Robins AFB PMEL Quality Manual Rev 4.doc

Robins AFB Quality Manual

Robins AFB Quality Manual

28 January 2008

Quality Manual Number:

PQM-001

Rev 4.0

Unit Issuing:

569th EMXS/MXDCA Approved by:

Jack McCormack Effective Date:

31 May 2008 Revision Date:

Page

AIR FORCE METROLOGY AND

CALIBRATION PROGRAM

QUALITY MANUAL

QM TABLE OF CONTENTS

Section Subject

Page i.

Quality Manual Table of Contents ii.

Table of Contents with References iii.

Changes and Reviews Page

Management Policy Statement

Organization and Management

Records

Personnel

Training

Signatories

Accepting New Work

Calibration Procedures

PMEL TMDE

Quality Programs

Recall and Notification

Exceptions and Limitations

Submitting Changes

Measurement Uncertainty

Processes

METCAL Procedures

A1

Appendix 1, Certifying Technicians

A2

Appendix 2, List of Signatories

A3

Appendix 3, Phone Directory

A4

Appendix 4, Contractors Task Competence Program

A5

Appendix 5, Robins AFB Root Cause and Nonconformity Codes

A6

Appendix 6, Local Form Listing

Table 1

CHANGES AND REVIEWS

The Quality Manual and associated documents are reviewed at least annually by the PMEL Services Flight Chief, PMEL Government Quality Manager, and personnel designated by management to ensure the documents are current, valid, and effective. Significant changes or revisions should also be documented.

Section 1

MANAGEMENT POLICY STATEMENT

1.1

This section contains management’s quality policy statement, including objectives for, and commitment to, good PMEL practices and quality of calibration service.

1.2

Should there be a conflict between the Performance Work Statement (PWS) and the references set forth herein, the PWS shall have precedence.

1.3 The Precision Measurement Equipment Laboratory (PMEL) Quality Manual was prepared by 569th EMXS/MXDCA. The PMEL workload at WR-ALC is manned as a partnering effort with the Air Force and Contractor. 569th EMXS/MXDCA takes responsibility for the format of the Quality Manual and updating information.

1.4

OBJECTIVE: This laboratory will ensure measurement traceability, provide quality services, and maintain 562d CBSG certification in support of the 562d CBSG and the Robins ALC mission:

562D CBSG MISSION STATEMENT

To develop and sustain precision measurement capabilities ensuring accurate, reliable, and safe air and space systems performance through effective management of the Air Force Metrology (AFMETCAL) Program.

ROBINS AFB PMEL MISSION STATEMENT

Our mission at Robins AFB Precision Measurement Equipment Laboratory (PMEL) is to provide high quality Test, Measurement, and Diagnostic Equipment (TMDE), that is certified as accurate, traceable, safe and reliable; enabling our customers to maintain Air Force weapon systems at full mission capability. Our goal is to provide impeccable customer service, implement continuous process improvements, and be a world-class PMEL in support of the Warfighter, 1.5

TRACEABILITY: All measurements will be performed under controlled conditions using standards, procedures, and practices prescribed in TO 00-20-14 to ensure measurement traceability through the Air Force Primary Standards Laboratory (AFPSL) to the National Institute of Standards and Technology (NIST) or other 562D CBSG approved sources.

1.6

QUALITY: It is our policy to provide the highest quality measurement services attainable through aggressive implementation of the Quality Program (QP) and continuous improvement of our quality system.

1.7 CERTIFICATION: This laboratory shall demonstrate compliance with TO 00-20-14 by maintaining certification through the 562D CBSG Assessment and Certification Program.

1.8 COMMITMENT: The Robins AFB PMEL Services Flight will implement, support, and embrace 562D CBSG quality procedures, policies, and initiatives to effectively manage the Quality System as identified by TO 00-20-14. This will be accomplished through in-depth trend analysis, implementation of effective process improvements and corrective actions. Our goal is to minimize product quality nonconformities, produce a quality product while providing the highest level of customer service. It is the responsibility of all employees of the Robins AFB PMEL to abide by all procedures, policies, and processes of the Robins PMEL Quality Manual.

Section 2

ORGANIZATION AND MANAGEMENT

2.1 This section contains organizational charts for Robins AFB PMEL, Type IIA and Organic. A phone directory of all personnel can be found in Appendix 3 of this manual.

ROBINS AFB PMEL

ORGANIZATION AND MANAGEMENT

ROBINS AFB PMEL

ORGANIZATION AND MANAGEMENT

ROBINS AFB PMEL

ORGANIC

ROBINS AFB PMEL

CONTRACTOR ORGANIZATIONAL CHART

(Provided by the contractor) Section 3

RECORDS

3.1 This section contains the procedures, responsibilities, and authorities for drafting, changing, approving, and issuing quality system documents. This includes the PMEL QM and related quality documentation such as local procedures and forms, internal audits, management reviews, customer complaints, etc.

3.2 All 562D CBSG program PMELs follow TO 00-20-14 for laboratory records management and document control. The following paragraphs outline local policies and procedures:

3.3 OFFICIAL DOCUMENTS. All official documents issued by this laboratory will be signed by the appropriate signatory as identified in Section 6. Official laboratory documents will be completed in permanent ink. Corrections are accomplished by drawing a line through the entry and then initialing the change. Notes should be included, as necessary, to explain the reason for the change.

3.4 Changes to the quality manual must be approved by the PMEL Government Quality Manager, PMEL Services Flight Chief and logged in Table 1 of this quality manual.

3.5 The quality manual will be posted on the 402nd Electronics Maintenance Group’s home page under 402 EXMG/MXVD-1 (PMEL). This PMEL intranet is accessible to all PMEL personnel. All PMEL personnel will be notified by either the Government PMEL Quality Manager or Government Quality Assurance Specialist (in building 162) by email of changes/revisions to the Robins Quality Manual. For personnel without e-mail capability, the contractor shall be responsible for providing a hard copy of the email to these individuals.

3.6 OFFICIAL FILES. The PMEL Flight Government Files Manager is the MXDCA Program Support Assistant.

3.7 Copies of the following records will be routed to the Government Files Manager for retention

a) PMEL Maintenance Data Collection Report 7808

b) PMEL Services Flight Policies

c) MXDCA Memos for record

3.8 Copies of the following records will routed through the area supervisor, to the MXDCAO Government Industrial Engineering Technicians for retention.

a) AFTO Form 45 (Request for Calibration Responsibility Determination)

b) AFTO Form 22 (Technical Manual (TM) Change Recommendation and Reply).

3.9 The Government Quality Assurance Specialist in Building 162 will maintain a file containing all WR-ALC PMEL Services Flight local polices.

3.10 Copies of shipping Documents DD Form 1149s (Requisition and Invoice/Shipping Document) are routed through shipping, to the customer, and then returned to the PMEL. Copies of these documents are maintained in the scheduling office by Government Production Control.

3.11 Upon receipt of Robins AFB PMEL Standards with certificates or reports of calibrations:

3.11.1 Contractor Quality Assurance Supervisor will make a copy of the certificate (if the copy that accompanies the advance 1149 has not arrived) and give it to the Contractor Office Manager for filing. The original will accompany the unit to the applicable calibration area and will be maintained with the unit or filed.

3.11.2 Customers of Robins AFB PMEL will be responsible for the care of their own standard certificates.

3.12 The following official documents will be issued and completed by the certifying technician. A copy of these documents will accompany the item when returned to the owner. The data supporting these certificates will be maintained in the Facility and Equipment Maintenance System (FEMS) database for future retrieval. The certifying technician’s computer logon/password is considered his/her official signature.

a) Robins PMEL generated calibration certificates or reports. These certificates will only be issued upon customer request or when T.O. directed and will be completed in accordance with TO 00-20-14 paragraph 5.7.

b) FEMS Work Order (Formerly AFMC Form 134). Maintenance data collection (MDC) and required calibration data will be entered into the FEMS database to include all standards per TO 00-20-14 paragraph 3.8.4, including calibration authority/date, certifying technician, materials, temperature, and humidity.

c) FEMS Slash Report shall be completed when items received by the PMEL are not within required specifications. The following information will be entered into the FEMS database.

I. Type of Report ( K-Action, Limited or Special Calibration, NRTS, )

II. Anti-Tampering Devices Intact, Notes (optional)

III. Any Excessive Vibration or Shock, Notes (optional)

IV. Values/Ranges Affected

V. Repair or Adjustments Performed

VI. General Equipment Condition

VII. Limited / Special Calibration Data: The Limited / Special block will include the: Limitation, Name of user authorizing limitation or special calibration, phone number, and date of approval/request

3.13 The following official document shall be issued in accordance with TO 00-20-1 Chapter 7 and AFMCI 21-127 paragraph 7.5.15 by the Contractor. These forms will be attached to PMEL Standards requiring periodic maintenance or inspection IAW Maintenance TO.

a) AFTO Form 244 (Preventative Maintenance Schedule).

3.14 The following official record shall be initiated by the MXVDPO Government Production Control Chief. As a minimum, the customer survey is conducted annually or as directed by the PMEL Services Flight Chief. In addition, a survey form is posted on the FEMWEB webpage and 402 EMXG/MAIL-1 home page for continuous customer feedback. The purpose of the survey provides valuable feedback on PMEL’s overall performance and possible areas for improvement. The survey results shall be included in the government quality assurance monthly activity summary upon completion.

a) 569TH EMXS/MXVDP Local Form 7 (Customer Survey)

3.15 QUALITY PROGRAM (QP) RECORDS. The Government PMEL Quality Manager is responsible for all quality program documentation.

3.16 Quality Assurance Activity records shall be kept for retention in accordance with TO 00-20-14 Section 9 paragraph 9.12. The Government Quality Assurance Specialist (QAS) located in Building 162 is responsible for the maintenance and retention of these quality records. Previous records are maintained in the FEMS QA Tracker Program for trend analysis.

3.17 The Government QAS prepares the monthly reports including Monthly Summary and Quality Activity Summary. These reports should be prepared no later than the tenth of each month.

3.18 The Quality Assurance Activity Summary is routed from the Government PMEL Quality Manager through the chain of command to the 402d EMXG Commander for review. The summary is returned to Government PMEL Quality Manager for retention in Building 162.

3.19 Copies of the following records shall be completed and routed to the Government Quality Manager for retention:

a. Process Review 569TH EMXS/MXDCA Local Form 1: Reviews shall fulfill all requirements as specified in TO 00-20-14 Section 9

b. Nonconforming Quality Review 569TH EMXS/MXDCA Local Form 2: Reviews will fulfill all requirements as specified in TO 00-20-14 Section 9

c. Nonconforming QDR’s 569TH EMXS/MXDCA Local Form 6

d. TMDE USER/OWNER Feedback Report 569TH EMXS/MXDCA Local Form 19

e. Monthly Quality Review

f. Quarterly Trend Analysis

g. Internal Audit

h. Management Review

3.20 Critical Nonconformity Process Reviews and Quality Reviews will be initiated by PMEL Quality Assurance. Root Cause analysis will be conducted in accordance with TO 00-20-14 and Section 9 of this Quality Manual. After completion, all reviews with critical nonconformities will be forwarded to the Government Quality Manager for retention IAW TO 00-20-14 Section 9.

3.21 Non-critical Process Review and Quality Review nonconformities: Upon discovering a non-critical Process or Quality Review nonconformity, the PQA shall enter the nonconformity into the FEMS Tracker Program. Non-critical nonconformities will be corrected as soon as possible and shall not require Root Cause Analysis. PMEL Management shall review the trend data summary during quarterly trend analysis and take action as required.

3.22 Internal Audits shall be conducted in accordance with TO 00-20-14 Section 10. Auditors shall possess the knowledge and skills to understand the process being audited. Results of the internal audits will be forwarded to the Government Quality Manager for review. The Government Quality Manager shall implement corrective action(s) or will task other PMEL personnel to create and/or implement corrective action(s) to resolve any area found not in compliance.

3.23 Management Reviews shall be conducted in accordance with TO 00-20-14 Section 10. The interval for the management review will be annually unless directed sooner by the PMEL Services Flight Chief. Problems shall be turned into action items with a point of contact (POC) and a estimated completion date (ECD). Results of corrective actions shall be sent to the Government PMEL Quality Manager for follow-up and retention.

3.24 Follow-ups and Reviews of Internal Audits, Management Review, and Trend Analysis meeting will be conducted on the 3rd Tuesday of each month to update follow-up actions.

3.25 The laboratory Environmental Monitoring System (EMS) located in Building 162, stores all laboratory environmental data on the PMEL server. On-site environmental data will be taken using certified environmental measuring devices at the time of calibration and stored in the FEMS database.

3.26 INPUT PRIORITY SYSTEM. All items processed through the PMEL will be assigned a priority work order code at the time the work order is generated.

3.26.1 ROUTINE THROUGHPUT TIME. Work orders for routine TMDE are generated by FEMS utilizing priority code “0”. The turnaround time is 7 days or 10 days if TMDE item is selected for a Quality Review (QR). The throughput time does not include the time the TMDE item is a hold status for awaiting parts, technical data, facilities, equipment, or standards.

3.26.2 For TMDE items that have exceeded 7/10 throughput days, the contractor shall provide written explanation to the PMEL Services Flight Chief. The explanation shall document reason(s) for delay and action taken to eliminate future TDME delays. Corrective action shall be approved by the Government prior to implementation.

3.26.3 The throughput time shall start once a item is placed into a Received by PMEL (RBP) status and stops once an item is in completed and placed Awaiting Government Quality (AWGQ). At this point the contractor presents the TMDE item for acceptance by the government.

3.26.4 EMERGENCY TMDE. Work orders for emergency TMDE are generated by FEMS utilizing priority code “5”. TMDE identified as requiring emergency calibration shall be placed into work immediately and worked continuously (around the clock) until completed or placed into a hold status described in paragraph 3.26.1. Once the reason for hold has been corrected, the TMDE item is placed back into in-progress and worked continuously (around the clock) until completed.

3.26.5 PARTNERSHIP TMDE. Work orders for partnership TMDE are generated by FEMS utilizing priority code “4”. Partnership is the creation of a government-vendor relationship where the TMDE is owned by a vendor, operated by either the vendor or government personnel to produce war fighter assets. The PMEL is considered sub-contractors responsible for calibration of vendor’s TMDE. The time allotted to complete partnership TMDE depends on the Implementation Agreement (IA) of the weapon system. If the IA does not state an allotted time, the throughput time is 3 days. Partnership TMDE is worked continuously during normal working hours until completed or placed into a hold status described in paragraph 3.26.1. Once the reason for hold has been corrected, the TMDE item is placed back into in-progress and worked until completed.

3.26.6 RE-ENGINEERING 21ST CENTRY (RE-21). Work orders for partnership TMDE are generated by FEMS utilizing priority code “3”. RE-21 is a consolidation of critical avionics and weapon systems from operational bases to Robins ALC. RE-21 TMDE is considered the same as mission essential TMDE. Work orders for partnership TMDE are generated by FEMS utilizing priority code “4”. The throughput time for RE-21 TMDE is 3 days. RE-21 shall be worked continuously during normal duty hours until completed or placed into a hold status described in paragraph 3.26.1. Once the reason for hold has been corrected, the TMDE item is placed back into in-progress and worked continuously until completed.

3.26.7 MISSION ESSENTIAL TMDE. Work orders for partnership TMDE are generated by FEMS utilizing priority code “2”.TMDE identified as Mission Essential Priority shall be worked continuously during normal working hours until completed or placed in a valid hold status. The throughput time for Mission Essential TMDE is 3 days. Mission Essential shall be worked continuously during normal duty hours until completed or placed into a hold status described in paragraph 3.26.1. Once the reason for hold has been corrected, the TMDE item is placed back into in-progress and worked continuously until completed.

3.26.8 PMEL OWNED STANDARDS. Work orders for partnership TMDE are generated by FEMS utilizing priority code “1”. PMEL standards shall be worked before routine TMDE. The throughput time for PMEL Standards is 5 days. PMEL standards that require continuous monitoring or testing over 5 days are exempt from the 5 day throughput. PMEL standards shall be worked during normal duty hours until completed or placed into a hold status described in paragraph 3.26.1. Once the reason for hold has been corrected, the TMDE item is placed back into in-progress and worked until completed.

3.26.9 Government PMEL Deputy Flight Chief shall approve a change in priority of any routine TMDE item to “emergency” or “mission essential” when the written justification from the owning work center Flight Chief warrants an increase in the priority level.

3.26.10 Emergency, Partnership, RE-21, and Mission Essential TMDE inducted into the Type IIA is approved by the Deputy PMEL Services Chief for all items being calibrated by the contractor in Building 162.

3.26.11 The contracting ACO shall approve the overtime for work performed by the Contractor. The contractor shall keep the PMEL Services Flight Chief and ACO apprised of the status of the emergency items.

Section 4

PERSONNEL

4.1

PMEL SERVICES FLIGHT CHIEF:

4.1.1 Job Description: Operates PMEL Services Flight that performs calibration, repair, and certification of Precision Measurement Equipment utilizing designated working standards to perform these worldwide functions. Position serves as Flight Chief with managerial responsibilities for overall planning and directing of four teams , the PMEL Quality Assurance Function, and serves as advisor and consulting authority to the Division and other organizations on matters pertaining to the PMEL Program. The PMEL Flight Chief ensures the implementation of the Air Force Metrology Calibration (562D CBSG) Program.

4.1.2 Responsibilities: The PMEL Flight Chief shall supervise and be responsible for all PMEL operations. The PMEL Flight Chief shall validate all operations of the PMEL Metrology Laboratory and Organic PMEL sections. The Robins AFB PMEL shall be operated in accordance with AFI 21-101, AFI 21-113, AFMCI 21-127, TO 33K-1-100-1, TO 33K-1-100-2 and TO 00-20-14.

4.1.3 Training: Position requires incumbent to have a working knowledge of AF Metrology Calibration Program, knowledge of TMDE, calibration, repair, and laboratory testing procedures and controls related thereto. Good judgment must be exercised in planning and operating the TMDE program, pinpointing deficient areas and directing practical corrective action as required.

4.2 GOVERNMENT PMEL QUALITY MANAGER

4.2.1 Job description: Administers the Air Force Metrology and Calibration Program by providing planning, directing, organizing, and exercising control over non-supervisory employees assigned to a Quality Assurance function of the PMEL. Serves as a first level supervisor to the Government QAEs, QAS, and Organic PQAs.

4.2.2 Responsibilities: The Government Quality Manager shall coordinate and manage all aspects and components of the PMEL Government Quality systems. The PMEL Government Quality Manager shall manage the PMEL Quality Assurance in the execution of the Quality Program (QP) dictated by TO 00-20-14. The QP shall be detailed in Flight level documents.

The Government PMEL Quality Manager shall lead the Quality Assurance Evaluators in the execution of the Contract Quality Monitoring process in accordance with AFI 63-124. The Quality Manager shall provide and interpret Quality System metrics. The Quality Manager shall be responsible for the design and maintenance of the Quality Program and the Robins PMEL Quality Manual. The Government Quality Manager shall have access to the highest levels of PMEL Management.

4.2.3 Training and knowledge: Considerable knowledge of quality assurance principles, practices and procedures. Knowledge of safety and security regulations, practices and procedures. Ability to plan, organize and direct the functions and staff of a small to medium sized organization. Ability to communicate effectively, both orally and in writing. Knowledge of Quality management theory and methodologies. Extensive knowledge of PMEL operations and related support functions such as scheduling, planning, and TMDE using activity mission requirements. In-depth knowledge of electronic theory, precision measurement techniques and calibration procedures of mechanical and/or electronic test equipment and precision measurement equipment.

4.3 CONTACT PROGRAM MANAGER

General Responsibilities: To be filled in by the contractor Specific Responsibilities: To be filled in by the contractor

4.4 CONTRACT TECHNICAL OPERATIONS SUPERVISOR

General Responsibilities: To be filled in by the contractor

Specific Responsibilities: To be filled in by the contractor 4.5

CONTRACTOR QUALITY ASSURANCE SUPERVISOR

General Responsibilities:

Specific Responsibilities:

Section 5

TRAINING

5.1 Personnel performing tasks will be individually qualified on the basis of appropriate education, training, experience and/or demonstrated skill. A list of all certifying technicians is in Appendix 1.

5.2 The Contractor shall provide and place a training plan in this section.

Section 6

SIGNATORIES

6.1 This section identifies the signatures required and personnel authorized to sign or approve laboratory documents. Signatories are selected, and appointed in writing, based on their qualifications to make the required decision. Signatories of calibration results are responsible for releasing a complete and accurate document.

6.1.1 Names of personnel appointed as signatories can be found in Appendix 2 of this manual.

6.2 Calibration Reports shall only be signed off by the following Personnel:

Contractor needs to supply who signs off.

6.3 Proficiency Testing / Measurement Assurance Program results will be signed by one of the following personnel:

Contractor needs to supply who signs off.

6.4 Certification Labels AFTO Form 99/398s on laboratory Standards will be appropriately signed or initialed in accordance with section 5 of TO 00-20-14 by the following personnel:

Contractor needs to supply who signs off.

6.5 Equipment condition tags: The following personnel are authorized to sign these records:

Contractor needs to supply who signs off.

6.6 Training records: The following personnel are authorized to sign training records.

Contractor needs to supply who signs off.

6.7 Periodic Maintenance Inspections Form 244 will be signed off by the technician performing these inspections in accordance with TO 00-20-1 and AFMCI 21-127 Chapter 7.

Contractor needs to supply who signs off.

6.10 QP reviews with critical nonconformities, will be signed by the following personnel:

Contractor needs to supply who signs off.

Section 7

ACCEPTING NEW WORK

7.1 This section contains the procedures for reviewing new work, such as local procedures for completing AFTO Form 45 Calibration Responsibility Determination. This ensures the PMEL has the appropriate support agreements, facilities, equipment, standards, and technical expertise necessary to support items new to the PMEL inventory.

This responsibility falls upon the Government to work. Therefore the contents of this section are removed to avoid confusion.

Section 8

CALIBRATION PROCEDURES

8.1 This section contains or references local procedures for requesting, posting, controlling, and using calibration and maintenance procedures. Refer to TOs 00-5-1 and TO 00-20-14 for specific Air Force and 562D CBSG guidance.

8.2 Calibration Technical Orders (T.O.) and Procedures: Calibration T.O. or other procedure selection shall be in accordance with paragraph 3.1.2 of TO 00-20-14.

8.3 All Air Force calibration and maintenance technical orders shall be validated for currency using the T.O. Index. The T.O. Index is located on the PMEL intranet page or can be found on the web at https://www.toindex-s.wpafb.af.mil/

8.4 The Contractor maintains a T.O. library located in building 162 for all Test, Measurement, and Diagnostic Equipment (TMDE) Standards maintained and calibrated by the Type IIA Laboratory.

8.7 Technical Orders: Technical orders will be signed out of the T.O. library using an AF Form 614 Technical Order Charge Out Record. The currency of the technical order will be verified using the T.O. Index prior to use.

8.8 Requests for new Calibration and Maintenance T.O.s will be processed through the TODO.

8.9 Requests for commercial manuals will processed through the appropriate Government Production Planner. Manuals will be added to the T.O. library when they are received.

8.10 Technical orders will be stamped with the date received by the TODO. The TODO has 5 working days from the date received to post the new routine Technical Order. Interim Operational Supplements and Safety Supplements will be filed as soon as possible.

8.11 Technical orders will be stamped with the date posted by the TODO.

8.12 General Calibration T.O.s will be used when TMDE does not possess sufficient identifiable characteristics; i.e., manufacturer, type number model number and/or stock number. All TMDE calibrated using these Calibration T.O.s will be calibrated in strict compliance with TO 33K-1-100-1 paragraph 3.1.

8.13 Commercial Data: Personnel will sign out commercial data using an AF Form 614, Charge Out Record.

8.14.1 The TODO in the Type IIA laboratory manages the commercial data utilized by the KAI. The commercial data manager will ensure that adequate and current technical data and catalogs are available.

8.14.2 Commercial data will be reviewed and validated prior to being used to certify equipment. The commercial data verification log will be updated upon completion of the verification. All commercial data used to certify TMDE will be reviewed and verified at least annually. (Form to be added) 8.14.3 Commercial data which cannot be verified due to age, company closure, will be annotated in the commercial data verification log as undetermined. Efforts to obtain data will be documented in the long description block of FEM.

Section 9

PMEL TMDE

9.1 This section outlines local procedures to ensure calibration, verification, and maintenance (including preventive maintenance) of equipment owned, rented, or leased by the Organic and Type IIA PMEL.

9.2 All Contractor TMDE owned, rented, leased, or borrowed having an affect on calibration services performed will be calibrated, verified, documented, and maintained IAW TO 00-20-14, applicable Air Force T.O.s and Instructions, or commercial data.

The Type IIA laboratory TMDE Equipment Coordinator and Equipment Custodian is? Contractor needs to supply who.

9.3 All laboratory equipment that has a calibration performed by a commercial source shall be approved by 562D CBSG. All TMDE certified by commercial and DOD agency will have an Air Force Certification Label applied IAW TO 00-20-14 Section 4.5.3

9.3.1 The Contractor shall process TMDE requiring commercial or DOD agency calibration. The Contractor shall update the FEMS database and apply and Air Force certification label to the TMDE IAW TO 00-20-14 Section 4.5.3

9.3.2 The Contractor will ensure correct documentation, physical condition, and calibration seals are intact.

9.4 Newly procured equipment or standards shall be inducted as unscheduled TMDE. This new equipment or standard shall be tested and certified to verify its performance is satisfactory. Initial commercial calibration of new equipment can be accepted if it includes a calibration certificate or report that complies with TO 00-20-14 paragraph 4.5.1.4 and if the commercial calibration meets the Air Force calibration authority specifications.

9.7 All laboratory standards/equipment sent out for contract or warranty repair will be inspected (and re-calibrated if capability exists) before use to insure repairs have been accomplished and items meet all parameters of the calibration T.O.

9.8 PMEL TMDE will be scheduled (RBP) through FEMS within 5 working days before the calibration due date.

9.9 Unscheduled PMEL TMDE shall be accompanied with an AFTO Form 350 tag. The AFTO Form 350 tag shall contain a clear description of the malfunction or reason for unscheduled maintenance/calibration, and name and phone number of Technician.

9.10 The AFTO 244, Industrial/Support Equipment Record, will be used to record periodic inspections on Precision Measurement Equipment Laboratory (PMEL) owned equipment/standards in accordance with TO 00-20-1 and AFMCI 21-127 Chapter 7. The AFTO 244 will not be used to record periodic calibrations or repair actions.

9.11 Preventive Maintenance requirements as outlined in RAFBI 21-127, Depot Maintenance Plant Management, are not applicable to PMEL owned Test, Measurement, and Diagnostic Equipment (TMDE). The requirement of RAFBI 21-127 applies to non-TMDE fixtures/test stands that require periodic maintenance.

9.12 The contractor will ensure all Standards and TMDE owned by the PMEL in building 162 requiring Preventative Maintenance Inspections (PMIs), have schedules attached (AFTO Form 244).

9.13 All TMDE having specific and periodic maintenance/servicing requirements (i.e. the 5700A Auto Zero), will have the AFT0 244’s attached to the equipment. The AFTO 244 will be filled out, maintained, and disposed of in accordance with TO 00-20-1 Section 7.

9.14 The Contractor will be responsible to ensure that the PMIs are performed on Standards/TMDE in their respective calibration areas and recorded on the AFTO Form 244’s.

9.15 In addition to the AFTO 244, additional information is required that is not covered in TO 00-20-1. This includes the Maintenance Technical Order or Commercial data information that has the chapter, page, and paragraph number of the preventive maintenance procedure/service to be performed. This can be on plain bond paper and attached to the AFTO 244 or TMDE, whichever is practical.

9.16 All TMDE shall be maintained in accordance with TO 33-1-27, Section 1.6. The preventive maintenance/service cannot compromise the integrity of calibration/certification of the TMDE.

9.17 No AFTO 244 is required on TMDE that requires just filter cleaning. Filters on TMDE will be inspected and cleaned (if necessary) prior to use. Filters on TMDE must be cleaned at least once every 30 days. Filters are cleaned in conjunction with daily/weekly clean-up efforts.

9.18 Standards (MMS weights, Class 3, etc.) which due to their individual make up cannot be married to their certification label will require special care during use. Because of the possibility of mixing items from one standard to the next, only one set of these standards will be used at a time.

9.19 TMDE used in areas which might cause damage to the certification label, is too small to affix a label, or its nature will not allow the affixing of a label will have links to these certifications and ID labels in such away that traceability is maintained. The certification label special block will include the model or part number and the serial number of the TMDE certified.

Section 10

QUALITY PROGRAM

10.1 This section contains internal quality assurance objectives and practices. This includes specific management policies for meeting requirements of the QP.

10.2 The QP is a significant part of the overall quality system. The purpose of the QP in the 562D CBSG program is to ensure weapon system accuracy, reliability, safety, and traceability.

10.3 Government PMEL Quality Manager: The Government PMEL Quality Manager as identified in the organizational chart in Section 2 of this manual is responsible to ensure the Robins PMEL Quality Program (QP) is established and operated in accordance with TO 00-20-14 chapter 9 and within the guidelines of this Quality Manual.

10.4 PMEL Quality Assurance: The Contractor PQAs are designated in writing by the Contract PM. Their duties and responsibilities include performance and reporting of quality reviews, process reviews, root cause analysis, and trend analysis.

10.5 Quality Reviews: The Quality Review selection rate shall be no lower than the minimum established requirements of TO 00-20-14 Section 9.

10.5.1 Government PMEL Flight Chief can increase/decrease the selection rate at their discretion if special circumstances warrant such action.

10.5.2 Changes in the sampling rates will be documented in the quarterly trend analysis.

10.6 When calibration of an item is complete, the Technician will place the item into COMP status in FEMS. If an item is selected by FEMS for a Quality Review, FEMS will identify the item as being selected for a Quality Review and assign a Quality work order.

10.7 Contract PMEL Quality Assurance personnel will initiate the Quality Review in a timely manner. Based upon the availability of standards, space, workload etc., PQA will coordinate with PMEL Area Supervisors, Users, Technicians, etc., a time to perform the quality review.

10.8 Parameter Verification: There are occasions when full parameter verification of TMDE is not possible or warranted. In these instances, the PQA will perform the Quality Review to extent prescribed in the following paragraphs as applicable.

10.8.1 For TMDE items selected for Quality Review that are Not Repairable This Station (NRTS), the PQA will validate the reason or action for the NRTS. This could range from inoperable/functionality of TMDE, lack of calibration/repair capability, lack of technical data, lateral support, etc. The PQA will verify that the NRTS action is appropriate.

10.8.2 For TMDE items selected for Quality Review that were processed with an action taken code “G” (minor repair), the Contractor PQA will verify that the minor repair was properly performed and that the repair does not affect calibration.

10.8.3 Items selected for a Quality Review that have returned from being shipped off base (AFPSL, Contract, and Lateral Support) will be reviewed by Contractor PQA for proper operation, physical damage, and documentation. Additionally, applicable TMDE items will be tested for compliance IAW TO 33K-2-11, Maintenance T.O., TO 33-1-32, commercial data, self-test etc. if the capability exists within the PMEL.

10.8.4 TMDE items selected for a Contract Quality Review that are listed in TO 33K-1-100-2 or CMS as USER/PMEL will be verified by the Contractor PQA that the unit has been repaired (operational).

10.8.5 TMDE items processed with an action taken codes “A” (Bench checked and repaired), “B” (Bench Checked-Serviceable) or “X” (Test-Inspect) and are not USER/PMEL will be verified by the Contractor PQA to the affected range(s) that were inspected or were suspected of improper operation.

10.9 Quality Review Pre-selection Policy: In accordance with TO 00-20-14, paragraph 9.3.1, Precision Measurement Equipment Laboratory (PMEL) Government PMEL Management has established and documented a policy for pre-selecting Test Measurement and Diagnostic Equipment (TMDE) for Quality Reviews that are inherently difficult to review once the calibration process is complete.

10.9.1 Only TMDE that fall into one or more of the following categories will be considered for pre-selection. The pre-selection process may only be utilized prior to the item being placed into the INPRG status and is not to be used to bypass quality reviews after an item has been completed. The criteria for considering pre-selection are as follows:

a) Mission critical priority TMDE (justified by a priority letter).

b) TMDE that would create a production line stoppage (justified by line stoppage letter).

c) TMDE that requires two or more days to calibrate.

d) TMDE calibrated on-site that is inherently difficult to review due to location or test method.

e) Approved partnerships that have a time requirement of 5 days or less.

10.9.2 Only ????, or their designated alternates may request an item for pre-selection process. This request must be made just prior to the Contractor Technician performing the calibration or repair.

10.9.3 The method of pre-selection utilized by Contractor Quality Assurance will be the shaking of four coins sealed within a container. This is to ensure there is no tampering with the results. An item is selected for a Quality Review when all four coins shaken, come up “heads”. This process should produce a sampling rate of 6.25 percent.

10.9.4 When an item is pre-selected by this process, a quality review work order will be generated and the next available Contractor PQA will perform the quality review.

10.9.5 Contract Quality Reviews electronically selected by FEMS, on items that have been subjected to the pre-selection process will be bypassed by the Government PMEL Quality Manager, and the contract quality review work order will be canceled in FEMS.

10.9.6 A log will be maintained on all TMDE subjected to this process, with the reason or justification for pre-selection, and the ??? requesting this process.

10.9.7 The Government Quality Assurance Supervisor located in Building 162 will maintain a master log with all Type IIA TMDE selected under the pre-selection process.

10.10 Quality Review Bypass: In accordance with TO 00-20-14 Section 9, paragraph 9.3.1, Government PMEL Management is directed to establish local policy for bypassing Quality Reviews (QR).

10.10.1 Only the PMEL Services Flight Chief or the Quality Manager may bypass a Quality Review.

10.10.2 Requests for bypassing a QR will be reviewed on a case by case basis and will be approved when extraordinary conditions or situations prevent Contractor Quality Assurance from performing the QR.

10.10.3 All bypassed reviews will be documented and included in the monthly PMEL Quality Activity Summary (accomplished by the government).

10.11 Process Reviews: Process Reviews will be selected in accordance with TO 00-20-14 Section 9, paragraph 9.6.2.

10.11.1 Each Quality containing a critical nonconformity will have a Process Review assigned to it in accordance with TO 00-20-14 Section 9 paragraph 9.6.2 (a).

10.11.2 Each K stamp holder will have at least two Process Reviews annually IAW TO 00-20-14 Section 9 paragraph 9.2.2.2. Strong emphasis should be placed by Contract quality assurance and Contract supervisors to select the appropriate TMDE item that the Contract Technician typically calibrates.

10.11.3 Government PMEL Management may target a Process Review to include any PMEL process or partial process. The Government Quality Assurance Specialist will initiate a quality work order(s) for the Contractor Quality Assurance Supervisor for targeted Process Reviews.

10.11.4 Government Planning, Scheduling, Supply, and Transportation functions will be reviewed at the Government PMEL Quality Manager’s discretion. The purpose of the review is to evaluate a particular process or procedure(s) to ensure compliance, as a step in root cause analysis, or to seek process improvement.

10.13 Critical Quality Program Nonconformities: When a critical nonconformity is identified as a part of a Quality or Process Review, the improvement process will begin. The improvement process will include the following steps as required by TO 00-20-14 Section 9, paragraph 9.10.

10.13.1 When a critical nonconformity is found during a Quality Review or, the Contractor PQA will initiate a Process Review in accordance with TO 00-20-14 Section 9 paragraph 9.6.2 (a).

10.13.2 The Government Quality Assurance Specialist and Contractor Quality Assurance Supervisor will initiate Process Review work orders for the Organic and Type IIA respectively.

10.13.3 If the associated Process Review has a critical nonconformity it shall be addressed and answered along with the Quality Review nonconformity.

10.14 Completed Root Cause Analysis is routed through the Contractor up to the Government PMEL Services Flight Chief to approve/disapprove the root cause analysis, corrective action and recall consideration.

10.14.1 If the Root Cause Analysis package is approved, the PMEL Services Flight Chief will check the approve block and sign the Nonconformity Worksheet.

10.14.2 If the corrective action is disapproved, the Root Cause Analysis package will be given back to the Contractor to obtain an alternate corrective action or go back and repeat the root cause process.

10.14.3 The Contractor is responsible for the completion of corrective actions. The corrective actions will be completed by the Contractor within 90 days.

10.14.4 The Government PMEL Quality Manager will maintain the RCA on the critical nonconformity in the Monthly Summary as required by TO 00-20-14 Paragraph 9.12. Nonconformity and Root Cause Analysis information will be maintained in the Tracker Program for a period of 6 years or the duration of the contract.

10.14.10 The Government PMEL Quality Manager will review Contractor’s follow-up action on root cause analysis to determine if the corrective action(s) is effective. If the corrective action is not effective, the RCA will be re-evaluated by the contractor.

10.15 Trend Analysis.

10.15.1 Government PMEL management (listed below) shall periodically review the data collected by the PMEL Quality Program and track the most frequent quality, process, and standard nonconformities. The required team members for the Trend Analysis and are:

a) The PMEL Services Flight Chief

b) The PMEL Services Deputy Flight Chief

c) The Government PMEL Quality Manager

d) The Government Technical Manager

e) The Government Production Control Chief

f) Contractor 10.15.2 Critical nonconformity trend analysis may include:

a) Part number analysis on A01, A02, A03, A04, A05, A06, A07, A08, A09, and A10 nonconformity codes and subcodes..

b) An analysis of a Technician’s performance (If Technician performance has some bearing on trend analysis).

10.15.3 The Quality Assurance Monthly Trend Analysis shall include (all data provided by the Government QAS):

a) Quality Review critical nonconformity codes: (bar chart showing critical nonconformity codes for previous 12 months).

b) Process Review critical nonconformity codes: (bar chart showing critical nonconformity codes for previous 12 months).

c) Quality Review root cause codes: (bar chart showing root cause codes for quality review nonconformities over pervious 12 months).

d) Process Review root cause codes: (bar chart showing root cause codes for process review nonconformities over previous 12 months).

e) Process review and quality review nonconforming reviews (number of critical and non-critical over previous 12 months).

f) MXDCA Critical Nonconformity percentage (bar chart showing percentage of nonconformities over previous 12 months).

g) MXDCA Critical Nonconformity Trend Graph (graph showing monthly PR and QR percentages).

10.15.4 Quarterly Trend Analysis shall include (data provided by the Government QAS):

a) Analysis of critical quality review nonconformity findings for the quarter, to include root cause findings for the quality review nonconformity of highest incidence.

b) Analysis of critical standard review nonconformity findings for the quarter, to include root cause findings for the standard review nonconformity of highest incidence.

c) Analysis of critical process review nonconformity findings for the quarter, to include root cause findings for the process review nonconformity of highest occurrence.

d) Non-critical quality, standard, and process review nonconformities will be reviewed at management’s discretion.

e) Analysis of a specific area for problem isolation may be required as necessary.

10.15.5 The Government PMEL Quality Manager will conduct a semi-annual trend analysis meeting. This meeting is for PMEL Management to review the top nonconformities in the PMEL (both Organic and Type IIA together).

10.15.5.1 The PMEL Management team will determine a root cause or trend for the nonconformities with the highest occurrence observed using the Process Improvement Module in TO 00-20-14 Section 9 paragraph 9.10 for quality and process reviews from the previous quarter.

10.15.5.2 The PMEL Management team will use the quarterly trend analysis per paragraph 10.15 plus the root cause analysis from the nonconformity of highest occurrence and root cause to aid in finding the root cause of the highest negative trends plaguing Robins PMEL.

10.15.5.3 The Government PMEL Quality Manager shall document the findings of the PMEL Management team findings in the trend analysis summary..

10.15.5.4 The entire package is forwarded to the PMEL Services Flight Chief to approve the corrective action(s) and sign the Trend Analysis Summary.

10.15.5.5 The Contractor will conduct follow-ups to assess the effectiveness of the corrective actions. The primary objective is to assess if the corrective actions have corrected the nonconformity or negative trend. The findings of the follow-ups will be presented during the next Quarterly Trend Analysis meeting.

10.16.1 The Government QAS in building 162 will input non-critical nonconformities on TMDE calibrated by Contractor Technicians. This information will be maintained in the tracker database for a period of 6 years..

10.16.2 All non-critical TMDE nonconformities will be corrected as soon as possible by the Contractor.

10.16.3 Upon discovering a non-critical nonconformity, the PQA will input the non-critical nonconformity into the Robins AFB PMEL Tracker Database.

10.17 562D CBSG Proficiency Testing Program.

10.17.1 The 562D CBSG Proficiency testing program will be carried out in strict accordance with section 7.4 of TO 00-20-14 and N40P of TO 33K-1-100-1.

10.17.2 Upon receiving a Proficiency Testing Artifact, the Government PMEL Quality Manager will be notified immediately.

10.17.3 All instructions for performing the tests, reporting results, notification of 562D CBSG and shipping will be in accordance with instructions included with the artifact.

10.17.4 The item will then be tested by a qualified Contract PMEL Technician using the same calibration methods used to calibrate customer equipment or methods directed by 562D CBSG.

10.17.5 A copy of instructions and the reporting of results will be forwarded to the Government PMEL Quality Manager.

10.17.6 The Contractor is expected to complete proficiency testing of a measurement artifact within the time allotted in the PT/MAP instructions.

10.18 569TH EMXS/MXDCA Nonconformity Codes and Root Cause codes are listed in Appendix 4

Section 11

RECALL AND NOTIFICATIONS

11.1 This section contains the decision process for recall of TMDE when a PMEL standard or critical customer-owned TMDE is found to be out-of-tolerance. This process includes nonconformities or discrepancies discovered during maintenance, use, QP reviews, internal audits, management reviews, and 562D CBSG evaluations. This also includes any standard or TMDE that has exceeded its calibration due date or is otherwise judged unreliable and is recalled or removed from service. (TO 00-20-14 paragraph 3.1).

11.2 Contract Technicians will notify the Contractor ????? of any Standard found to be out of tolerance.

11.3 A FEMS Slash report will be provided to the customer on any TMDE item that has an out of tolerance condition(s). The out of tolerance condition will be specified in the report.

11.4 All laboratory standards found to be out-of-tolerance will be analyzed by the contractor for the potential impact on TMDE certified with the defective standard.

11.5 All laboratory standards subject to a quality review found to be out-of-tolerance or defective will be analyzed by the Contractor to determine the potential impact on other TMDE certified.

11.6 Recall of TMDE from a PMEL perspective is accomplished at two levels. One as the result of findings discovered during a quality or process review, or two as the result of out of tolerance condition discovered during a standards calibration. Each must have contractors responsibility for the completion of the recall.

11.7 Recall based on the results for a quality or process review.

11.7.1 All recalls of this type will be initiated and completed by the Contract PQA.

11.7.2 The Contract PQA will run a PMEL working standard tracking report (PMLWSTRK) for the item over the interval in question.

11.7.3 The Contract PQA will research and determine which items require recall.

11.7.4 The Contract PQA will prepare all recall notification and recall results documentation. (Local Forms 4 & 5)

11.7.5 The Contractor PQA will fill out and email filled out forms to the Government PMEL Quality Manager to review and verify and then forwards them to the PMEL Services Flight Chief for approval.

11.7.6 If approved these documents will be scanned in and emailed to the customers by the Government QAS.

11.7.7 The Government Scheduling Section will notify the Contractor PQA upon arrival of the recalled TMDE items.

11.7.8 The Contractor PQA will verify…