ARMY MIL-HDBK-3006 C-2008 GUIDELINES FOR AUDITING FOOD ESTABLISHMENTS《食品企业审计指导》.pdf

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1、NOT MEASUREMENT SENSITIVE MIL-HDBK-3006C 1 June 2008 _ SUPERCEDING MIL-HDBK-3006A 7 June 2002 DEPARTMENT OF DEFENSE MILITARY HANDBOOK GUIDELINES FOR AUDITING FOOD ESTABLISHMENTS This handbook is for guidance. Do not cite this document as a requirement. AMSC N/A FSG 89GP DISTRIBUTION STATEMENT A. App

2、roved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-HDBK-3006C FOREWORD 1. This handbook is approved for use by all Departments and Agencies of the Department of Defense (DOD). 2. This handbook is

3、used in conjunction with the requirements delineated in MIL-STD-3006C, its appendices and supporting Government or non-Government publications. Other requirements that are not prescribed in the referenced documents do not apply. 3. This handbook contains guidelines for auditing commercial food estab

4、lishments, including manufacturing, packaging, and storage facilities. 4. Each appendix is based on regulatory, industry and DOD requirements. 5. Comments, suggestions, or questions on this document should be addressed to the Director, DOD Veterinary Service Activity, Office of the Surgeon General/H

5、QDA, 5109 Leesburg Pike, Falls Church, VA 22041-3258. Since contact information can change, you may want to verify the currency of this address information using the ASSIT Online database at http:/assist.daps.dla.mil. iiProvided by IHSNot for ResaleNo reproduction or networking permitted without lic

6、ense from IHS-,-,-MIL-HDBK-3006C CONTENTS PARAGRAPH PAGE FOREWORD ii 1. SCOPE . 1 1.1 Scope. 1 1.2 Application. 1 1.3 Objectives. 1 1.4 Limitations. 1 2. APPLICABLE DOCUMENTS 1 2.1 General. 1 2.2 Government Documents. 1 2.2.1 Standard . 1 2.2.2 Other Government publications . 2 3. DEFINITIONS 2 3.1

7、General. 2 3.2 Acceptable Sanitation Audit Rating. . 2 3.3 Adulterated. . 2 3.4 Allergens. . 2 3.5 Bioterrorism. . 2 3.6 Corrective Action Request (CAR). 2 3.7 Controlled Atmosphere Packaging (CAP) 3 3.8 Critical Finding. 3 3.9 Directed Routine Sanitation Audit. . 3 3.10 Dual-Listed Establishments.

8、3 3.11 Food Defense Finding. 3 3.12 Food Defense Plan. 3 3.13 Food Defense Program. 3 3.14 Food Operational Risk Management (FORM). . 3 3.15 Food Safety and Defense. . 3 3.16 Food Safety Program (FSP). 4 3.17 Functional Area. 4 3.18 Imminent Health Hazard. 4 3.19 Initial Sanitation Audit. 4 3.20 Maj

9、or Finding. 4 3.21 Modified Atmosphere Packaging (MAP). . 4 3.22 Objective Evidence 4 3.23 Observation. 4 3.24 Pre-operational Sanitation Inspection. . 4 3.25 Qualified Auditor (QA). . 5 3.26 Reduced Oxygen Packaging (ROP). 5 3.27 Root Cause. 5 iiiProvided by IHSNot for ResaleNo reproduction or netw

10、orking permitted without license from IHS-,-,-MIL-HDBK-3006C 3.28 Routine Sanitation Audit. . 5 3.29 Sanitation Audit. . 5 3.30 Sanitation Audit Rating. . 5 3.31 Sanitation Audit Report (SAR) 5 3.32 Special Sanitation Audit. 5 3.33 Unacceptable Sanitation Audit Rating 5 3.34 Vacuum Packaging. 5 3.35

11、 Validation. 6 3.36 Verification. . 6 3.37 Veterinary Corps Officer (VCO). 6 3.38 Vulnerability. . 6 3.39 Water Potability Certificate. 6 3.40 Working Papers. . 6 4. GENERAL GUIDANCE 6 4.1 Auditing Personnel 6 4.1.1 Sanitation Audits. . 6 4.1.2 Joint Audits. . 6 4.1.3 Certification Program. . 7 4.2

12、Audit Performance. . 7 4.2.1 Sanitation Approval Requirements for Procurement. 7 4.2.2 Establishments that may not have to be Worldwide Directory Listed. 7 4.3 Thermally Processed Food in Hermetically Sealed Containers. 7 4.4 Irradiated Foods 7 4.5 Food Handlers Certificates. 9 4.6 Change in Establi

13、shments Name or Ownership. 9 4.7 Change in Establishment Location (Relocation). . 9 4.8 Sanitation Audit Frequency. 9 4.9 Use of Documents. . 9 4.9.1 Appendix A Subparts. . 9 4.9.2 Sanitation Audit Report Scoring Findings. . 9 5. AUDIT PROCEDURES FOR SANITATION AUDITS . 10 5.1 Planning, Scheduling,

14、and Conducting the Sanitation Audit. 10 5.1.1 Scheduling the Sanitation Audit. 10 5.1.2 Assemble and Review all Reference Materials. . 11 5.1.3 Pre-audit Preparation. . 11 5.2 Performance of the Sanitation Audit. . 12 5.2.1 Arrival at Establishment. . 12 5.2.2 Refusal of Entry. . 12 5.2.3 Confidenti

15、ality. . 12 5.2.4 Harassment or Abuse. 13 5.2.5 Pre-audit Meeting. . 13 5.2.6 Conducting the Audit - Document Review. 15 5.2.6.1 Water 1-800-553-6847; or download from web site: http:/www.usapa.army.mil/.) 3. DEFINITIONS 3.1 General. The definitions and interpretations of terms found in 21 CFR 110 a

16、re applicable to this handbook. 3.2 Acceptable Sanitation Audit Rating. No Critical findings or no more than three Major findings. Observations will not result in an “Unacceptable“ rating. The cumulative effect of multiple observations indicating an out-of-control process may require an upgrade to o

17、ne Major Finding, due to increased public health significance. 3.3 Adulterated. A food is deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health IAW the Federal Food, Drug and Cosmetic Act, Section 402. 3.4 Allerg

18、ens. Ingredients that are “known” allergens include eggs, milk, fish, soybeans, peanuts, tree nuts, crustacea and wheat or any food that contains proteins derived from these foods. 3.5 Bioterrorism. Bioterrorism is the use of biological agents, such as pathogenic organisms or agricultural pests, for

19、 terrorist purposes against a civilian or military population by a Government, organization, or individual. 3.6 Corrective Action Request (CAR). A written request from the auditor to management addressing specific findings that require a response from management as to the root cause of the finding a

20、s well as the action(s) taken to correct and prevent recurrence of the finding(s). 2Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-HDBK-3006C 3.7 Controlled Atmosphere Packaging (CAP). The packaging of a product in a modified atmosphere followed

21、 by maintaining subsequent control of that atmosphere. 3.8 Critical Finding. An imminent health hazard caused by a condition which presents a biological, chemical or physical food safety or food defense hazard that if not prevented, eliminated or reduced by a subsequent process, practice, step or pr

22、ocedure (hurdles); or that may cause food to be unsafe for consumption or otherwise adulterated. 3.9 Directed Routine Sanitation Audit. Conducted at the direction of the applicable MACOM Veterinarian within establishments listed in the Worldwide Directory when laboratory results indicate a need for

23、further sanitation cognizance or other reasons. The focus of this audit is normally limited to the areas of concern. 3.10 Dual-Listed Establishments. Dual-Listed establishments are establishments listed in the Worldwide Directory and another recognized Federal or State approved listing. 3.11 Food De

24、fense Finding. Any condition, practice, step or procedure noted relating to the risk of intentional food tampering or increased food vulnerability. Food Defense Findings can occur at any stage during receipt, storage, in-processing, packaging, packing, warehousing or distribution. Severity of findin

25、gs will be classified as Critical, Major or Observation as defined within this handbook. 3.12 Food Defense Plan. A written document or approach that uses established risk management procedures for preventing intentional food tampering and responding to threats or actual incidents of intentional tamp

26、ering. 3.13 Food Defense Program. A program developed by an establishment to assess and mitigate the vulnerabilities within the food system or infrastructure to an attack from deliberate or intentional acts of food destruction, contamination or tampering. By conducting a vulnerability assessment and

27、 determining the most vulnerable points in the system, the establishment can then determine which vulnerabilities can be addressed and improved to increase the overall food defense level of their establishment and products. 3.14 Food Operational Risk Management (FORM). A simplified food safety and d

28、efense risk assessment process based on severity and frequency to prioritize risks, target resources and focus efforts on short-term accomplishments. The approach is similar to a Hazard Analysis Critical Control Point (HACCP) plan and used to minimize food safety and defense risks. Components of FOR

29、M include: (1) Identify the hazards; 2) Assess the risk; 3) Analyze risk control measures; 4) Make control decisions; 5) Implement risk controls; and 6) Supervise and review. FORM provides for a more effective use of resources and can be used to improve food safety and defense. Note: A HACCP plan su

30、pports, but does not substitute a FORM assessment. 3.15 Food Safety and Defense. A food is deemed safe when it has been received, prepared, packed, stored and distributed under sanitary conditions whereby it has not been rendered injurious to health. Food Defense is the implementation of programs or

31、 barriers that 3Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-HDBK-3006C prevent or reduce the susceptibility and/or vulnerability of food systems to deliberate or intentional acts of destruction, contamination or tampering. 3.16 Food Safety Pr

32、ogram (FSP). A written or practiced non-regulatory plan (similar to HACCP) that is implemented and practiced by establishment personnel and is designed to ensure the safe production of food. To differentiate mandatory (regulatory) HACCP from a voluntary program, this document makes reference to the

33、Food Safety Program. 3.17 Functional Area. Areas (commonly referred to as Unit Operations) within a food processing establishment where food is received, stored, staged, prepared, processed, packaged, packed, and distributed (shipped). 3.18 Imminent Health Hazard. A significant threat or danger to h

34、ealth that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on: (1) the number of potential injuries, and (2) the nature, severity

35、, and duration of the anticipated injury. 3.19 Initial Sanitation Audit. A comprehensive evaluation of a commercial food establishment that determines the sanitary status for the first time. The Initial sanitation audit is triggered by a request to list a commercial establishment in the Worldwide Di

36、rectory. This audit is used to approve or disapprove the establishment as a source for Armed Forces procurement. Initial sanitation audits are a complete assessment of the facilities production procedures, and food safety and food defense control systems. 3.20 Major Finding. Condition, practice, ste

37、p or procedure which in itself does not present a food defense or imminent health hazard yet has the potential to affect food safety or the products intended use due to loss or lack of verifiable control. 3.21 Modified Atmosphere Packaging (MAP). The packaging of a product in an atmosphere which has

38、 had a one-time modification of gaseous composition so that it is different from that of air, which normally contains 78.08% nitrogen, 20.96% oxygen, 0.03% carbon dioxide. MAP is achieved by two distinct processes, active or passive. 3.22 Objective Evidence. Data confirming the status (presence or a

39、bsence) of a condition, practice, step or procedure. Objective evidence may be obtained through observation, interviews, measurement, tests, record reviews, or other means. 3.23 Observation. Condition, practice, step or procedure that is not in accordance with food safety and defense requirements, a

40、nd does not meet the criteria of a Critical or Major finding. 3.24 Pre-operational Sanitation Inspection. Verification of proper sanitation of functional areas and equipment before production. This may or may not include visual verification of cleaning and sanitizing techniques. 4Provided by IHSNot

41、for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-HDBK-3006C 3.25 Qualified Auditor (QA). An individual certified by education, experience, technical ability, and temperament in accordance with governing regulations. 3.26 Reduced Oxygen Packaging (ROP). Provides an e

42、nvironment that contains little or no oxygen. 3.27 Root Cause. A true cause of a finding based on an in-depth investigation. 3.28 Routine Sanitation Audit. An evaluation to determine the current sanitary status and overall status of the sanitation and food defense programs of an establishment provid

43、ing subsistence to the Armed Forces. These audits result in the continued approval of the establishment or a notice to its management of the possibility of disapproval if the sanitary findings observed are not corrected in a reasonable amount of time, as determined by the MACOM Veterinarian. Routine

44、 sanitation audits will be thorough enough, and at a frequency that allows the auditor to evaluate the current conditions of the establishment and associated operations. The in-plant assessment during Routine Sanitation Audits are normally performed in the same depth and complexity as Initial Sanita

45、tion Audits. 3.29 Sanitation Audit. An in-depth examination of an establishments policy and procedures to determine effectiveness and compliance as it applies to the protection of food. Sanitation audits examine and evaluate the adequacy of an establishments food safety, food defense, and other appl

46、icable control systems. Sanitation audits include Initial, Routine, Directed Routine, and Special audits. 3.30 Sanitation Audit Rating. A rating based upon the results of the sanitation audit, rated as either “Acceptable” or “Unacceptable”. 3.31 Sanitation Audit Report (SAR). A written record of the

47、 results from a sanitation audit. 3.32 Special Sanitation Audit. An evaluation to determine whether the establishment will remain an approved source for the procurement of subsistence for the Armed Forces. This audit is performed after an establishment has been rated “Unacceptable“ after a Routine o

48、r Directed Routine sanitation audit, or the MACOM Veterinarian has reason to suspect products may be a threat to public health. The focus of this audit is normally limited to the findings found during a previous audit that was rated “Unacceptable”. 3.33 Unacceptable Sanitation Audit Rating. The rati

49、ng given to an establishment that does not comply with the requirements of the sanitation audit. One Critical finding or more than three Major findings constitute an unacceptable audit rating. Observations alone will not result in an “Unacceptable“ rating. The cumulative effect of multiple Observations indicating an out-of-control process may requir