
Instructions: Record the name of the employee and the completion date for each training component. Use additional sheets if needed.
Employee name
Start Date
Basic Food Inspection
Curriculum
Course
Field
work
work
Advanced Food Inspection Curriculum
Area of specialty
Course
work
Field
work
Continuing Education
Course
work
Field
work
32
Assessment completed by:
September 2010
__________________________________________________________________________________________________________
(NAME)
(DATE)
Appendix 2.2
Appendix 2.2
Individual Training Record
State agency ______________________________________________________________________________
Name of inspector _______________________________________ Start date ________________________
Basic Food Inspection Curriculum
Coursework
Completion
Please provide the course name and location for the
Date
subject areas listed here.
Inspector’s
Initials
Supervisor’s
Initials
Prevailing statutes, regulations, and ordinances
Public health principles
Communication skills
Microbiology
Epidemiology
Basics of HACCP
Control of allergens
Basic food labeling
Manufactured Food Regulatory Program Standards
33
September 2010
Appendix 2.2
Basic Food Inspection Curriculum
Fieldwork
Completion
Joint Inspections
Date
Inspector’s
Initials
Supervisor’s
Initials
Please provide the name of the food plant and
identification number.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Evaluations
1.
2.
Manufactured Food Regulatory Program Standards
34
September 2010
Appendix 2.2
Advanced Food Inspection Curriculum
Coursework
Please provide the name and location of the course.
Completion
Date
Inspector’s
Initials
Supervisor’s
Initials
Applications of foodborne illness investigations
Traceback investigations
Nutrition labeling
Acidified food
Conducting Acidified Food Inspections (FD202)
Note: Acidified food inspections done under FDA contract shall only be
performed by state inspectors who have successfully completed the FDA
course, Conducting Acidified Food Inspections (FD202).
Low acid canned food
Conducting LACF Inspections (FD203)
Note: LACF food inspections done under FDA contract shall only be
performed by state inspectors who have successfully completed the FDA
course, Conducting LACF Inspections (FD203).
Juice HACCP
Juice HACCP and Conducting Juice HACCP Inspections
(FD219)
Note: Juice HACCP inspections done under FDA contract shall only be
performed by state inspectors who have successfully completed the FDA
course, Juice HACCP and Conducting Juice HACCP Inspections
(FD219).
Seafood HACCP
Conducting Seafood Inspections (FD249)
Note: Seafood HACCP inspections done under FDA contract shall only
be performed by state inspectors who have successfully completed the
FDA course, Seafood HACCP Inspections (FD249).
Manufactured Food Regulatory Program Standards
35
September 2010
Appendix 2.2
Advanced Food Inspection Curriculum
Fieldwork
Specialized food inspection:
Joint Inspections
Completion
Date
Inspector’s
Initials
Supervisor’s
Initials
Completion
Date
Inspector’s
Initials
Supervisor’s
Initials
Please provide the name of the food plant and
identification number.
1.
2.
3.
Evaluations
1.
2.
Specialized food inspection:
Joint Inspections
Please provide the name of the food plant and
identification number.
1.
2.
3.
Evaluations
1.
2.
Manufactured Food Regulatory Program Standards
36
September 2010
Appendix 2.2
Continuing Education
Coursework
Please provide the name and
location of the course.
Joint Inspections
Completion
Date
Contact
Hours 1
Continuing Education
Fieldwork
Completion
Date
Inspector’s
Initials
Inspector’s
Initials
Supervisor’s
Initials
Supervisor’s
Initials
Please provide the name of the food plant and
identification number.
1.
2.
1
The inspector will earn contact hours at a rate of one contact hour for every course hour.
Manufactured Food Regulatory Program Standards
37
September 2010
Appendix 3.1
Appendix 3.1
Self-Assessment Worksheet
State agency: __________________________________________________________________________
Program Elements
Section I. Risk-based inspection system
a. Is the establishment inventory updated?
• Does inventory have both licensed and unlicensed
firms?
• Are addresses for the physical locations of firms
listed in the inventory?
b. Are eSAF (electronic State Access to FACTS) entries
hard-copy inspection reports cross referenced to
ensure the firm information is accurately entered?
c. Are establishments grouped based on identified risk
factors?
d. Are risk categories used to prioritize inspections,
assign routine inspection frequencies, and allocate
resources?
Section II. Inspection protocol
Does the program’s inspection protocol require
inspectors to:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Yes/No If no, please explain why element is not met
Review the establishment file, consumer complaints,
and other relevant documents prior to inspection?
Use appropriate equipment and forms?
Establish jurisdiction?
Select appropriate product/process (high risk products
and processes)?
Assess employee practices critical to the safe
production and storage of food?
Properly evaluate the likelihood that conditions,
practices, components, and labeling could cause the
product to be adulterated or misbranded?
Recognize significant violative conditions or
practices, and record findings consistent with program
procedures?
Distinguish between significant and insignificant
observations, and isolated incidents and trends?
Review and evaluate the appropriate operational
records and procedures and apply the information
obtained from this review?
Collect adequate evidence and documentation in
accordance with program procedures given the nature
of the inspectional findings?
Manufactured Food Regulatory Program Standards
38
September 2010
Appendix 3.1
k. Verify correction of deficiencies from a previous
inspection?
l. Behave professionally and demonstrate proper
sanitary practices during the inspection?
m. Use the “Fish and Fishery Products Hazards and
Controls Guide” or the “Juice HACCP Hazards and
Controls Guide,” to identify and evaluate the hazards
associated with the product and process?
n. Assess the firm’s implementation of sanitation
monitoring for the applicable eight key areas of
sanitation?
o. 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?
p. Recognize deficiencies in the firm’s monitoring and
sanitation procedures through in-plant observations?
q. Identify himself/herself, present credentials, and make
appropriate introductions, including explaining the
purpose and scope of the inspection?
r. Use suitable interviewing techniques?
s. Explain findings clearly and adequately throughout
the inspection?
t. Alert the firm’s appropriate management when an
immediate corrective action is necessary?
u. Write findings accurately, clearly, and concisely on
the State document?
v. Answer questions and provide information in an
appropriate manner?
w. And, does the program have an adequate
recordkeeping system and does this system contain
prescribed records associated with inspections?
Section III. Food recalls
Does the recall system include:
a. Guidance for sharing information?
b. Procedures for prompt removal of recalled products?
c. Procedures for recall audit checks?
d. And, does the program have an adequate
recordkeeping system and does this system contain
prescribed records associated with food recalls?
Section IV. Consumer complaints
a. Does the program have procedures for receiving,
tracking, evaluating, responding to, and closing
consumer complaints?
b. Does the program have a recordkeeping system and
are records associated with consumer complaints
retained?
Manufactured Food Regulatory Program Standards
39
September 2010
Appendix 3.1
Section V. Food industry inspection complaints
a. Does the program have procedures for receiving,
evaluating, responding to, and recording food
industry complaints about inspections?
b. Does the program have a recordkeeping system and
are records associated with food industry inspection
complaints retained?
Assessment completed by:
___________________________________________________________________________________
(NAME)
Manufactured Food Regulatory Program Standards
(DATE)
40
September 2010
Appendix 3.2
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. A key requirement of this standard is that the State program uses a science-based and
risk-based method for classifying food plants into at least three risk categories with a baseline
inspection frequency specified for each category. 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.
Manufactured Food Regulatory Program Standards
41
September 2010
Appendix 3.2
Risk Classification Criteria for Food Plants
Many classification schemes prioritize products intended for use by highly-susceptible
populations 1 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.
The risk classification criteria listed on the next page are intended solely to assist State
programs with establishing their own classification system. Risk categories and inspection
frequencies can also be found in the statement of work for the food contract.
1
Highly-susceptible populations 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).
Manufactured Food Regulatory Program Standards
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September 2010
Appendix 3.2
Risk Classification Criteria for Food Plants
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
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
Volume of product manufactured/distributed
Higher
High volume operations with broad distribution
Lower
Low volume operations or operations with localized distribution
Target population
Higher
Foods consumed by susceptible populations
Lower
Foods consumed solely or primarily by the general population
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
Manufactured Food Regulatory Program Standards
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September 2010
Appendix 4.1
Self-Assessment Worksheet
State agency: _______________________________________________________________
The results of the field inspection and desk audits are summarized below. Performance
ratings that fall below 80 percent indicate a need for improvement and require corrective
action. Worksheets 4.2 – 4.4 can be used to identify the specific aspects of the inspection
program that need improvement.
Overall Audit Rating
(based on five-year average)
Circle one:
Performance rating criteria:
All performance rating averages ≥ 80 percent.
Acceptable
One or more performance rating averages
< 80 percent.
Needs improvement
Audits
Field inspection
Inspection report
Sample report
Year ________
________
________
________
Year ________
________
________
________
Year ________
________
________
________
Year ________
________
________
________
Year ________
________
________
________
Five-year
average
Assessment completed by:
______________________________________________________________________
(NAME)
Manufactured Food Regulatory Program Standards
(DATE)
44
September 2010
Appendix 4.2
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.
Worksheet 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 worksheet 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 worksheet 4.2 to identify and make notes about
single performance factors rated as “needs improvement” in multiple
audits.
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September 2010
Worksheet 4.2 Performance rating for the field inspection audits
Manufactured Food Regulatory Program Standards
State agency: _____________________________________________________________________________
Performance period: ______________________________
Performance rating (4): ___________
Reviewed by: _______________________________________________
Office: _________________________________________ Date: ______________
Auditor’s initials and date of audit (1)
Performance
factors (5)
At
(3)
Performance ratings (2)
46
September 2010
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.
NIt
(3)
Worksheet 4.2
Continuation sheet
Manufactured Food Regulatory Program Standards
State agency: __________________________________________________________
Performance period: ______________________________
Auditor’s initials and date of audit (1)
Performance
factors (5)
At
(3)
Performance ratings (2)
47
September 2010
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.
NIt
(3)
Appendix 4.3
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.
Worksheet 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 worksheet 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 worksheet 4.3 to identify and make notes about single
performance factors rated as “needs improvement” in multiple audits.
Manufactured Food Regulatory Program Standards
`
48
September 2010
Worksheet 4.3 Performance rating for the inspection report audits
State agency: _____________________________________________________________________________
Performance period: ______________________________
Manufactured Food Regulatory Program Standards
Performance rating (4): ___________
Reviewed by: _______________________________________________
Performance
factors (5)
Office: _________________________________________
Firm identification number and date of inspection (1)
At
(3)
Performance ratings (2)
49
September 2010
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
II.11
II.12
III.1
III.2
III.3
III.4
IV.1
IV.2
IV.3
IV.4
IV.5
IV.6
V.1
V.2
V.3
V.4
V.5
V.6
V.7
V.8
Subtotal
Total
Date: ______________
Enter the sum of the totals from all continuation sheets.
Enter the final sums (subtotal + sums of (3) on this form).
NIt
(3)
Worksheet 4.3
Continuation sheet
State agency: ____________________________________________________
Performance period: ______________________________
Manufactured Food Regulatory Program Standards
Firm identification number and date of inspection (1)
Performance
factors (5)
At
(3)
Performance ratings (2)
50
September 2010
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
II.11
II.12
III.1
III.2
III.3
III.4
IV.1
IV.2
IV.3
IV.4
IV.5
IV.6
V.1
V.2
V.3
V.4
V.5
V.6
V.7
V.8
Total
Enter the sums of (3).
NIt
(3)
Worksheet 4.3
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS IMPROVEMENT” IN MULTIPLE AUDITS.
Manufactured Food Regulatory Program Standards
51
September 2010
Appendix 4.4
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.
Worksheet 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 worksheet 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 worksheet 4.4 to identify and make notes about
single performance factors rated as “needs improvement” in multiple
audits.
Manufactured Food Regulatory Program Standards
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September 2010
Worksheet 4.4 Performance rating for the sample report audits
Manufactured Food Regulatory Program Standards
State agency: _____________________________________________________________________________
Performance period: ______________________________
Performance rating (4): ___________
Reviewed by: _______________________________________________
Office: _________________________________________ Date: ______________
Sample report identification number and date of sample collection (1)
Performance
factors (5)
At
(3)
Performance ratings (2)
53
I.1
I.2
I.3
I.4
I.5
II.1
II.2
II.3
II.4
II.5
II.6
II.7
III.1
III.2
III.3
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.
NIt
(3)
September 2010
Worksheet 4.4
Continuation sheet
Manufactured Food Regulatory Program Standards
State agency: _________________________________________________________________
Performance period: ______________________________
Sample report identification number and date of sample collection (1)
Performance
factors (5)
At
(3)
Performance ratings (2)
54
I.1
I.2
I.3
I.4
I.5
II.1
II.2
II.3
II.4
II.5
II.6
II.7
III.1
III.2
III.3
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.
NIt
(3)
September 2010
Appendix 4.5
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
Improvement
PREINSPECTION ASSESSMENT
I.
Needs
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)
2. DID THE INSPECTOR HAVE THE APPROPRIATE EQUIPMENT AND FORMS TO PROPERLY CONDUCT THE INSPECTION?
Acceptable
Needs Improvement
COMMENTS (required for Needs Improvement)
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Appendix 4.5
INSPECTION OBSERVATIONS AND PERFORMANCE
II.
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)
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Manufactured Food Regulatory Program Standards
September 2010
Appendix 4.5
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)
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)
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Appendix 4.5
7. DID THE INSPECTOR REVIEW AND EVALUATE THE APPROPRIATE RECORDS AND PROCEDURES FOR THIS
ESTABLISHMENT’S OPERATION ANDEFFECTIVELY 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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Appendix 4.5
INSPECTION OBSERVATIONS AND PERFORMANCE (Continued)
II.
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)
INSPECTION OBSERVATIONS AND PERFORMANCE FOR ’HACCP-REGULATED’ FACILITIES
II. A.
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)
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Manufactured Food Regulatory Program Standards
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Appendix 4.5
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)
4. DID THE INSPECTOR RECOGNIZED EFICIENCIES IN THE FIRM’S MONITORING AND SANITATION PROCEDURES THROUGH
IN-PLANT OBSERVATIONS?
Acceptable
Needs Improvement
COMMENTS (required for Needs Improvement)
ORAL AND WRITTEN COMMUNICATION
III.
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)
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Manufactured Food Regulatory Program Standards
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Appendix 4.5
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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Appendix 4.5
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)
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.
62
Manufactured Food Regulatory Program Standards
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Appendix 4.5
7ADDITIONAL COMMENTS
SIGNATURE OF FDA AUDITOR
DATE
63
Manufactured Food Regulatory Program Standards
September 2010
Appendix 4.5a
Guidance for Completing the Contract Audit Form (FDA Form 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 followup 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.
Manufactured Food Regulatory Program Standards
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September 2010
c. 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
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 highrisk 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 institutionalsized root beer syrup, the inspector ignores a bottled water processing operation at
that site.
Manufactured Food Regulatory Program Standards
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September 2010
Appendix 4.5a
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.
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.
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September 2010
Appendix 4.5a
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.
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September 2010
Appendix 4.5a
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.
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.
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September 2010
Appendix 4.5a
c. The inspector fails to follow up on deficiencies from the previous inspection for
cooked, ready-to-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
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.
Manufactured Food Regulatory Program Standards
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Appendix 4.5a
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
HAACP plan. The inspector cites the firm’s failure to have a HAACP 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 preoperation 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
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.
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Appendix 4.5a
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.
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.
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Appendix 4.5a
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
Manufactured Food Regulatory Program Standards
Inspection Report Audit Form
Auditor
Date of audit
Firm identification number
Date of inspection
I.
1.
Introduction
FORMAT OF THE INSPECTION REPORT FOLLOWED THE STATE PROGRAM’S CURRENT
PROCEDURES AND POLICIES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
REQUIRED FIELDS ON INSPECTION REPORT OR RELATED REPORT FORMS ARE COMPLETED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
II.
1.
Evidence Development
IDENTIFIED FIRM MANAGERS AND KEY PERSONNEL AND DESCRIBED THEIR RESPONSIBILITIES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
VERIFIED LEGAL STATUS OF FIRM AND CORPORATE OFFICERS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
DOCUMENTED INDIVIDUAL RESPONSIBILITY.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
4.
REVIEWED QUALITY ASSURANCE PROGRAM AND FIRM’S PROCEDURES FOR IDENTIFYING RISK
AND MAINTAINING CONTROLS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
5.
IDENTIFIED VIOLATIONS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.6
Page 2
6. DOCUMENTED SIGNIFICANT FINDINGS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
7.
DOCUMENTED POSSIBLE CAUSES OF CONTAMINATION.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
8.
COLLECTED SUFFICIENT SAMPLES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
9.
COLLECTED EXHIBITS, PHOTOGRAPHS, OR PHOTOCOPIES TO DOCUMENT FINDINGS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
10. DESCRIBED FIRM’S SYSTEM FOR PRODUCT AND LOT CODING.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
11. REPORTED PRODUCT DISTRIBUTION.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
12. REVIEWED RECORDS OF COMPLAINTS RECEIVED BY FIRM.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
III.
Discussions With Management
1. DISCUSSED FINDINGS AND VIOLATIONS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.6
Page 3
2. REPORTED RESPONSES OR REPLIES FROM THE FIRM.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
RECORDED ANY WARNINGS OF POSSIBLE FURTHER ACTIONS (REINSPECTION, EMBARGO,
REVOCATION OF LICENSE, OR LEGAL CONSEQUENCES OF VIOLATIVE CONDITIONS) GIVEN TO
THE FIRM.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
4.
RECORDED ANY REFUSALS ENCOUNTERED DURING THE INSPECTION.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
IV.
Organization of the Report
1. REFERENCED EXHIBITS IN THE REPORT.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
WRITTEN OBSERVATIONS WERE CLEAR AND CONCISE.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
OBSERVATIONS WERE FACT BASED AND SUPPORTED BY LAWS AND REGULATIONS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
4.
EMPHASIZED SIGNIFICANT OBSERVATIONS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
5.
OBSERVATIONS WERE REPETITIOUS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.6
Page 4
6. SUBMITTED REPORT WITHIN TIMEFRAMES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
V.
1.
Supervisory Review
STATED THE REASON FOR THE INSPECTION, A BRIEF HISTORY OF THE FIRM, AND FOLLOW-UP
TO THE PREVIOUS INSPECTION, IF NECESSARY.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
A SUMMARY OF FINDINGS AND DISPOSITION OF INSPECTION WERE RECORDED IN THE REPORT.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
REINSPECTION SCHEDULE AND RECOMMENDATION FOR COMPLIANCE FOLLOW UP WERE
GENERATED AND RECORDED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
4.
CLASSIFICATION AND FOLLOW-UP WERE CONSISTENT WITH THE LAW, CURRENT POLICIES,
AND INSPECTIONAL FINDINGS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
5.
SUPERVISORY REVIEW AND ACTION WERE DONE WITHIN ADMINISTRATIVE TIMEFRAMES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
6.
VERIFIED AND DESCRIBED CORRECTIVE ACTIONS FROM PREVIOUS INSPECTION FINDINGS.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.6
Page 5
7. DATES IN REPORT, COVERSHEET, AND CODING OR OTHER ADMINISTRATIVE DATA WERE
RECORDED ACCURATELY.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
8.
DISTRIBUTION OF REPORT WAS RECORDED ACCURATELY ON THE COVERSHEET.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.7
Manufactured Food Regulatory Program Standards
Sample Report Audit Form
Auditor
Date of audit
Sample identification number
Date of collection
I.
1.
Introduction
REASON FOR SAMPLE COLLECTION WAS RECORDED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
SAMPLE SIZE WAS DESCRIBED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
LOT AND PRODUCT CODING WERE RECORDED ON SAMPLE REPORT.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
4.
MANUFACTURER, SHIPPER, DEALER, AND THE RESPONSIBLE FIRM WERE RECORDED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
5.
REQUIRED FIELDS ON THE SAMPLE REPORT (SR) OR RELATED REPORT FORMS ARE COMPLETED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
II.
1.
Evidence Development
METHOD OF COLLECTION WAS APPROPRIATE FOR TYPE OF PRODUCT.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
METHOD OF COLLECTION, INCLUDING SAMPLE SIZE, WAS APPROPRIATE FOR THE LABORATORY
ANALYSES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
SAMPLE, LABELS, AND LABELING, BEAR IDENTIFICATION MARKS AND WERE ACCURATELY REPORTED ON
THE SR.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.7
Page 2
4.
PRODUCT LABEL AND LABELING WERE SUBMITTED WITH SR.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
5.
RECEIPT FOR SAMPLE WAS OBTAINED.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
6.
AFFIDAVITS WERE CLEAR, LEGIBLE, AND COMPLETE.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
7.
SR WAS SUBMITTED WITHIN TIMEFRAMES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
III.
1.
Sample Integrity
SAMPLE WAS HANDLED, PACKAGED, AND SHIPPED TO PREVENT COMPROMISING THE CONDITION OR
INTEGRITY OF THE SAMPLE.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
2.
SAMPLE WAS DELIVERED OR SHIPPED TO THE APPROPRIATE LABORATORY WITHIN ACCEPTABLE
TIMEFRAMES.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
3.
SAMPLE DELIVERY (DATE AND CUSTODIAN) WAS RECORDED ON SR.
Acceptable
Needs improvement
COMMENTS (required for needs improvement)
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Appendix 4.8
Corrective Action Plan
Manufactured Food Regulatory Program Standards
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: ________________________________________________________________________________________________
Completed by: __________________________________________________________________________
(NAME)
Type of audit:
(DATE)
FIELD INSPECTION
INSPECTION REPORT
SAMPLE REPORT
(circle one)
Performance factor
(record number from
audit form)
Description of deficiency
Corrective action(s)
Date of
next audit
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Appendix 5.1
Self-Assessment Worksheet
Food-related Illness and Outbreak Response
State agency: ________________________________________________________________
Program Elements
Yes/
No
If no, please explain why element is not met
The State program uses epidemiological
information from agencies at all government
levels.
1. Is the State program responsible for
epidemiological investigations identified?
If no, attach agreement with lead agency.
2. Is there a system to coordinate agreements
between the food and epidemiology programs
and that clearly identifies the roles, duties, and
responsibilities of each program?
The State program has an established system to
investigate reports of illness, injury, and
suspected outbreaks.
1. Are complaints alleging food-related illness,
injury, or terrorism maintained in a log or
database?
2. Does the State program initiate a response to
reports of illness or injury within established
timeframes?
3. Does the State program use established
epidemiology procedures to conduct illness or
injury investigations and collect information?
4. Are the factors that caused the illness, injury,
or incidents reported?
The State program notifies the public.
1. Is a procedure in place that outlines criteria
for releasing information to the public?
2. Does the State program provide food safety
education to the public and regulated
industry?
3. Are enforcement tools utilized to reduce and
contain illness and injury?
Manufactured Food Regulatory Program Standards
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Appendix 5.1
Program Elements
Yes/
No
If no, please explain why element is not met
Outbreak reports and surveillance summaries are
distributed to the appropriate agencies.
1. Does the State program maintain a current list
of communication links with the appropriate
agencies?
2. Is a coordinator designated to guide
investigative efforts of all agencies involved?
3. Are investigations coordinated with the
appropriate agencies?
4. Is a procedure in place to conduct tracebacks
of food implicated in an illness, injury, or
outbreak, including coordination with the
appropriate agencies?
5. Are final reports of the State program’s
findings of foodborne illness and injury
investigations maintained and shared with the
appropriate agencies?
The State program provides guidance for
immediate notification of appropriate law
enforcement agencies when intentional food
contamination or terrorism is suspected or
threatened.
1. Does the State program have written
procedures for reporting threats of intentional
food contamination or terrorism?
2. Has the State program identified a
coordinator to lead investigations of
suspected or threatened intentional food
contamination and terrorism?
3. Has the State program identified the
appropriate agencies to be contacted and the
name and phone number of designated
contact persons in such agencies?
4. Does the State program collaborate as
necessary with FDA and other jurisdictions
when conditions of increased threat of
intentional contamination occur?
Assessment completed by:
__________________________________________________________________________________
(NAME)
(DATE)
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Appendix 5.2
Memorandum of understanding between the department of health and the department of
agriculture concerning the investigation of foodborne illnesses associated with food service
establishments and food plants
I. GENERAL
This Memorandum of Understanding (MOU) replaces the MOU dated ________, and effective on
_________, between the Department of Health (Health) and the Department of Agriculture
(Agriculture).
The purpose of this MOU is to clarify the respective responsibilities of Agriculture and Health in the
surveillance for, and investigation of, foodborne illnesses, and in furtherance of such purpose, to
broaden cooperative efforts between the two agencies.
Responsible Agencies
Agriculture and Health are the responsible agencies for the implementation of this MOU. Under the
authority of Sections ________________________ of the Public Health Law and pursuant to the
power granted to the State Commissioner of Health by Agriculture Law to certify and approve service
food establishment permit and inspection programs of local health agencies, the State Commissioner of
Health, by execution of this instrument, binds all city and county health departments and State district
health offices (local health units) to its terms and conditions.
For purposes of this agreement, Health and Agriculture will be responsible for its implementation.
Jurisdiction
This MOU applies to the entire State and includes all city and county health departments.
Effective Date
This agreement will be effective _______________.
Legal Authority
The _________________________________________________________ provides requisite
authority for Agriculture and Health to enter into this MOU. Section ______ of the Public Health Law
and Section _____ of the Agriculture Law also authorize this MOU.
II. RESPONSIBILITIES AND IMPLEMENTATION
Determination of Responsibility
When a food-related illness from a manufactured food product regulated by Agriculture, Health, and
local health departments is reported, Health will be responsible for conducting the epidemiologic
investigation. Agriculture will be responsible for investigating the food preparation areas and
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Appendix 5.2
conducting an investigation at the food plant. Agriculture will send a copy of these reports to Health.
Agriculture will also coordinate any resulting actions to remove the contaminated food from
distribution. Laboratory support for investigations will be coordinated by each agency under separate
existing agreements.
Implementation
Agriculture will inform its field representatives of their areas of responsibility. Health will define areas
of responsibility among its local health units. Responsibilities of other State and Federal agencies also
will be specified.
Health, Agriculture, and local health units will provide or sponsor joint training sessions in the
interpretation and application of principles, regulations, standards, and techniques of common concern
or interest.
III. MECHANISMS FOR INFORMATION EXCHANGE
Health, Agriculture, and each local health unit shall maintain rosters of regional and local Health
officials and Agriculture food program supervisors and make such rosters available to each other.
If Agriculture becomes aware of actual or suspected cases of foodborne illness, it shall report such
cases by telephone--without delay--to the local health unit having jurisdiction for that locality. Health
and Agriculture will jointly investigate and complete final reports involving illnesses that occur at, or
due to, establishments regulated by Agriculture. These reports will be forwarded to Agriculture and to
Health.
Whenever one agency learns of an FDA Class I or similar recall of food or food products, it shall
immediately notify the other agency of such recall. Throughout the recall process, both agencies at all
levels will make a maximum effort to keep the other agency informed and cooperate in every way
possible to expedite the removal of hazardous food from the marketplace.
IV. MECHANISMS FOR EMBARGO/SEIZURE OF FOOD SOURCES IMPLICATED IN
EPIDEMIOLOGIC INVESTIGATIONS
Epidemiologic Investigation
Health will investigate foodborne disease outbreaks. These investigations are conducted by county,
city health departments, and/or State health departments following procedures outlined in the
“Environmental Health Manual.” Health will notify Agriculture of all on-going investigations where a
contaminated food source is the suspected cause of a disease outbreak. Agriculture will provide
assistance in the investigation and may play the lead role in tracing contaminated foods back to their
source by visiting retailers, wholesalers, and producers to review and obtain records that document the
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Appendix 5.2
chain of distribution for the products. Health will analyze the findings of the epidemiologic and source
investigations and make a determination as to the likelihood of an association between the illness
outbreak and its cause being one or more sources. When warranted, based on the evaluation of the
investigation data and analysis, the Commissioner of Health will certify to the Commissioner of
Agriculture that food from the source(s) constitute(s) a danger to the health of the people of the State
and that such source(s) is/are unapproved source(s) for food service establishments in the State.
Embargo, Seizure, Recall, and Public Notification
After receiving certification from the Commissioner of Health, the Commissioner of Agriculture shall
direct the seizure quarantine and/or destruction of the food in question pursuant to the provisions of
Section ____ of the Agriculture Law, following his or her determination that said food is adulterated
within the meaning of Section ____ of the Agriculture Law and, as such, that the manufacture,
processing, possession, sale, offering, or exposure for sale of such food would violate Section _____ of
the Agriculture Law. Where they deem it appropriate, the Commissioners of Health and Agriculture
shall direct that a recall of such adulterated food be implemented and that the public be notified of such
recall. Health shall assist in cases involving such seizures, quarantines, destructions, and recalls by
assuring the removal of any remaining contaminated food from food service establishments and food
plants and by making available witnesses for any administrative proceedings and/or litigation
associated with such actions.
Nothing herein contained shall be construed to restrict the power of the Commissioner of Health to
take Summary Action under Public Health Law Section ___ to require the discontinuance of conditions
or activities constituting a danger to public health when such action is deemed appropriate under the
circumstances.
V. REVIEW OF AGREEMENT
This agreement between the two departments shall be submitted annually to the Governor's Office and
the Division of the Budget for their review of effectiveness and to solicit their recommendations to
both Agriculture and Health as to changes of policies and procedures with respect to this agreement.
For the Department of Agriculture
For the Department of Health
Signature_______________________________
Signature _________________________
Title
_______________________________
Title _____________________________
Date
_______________________________
Date ____________________________
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Appendix 6.1
Self-Assessment Worksheet
State agency: ___________________________________________________________
The State program will explain its compliance and enforcement program. Laws,
regulations, and manuals should be cited. If applicable, include web links to electronic
versions.
Your written response should include:
a. Forms that are required for enforcement actions, such as Notice of Embargo, Notice
and Directive to Cease and Desist, Agreement for Disposition of Product,
b. Examples of enforcement strategy(ies) and describe how they are uniformly applied,
c. A description of the system used to track critical and chronic violations and violators,
d. A description of the risk-based process used to determine when a directed
investigation, follow-up, or a re-inspection is needed,
e. A description of the timeline for progressive compliance actions including but not
limited to license revocation, embargoes, warning letters, and injunctions, and
f. A description of how non-supervisory and supervisory staffs receive verbal and
written policy and guidance that impact their compliance decisions.
Assessment completed by:
_______________________________________________________________________
(NAME)
(DATE)
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Appendix 6.2
Performance Review of Enforcement Actions
Worksheet 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 Worksheet 6.2.
FORMULA:
Performance factor rating = [ At / ( At + NIt )] x 100
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Worksheet 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)
Enter the sum of the
totals from all
continuation sheets.
Enter the final sums -subtotal + sums of (2) -on this form.
Compliance
procedures
followed? (2)
At =
NIt =
At =
NIt =
USE THIS SPACE TO EXPLAIN
IMPROVEMENTS NEEDED TO
FOLLOW COMPLIANCE
PROCEDURES
Assessment conducted by:
_____________________________________________________________________________________________
(NAME)
(DATE)
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Worksheet 6.2
Continuation sheet
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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Manufactured Food Regulatory Program Standards
September 2010
Appendix 7
Self-Assessment Worksheet
State agency: __________________________________________________________________
This worksheet is completed by the State program to document outreach activities. 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 (circle one):
seminar
workshop
training course
other: _______________________
b. Subject or name of outreach activity: ___________________________________
c. Date of outreach activity: _____________________________________________
Section II. Evaluation of Outreach Activity
Program Elements
a. The purpose and objectives were clearly defined
b. The context of the training activity 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 the Section III of the form.
Yes/No
If no, please explain.
Section III. Critique of Outreach Activity
Discuss what went well, what could be done better, and what more could be done to improve the
outreach activity.
Assessment completed by:
_____________________________________________________________________________
(NAME)
(DATE)
91
Manufactured Food Regulatory Program Standards
September 2010
Appendix 8.1
Self-Assessment Worksheet
Manufactured Food Regulatory Program Standards
State agency: __________________________________________________________________________
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.
1
Standard
Regulatory
Foundation
92
2
Training Program
3
Inspection Program
4
Inspection Audit
Program
Food-related Illness
…Outbreaks…Food
Defense…
Compliance and
Enforcement
Industry and
Community
Relations
5
6
7
September 2010
8
Program Resources
9
Program
Assessment
10
Laboratory Support
Funding
Staffing
Equipment
Other resources needed
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 1 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) 2
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
1
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.
2
Inspection times based on calculations presented in “DHHS Office of Inspector General’s FDA Oversight of State Food Firm
Inspections” dated June 2000.
93
Manufactured Food Regulatory Program Standards
September 2010
Appendix 8.3
Inspection Equipment
State agency: _______________________________________________________________
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 whether the
equipment is assigned or available to inspectors. Equipment requested by inspectors but not
available should be marked “wish list.”
Equipment
Assigned
Available
Wish list
Computer and printer
Camera
Digital 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
94
Manufactured Food Regulatory Program Standards
September 2010
Worksheet 9
Self Assessment and Improvement Plan Report
State agency: _________________________________________________________________________
Report completed by: __________________________________________________________________________
(NAME)
Standard
1
2
3
4
5
(DATE)
Self Assessment
Regulatory
Foundation
Complete
Incomplete
Hours used
Training
Program
Complete
Incomplete
Hours used
Inspection
Program
Complete
Incomplete
Hours used
Inspection
Audit Program
Complete
Incomplete
Hours used
Food-related
Illness
…Outbreaks…
Food Defense…
Complete
Incomplete
Hours used
____
____
____
____
____
Implementation
Explain improvements needed to fully implement
standard (required for incomplete self assessment or
partial implementation)
Full
Partial
Full
Partial
Full
Partial
Full
Partial
Full
Partial
95
Manufactured Food Regulatory Program Standards
September 2010
Worksheet 9 – cont’d.
State agency: _________________________________________________________________________
Report completed by: __________________________________________________________________________
(NAME)
Standard
6
7
8
9
10
(DATE)
Self Assessment
Compliance and
Enforcement
Complete
Incomplete
Hours used
Industry and
Community
Relations
Complete
Incomplete
Hours used
Program
Resources
Complete
Incomplete
Hours used
Program
Assessment
Complete
Incomplete
Hours used
Laboratory
Support
Complete
Incomplete
Hours used
____
____
____
____
____
Implementation
Explain improvements needed to fully implement
standards (required for incomplete self assessment and
partial implementation)
Full
Partial
Full
Partial
Full
Partial
Full
Partial
Full
Partial
96
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September 2010
Appendix 10
Self-Assessment Worksheet
State agency: ____________________________________________________________
Program Elements
Does the State program have:
a. A current list of servicing
laboratories
b. A list of analytical capabilities
for each servicing laboratory
c. A servicing laboratory to
analyze samples that may
contain biological hazards.
d. Contracts or written
agreements with servicing
laboratories.
e. Verification of the servicing
laboratory’s accreditation or
certification
The servicing laboratory’s QAP
contains the requirements listed
here:
a. Calibration, verification, and
maintenance of equipment
b. Documentation of analytical
results
c. Recordkeeping
(worksheets, sample records)
d. Sample accountability
e. Sample integrity and chain of
custody
f. Qualifications of analysts
(training included)
g. Audit procedures
Yes/No If no, please explain why element is not met
Assessment completed by:
________________________________________________________________________
(NAME)
(DATE)
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| File Type | application/pdf |
| File Title | Manufactured Food Regulatory Program Standards |
| Author | Division of Federal-State Relations |
| File Modified | 2013-08-13 |
| File Created | 2011-01-31 |