Attachment 18 Quality Management Procedures.pdf

CDP COBRATF Training Operations and Support Services

Attachment 18

Quality Management Procedures i

QUALITY MANAGEMENT PROCEDURE

Organization: Center for Domestic Preparedness Date: May 31, 2019 Title: Quality Management Procedures

CDP-COBRATF-QMP 001.4

I. Purpose

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

II. Supercession

This document supersedes Quality Management Procedures, QMP 001.2 effective date October 26, 2017

III. Authority

ISO 9001: 2015

CASARM QA Plan for Chemical Agent Air Monitoring (where applicable)

IV. References

A. International Organization for Standardization 9001

B. Chemical Surety Program Surety Standards Document

C. CASARM QA Plan for Chemical Agent Air Monitoring (CQPCAAM)

D. COBRATF Air Monitoring SOP’s and Work Instructions

E. COBRATF Chemical Hygiene Plan

F. COBRATF Air Monitoring Program Quality Control Plan

G. COBRATF OPS SOP 001.0 Chemicals Management

H. COBRATF Physical Security Plan

I. CDP Records Management Directive

J. CDP Document Guidelines and Procedure

K. Technical Library Index

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

Air Monitoring Program

Biological Program

Quality

O&M

PC&E

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Industrial Hygiene/Chemical Hygiene (includes environmental)

Training Operations, Delivery and Support

Medical

Security

Safety

Surety

V. Acronyms and Definitions

A. AD – Assistant Director

B. AMP- Air Monitioring Program

C. Auditee – The quality function to be audited

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

E. CAR – Corrective Action Request

F. CASARM – Chemical Agent Standard Analytical Reference Material

G. CIA - Continuous Improvement Action

H. FAR - Federal Acquisition Regulations (FAR)

I. FMEA- Failure Mode and Effects Anaylsis

J. IAW – In Accordance With

K. IH – Industrial Hygienist

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

M. ISO – International Organization for Standardization

N. 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

O. MRT – Management Review Team P. NIST – National Institute of Standards and Technology

Q. O&M – Operations and Maintenance

R. PAR – Preventive Action Request

S. PC&E – Protective Clothing and Equipment

T. PDCA – Plan Do Check Act

U. QA – Quality Assurance

V. QC – Quality Control

W. QMP – Quality Management Procedure

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X. QMR-Quality Managemnt Review

Y. QMS – Quality Management System

Z. SWOT- Strenghts Weakness Oppertunities Threats

AA. TMDE – Testing, Measuring and Diagnostic Equipment

VI. Responsible Office

Quality Section

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Table of Contents

I. Purpose ....................................................................................................................................... i

II. Supercession ............................................................................................................................... i

III. Authority .................................................................................................................................... i

IV. References .................................................................................................................................. i

V. Acronyms and Definitions ........................................................................................................ ii

VI. Responsible Office ................................................................................................................... iii

VII. Quality Management Procedures

A. Quality Management System Review

B. Document Control

C. Records Management

D. Internal Quality System Audits

E. Quality Improvement Actions

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

G. Analysis of Data

H. Purchasing

I. Calibration

VIII. Forms Prescribed

APPENDIX A

APPENDIX B

APPENDIX C……………………………………………………………………………….26

VII. Quality Management Procedures

A. Quality Management System Review

1. The QMS Representative:

a. Is appointed, in writing, by executive management

b. 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.

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

2. Management Review Input

a. 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.

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

(1) Status of actions from previous management reviews;

(2) Changes in external and internal issues such as new technology, changes and risks in the business environment, changing or new regulations, organizational changes, etc., that are relevant to the product and/or quality management system;

(3) The performance and effectiveness of the QMS, including trends in:

Customer satisfaction and feedback from relevant interested parties;

The extent to which quality objectives have been met;

Process performance and conformity of products and services;

Nonconformities and corrective actions;

Monitoring and measuring results;

Audit results;

The performance of external providers;

(4) The adequacy of resources

(5) The effectiveness of actions taken to address risks and opportunities (reference QC Plan section 2.4.3.2);

(6) Opportunities for improvement

(7) Old business

(8) New business

c. (9) Records of QMS reviews shall be maintained by the quality section and archived as deemed necessary by the QMS representative.

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3. Management Review Outputs

a. The outputs of the management review shall include decisions and actions related to:

(1) Opportunities for improvement to quality systems, processes and products;

(2) Any need for changes to the QMS to include the quality policy and quality objectives;

(3) Resource needs

b. All action items generated during the management review shall have periodic follow-up (i.e., do intermediate reviews) to verify implementation and evaluate the status of each action until all action items have been completed and documented.

c. A summarizing statement of the OMS’s suitability, adequacy, effectiveness, product conformity, and process performance shall be made. The organization shall retain records as evidence of the results of management reviews.

B. Document Control

NOTE 1: The document control system shall apply to all documents, forms, and internally developed computer software programs and, to the extent applicable, documents or external origin to ensure that changes and current revision status are identified. Examples of controlled documents are: Plans/Manuals, SOPs, WIs, forms, blueprints, or any other document that contains information or data relevant to the

QMS.

1. Prior to submitting any new or revised document for review and approval, process owners are responsible for coordinating with the Industrial Hygienist regarding need for hazard assessment of the document. Completion of this step is documented on CDP COBRATF QMPF 001. If this step is not documented, the review and approval process is not initiated. Upon determining the need for a hazard assessment, each department is responsible for developing the hazard assessment, based on an analysis of the department. The IH will have to approve the hazard assessment before submitting to Document Control.

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, Industrial Hygienist 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 2: 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

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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. Retained obsolete documents will be marked accordingly.

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 (in the appropriate format), 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.

e. If a published procedure requires a deveriation form the instructions given in the procedure a request for an immediate variance is submitted using SF 001 and must have the approval of the area supervisor, the Quality Manager, the Industrial Hygienist, and the AD.

5. Review

NOTE 3: All documents are reviewed annually or as necessary. An annual review of all controlled documents is performed by document proponents, the Quality Manager, the IHO 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.

This is to include an updated process map and hazard assessment. These reviews are documented on the initiation and review form QMPF 023, or in an annual review form memo and included with the appropriate document.

a. The document control clerk ensures appropriate personnel review proposed changes and the review is recorded on the initiation and review form. The AD determines reviewers for each SOP.

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.

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. The document control clerk notifies the process owner or reviewer by email requesting the completion of QMPF 023 (justification for extension). It is the process owner’s or reviewer’s responsibility to obtain an extension from the AD. Once approval is granted, the QMPF023 should be forwarded to the document control office for archival.

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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.

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

g. 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.

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

c. Electronic uncontrolled copies of the most current documents, forms and workbooks are protected and posted on a designated computer drive; these documents are available for print.

d. All individuals who print uncontrolled copies of documents from the designated computer drive are responsible for destruction of those documents after use and ensuring printed documents are the most current.

e. Controlled printed copies of documents are also provided to select individuals who are maintained on document holders master lists; when revised documents are distributed, the document holder is responsible for returning the obsolete document(s) that is being replaced.

f. When documents become obsolete they are marked accordingly. Copies of obsolete documents may be requested from the document control clerk. These documents are issued for information purposes only and are clearly identified as

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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).

d. External documents are maintained and controlled by the document control clerk who ensures the proper revision is available, and maintains a master list and a list of holders.

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. The Document Control log will list indivduals having controlled copies of documents

11. An annual review of all controlled documents is performed by document proponents, the Quality Manager, the IHO 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 QMPF 023 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 Appendix A and C 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.

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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.

6. Records are submitted to the quality section for archival by the process owners IAW Appendix A and C of this document.

a. The personnel who generates 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 only.

D. Internal Quality System Audits

NOTE 4: Functional areas shall be audited IAW an approved audit schedule; 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 or designee determines an audit schedule and communicates the audit schedule to appropriate personnel using the audit schedule form (QMPF 003).

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

(1) Obtaining an audit number from the quality section.

(2) Assembling an audit team. The team should consist of auditors who have completed an auditor training class and have been certified.

(3) Conducting a meeting with the audit team to assign areas of responsibility and to plan the audit

(4) Conducting, along with the audit team, an internal audit of the areas identified on the audit schedule

b. 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.

c. 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.

d. Upon completion of each audit, the auditor documents all findings on an audit checklist (QMPF 005). The checklist should include questions asked during the audit.

e. 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.

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f. 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.

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

(1) 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

(2) 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

(3) 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

(4) Commendation – a positive reinforcement statement rendered by an auditor in reference to a product, process or system

h. When the audit report is complete, the LA(s) notifies the quality manager. The quality manager or quality section schedules an internal audit closing meeting. The findings of the audit are presented at the closing meeting. The required attendees are determined by the quality representative. Records of all internal audits are maintained by the Quality Section and are not archived until two calendar years, at a minimum, after the completion of the audit.

i. In the event corrective action is required in relation to audit findings, a findings report is completed (QMPF 004). If corrective action needs to be elevated to a CAR, action will be IAW established procedures.

j. Findings are entered into a database by the quality section.

k. The database is used to track findings and ensure closure.

(1) The quality section is responsible for ensuring the finding is closed by validating the results and updating the database

l. Any findings relating to changes in documentation should be sent forward to the document control clerk who will place them in a spreadsheet.

(1) The document control clerk is responsible for updating the process owner of the need to revise the document based on these audit findings during the annual review process

(2) The document owner is responsible for editing the document to include a resolution to the findings as stated on findings report.

m. Findings such as those made during in process inspections, outside of internal audits, should be documented on a findings report which will be entered into the

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Findings Report Log QMPF 026 to ensure proper closure and then entered into the quality database for tracking. External audit findings will be added to the quality database and handled in the same manner as an internal audit findings. These findings can include but are not limited to external audit findings found during external audits by various agencies.

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 via CIA form. 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.

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.

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

g. 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.

h. 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.

i. 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.

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

k. 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.

l. 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.

m. 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.

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

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

2. Plan- Do- Check and Act Cycle

NOTE 5: The Plan-Do-Check Act (PDCA) cycle ensures that processes are resourced and that opportunities for improvement are found and acted on. PDCA cycle is a quick check on a process anyone can perform. When completing forms and tasks following the Plan- Do-Act (PDCA) cycle will aid the technician or operator to ensure the task is complete and correct. For more information on PDCA cycle see CQAPCAAM Section 2

a. PDCA cycle is a process anyone can perform when they complete any action. The steps of the PDCA cycle are outlined below:

(1) Plan – Activities before you start a procedure or process

(2) Do – Perform the activity

(3) Check – Check over the work done to ensure it was performed properly

(4) Act – Act on any issues found and bring any ideas for continuous improvement to the attention of your process owner.

3. Corrective Action Procedures

NOTE 6: 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 include manuals, plans, quality management procedures, standard operating procedures, work instructions and forms.

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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) How was discovery made (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)

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

c. 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.

d. If the decision is made not to issue a formal CAR, the process owner is responsible for taking action to best resolve the issue (if the issue becomes systemic or more critical it must be re-evaluated). The finding should be documented on a Findings Report Log QMPF 026 and placed in the quality database as an in-process finding. The closure for the finding must be verified by a member of the quality department. The quality manager must sign off on finding closure.

e. If the decision is made to issue a CAR, the information above is trasfered to or completed on CAR form (QMPF 008):

f. The quality section will

(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)

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

h. 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.

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

j. The quality section organizes and facilitates a root cause analysis group. The QMS Representative establishes a suspense date for completion of the root cause

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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.

k. During the review process the group shall also determine if similar onconformities exist, or could potentially occur. These findings should be included in the CAR which is sent to QMS Representative.

l. 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 corrective action.

m. Once approval signatures are obtained, the QMS Representative establishes the time frame for follow-up verification of the corrective 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.

n. 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 by the QM signature. Procedural changes resulting from corrective actions shall be verified, confirmed and validated in appropriate SOP and/or WI. If the corrective action is found to not have been implemented or effective actions needed to close the CAR will be discussed. Actions can include reverification at a later date or the CAR can be reissued to the process owner.

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

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

4. Risk Assessment

NOTE 7: Risk based thinking is critical to the growth of a process. Determining the organization’s risks helps the organization to develop strategies to deal with the challenges and opportunities in their organization. There are several tools in place which foster risk based thinking such as: strengths, opportunities, weaknesses and threats (SWOT) analysis, Decision Authority Matrix, and Failure Modes Effects Analysis (FMEA). For more information of these risk assessment methods refer to Appendix J of CQAPCAAM. SWOT analysis can be done during QMR meetings and included in the minutes of the meeting. A SWOT analysis can be performed by anyone and should help the organization determine its strategic direction. For an example of a SWOT analysis of the COBRATF see SWOT Anaylsis Notebook maintained in the quality office. A SWOT is performed at least annually.

a. Performing a SWOT analysis:

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(1) A SWOT will be completed annually by the COBRATF management.

(2) Start a SWOT by completing a matrix which can be a simple 2x2 table in a word document.

(3) Label the four cell of the table: Strengths, Weakness, Threats and Opportunities.

(4) Questions are asked about each category (for examples of question see Appendix B).

(5) Complete the matrix as the questions are answered.

(6) After the matrix is complete keep a copy for official the record.

NOTE 8: Use of Decision Authority Matrix Generate a table to determine the level of risk by looking at the likelihood of the event to occur and the severity of hazard if it occurs. If something is going to occur and would have catastrophic effects, then there may be focus to control that risk. If there is something that is unlikely to occur and won’t have much impact, then the organization may be willing to just accept that risk without taking any control measures. A simplified Decision Authority Matrix is completed for vendor evaluation. For a more complex explanation of Decision Authority Matrix refer to Appendix B.

b. Performing a Decision Authority Matrix for Vendor

(1) A Decision Authority Matrix is completed when risks need to be assessed for a process.

(2) A simplified Decision Authority Matrix is included in form QMPF 015.

(3) Follow the instruction to complete the form.

(4) Follow the instruction in Section H of this procedure to obtain vendor approval.

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

NOTE 9: The definition of non-conforming material, products and services are those materials, 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. Applicable functional areas 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. Applicable functional areas shall determine, collect and analyze 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

g. Continual improvement

3. Measureable quality objectives are established in applicable functional areas 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

NOTE 10: Purchases are made by federal staff according to Federal Acquisition Regulations (FAR). Federal purchases are made using FEMA form 143. This system is monitored under the FEMA asset management regulations. Issues with quality of end product or issues concerning vendor performance should be reported to the COBRATF asset representative. The issues will be documented and forwarded to a FEMA asset representative.

1. Purchase Requests

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

The requestor completes 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. If the product is a service a description of the service will provide sufficient information to make the purchase.

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.

(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. Vendors will be hyperlinked to the approved vendor list for quick reference and visibility.

(4) If chemicals are purchased, the items are checked against the MINICAMS Interferent List. If the item has been tested and approved, no other action is required. If the item has not been tested or has not been approved, request that the product be evaluated IAW OPS SOP 001.

c. Once sections one through three of the purchase request are complete, send the purchase request to the purchasing department. Supervisor (government purchases) or Project Manager (contract purchases) must fill out section three authorizing purchase. For Air Monitoring Program purchases, the Chemist, Physical Science Techician or AD reviews and signs the review portion of section three.

d. Purchase Receipt

NOTE 11: All vendors are subject to continuous evaluation. If issues develop with any vendor, they may be evaluated outside of the normal annual/recertification requirement.

Action will be taken based on evaluation.

(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. Any items rejected are handled as non-conforming material.

(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

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list. The vendor may apply for reinstatement after 90 days. Reinstatement requires approval by the Quality Manager.

(3) All results of inspections are documented on Section 4 of the QMPF 012. The Quality Manager will be contacted if an item is rejected. If inspected items are rejected Quality Manager will be consulted to ensure the items are properly segregated and the issue is resolved in the proper manner. All contact with a vendor which has supplied rejected items or has an unresolved issue will be documented on complaint form (QMPF 024) and sent to the quality section.

The quality section will determine actions taken including removal of the vendor from the approved list.

2. Purchases shall be from vendors listed on an approved vendor list (QMPF 013) maintained by the Quality Section and posted on a common computer drive. The Quality Section also maintains an unapproved vendor list (QMPF 022) which is posted on a common computer drive. No purchases can be made from vendors listed on the unapproved vendor list.

a. The vendor evaluation will be documented on the vendor status report (QMPF 014).

NOTE 12: All vendors included on the GSA.gov website (except high risk vendors) are initially considered approved vendors and shall be added to the approved vendor list.

All vendors are subject to continuous evaluation.

(1) All vendors are evaluated for risk and assigned a risk category. The risk categories are high, medium, and low. High risk vendors should be considered for an on-site vendor audit. QMPF 015 is used to assess risks.

(2) Risks are determined by evaluating the impact of the product or the service to the COBRATF. All vendors are evaluated and the result of the evaluations are posted on common drive. The date is updated on the approved vendor list.

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

c. Every vendor included on the approved vendor list shall have an initial copy of a vendor status report (QMPF 014) on file in the quality database. QMPF 014 will be completed each time QMPF 015 is updated.

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

e. Approved Vendor Requirements (these requirements are in addition to the risk assignment process listed above):

(1) ISO or GSA.gov vendors will 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. When the

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certificate on file expires a QMPF 014 vendor status form and QMPF 015 survey form will be completed and a new certificate will be placed on file.

(2) If not ISO or GSA.gov certified, a vendor must maintain a documented quality system. The quality system documentation must be reviewed and verified by a quality representative.

(3) The purchasing clerk verifies the expiration date of the certificates and updates files as necessary.

(4) Vendors which are not ISO or GSA certified will have an evaluation survey (QMPF 015) completed by the end user at least once annually.

(5) If problems with the vendor evolve, complete complaint form QMPF 024 and turn the form into the quality representative.

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

f. Conditionally Approved Vendor Requirements:

NOTE 13: The intention of conditional vendors is to ensure a product/service may be purchased if not available from a vendor already on the approved vendor list. If a product/service can be purchased from an approved vendor, the use of a conditional vendor is not authorized.

(1) To reduce the variation associated with using multiple vendors for the same product/service(s), the existing approved vendor list must be reviewed by the person wishing to add a conditional vendor to ensure a previously approved vendor cannot supply the product/service being purchased.

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

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

g. Conditionally approved vendors may not exceed three transactions within a calendar year.

(1) Each conditionally approved vendor is reviewed by the Quality Section after the three allowed transactions are completed. The review is used to determine if the vendor will continue to be used or removed from the approved vendor list.

(2) The functional area using a conditional vendor may request the Quality Section perform an audit of the vendor in an attempt to change the vendor’s status designation. The Quality Manager makes the final determination of status change based on past performance and audit findings. Any vendor that refuses to be audited is placed on the unapproved vendor list.

h. Sole Source Vendors:

(1) If needed items are only available from one sole source, the sole vendor

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may be added to the approved vendor list with the review and approval of the AD.

(2) An evaluation survey shall be completed by the end user 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 to include manufacturer and model

b. TMDE type

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

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

e. Date of last calibration and the calibration due date

f. Identification of the person or entity that performed calibration

g. The identification and/or serial number of the standard(s) instruments used to calibrate the equipment. External agencies (third party) shall use identifications and standards which are NIST traceable. A certificate of traceability will be supplied by third party vendor and filed by calibration coordinator.

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

NOTE 14: Calibration frequency is determined from the calibration performed and the calibration date.

a. Calibration Notification Procedures

b. Calibration Program will email notification to each user fifteen (15) days prior to the month due

c. Items are due to the Calibration Coordinator no later than five (5) working days prior to the month due

d. If items are calibrated through a third party vendor the Calibration Coordinator should be notified with the date the third party vendor will perform the calibration.

This date should be not later than five (5) working days prior to the month due.

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

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recorded on the form. Gauge tolerances are determined by the manufacturer and calibrated accordingly to those specifications. Master gauges will be calibrated off-site by a third party and identified (as master gauges highlighted in green) in the calibration database. These gauges must be calibrated at a higher level than equipment they are intended to calibrate. 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 vendor that is included on the approved vendor list IAW established purchasing procedures.

The third party calibration vendor will supply a documentation which states the measurement accuracy, actual test results and as found condition of the instrument.

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) for in house calibrations. Third party vendor use their own calibration stickers. Ensure calibration is current before 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 data produced when TMDE is found not to conform to requirements, including the “as found” is out of tolerance and verifying measurements obtained with the TMDE when applicable. This assessment must be documented and delivered to the calibration coordinator for their records

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

k. Ensuring items being sent to third party vendor must be mailed no later than the last working day prior to the end of the month due. A tracking number will be provided to the Calibration Coordinator

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l. Ensuring internal calibration must be scheduled by the last working day of the month prior to the month due. A schedule will be provided to the Calibration Coordinator

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