Attachment_33_COBRATF_Quality_Management_Procedure.pdf

Training Operations and Support

Services – COBRATF

Attachment 33

COBRATF Quality Management Procedure (QMP)

FOR OFFICIAL USE ONLY

QUALITY MANAGEMENT PROCEDURE

Organization: Center for Domestic Preparedness Date: September 16, 2013

Title: Quality Management Procedures

I. Purpose

To establish, document, implement and maintain a quality management system and continually improve its effectiveness

II. Supercession

This document supersedes the following documents:

A. QMP 201.4.1, Document Control, Effective 02/13/2012

B. QMP 201.4.2, Records Management, Effective 11/14/2011

C. QMP 201.5.1, Management Review Procedures, Effective 11/14/2011

D. QMP 201.7.4, Purchasing, Effective 02/22/2012

E. QMP 201.8.1, Internal Quality System Audits, Effective 04/18/2012

F. QMP 201.8.2, Quality Improvement Actions, Effective 11/14/2011

G. QMP 201.8.4, Analysis of Data Procedures, Effective 11/14/2011

H. SOP 14.1.7, Calibration, Effective 01/17/2012

III. Authority

COBRATF Quality Manual

IV. References

A. International Organization for Standardization 9001

B. CASARM QA Plan for Chemical Agent Air Monitoring at Training Facilities

C. COBRATF Chemical Hygiene Plan

D. COBRATF Quality Control Plan for the Air Monitoring Section

E. COBRATF Quality Control Plan for the Chemical Agent Laboratory

F. COBRATF Physical Security Plan

G. CDP Records Management Directive

H. CDP Document Guidelines and Procedures

I. Technical Library Index

J. For the purpose of assigning requirements within this document, the term “functional areas” is defined as the following:

Air Monitoring

Agent Lab/Biological Lab/Chemical Lab

CDP-COBRATF-QMP-001.0

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Quality

O&M

PC&E

Industrical Hygiene/Chemical Hygiene

Training Operations, Delivery and Support

Medical

Security

Safety

Surety

V. Acronyms and Definitions

A. AD – Assistant Director

B. Auditee – The quality function to be audited

C. Auditor – Member of audit team qualified to conduct QMS audits through training and/or experience

D. CAR – Corrective Action Request

E. CASARM – Chemical Agent Standard Analytical Reference Material

F. CHO – Chemical Hygiene Officer

G. CIA – Continuous Improvement Action

H. IAW – In Accordance With

I. Internal Quality Audit – A systematic and independent analysis of quality systems to determine if activities and results meet requirements established in appropriate procedures

J. ISO – International Organization for Standardization

K. LA – Lead Auditor; lead audit team member who has successfully completed a registrar accreditation body recognized lead assessor course; the lead auditor shall be appointed by the Quality Manager

L. MRT – Management Review Team

M. NIST – National Institute of Standards and Technology

N. O&M – Operations and Maintenance

O. PAR – Preventive Action Request

P. PC&E – Protective Clothing and Equipment

Q. QA – Quality Assurance

R. QC – Quality Control

S. QMP – Quality Management Procedure

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T. QMS – Quality Management System

U. TMDE – Testing, Measuring and Diagnostic Equipment

VI. Responsible Office

Quality Section

VII. Quality Management Procedures

A. Quality Management System Review

1. The QMS Representative:

a. Is appointed, in writing, by executive management

b. Appoints, in writing, an MRT

c. Ensures that, at a minimum, a meeting is conducted with the MRT once per twelve months and prior to the CASARM Quality Assurance Team audit.

2. The required annual management review always addresses, but is not limited to, the air monitoring program and should encompass all products, processes and procedures.

3. The quality section sets the agenda, develops source material (handouts), and facilitates the MRT meeting. All actions taken, and/or items developed to facilitate the QMS review are subject to the approval of the QMS Representative.

4. At a minimum, the following areas shall be reviewed:

a. Follow up actions from previous reviews

b. Findings resulting from internal and external audits and actions taken to address the findings

c. Preventive actions

d. Corrective actions

e. Customer surveys and feedback

f. Consideration of external influences (new technologies, business environment, applicable regulations, organizational changes, etc.)

g. Review of the QMS and assessment of its effectiveness, suitability, adequacy, product conformity and process performance

h. Review of audits performed which focus on subcontractors and/or suppliers to ensure any corrective actions taken are adequate, if applicable

i. Recommendations and/or courses of action for improvements of the quality system, processes and products

j. Status of actions identified for implementation

k. Quality policy

l. Quality objectives

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5. Records of QMS reviews shall be maintained by the quality section and archived as deemed necessary by the QMS Representative.

B. Document Control

1. Hazard analyses are required to support the development of operational processes and any other processes determined by the QMS Representative and/or MRT. Hazard analysis are performed for, and included with, appropriate new and revised documents. Hazard analyses are performed IAW the COBRATF Chemical Hygiene

Plan. This applies to all processes, chemical or non-chemical.

2. If deemed necessary by the AD, new documents or revisions are validated prior to final document approval. This must be done with the knowledge of the Quality

Manager, Chemical Hygiene Officer and AD before the validation process to ensure safety and security. Any problems or inconsistencies encountered during a validation should be noted and corrected before the document is submitted to the document control clerk.

NOTE: For guidance regarding format of documents and process mapping, see document control clerk.

3. All documents submitted to the document control clerk shall be formatted by the proponent IAW established guidelines and be accompanied by a process map(s).

4. Submission Process

a. A document revision is requested by the proponent from the document control clerk. The document control clerk issues an uncontrolled electronic copy of the document with edit privileges.

b. The proponent electronically submits a request for a new document or revision to the document control clerk along with an initiation and review form (QMPF 001).

All proposed changes made to the document shall be highlighted. Proponents certify on the initiation and review form that all references within the document are accurate, current and contained in the technical library.

c. A request for retirement of a document is submitted using QMPF 001. References included in the document shall be researched by the proponent before submittal to ensure they are not included in other controlled documents.

d. If an interim change to an existing document is requested, the AD determines whether to issue an interim change. If an interim change is issued, the change is incorporated into the document upon the next annual review. A document cannot exceed three interim changes; after the third change, a revision is required.

5. Review

a. The document control clerk ensures appropriate personnel review proposed changes and the review is recorded on the initiation and review form.

b. Each reviewer is allotted five business days to conduct review. In the event that more time is needed, the reviewer may request an extension from the AD.

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c. If a reviewer keeps a document for more than eight business days, the document is returned to the document control clerk who notates on the initiation and review form that the reviewer has no comments.

d. The document control clerk uses QMPF 020 and QMPF 021 to track the progress of all document reviews.

e. After review by all appropriate personnel, the document control clerk evaluates comments made during the review process.

(1) Comments that do not alter the context of the document are incorporated with no further review, i.e. spelling, sentence structure, format, etc.

(2) When comments made by reviewers alter the context of the document, the document control clerk sends comments to all reviewers to ensure all comments are seen by all reviewers. If the final outcome of a document cannot be agreed upon, the proponent informs the AD, who determines if a technical working group is needed.

(3) Once final changes are agreed upon by the appropriate personnel, the proponent, in conjunction with the document control clerk, applies final changes to the document.

6. Approval/Disapproval of Document

a. Approval of documents is recorded within the pages of the document with the exception of forms where the initiation and review form serves as record of review and approval.

b. All documents, at a minimum, require the review of the Chemical Hygiene Officer and Quality Manager, and the approval of the AD.

7. Issuing of Approved Documents

a. The document control clerk coordinates the proposed effective date of the new or revised document with the proponent to ensure ample time for training (if required) is allotted and compliance with additional quality procedures.

b. The document control clerk distributes hard copies to holders of new or revised documents. Notification of distribution is made via email. Electronic uncontrolled copies of the most current documents are posted on a designated computer drive.

New or revised forms and workbooks are protected and placed on a designated computer drive.

c. In the case where a revision is issued, the previous revision and all attached interim changes become obsolete.

d. The document holder is responsible for posting new, revised, and interim change documents and returning all obsolete documents to the document control clerk.

All individuals who print uncontrolled copies of documents from the designated computer drive are responsible for destruction of those documents after use.

e. Copies of obsolete documents may be requested from the document control clerk.

These documents are issued for information purposes only and are clearly

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identified as such. Once the intended use has been completed, the requestor is responsible for destroying the document.

8. Publications/External Documents

a. Document proponents ensure the current version of all external documents referenced in quality documents are maintained in the technical library.

b. An index of all reference material is maintained on a designated computer drive.

c. Reference materials may be signed out of the technical library using the technical library sign out log (QMPF 002).

9. Nomenclature

a. Process specific documents are assigned identifying alphanumeric characters at their initial release by the document control clerk. Subsequent document release follows a sequential pattern.

b. The number after the last decimal place reflects the current revision.

c. The initial release of a document is identified as revision 0 (zero).

d. The effective date is published on the document.

10. The document control clerk maintains a master list of all documents, including the latest revision number and the locations/individuals having controlled copies of each document.

11. An annual review of all controlled documents is performed by document proponents, the Quality Manager, the CHO and the AD within approximately one year of the current effective date. A full biennial review is conducted by the document proponent and all necessary personnel. These reviews are documented on the initiation and review form or in an annual review memo and included with the appropriate document.

C. Records Management

1. Records that are kept as a requirement of air monitoring activities, and supporting areas, are listed in Index 1 of this document.

2. Records may be kept in a redundant manner, but the originally produced document is considered the document of record. This includes hand written or computer generated data.

3. Quality records shall be maintained and archived by the process owner in a way that ensures traceability.

4. It is the responsibility of personnel generating records to ensure that the data is legible, accurate, and recorded on a medium that is probable to last the prescribed archived time.

5. Records are maintained in the appropriate area prior to archival. These records are kept in a manner to ensure preservation of the legibility, and accessibility, by personnel who have a need to reference the contained data.

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6. Records are submitted to the quality section for archival by the process owners IAW

Index 1 of this document.

a. The personnel who generated the records package them IAW CDP policies and procedures.

b. The Quality Manager, or his/her representative, transfers custody of archival records to CDP archival personnel using the record submission section of Form

CDP TF 20.

c. Records of the archival activity are kept according to CDP policies and procedures. These records are not part of the archive itself.

7. The records archived are available for retrieval by authorized personnel.

D. Internal Quality System Audits

NOTE: All functional areas shall be audited once per calendar year at a minimum;

however, internal auditors may document findings at any time. Internal auditors shall be independent of the areas they are assigned to audit.

1. The Quality Manager determines an audit schedule and submits it to the QMS

Representative for approval. Once approved, the Quality Manager communicates the audit schedule to appropriate personnel using the audit schedule form (QMPF 003).

2. The Quality Manager assigns an LA(s) who is responsible for:

a. Assembling an audit team

b. Conducting a meeting with the audit team to assign areas of responsibility and to plan the audit

c. Conducting, along with the audit team, an internal audit of the areas identified on the audit schedule

3. The Quality Manager schedules an internal audit opening meeting to include auditors, process owners and the QMS Representative. Process owners may invite additional personnel as they deem necessary.

4. Auditors shall schedule individual audits in conjunction with the process owners. The

LA(s) and Quality Manager shall be notified of the agreed upon audit schedule for each process/area.

5. Each day an audit in a process/area is conducted, the auditor documents any findings resulting from the audits on a findings report (QMPF 004). A copy of this form is supplied to the process owner and Quality Manager.

6. Upon completion of each audit, the auditor documents all findings on an audit checklist (QMPF 005).

7. Auditors provide all checklists, objective evidence collected and notes to the LA(s).

The LA(s) generates an audit report including all findings discovered during the audit.

8. The Quality Manager assigns the classification of audit findings and notifies the process owner. In the event the process owner disagrees with the classification of the

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finding, the QMS Representative makes the final determination of classification. The findings are classified in one of four categories:

a. Non-Conformance – the failure to meet documented process requirements with actual practice or action; requirements are established by internal controlled documents and external documents that establish statutory, regulatory or implied product, process or system requirements

b. Observation – an item of evidence found during an audit that relates to the quality of a product, process or quality system; an observation may be positive, negative or neutral and may or may not require corrective action

c. Recommendation – a suggestive statement documented, by an auditor, to provide input to a product, process or system, based on prior experiences of the auditor in the area being audited

d. Commendation – a positive reinforcement statement rendered by an auditor in reference to a product, process or system

9. When the audit report is complete, the LA(s) notifies the Quality Manager and the

QMS Representative. The Quality Manager and the QMS Representative schedule an internal audit closing meeting. The findings of the audit are presented at the closing meeting. The required attendees are determined by the Quality Manager and the QMS

Representative.

10. Records of all interal audits are maintained by the Quality Manager and are not archived until two calendar years, at a minimum, after the completion of the audit.

11. In the event corrective or preventive action is required in relation to audit findings, the action is taken IAW established procedures.

E. Quality Improvement Actions

1. Continuous Improvement Actions

a. Improvements can, and are encouraged to be, identified by all personnel. The person identifying a possible improvement action notifies the process owner. If the process owner concurs with CIA, they will document the proposed action on

CIA form QMPF 006 by filling in the following sections of the form:

(1) Date

(2) Process to be Improved

(3) Improvement Proposed By

(4) Proponent of Process

(5) Statement of Possible Improvement

(6) Process improvement team members

(7) Statement of improvement goals

b. Once this information is documented, the CIA is presented to the AD for approval.

The AD always has final approval of improvement goals and team members.

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c. If action is approved by the AD, the CIA is presented to the quality section for issue of a CIA number and entry into the CIA log (QMPF 007). Once logged, the process owner presents the CIA to the improvement team.

d. The team establishes a meeting schedule and chooses a team leader who is responsible for communicating team progress and requesting needed resources.

e. The team maps the process to identify any actions that could simplify the process.

The team reviews the process map to determine possible points where the process can be measured for determination of control and past performance. The measurement of a process is not always possible, however, the team should make every effort to establish process metrics.

f. The team continues to meet based upon the established schedule until recommendations of improvement actions are developed, including the metrics identified. These changes should be supportive of the initial stated goals for the improvement of the process.

g. A list of recommended improvement actions developed by the team are documented on the CIA form. The form is then presented to the process owner and the AD for approval.

h. The process owner and AD make the determination of which improvement actions are implemented.

i. A process map is created by the process owner which compares the improved process and the initial process. The comparison should be documented to ensure improvements are captured. The updated process map is also compared to the current procedure to ensure that it correctly reflects the process currently used.

j. The process owner facilitates implementation of the changes and the procedure is revised IAW established procedures to reflect the new process. Once improvement actions are implemented, the process is measured and/or observed by the process owner for effects of the changes.

k. The data collected, a record of observations, the documented comparison of the process maps and the CIA form are given to the quality section for evaluation/verification of improvement results. The evaluation/verification is conducted by an internal auditor appointed by the Quality Manager. After the evaluation/verification is completed, the CIA is circulated for approval signatures listed on the form.

l. When the CIA is closed, an entry is made on the CIA log indicating the CIA has been closed.

m. Records of continuous improvement activity are maintained by the quality section.

2. Corrective Action Procedures

NOTE: A CAR is issued to address the discovery of a non-conformance. A non-conformance can be a violation of a requirement established by a regulatory agency, certifying body, management directive, or an internally approved document to

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include manuals, plans, quality management procedures, standard operating procedures, work instructions and forms.

a. All personnel are expected to communicate all potential non-conformances to the process owner and to the quality section. When a potential non-conformance is identified, a findings report (QMPF 004) is initiated. The following areas of the form are completed at a minimum:

(1) Discovery point (in process, internal/external audit)

(2) Name of individual who identified the potential non-conformance (author)

(3) Date of discovery

(4) Process owner/representative (if the process owner is unavailable, notification of a process representative is sufficient)

(5) Findings statement (include as much detail as possible)

(6) Requirement statement (must be quoted from requirement documentation)

The remaining sections of the form are completed by the quality section.

b. The authority to issue or not issue a CAR is retained by the quality section. The decision should be made after consultation with the process owner and the QMS

Representative.

c. If the decision is made to issue a CAR, a member of the quality section initiates a

CAR form (QMPF 008):

(1) Enter date

(2) Assign a CAR number

(3) Enter the author

(4) Enter description of the non-conformance (include quote of requirement violated and the source document)

d. CAR information is entered onto the CAR log (QMPF 009).

e. The CAR is given to the process owner for completion of the “Immediate

Corrective Action Taken” section. The process owner has four business days to complete this section and return the CAR to the quality section.

f. The quality section circulates the CAR for signatures which serve as acknowledgement of the non-conformance.

g. The quality section organizes and facilitates a root cause analysis group. The

QMS Representative establishes a suspense date for completion of the root cause analysis. An established method of root cause will be used, i.e. The 5 Whys, Cause and Effect Diagram, etc. The process owner is consulted for the identification of participants. The group should consist of five to seven members;

more than seven or less than five can be utilized if deemed necessary by the process owner. The identified root cause(s) is documented on the CAR by the process owner.

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h. Once the root cause is determined, the process owner has four business days to determine and document the corrective action to be taken. If additional time is needed, the process owner may request an extension from the QMS

Representative. The CAR is then returned to the quality section who circulates the form for signatures indicating approval of the identified correction action.

i. Thirty days after the approval signatures are obtained, the quality section conducts a follow-up verification of the correction action. In the event additional time is needed for implementation, the process owner may request an extension from the

QMS Representative; no more than two extensions will be granted.

j. If the corrective action is found to have been implemented and effective by the quality section, objective evidence is collected and the CAR is closed. If the corrective action if found to not have been implemented or effective, the CAR is re-issued to the process owner.

k. When the CAR is closed, an entry is made on the CAR log indicating the CAR has been closed.

l. Records of corrective actions are maintained by the quality section and archived as necessary.

3. Preventive Action Procedures

NOTE: A PAR is issued to address the identification of a potential non-conformance. All personnel are encouraged to identify and communicate the identification of any potential non-conformance.

a. The potential non-conformance is communicated to the quality section and the process owner. When a potential non-conformance is identified, a findings report

(QMPF 004) is initiated. The following areas of the form are completed at a minimum:

(1) Discovery point (in process, internal/external audit)

(2) Name of individual who identified the potential non-conformance (author)

(3) Date of discovery

(4) Process owner/representative (if the process owner is unavailable, notification of a process representative is sufficient)

(5) Findings statement (include as much detail as possible)

(6) Requirement statement (must be quoted from requirement documentation)

The remaining sections of the form are completed by the quality section.

b. The quality section determines if the findings should be addressed through the

PAR process.

c. If the decision is made to issue a PAR, the individual intiates a PAR form (QMPF

010) and documents the following:

(1) Date

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(2) Author (person identifying the potential non-conformance)

(3) Process owner

(4) Potential non-conformance

d. The individual initiating the PAR presents the potential non-conformance to the quality section. The quality section assigns a PAR number and enters the PAR onto the PAR log (QMPF 011).

e. The process owner and PAR author conduct/facilitate a root cause analysis group to identify as many root causes of the potential non-conformance as possible and document them on the PAR. The process owner and PAR author make the determination of personnel required for the root cause analysis group. The quality section provides any requested support.

f. Once root cause(s) is determined and documented on the PAR, the process owner and/or PAR author determine the recommended preventive actions and document them on the PAR.

g. The PAR is returned to the quality section who circulates the form for signatures indicating the approval of the recommended preventive action(s).

h. The process owner ensures implementation of the approved preventive action(s) and, after implementation is complete, requests verification by the quality section.

i. The quality section conducts/facilitates a follow-up verification and indicates the findings on the PAR.

j. If the preventive action is found to have been implemented and effective, the quality section closes the PAR and indicates it has been closed on the PAR log.

k. If the preventive action is found to have not been implemented and/or effective, the process is re-issued.

F. Control of Non-Conforming Materials, Products and Services

NOTE: The definition of non-conforming material, products and services are those materials, products, and/or services that do not meet specified requirements.

Requirements are specified by documents (purchase orders, engineering packages/drawings, etc.) or are inherent to the product or service. For example, water pipes should not have holes that allow leaks.

1. Each functional area shall establish and document a process by which non-conforming materials, products and services are controlled. The process shall, at a minimum, establish methods for:

a. Identification of the material, product, or service as being non-conforming

b. Segregation of the non-conforming material, product, or service to ensure it is not unintentionally used

c. Evaluation of the material, product or service for final disposition

d. Documentation of the final disposition

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e. Re-verification of corrected materials, products and services, if applicable

2. Records of non-conformities and subsequent actions taken are maintained by each functional area and made available for review by quality representatives upon request.

G. Analysis of Data

1. Each functional area determines, collects and analyzes appropriate data to determine the suitability and effectiveness of their processes ability to meet requirements and satisfy both internal and external customers.

2. The analysis provides information in areas relating to:

a. Measureable quality objectives

b. Process/product trends and characteristics

c. Conformity of air monitoring data (when applicable)

d. Suppliers

e. Data reports

f. Customer satisfaction (internal and external)

g. Preventive action

h. Continual improvement

3. Measureable quality objectives are established in each functional area and the data collected enables the determination of the objectives being met. Objectives should be realistic, attainable and measureable. All measureable quality objectives are subject to approval by the QMS Representative.

4. Reporting of progress occurs once per 90 days at a minimum. Reports consist of:

a. A statement of the goals and objectives

b. Presentation/interpretation of data collected

c. Method(s) of improvement to meet goals or objectives

d. Customer satisfaction levels, if applicable

e. Assessment of need for changing objectives

f. Summary statement of evaluation period

H. Purchasing

1. Purchase Requests

a. All purchase requests are submitted using a purchase request form (QMPF 012).

Fill out section one of the form completely, including sufficient details, i.e. size or weight restrictions, manuals needed, intended purpose/location for item(s), equipment power needs, warranty, etc., to ensure the best review, approval and purchase is made.

b. Fill out section two of the purchase request form. The purchasing clerk may fill out section two if the requestor is not certain about the status of the vendor.

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(1) If the vendor is included on the approved vendor list as an approved vendor, purchase requests are submitted for signatures IAW section three of the requisition form.

(2) If the vendor is on the approved vendor list as a conditionally approved or sole source vendor, the request must be sent to the Quality Manager for review and approval.

(3) If the vendor is not on the approved vendor list, steps shall be taken IAW established procedures to place the vendor on the approved vendor list before moving forward with the purchase requisition.

c. Once sections one through three of the purchase request are complete, send the purchase request to the purchasing clerk.

d. Purchase Receipt

(1) All items received from vendors are inspected upon receipt by the requestor to ensure they meet the criteria specified on the purchase requisition and any engineering specifications from a work control plan, etc. Results of all inspections are documented on section four of the requisition form.

(2) Any item(s) purchased that is not usable and rejected at the fault of the vendor shall be documented on the purchase request form. Details on action taken as a result of the rejection shall be documented on the purchase request form and maintained by the purchasing clerk in the vendor’s file. Rejection of items and/or services occurring more than three times in a calendar year result in the vendor being removed from the approved vendor list. The vendor may apply for reinstatement after 90 days. Reinstatement requires approval by the Quality Manager.

(3) All results of inspections are reviewed by the Quality Manager.

2. Purchases shall be from vendors listed on an approved vendor list maintained by the

Quality Section. The approved vendor list (QMPF 013) is available on a common computer drive.

NOTE: All vendors included on the GSA.gov website are initially considered approved vendors and shall be added to the approved vendor list.

a. The approved vendor list shall indicate if the vendor is approved, conditionally approved, sole source or a GSA.gov vendor.

b. Every vendor included on the approved vendor list shall have an initial copy of a vendor status report (QMPF 014) on file which shall be updated annually.

c. All vendors are subject to periodic QMS audits conducted by a COBRATF representative as determined by the Quality Manager.

d. Approved Vendor Requirements:

(1) Maintain a quality system certified to ISO 9000 or similarly recognized quality standards.

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(a) Vendors supply a copy of the certificate, issued to show compliance to the standard(s). All certificates are reviewed and verified by the

Quality Manager and kept on file by the purchasing clerk.

(b) The purchasing clerk verifies the currency of certificates and updates files as necessary.

(c) An evaluation survey (QMPF 015) shall be completed for vendors annually.

(2) If not ISO 9000 certified, must maintain a documented quality system.

(a) The quality system documentation must be reviewed and verified by the Quality Manager.

(b) The purchasing clerk keeps all documentation on file.

(c) An evaluation survey shall be completed for vendors annually.

e. Conditionally Approved Vendor Requirements:

(1) Evaluation must be conducted, documented on an evaluation survey, and reviewed/approved by the Quality Manager prior to any transaction.

(2) An evaluation survey must be completed after each transaction by the person(s) receiving the equipment/service and reviewed/approved by the

Quality Manager.

(3) Vendors may not exceed three transactions within a calendar year.

(4) After one calendar year of being a conditionally approved vendor, another evaluation survey must be completed and presented to the Quality Manager who shall decide if the vendor should remain on the approved vendor list.

f. Sole Source Vendors:

(1) If needed items are only available from one sole source, the sole vendor may be added to the approved vendor list with the review and approval of the

Quality Manager.

(2) An evaluation survey shall be completed for vendors annually.

I. Calibration

1. The calibration coordinator is responsible for oversight of periodic calibration of

TMDE used to measure physical properties directly such as balances, flow meters, thermometers, etc.

2. The calibration coordinator maintains a database documenting all TMDE subject to periodic calibration. The database documents:

a. Each piece of TMDE and its unique, assigned number

b. TMDE type

c. TMDE status (calibrated, out of service, etc.)

d. TMDE owner (location of person in possession of the equipment)

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e. Date of last calibration and the calibration due date

f. Identification of the person or entity that performed calibration

3. The calibration coordinator provides notification to TMDE owners that calibration is due on the TMDE in their area(s).

4. All periodic calibrations are conducted with standards that are traceable to NIST or other internationally recognized bodies.

5. Periodic calibrations performed in-house are performed by a trained technician and recorded on a calibration certificate (QMPF 016). The equipment is calibrated throughout its functional range and observed readings at each measurement point recorded on the form. The certificate includes documentation of the “as found condition” of the TMDE.

6. Periodic calibrations that cannot be performed in-house are performed by a calibration vendor that is included on the approved vendor list IAW established purchasing procedures.

7. TMDE owners (individuals in possession of and/or using the TMDE) are responsible for the following:

a. Ensuring all TMDE in their respective areas used to conduct measurements to meet requirements is included in the calibration program.

b. Ensuring equipment is marked with a calibration sticker (QMPF 017) while in use.

c. Ensuring equipment not being used is tagged with an out of service sticker (QMPF

018) and is given to the calibration coordinator for storage.

d. Ensuring equipment used that does not require calibration is marked with a calibration not required sticker (QMPF 019).

e. Assessing the impact on the QMS when TMDE is found not to conform to requirements, including verifying measurements obtained with the TMDE when applicable.

f. Ensuring all calibrated TMDE is safeguarded in a manner that prevents adjustments being made that would invalidate measuring results.

g. Ensuring all calibrated TMDE is protected from damage or deterioration during handling, maintenance and storage.

h. Assisting the calibration coordinator in establishing recall intervals for all TMDE, in their possession, requiring calibration.

i. Ensuring primary records of TMDE calibrations are presented to the calibration coordinator.

j. Ensuring validation of data collected with TMDE that cannot be recalibrated and is removed from service as a result. The validation shall be recorded on the calibration certificate.

8. Records of all periodic calibration activities are maintained by the calibration coordinator and are stored in multiple locations to protect against loss. Equipment

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owners may maintain records of the specific equipment within their areas of responsibility; however, the records maintained by the calibration coordinator are considered the official record. These records are archived as necessary.

VIII. Forms Prescribed

A. CDP COBRATF QMPF 001, Controlled Document Initiation and Review Form

B. CDP COBRATF QMPF 002, Technical Library Sign Out Log

C. CDP COBRATF QMPF 003, Quality System Audit Schedule

D. CDP COBRATF QMPF 004, Quality Assurance Findings Report

E. CDP COBRATF QMPF 005, Audit Checklist

F. CDP COBRATF QMPF 006, Continuous Improvement Action

G. CDP COBRATF QMPF 007, Continuous Improvement Action Log

H. CDP COBRATF QMPF 008, Corrective Action Request

I. CDP COBRATF QMPF 009, Corrrective Action Request Log

J. CDP COBRATF QMPF 010, Preventive Action Request

K. CDP COBRATF QMPF 011, Preventive Action Request Log

L. CDP COBRATF QMPF 012, Purchasing Request Form

M. CDP COBRATF QMPF 013, Approved Vendor List

N. CDP COBRATF QMPF 014, Vendor Status Report

O. CDP COBRATF QMPF 015, Vendor Evaluation Survey

P. CDP COBRATF QMPF 016, Periodic Calibration Certificate

Q. CDP COBRATF QMPF 017, Calibrated Sticker

R. CDP COBRATF QMPF 018, Out of Service Sticker

S. CDP COBRATF QMPF 019, Calibration Not Required Sticker

T. CDP COBRATF QMPF 020, Document Review Routesheet

U. CDP COBRATF QMPF 021, Document Submission Log Sheet

V. Form CDP TF 20, Record Archival Form

FOR OFFICIAL USE ONLY 18

APPROVED BY:

Gary L. Milner Date

Assistant Director, COBRATF

Center for Domestic Preparedness

Quality Review Date Chemical Hygiene Review Date

CDP-COBRATF-QMP 001.0

FOR OFFICIAL USE ONLY 19

Index 1

Master Records Management Index

Records Retention Index for the Air Monitoring Section – All records archived IAW CDP directive.

Document Title Archival Period Storage Location Retention Period

Phase 2 training record for A/M Techs Archive at termination of employment CDP Archive 40 years

MINICAMS precision and accuracy test Archive when method/instrument obsolete CDP Archive 40 years

MINICAMS operator certification test Archive at termination of employment CDP Archive 40 years

Operator proficiency test Archive at end of year produced + 1 year CDP Archive 40 years

MINICAMS instrument 2-day certification data Archive when method/instrument obsolete CDP Archive 40 years

Mass Flow Controllers Calibration Certificate Archive after MFC recalibrated or replaced CDP Archive 40 years

Logs for working standard solutions Archive at end of year produced + 1 year CDP Archive 40 years

MINICAMS calibration and challenge data (QPs) Archive at end of year produced + 1 year CDP Archive 40 years

MINICAMS challenge data (QPs) Archive at end of year produced + 1 year CDP Archive 40 years

Sample lines, challenges, flow checks Archive at end of each year when line is removed from service CDP Archive 40 years

Pre-concentrator tube inspection data Archive at end of year produced + 1 year CDP Archive 40 years

Corrective action requests/reports (copies) May archive CAR copies in Air Monitoring area or destroy Air Monitoring N/A

Floppy disk of MINICAMS data To QA/QC monthly. Archive at end of year produced + 1 yearQA/QC/CDP Archive 40 years

CDs of Chrom-Net data Archive at end of year produced + 1 year CDP Archive 40 years

Instrument logbooks w/ PM entries Archive within 2 years of logbook being filled CDP Archive 40 years

Printer output of MINICAMS Archive at end of year produced + 1 year CDP Archive 40 years

3X Decontamination Verification forms Archive at end of year produced + 1 year CDP Archive 40 years

MINICAMS alarm reports Archive at end of year produced + 1 year CDP Archive 40 years

Hydrogen leak detector test Archive at end of year produced + 1 year CDP Archive 40 years

Calibration certificate for Refrigerator Thermometer Archive when instrument is replace CDP Archive 40 years

MINICAMS Error Reports Archive at end of year produced + 1 year CDP Archive 40 years

Sample Line V to G & Backup Pads Change-Out Archive at end of year produced + 1 year CDP Archive 40 years

FOR OFFICIAL USE ONLY 20

Records Retention Index for Chemical Agent Laboratory – All records archived IAW CDP directive.

Document Title Archival Period Storage Location Retention Period

Phase 2 training record for Chemical Lab Techs Archive at termination of employment CDP Archive 40 years

GC certification data Archive when method/instrument is obsolete CDP Archive 40 years

GC operator 2-day certification data Archive at termination of employment CDP Archive 40 years

CASARMS stock stds/working stds solutions logs Archive end of year lot expires + 1 year CDP Archive 40 years

DAAMS GC Type 2A Quality Data Archive at end of year produced + 1 year CDP Archive 40 years

GC challenge data (QPs) Archive at end of year produced + 1 year CDP Archive 40 years

DAAMS tube inspection data Archive at end of year terminated + 1 year CDP Archive 40 years

Corrective action requests/reports (copies) May archive CAR copies in chemical lab or destroy Chemical Lab N/A

Instrument log books w/ PM entries Archive when inst. taken out of service + 1 year CDP Archive 40 years

Hardcopy of GC data output Archive at end of year produced + 1 year CDP Archive 40 years

Central data logger archives (TurboChrom files) Archive at end of year produced + 1 year CDP Archive 40 years

TMDE calibration data Archive when inst. taken out of service + 1 year CDP Archive 40 years

In-house calibration certificates Archive at end of year produced + 1 year CDP Archive 40 years

Silver Fluoride data Archive at end of year produced + 1 year CDP Archive 40 years

DAAMS sampling report Archive at end of year produced + 1 year CDP Archive 40 years

Refrigerator Temperature Report Archive at end of year produced + 1 year CDP Archive 40 years

3X decontamination verification forms Archive at end of year produced + 1 year CDP Archive 40 years

Quality records are maintained in the quality office and archived as deemed necessary. CDP Archive 40 years