Attachment 6--Quality System Plan Evaluation.docx

QUALITY SYSTEM PLAN EVALUATION

The Quality Standard ANSI/ISO/ASQ Q9001 Quality Management Systems -Requirements, is the quality standard referenced in Operational Rations contracts/Technical Data Packets. This standard, ANSI/ISO/ASQ Q9001, is applicable to suppliers required to submit a documented Quality System Plan (QSP) and performing under the higher-level contract quality requirements. Documented QSPs modeled using ISO 9002:1994 should reference ANSI/ISO/ASQ Q9001. Suppliers that currently have a QSP rated acceptable and are successfully performing under the higher-level contract quality requirements should continue performing under their approved documented QSP.

This workbook was developed using the guidance and requirements of the following documents: ANSI/ISO/ASQ Q9001 Quality Standard; DLAR MPC Clause 52-246-9001 Manufacturing Process Controls and In-Process Inspection; Statistical Process Control Quality Assurance Provision (SPC QAP); and ISO 10012-1 Control of Inspection, Measuring, and Test Equipment, and; general requirements cited in the Operational Rations Technical Data Packets (TDP) specifying Higher Level Contract Quality requirements. The workbook was developed to standardize the evaluations of documented QSPs developed using ANSI/ISO/ASQ Q9001, other recognized industry quality standards, or a non-standard supplier’s specific process control system. When the Higher Level Contract Quality requirements are cited in the contract, suppliers are to clearly specify their preferred documented quality system in accordance with ANSI/ISO/ASQ Q9001, a system that meets other recognized industry quality standards, or a process control system that is equivalent to or better than ANSI/ISO/ASQ Q9001. If the supplier proposes an alternate (i.e., non-standard) process control system, this shall be clearly stated in the QSP. Regardless of the standard or non-standard document used to model the QSP, the QSP shall address, at a minimum, the elements cited in the contract and, within each element, the supplier shall provide the information requested in each section of this workbook.

This revision contains the following significant changes:

1. DLA Troop Support’s Organizational changes and responsibilities.

2. Food Defense Plans will be maintained as a separate program and evaluated by the DLA TROOP SUPPORT-FTSB personnel.

3. Integrated Pest Management cited in Section IX. Regulatory Controls was revised. Program will be maintained as a separate program and evaluated by the DLA TROOP SUPPORT-FTSC entomologist.

4. Minor changes were made to some sections to facilitate the planning and performance of DLA Troop Support quality system audits.

5. The FDA CFR requirements apply (a) CFR Title 21, Chapter 1, PART 117 Current Good Manufacturing Practice, Hazard Analysis, Risk Based Preventive Controls for Human Food;

(b) CFR Title 21, PART 113, FDA Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers- (LACF), and (c) CFR Title 21, Part 121 Mitigation Strategies to Protect Food Against Intentional Adulteration (IA regulation).

To download a copy of this guideline go to the DLA Troop Support Subsistence web-site at https://www.dla.mil/Portals/104/Documents/TroopSupport/Subsistence/FoodSafety/FoodQuality/TS_qsp_ 151204.pdf or contact the Supplier Support Division, Quality Audit & Food Defense Branch (DLA Troop Support- FTSB) or the applicable Contracting Officer. Beneficial comments (recommendations, additions, and deletions) of any pertinent data which may be used in improving this document should be addressed to: Defense Logistics Agency-Troop Support, Directorate of Subsistence, Bldg. 6 FTSB, 700 Robbins Avenue, Philadelphia, PA 19111-5092, and telephone: (215) 737-8656 or 5353.

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SPE3S1-22-R-0012

Attachment 6

TABLE OF CONTENTS

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LIST OF TERMS, ABBREVIATIONS AND ACRONYMS

1. ANSI: American National Standards Institute

2. ASQC: American Society of Quality Control

3. CAR: Corrective Action Request

4. CFR: Code of Federal Regulations

5. DFAR: Defense Federal Acquisition Regulation.

6. DLA: Defense Logistics Agency

7. DLAM: Defense Logistics Manual

8. DLAR: Defense Logistics Regulation

9. DLA-TS: Defense Logistics Agency Troop Support

10. FAR: Federal Acquisition Regulation

11. FDA: Food and Drug Administration

12. FDP: Food Defense Plan

13. HACCP: Hazard Analysis Critical Control Point

14. IPMSP: Integrated Pest Management and Sanitation Program

15. ISO: International Organization for Standardization

16. LCL: Lower Control Limits

17. LSP: Lower Specification Limits

18. MPC: Manufacturing Process Controls

19. QA: Quality Assurance

20. QAP: Quality Assurance Provision

21. QAR: Quality Assurance Representative

22. QAS: Quality Assurance Specialist

23. QC: Quality Control

24. QIIR: Quality Improvement Initiative Report

25. QS: Quality System

26. QSP: Quality System Plan iv

27. SPC: Statistical Process Control

28. TDP: Technical Data Package

29. UCL: Upper Control Limits

30. USA PHC: United States Army Public Health Center

31. USDA: United States Department of Agriculture

32. USDA-AMS: (USDA Agricultural Marketing Services)

33. USDA-FSIS: USDA Food Safety Inspection Services

34. USL: Upper Specification Limits

35. VECP: Value Engineering Change Proposal Program v

GENERAL QUALITY SYSTEMS PLAN AND QUALITY SYSTEMS REQUIREMENTS (ISO 9001 ELEMENTS 1 – 3 AND SECTION E OF THE TDP)

1. SCOPE

1.1. GENERAL: This workbook was developed using the guidance and requirements of the following documents: ANSI/ISO/ASQ Q9001 Quality Management Systems- Requirements; DLAR MPC Clause 52-246-9001 Manufacturing Process Controls and In-Process Inspection; Statistical Process Control Quality Assurance Provision (SPC QAP); ISO 10012-1 Control of Inspection, Measuring, and Test Equipment, and; general requirements cited in the Operational Rations Technical Data Packets (TDP) specifying Higher Level Contract Quality requirements. The workbook was developed to standardize the evaluations of documented Quality Systems Plans (QSPs) developed using ANSI/ISO/ASQ Q9001, other recognized industry quality standards, or a non-standard supplier’s specific process control system.

1.2 APPLICATION: When the Higher Level Contract Quality requirements are cited in the contract, suppliers are to clearly specify their preferred documented quality system in accordance with ANSI/ISO/ASQ Q9001, a system that meets other recognized industry quality standards, or a process control system that is equivalent to or better than ANSI/ISO/ASQ Q9001. If the supplier proposes an alternate (i.e., non-standard) process control system, this shall be clearly stated in the QSP. Regardless of the standard or non-standard document used to model the QSP, the QSP shall address, at a minimum, the elements cited in the contract and, within each element, the supplier shall provide the information requested in each section of this workbook. Documented QSPs are submitted by suppliers for the purpose of demonstrating their capability to meet the higher-level contract quality requirements and for Procurement Contracting Officers (PCO) to assess a supplier’s capability to meet these requirements. The Government will recognize a supplier’s quality system whenever it meets the contract requirements, whether the quality system is modeled on military, commercial, national or international quality systems standards. The design and implementation of a QSP will be influenced by the varying needs of a company, its particular goals and objectives, the products produced, and the processes and specific practices employed in the operation. The intent of the requirements is for suppliers to improve process capability, process control which, when used effectively, can result in a prevention- oriented approach rather than a detection approach that will improve product quality and lower cost through a single quality system in any supplier facility. Suppliers are required to establish, document, submit for Government evaluation, and maintain a quality system as a means of ensuring that product conforms to the requirements of the contract. However, it should be emphasized that the quality system requirements cited in the selected standard/non- standard document are complementary (not alternative) to the contract specified requirements.

2. NORMATIVE REFERENCE:

A. The documented QSP shall include the quality system procedures, reference or include working instructions and forms, and outline the structure of the documentation used in the quality system. The Higher Level Contract Quality Requirements (HLCQR), MPC Clause, SPC QAP apply to all operational rations Contractor-Furnished Material (CFM) and Government-Furnished Material (GFM) food components and Sub-Assembly and Assembly Operations, unless specifically excluded in the contract (only the SPC QAP is entirely excluded from some contracts and for some components in some contracts). However, regardless of the standard or non-standard document used to model the QSP, if the QSP satisfactorily addresses, at a minimum, the elements cited in the contract and, within each element, the supplier submit the required documentation and provides the information requested in each section of this workbook, the supplier’s QSP will be demonstrating their capability to meet the higher-level contract quality requirements, the requirements cited in ANSI/ISO/ASQ Q9001, MPC Clause, and the SPC QAP. Redundant areas/requirements (cited in the MPC Clause or the SPC QAP) need only be addressed once in the QSP and must encompass the requirements of the most stringent document. The calibration of measuring and testing equipment shall, as a minimum, adhere to the requirements of ISO 10012-1 (supplier must identify in QSP the document selected for their calibration system).

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If the quality manual (QM) or QSP’s tier or procedures submitted do not include the documents requested or satisfactorily answer the questions in this workbook; the working instructions, forms (containing instructions), or other secondary documents must be included (regardless of QM or QSP’s tier) in order to receive an acceptable rating. A DLA Troop Support Quality System Qualification Certificate will be issued once the supplier’s QSP is rated acceptable and a Government Quality System Compliance Audit has been conducted to verify the implementation and compliance of the approved QSP and the effectiveness of the system implemented in consistently producing conforming product meeting the requirements specified in the contract. The acceptability of the QSP and the quality system qualification may be withdrawn under the following circumstances or as indicated in the contract: The supplier fails to implement and comply with the approved QSP; fails to submit QSP revisions for Government review and approval (as indicated in the contract); and/or fails to make changes to the QSP when this is no longer effective or the system implemented is not capable of consistently producing conforming product.

B. Documented QSPs will be evaluated by the Supplier Support Division, Quality Audit & Food Defense Branch personnel, the Operational Rations Coordinators from each respective inspection office (USDA-AMS/USA Public Health Center) and the Government In-Plant QARs assigned to perform Government QA at the supplier’s plant. Aforementioned Government personnel will use this evaluation guideline (in conjunction with the standard or other documents identified in the supplier’s QSP and other general requirements cited in the TDPs), as the basic framework against which they will evaluate documented QSPs.

C. This workbook is divided into 13 sections. Note that Section XIII Improvement is a requirement not an option. The language cited in this section contains requirements cited in element 8 of ANSI/ISO/ASQ Q9001 and the Operational Rations TDP. Each section of the workbook contains the applicable reference document: The applicable elements of ANSI/ISO/ASQ Q9001; MPC Clause; SPC QAP; ISO 10012-1; Code of Federal Regulations, and other general requirements cited in the Operational Rations TDPs. If additional information or clarification is necessary, the referenced documents shall be consulted.

NOTE: TO THE EXTENT OF ANY INCONSISTENCY BETWEEN THE CONTRACT OR ITS GENERAL PROVISIONS AND A SUPPLIER’S QSP, THE QUALITY STANDARD SELECTED, THIS WORKBOOK, AND/OR IMPLEMENTED QUALITY SYSTEM, THE CONTRACT AND THE GENERAL PROVISIONS SHALL CONTROL.

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SECTION I

MANAGEMENT RESPONSIBILITY AND QUALITY SYSTEM DESIGN

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, Specific Product Specifications or Commercial Item Descriptions, ISO 9001 (4, 4.1, 4.2.1, 4.2.2, 5, 5.1, 5.3, 5.4.1, 5.5, 5.5.1, 5.5.2, 5.6, 6, and 6.2) and ANSI/ASQC Z1.4.

AREA 1. MANAGEMENT RESPONSIBILITY (ISO 5):

A. QUALITY POLICY (ISO 5.1, 5.2, 5.3, and 5.4.1):

1. Are the company's policy, objectives, and commitment to quality identified?

2. If statistical process control techniques are used, does the QSP identify the policy for applying SPC and the goals and commitments for using SPC?

3. Is the company’s policy relevant to the overall organizational goals and the expectations and needs of the Government?

4. Does the QSP identify how top management ensures that the quality policy is communicated, understood, and maintained at all levels of the organization?

B. ORGANIZATION (ISO 5.5 and 5.5.1):

1. Responsibility and authority: Specific names of individuals do not have to be provided as long as the positions are identified. An organization chart must be included to illustrate and explain the relationship of the quality assurance (QA) and production personnel to the rest of the organization and the assignment and responsibilities of QA and production personnel within the organization:

a. Was a copy of the organization chart included?

b. Does the chart clearly illustrate and identify the relationship of quality to production personnel?

c. Is the relationship of quality and production to the overall organization clearly identified?

2. Resources requirements (ISO 6 and 6.2):

a. Does the QSP identify management personnel (by position and assignment) responsible for the overall implementation and effectiveness of each section of the QSP?

b. Does the QSP identify the assignment of trained personnel responsible for the supervision, performance of work, and verification activities such as inspection and testing at each location identified in the QSP?

3. Management Representative (ISO 5.5.2): Does the company identify the manager(s), irrespective of other responsibilities, who have the defined authority for: (1) Ensuring that the quality system is established, implemented, and maintained in accordance with the quality standard selected and the contract specified quality requirements; (2) reporting on the performance of the quality system to the company’s top management for review and as the basis for improvement of the system, and or; (3) represent the company as a liaison between the contractor and DLA Troop Support on matters relating to the company's quality system?

C. MANAGEMENT REVIEW (ISO 5.6):

SECTION I Continued

1. Does the company's identify the manager, with executive responsibility, who is responsible for reviewing the quality system to ensure its continuing suitability and effectiveness in satisfying the requirements of the quality standard selected, the company's stated quality policy and objectives, and the requirements of DLA Troop Support contracts?

2. Is the interval for management's quality system review defined?

3. Is the interval sufficient to meet the requirements of the standard selected, contract requirements, and company's stated quality policy and objectives? The frequency shall not be less than the frequency of DLA Troop Support compliance audits for a contractor’s facility (at least annually).

4. Does the company indicate the type of records to be maintained for the management reviews?

AREA 2 QUALITY SYSTEM (ISO 4): The information required in this area needs to be evaluated after all other sections of the QSP are evaluated.

A. QUALITY SYSTEM DESIGN (ISO 4, 4.1, and 4.2.1):

1. Is the quality standard used to develop the QSP identified (if a non-standard document was used or if the supplier used this guideline, workbook I, to develop their QSP, this must clearly be indicated in the QSP).

2. Does the QSP, at a minimum, cover the elements cited in the contract TDP?

B. QUALITY SYSTEM PROCEDURES (ISO 4.2.2):

1. Does the QSP include procedures covering the quality system implemented as a means of ensuring product conformance to contract requirements? NOTE: If the quality manual (QM) or QSP tier or procedures submitted do not include the documents requested or satisfactorily answer the questions in this workbook, the working instructions, forms (containing instructions), or other secondary documents must be submitted (regardless of QM or QSP tier) in order to receive an acceptable QSP rating.

2. Are the procedures consistent with the requirements of the quality standard selected and the requirements of the contract?

3. If the working instructions (that define how each activity is performed) and forms used were not included with the QSP, are these identified in the document master list and referenced in the documented procedures?

C. QUALITY PLANNING (ISO 5.4.1):

1. Does the QSP clearly define how the requirements for quality will be met?

2. Is the QSP consistent with the company's policy and quality objectives, documented to suit the company's method of operations, and the requirements of the contract?

SECTION I AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed):

SECTION II TRAINING

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, CFR, ISO 9001 (6.2.2) and the DLA TROOP SUPPORT Food Defense Checklist

GENERAL: The contractor shall establish and maintain documented procedures for identifying training needs and provide the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training and or experience, as required by the contract, regulatory agency, and company for each position. Copy of records (certificates, diplomas, and other record of attendance of internal or external training) shall be maintained for each employee.

A. Training Manager: Does the QSP identify the company's manager (by position) responsible for the overall implementation and effectiveness of the contractor's training program and the person responsible for maintaining training records?

B. Training and Qualification Requirements:

1. Supervisory Personnel: Does the QSP identify the training/qualification requirements for supervisory personnel (by position as identified under resource requirements) responsible for ensuring implementation compliance and effectiveness of the quality systems program (covering the 13 areas of the QSP) and the Food Defense Plan)?

2. Non-supervisory personnel: Does the QSP identify the qualification and training requirements for personnel (by position/grouping of positions) performing inspections, testing, monitoring, and recording the following activities (as applicable to the assigned position): document and data control; Integrated Pest Management and Sanitation Program; handling, storage, packaging, preservation, and delivery program; product identification and traceability; control of nonconforming material; contract reviews and purchasing; receipt inspection and testing; in-process and process inspection and testing; regulatory requirements and controls; statistical process controls; end item inspection and testing; internal audits; corrective and preventive actions; and Food Defense compliance.

3. Regulatory/Contractual Training Certification Requirements: Does the QSP identify personnel by position required by regulatory agencies, contract and/or the contractor to be certified or trained in a specific technical skill (e.g., Processing Authority, retort supervisors, retort operators, HACCP manager, container integrity/can seam technicians, water treatment technicians, sanitation personnel, pest management personnel, etc.)?

4. Compliance with Training Certification Requirements: Does the QSP identify the steps to be taken to ensure personnel (responsible for performing, monitoring or ensuring compliance to regulatory requirements) obtain the required certifications/qualifications for each position identified above (training may be the same for same or similar positions)?

C. The QSP must identify the following for each section or quality activity identified above, other areas of the QSP and Food Defense Plan: (same or similar jobs may be grouped together if the training requirement is the same):

1. Who will be trained (by position)?

2. How much training is planned (new employees and current employees)?

3. Types and extent of training (academic, On-the-Job-Training, or combination).

4. Who will conduct the training and where will the training take place (internal or external source)?

TOTAL POINTS :

SECTION II AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed):

SECTION III

DOCUMENT AND DATA CONTROL AND CONTROL OF QUALITY RECORDS

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, Specific Product Specifications or Commercial Item Descriptions, and ISO 9001 (4.2, 4.2.1, 4.2.3 and 4.2.4).

GENERAL: The contractor shall establish and maintain documented procedures to control all records and documents related to the requirements of the quality standard selected and the contract requirements. The procedure must also include control of documents of external origin such as commercial or Government standards, specifications, regulations, other documents, and all data generated by the quality system.

AREA 1. DOCUMENT AND DATA CONTROL (ISO 4.2.1 and 4.2.3):

A. Does the QSP include a master list or equivalent document-control procedure identifying the current revision status of documents being used by the company (procedures, working instructions, forms, reports or other documents)?

B. Does the QSP state how documents and data are reviewed and approved for adequacy prior to issue?

C. Does the QSP indicate how the contractor ensures the appropriate documents (procedures, working instructions, specifications, contract, or other documents) are available at all locations where operations essential to the effective functioning of the quality system are performed?

D. Does the procedure ensure against the unintended use of invalid and or obsolete documents at all points of issue or use?

E. Does the QSP indicate that changes to documents shall be reviewed and approved using the same procedure and by the same function that performed the original review and approval? If not, the plan should specifically designate otherwise.

AREA 2. CONTROL OF QUALITY RECORDS (ISO 4.2.4): The contractor shall establish and maintain documented procedures for the identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records and other records generated by the system.

A. Does the procedure indicate how records will be identified/collected/ indexed/filed (e.g., by product, lot number, etc.)?

B. Does the procedure indicate how and where (internal/external location) records will stored/ maintained? Based on the storage location identified, does it appear that records can be readily retrievable? NOTE: Ready retrievable is defined as retrievable within 1 day (24 hours) of request during an audit or in the case of a hazardous food recall.

C. Is the storage facility identified (location of storage) suitable to prevent damage or deterioration and to prevent loss of records?

D. Retention period and review: Does the record retention procedure indicates that all records, documentation pertaining to DLA Troop Support contracts will be retained and be available for review and evaluation by Government personnel during production of the contract and for a period of three years after completion of the contract?

SECTION III AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed)

SECTION IV

GENERAL: The contractor shall establish and maintain documented procedures to control, calibrate, and maintain inspection, measuring, and test equipment and measuring devices used by the company to demonstrate the conformance of product to requirements of the contract and the contractor’s QSP requirements. The procedures must be developed based on the requirements cited in ISO 10012-1 (the document selected must be identified) and other requirements of the contract as applicable.

A. Does the QSP include a clear and complete calibration program that complies with the above documents for all inspection, measuring and test equipment? A master list of all measurement and test equipment that will be used for all inspections and testing activities and indication whether the equipment needs calibration, adjustment or maintenance must be included with the QSP. NOTE: Although the current calibration dates are not required to be reflected on the list, the list must, at a minimum, contain the following (a revised list needs to be submitted when a new piece of equipment is added or deleted or calibration frequencies are changed):

1. List of all equipment (by description) that require calibration/certification.

2. List of standards (test weights, certified thermometers, etc.) used to perform internal calibrations or pre- operational checks on equipment.

3. Identification (serial number/other ID) of each piece of equipment and standard listed.

4. Calibration frequency for equipment (and standard calibration/certification frequency) and who performs the calibration for each piece of equipment (internal or external source).

5. If a pre-operational check is conducted, identify the frequency and acceptable calibration tolerance for each piece of equipment that requires a pre-operational check prior to use.

6. Location of equipment (if not at same location indicate portable).

Example of List

*Replaced or re-certified when damaged

B. Procedures/Documentation: Does the QSP provide for complete documentation of the calibration program (references or includes procedures, working instructions and forms or reports used to insure all required information is properly documented and records are maintained)?

1. For each piece of equipment or grouping of equipment (e.g., scales, thermometers) that requires calibration, pre- operational check, adjustment, maintenance, as applicable, the procedures shall include the following: The reference to the applicable calibration instruction/procedure for internal calibrations or pre- operational checks conducted or the procedure itself, acceptable calibration tolerance for each piece of equipment that requires a pre-operational check or calibration, and measurement standard that applies. Note: This information may be included on the master list.

SECTION IV Continued

2. Does the QSP require that operators perform a pre-operational check to ensure equipment is functional and within tolerance?

3. Does the QSP indicate how and when (frequency) the seal bars for each sealing machine/ seamer are checked? Does the QSP identify the optimum temperature range/requirement to obtain an acceptable seal and form used to record results? NOTE: The DoD Task Force of 1986 identified not checking the seal bars as a major weakness in the system and a possible contributor to flexible pouches seal problems and the contractors’ inability to identify the “real” root cause of the problem and take effective corrective/preventive action.

4. Does the QSP indicate that all measuring and test equipment and measurement standards will be labeled to indicate calibration status (the calibration sticker attached to of each piece of equipment/standard must identify the date calibration was performed, next calibration due date, and who performed the calibration).

5. Does the QSP include a procedure to recall equipment that is due for calibration (for example, how the contractor ensure each piece is calibrated at the established intervals)?

6. Does the QSP include a procedure for identification and prevention from use of faulty equipment? NOTE: Faulty equipment should be tagged/labeled and, if possible, removed from production areas/point of use.

C. Does the QSP stipulate the contractor will make available all measuring and test equipment required by the Government QAR to perform Government verification inspections at the contractor or subcontractor’s facilities and upon request make personnel available for operation of such equipment?

SECTION IV AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed)

SECTION V

CONTROL AND PROTECTION OF PRODUCT

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, Specific Product Specifications or Commercial Item Descriptions, and ISO 9001 (7.5.3, 7.5.5, and 8.3) and ANSI/ASQC Z1.4.

AREA 1. HANDLING, STORAGE, PACKING, PACKAGING, PRESERVATION, AND DELIVERY PROGRAM (ISO 7.5.5):

A. Does the QSP include a procedure that identifies the methods for the handling, preservation, and protection of product and packaging materials (especially packaging that comes in direct contact with the product) to prevent its contamination, cross-contamination, or damage during production or clean-up?

B. Does the QSP include a procedure that identifies the designated areas or stock rooms and the methods of storing product and packaging materials (especially packaging that comes in direct contact with the product) to prevent contamination, cross-contamination, damage or deterioration of product/materials pending use, storage, or delivery?

C. Does the QSP include a procedure that identifies the appropriate methods used for authorizing receipt and release of product/ingredients/materials from storage areas?

D. Does the QSP include a procedure that identifies an appropriate interval to assess the condition of product in stock to detect damage or deterioration?

E. Does the QSP include a procedure that identifies the methods to control packing, packaging and marking processes (including materials used) to ensure conformance to contract requirements?

AREA 2. PRODUCT IDENTIFICATION AND TRACEABILITY (ISO 7.5.3):

A. Does the QSP include a procedure for identifying product from receipt and during all stages of production, assembly, and delivery?

B. Does the QSP include a procedure for unique identification of individual products or batches?

C. Does the QSP include a procedure for hazardous food recalls mandated by Government regulatory agencies or for contractor’s voluntary recalls of products found to be nonconforming with contract requirements or posing a potential health hazard to the consumer?

D. Does the QSP indicates if mock test recalls are conducted to test the effectiveness of the contractor’s food recall program? If no, does the QSP indicate how the contractor measures the effectiveness of their recall capability?

AREA 3. INSPECTION AND TEST STATUS AND RECORDS (ISO 4.2.3, 4.2.4 and 7.5.3):

A. Inspection and test status (applicable to all stages of the processes describe in Section VII, VIII, IX, and X):

SECTION V Continued

1. Does the QSP describe the methods used to identify and maintain the inspection status (conforming or nonconforming) of ingredients/components/ materials throughout the process (from receipt to finished product), to ensure only conforming ingredients/components/materials are released for production/ assembly, and only conforming product is released for shipment?

2. Does the QSP provide for an adequate method to place product on hold until all the required inspections and tests have been completed or necessary reports or approvals have been received and verified by authorized personnel prior to releasing ingredients/components/ materials for production/assembly and/or end item lots for shipment?

B. Inspection and test records (ISO 4.2.3 and 4.2.4):

1. Does the QSP contain procedures and indicate that records must be established and maintained to provide evidence that the end item lot has been inspected and tested and that it has passed the contractor’s end item inspection based on the defined acceptance criteria cited in the contract (prior to submitting the lot for Government verification inspection)?

2. Does the QSP stipulate that if a product fails any inspection, the nonconformance requirements cited in the contract, as applicable, and the procedures for control of nonconforming product shall apply?

3. Does the QSP identify the person (maybe different positions) with the authority for the release of ingredients/components/materials during receipt, storage, production, assembly, and/or shipment?

AREA 4. CONTROL OF NONCONFORMING PRODUCT (ISO 8.3):

A. Does the QSP include a procedure to prevent the unintended use of ingredients or assembly of product that does not conform to specified contract requirements, pending test or inspection results, or other contractor’s requirements? NOTE: Pallets/cases of items placed on hold (for any reason) must be prominently marked or tagged with hold tags. Hold tags shall include, at a minimum, the following information: Identification of the item; lot number/subcodes if applicable; quantity (case quantity and/or partial case quantities); reason for hold; and date placed on hold. All items placed on hold must (as much as possible) be maintained together and each pallet must be tagged. As an option, if pallets are maintained together, pallets can be cordoned-off with caution tape (or other appropriate tape) and one tag placed on front of the pallets.

B. Does the QSP provide an effective system to identify the inspection status (conforming or nonconforming) of components and materials and is system distinctly different from the Government's identification system? NOTE: Product found nonconforming by the contractor’s inspection system must be tagged by the contractor with contractor’s tags. Product found nonconforming by the GQAR’s during a Government verification inspection must be tagged with a Government tag by the GQAR (with contractor’s personnel assistance). Only a GQAR is authorized to remove Government tags.

C. Hold record/log: Does the procedure provide for the identification, documentation, evaluation, segregation, and disposition of nonconforming product? NOTE: The contractor must develop and maintain a running record/log of ingredients/products/materials placed on hold (by the contractor or the GQAR).

This record/log must, at a minimum, contain the following information: Identification of the product; lot number/ subcodes, as applicable; quantity; date placed on hold; reason for hold; who placed the product on hold (contractor or GQAR); location and/or hold tag number; date released from hold; who released the product; and, the final disposition of the product. This is a quality history record that needs to be retained for the period indicated in the contract.

D. Does the QSP identify the person (maybe different positions) with the authority for the release of items placed on hold and include a procedure for the review and authority for the disposition of nonconforming items found during any stage of the process (receipt, storage, production, assembly, end item, shipment, etc.)?

SECTION V Continued

E. Does the procedure indicate that the Government must approve rework procedures or plans and reworked product must be inspected according to Government approved procedures (as indicated in the contract) if the contractor opts to rework nonconforming product?

F. Disposal of Product Intended, Produced or Manufactured for the U.S. Government thru Commercial Channels: Does the QSP include a procedure that indicates the steps to be taken by the contractor if they decide to donate, sell or dispose in commercial channels of any end item or any part of it intended, produced or manufactured for the U.S. Government? As a minimum, the procedure must include the following: Steps taken for the removal/obliteration/wipe-out from a product and it's packing and packaging, any markings, symbols, or other representation that the end item or any part of it was intended, produced or manufactured for the U.S. Government; identify the person (by position) responsible for verifying this action; identify the form/ report used to record the action taken (identifying product, lot/subcode, quantity produced, quantity donated/ sold/ disposed of by lot/subcode, the reason for this action, etc.)and; the procedure must also indicate that the In-Plant Government QAR shall be notified prior to such action taking place.

TOTAL POINTS: 100

SECTION V AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed)

SECTION VI

CONTRACT REVIEW, PURCHASING AND CONTROL OF CUSTOMER-SUPPLIED PRODUCT

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, Specific Product Specifications or Commercial Item Descriptions, and ISO 9001 (4.2.3, 4.2.4, 7.2, 7.2.3, 7.4, 7.4.1, 7.4.2, 7.4.3, and 7.5.4) and ANSI/ASQC Z1.4.

AREA 1. CONTRACT REVIEW (ISO 7.2): The contractor must establish and maintain documented procedures for contract reviews, document, data and record control and for the coordination of these activities.

A. REVIEW:

1. Does the QSP identify company's manager or personnel responsible for contract reviews (before submission or acceptance of a contract or order)?

2. Does the QSP indicate how contract reviews are performed?

B. AMENDMENT TO A CONTRACT (ISO 7.2.3): Does the QSP indicate how amendments to a contract are transferred and communicated to the functions concerned within the organization (to include the Government QAR) and external functions (subcontractors and suppliers) as applicable?

C. RECORDS (ISO 4.2.3 and 4.2.4): Does the QSP indicate who and where (location) records of contracts' reviews will be maintained?

AREA 2. PURCHASING (ISO 7.4): The contractor shall establish and maintain documented procedures to ensure that purchased ingredients or components conform to contractor’s specified requirements and the contract requirements. A master list of all ingredients and material used in the production must be included with each supplier identified for each ingredient.

A. EVALUATION OF SUBCONTRACTORS/SUPPLIERS (ISO 7.4.1):

1. Does the QSP indicate how suppliers/subcontractors are selected and evaluated (criteria used, product or on-site audits conducted, etc.)?

2. Does the QSP define the type and extent of control exercised by the contractor over subcontractors?

3. Does the QSP indicate what subcontractors are required to have a documented QSP, require Government source inspection, and or any other specific quality assurance requirement (such as SPC)?

B. PURCHASING DATA (ISO 7.4.2):

1. The contractor must develop and submit with the QSP a master list of all ingredients/ components/materials used in the production/assembly of products intended for the Government. This list must identify the following for each ingredient/product/material (may be identify by grouping if same requirement): Paperwork/documents that are required to be received with each shipment (Certificate of Conformance, Certificate of Analysis, USDA Grading Certificate, Supplier Certification, Bill of Lading, etc.). If a COC covers several shipments (or entire contract), the period covered must be identified by the applicable item. The GQAR and receipt inspectors must be provided with a copy of this list. NOTE: The entire Section will be rated unacceptable if this information is not provided.

2. Does the QSP indicate how the contractor conveys purchase requirements to suppliers for components and materials requiring Government source inspection, physical or chemical characteristic testing, requirements for approval or qualification of ingredient or product, or other specific requirements?

3. Does the QSP identify the steps taken if a subcontractor is required to submit a documented QSP to the contractor or DLA Troop Support?

4. Does the QSP include a procedure for the review and approval of purchasing documents for the specified ingredient/product prior to release?

SECTION VI Continued

C. VERIFICATION OF PURCHASED PRODUCT (ISO 7.4.3):

1. Does the QSP indicate the steps to be taken if the contractor requires Government verification of ingredient or product conformance at source (the subcontractor’s plant) or if an ingredient or product requires Government source inspection??

2. Does the QSP indicate that the Government has the right to verify, at the subcontractor’s facilities, that subcontracted product and/or quality system conforms to contractual requirements?

3. Does the QSP indicate or include a procedure to ensure that all inspection documents and referenced data for purchased supplies that require Government source inspection or have particular requirement to be reviewed for accuracy and maintained on file for review by the Government QAR?

4. Does the QSP stipulate that the Government QAR shall be provided copies of Government source inspection documents (grading certificates, laboratory analyses, etc.) and purchasing documents for other products for review within the contractor's facility or for verification at the supplier/ subcontractor's facility, as deemed necessary by the Government?

AREA 3. CONTROL OF CUSTOMER-SUPPLIED PRODUCT (ISO 7.5.4):

A. Does the QSP contain a procedure for the inspection, storage, and maintenance of Government- furnished material (GFM) provided for incorporation in the assembly of operational rations or to use in related activities?

B. Does the QSP contain procedures for the recording and reporting of GFM that is lost, damaged or otherwise unsuitable for use by the Government?

SECTION VI AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed)

SECTION VII

RECEIPT INSPECTION AND TESTING

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, Specific Product Specifications or Commercial Item Descriptions, and ISO 9001 (4.2.3, 4.2.4, 7.4.3, 7.5.3, and 8.2.4) and ANSI/ASQC Z1.4.

GENERAL: The contractor shall establish and maintain documented procedures for receipt inspection and testing activities to verify that the requirements for the product or ingredient (contractor’s specified requirements and contract requirements) are met. The required inspection and testing and the records to be established, shall be detailed in the QSP.

A. Does the QSP include clear and complete receipt inspection procedures: Sampling plan (acceptance/rejection criteria) and what constitutes a nonconformance for items that require receipt inspection in accordance with contractor’s specified requirements or the contract requirements?

B. The contractor must develop and submit with the QSP a master list of all ingredients/components/materials used in the production/assembly of products intended for the Government. Is the list included with the QSP?

NOTE: The list or the procedures must identify and clearly define the following for each ingredient/product/ material (may be done by groupings if same requirement): How the lot size is expressed for each item or group of items received (e.g. number of boxes, cans, pounds, yards, patties, steaks, pouches, containers received, etc.); the sample unit (e.g., the sample unit may consist of one or more units of product drawn from a lot for inspection purposes for each group of items received - number of boxes, cans, pounds, rolls, yards, pouches, one pound/one cup of product from large containers, 2 steaks/patties per sample unit/box, etc.); how samples will be selected (for example random throughout the shipment, selected proportionally from each supplier’s lot/subcode/date of pack received, etc.); type of inspection (paperwork/certification verification with items received, visual/nondestructive, and/or destructive inspection/testing, etc.); number of temperatures taken and temperature requirements for frozen/chill products/ingredients; acceptance/rejection level; paperwork/ documentation that is required to be received with the shipment; and the protocol for coordination when a nonconforming item is received and/or required paperwork is not received with the shipment.

NOTE: The entire Section will be rated unacceptable if this information is not provided.

C. Does the QSP include or reference working instructions and forms to be used by contractor personnel to ensure required information is properly documented and records are maintained?

D. Does the QSP contain a program that ensures only contractual inspection procedures (or Government approved alternative procedures as detailed in the contractor’s QSP) are used for all receipt inspections?

E. Does the procedure ensure incoming product or ingredients are not used or processed until it has been inspected or otherwise verified as conforming to specified requirements?

F. Is the amount and nature of receiving inspection consistent with the amount of control exercised at the subcontractor’s plant and the recorded evidence of conformance provided (Government inspection at subcontractor facility, USDA grading certificates, certificate of analysis, etc.)?

G. Does the QSP include a procedure positively identifying and recording product or ingredients released for urgent production purposes prior to verification to permit immediate recall in the event of nonconformance to specified requirements? Does the procedure indicate that the Government QAR will be notify before such action takes place?

TOTAL POINTS:

SECTION VII AUDITOR’S NOTES (justification/comments must be provided for areas/questions found marginally acceptable, unacceptable or not addressed)

REFERENCE: Contract TDP Section E, MPC Clause, SPC QAP, Specific Product Specifications or Commercial Item Descriptions, and ISO 9001 (4.2.2, 4.2.3, 4.2.4, 5.2, 5.3, 5.5.1, 6.2.2, 7.1, 7.4, 7.5, 7.5.1, 7.5.2, 7.5.3, 7.6, 8.2.2, 8.2.3, 8.2.4 and 8.4),ANSI/ASQC Z1.4, and ANSI/ASQC Z1.1thru ANSI/ASQC Z1.4.

GENERAL: The contractor shall establish and maintain documented procedures for all in-process and process control inspection and testing activities to verify that the specified requirements for the product (cited in contractor’s QSP and the contract) are met. The required inspection and testing and the records to be established shall be detailed in the QSP procedures.

AREA 1. PROCEDURES: The QSP must include procedures that describe the production/assembly operations and how the contractor ensures these are carried out under control conditions to assure that product characteristics and criteria specified in the contract are achieved and maintained in the finished product (end item).

A. Does the QSP identify and define each in-process control…