Attachment 21 - COBRATF Quality Management System.pdf

CDP Medical Support Services

Attachment 21

COBRATF Quality Management System

UNCONTROLLED

QUALITY MANAGEMENT PROCEDURE

Organization: Center for Domestic Preparedness Date: April 1, 2020

Title: Quality Management Procedure

CDP-COBRATF-QMP 001.5

Lead’s / Supervisor’s Statement

1. The lead/supervisor will sign this statement:

a. When first assigned as lead/supervisor of the operation.

b. When an approved change is made to the operation.

c. At least annually during continuing operations.

d. After absence exceeding 30 consecutive workdays.

2. I have personally reviewed each of the operational steps of this procedure/instruction and this procedure/instruction can be performed safely, efficiently, and in compliance with applicable federal, state, and local regulations. I have verified that operators have been trained and are capable of performing this procedure/instruction in a safe and efficient manner and have instructed them to follow the procedure/instruction without deviation.

Printed Name

Signature

Date

Organization: Center for Domestic Preparedness Date: April 1, 2020

Title: Quality Management Procedure

CDP-COBRATF-QMP 001.5

Operator’s Statement

1. The operator will sign this statement:

a. When first assigned to the operation.

b. When an approved change is made to the operation.

c. At least annually during continuing operations.

d. After absence exceeding 30 consecutive workdays.

2. I have read and understand the general and specific safety and operational requirements necessary to accomplish my operation. I have been thoroughly trained in and am familiar with the operation. I am confident in my ability to perform this operation as written, and I agree to abide by this procedure/instruction throughout my assignment to the operation.

Printed Name

Signature

Date

Title: Quality Management Procedure

Printed Name

Operator’s Statement

Signature

Continuation Page

Date

Title: Quality Management Procedure i

I. Purpose

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

II. Supersession

This document supersedes Quality Management Procedures, QMP 001.4 effective May 31, 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 (CQAPCAAM)

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/Biosafety Program

Chemical Surety

Environmental Management

Facilities Operations and Maintenance

Industrial Hygiene/Chemical Hygiene

Occupational Health/Medical Support ii

Protective Clothing and Equipment

Quality

Safety

Security

Training Delivery and Support

Training Operations and Support

V. Acronyms and Definitions

A. AD – Assistant Director

B. AMP- Air Monitoring 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 Analysis

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. Non-conforming material – products and services of those materials, products, and/or services that do not meet specified requirements.

Q. NIST – National Institute of Standards and Technology

R. NOTE –An explanation of something referenced in a specific step of the document.

Notes are not to be used to detail steps in the document, only to elaborate on a step that needs further clarification.

S. O&M – Operations and Maintenance

T. PAR – Preventive Action Request iii

U. PC&E – Protective Clothing and Equipment

V. PDCA – Plan Do Check Act

W. QA – Quality Assurance

X. QC – Quality Control

Y. QMP – Quality Management Procedures

Z. QMR-Quality Management Review

AA. QMS – Quality Management System

BB. SWOT- Strengths Weakness Opportunities Threats

CC. TMDE – Testing, Measuring and Diagnostic Equipment

DD. TOWS – Threats Opportunities Weakness Strengths

VI. Responsible Office

Quality Section iv

Table of Contents

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

II. Supersession ............................................................................................................................ i

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

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

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

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

VII. Quality Management Procedure

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

VII. Quality Management Procedure

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 therein.

d. For the purposes of this document, the COBRATF AD serves as the QMS

Representative. Throughout the rest of this document, the QMS Representative is referred to as AD.

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 AD.

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

(1) Old business

(2) Status of actions from previous management reviews;

(3) 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;

(4) 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;

(5) The adequacy of resources

(6) The effectiveness of actions taken to address risks and opportunities

(reference AMP QC Plan section 2.4.3.2);

(7) Opportunities for improvement

(8) New business

c. Records of QMS reviews shall be maintained by the quality section and archived according to the archival schedule listed in Appendix A and B.

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., 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 QMS’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

1. The document control system shall apply to all documents, forms, and internally developed computer software programs and, to the extent applicable, documents of 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.

2. Prior to submitting any new or revised document for review and approval, process owners are responsible for coordinating with the Industrial Hygienist (IH) regarding the procedural hazard assessment. Completion of this step is documented on CDP

COBRATF QMPF 001. Upon determining the need for a hazard assessment, each process owner is responsible for developing the hazard assessment, based on an analysis of the procedure. The IH must approve the hazard assessment before submitting any document to the document control clerk.

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

Manager, Industrial Hygienist and AD before the rehearsal process to ensure safety and security. Any problems or inconsistencies encountered during a procedure rehearsal 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 the document control clerk.

4. All documents submitted to the document control clerk shall be formatted by the process owner IAW prescribed format and be accompanied by a process map(s) and hazardous assessment.

5. Submission Process

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

b. The process owner 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.

Process owners 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 process owner before submittal to ensure they are not included in other controlled documents.

Retained obsolete documents will be marked accordingly.

d. An interim change to an existing document must be requested when procedures change. 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 deviation from the instructions given in the procedure a request for an immediate variance shall be submitted by the process owner using SF 001 and must have the review of the area supervisor, the Quality

Manager, the Industrial Hygienist, and the approval of the AD. Immediate variances cannot exceed the end date on the approved SF 001 form.

6. Review

a. All documents are reviewed annually by process owners. Biennially a review of all controlled documents is performed by process owners, the Quality Manager, and the IH; document review schedule is calculated by the document control clerk using the current effective date. Biennial review includes submission of an updated procedural process map and hazard assessment. These reviews are documented on the initiation and, review form QMPF 001, or on the document review form QMPF 023.

b. The document control clerk ensures appropriate personnel review proposed changes to a document and the review is recorded on the initiation and review form QMPF 001. Document reviewers are listed in the document review matrix

(Appendix C).

c. Each reviewer is allotted five (5) business days to conduct review. In the event that more time is needed, the reviewer may request a five (5) day extension from the Quality Manager. No more than two extensions may be granted to the reviewer on an individual document. During extenuating circumstances, the reviewer may obtain a third extension, not to exceed 90 days, with the approval of the AD.

d. If a reviewer keeps a document for more than eight business days, the document control clerk 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. Once approval for extension is granted, the QMPF023 should be forwarded to the document control clerk.

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

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

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

h. 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 document control clerk informs the Quality Manager, who determines if a technical working group is needed.

i. Once final changes are agreed upon by the appropriate personnel, the process owner, in conjunction with the document control clerk, applies final changes to the document.

j. Before a document is finalized, the document control clerk will run an electronic spell check on the document to ensure that spelling errors are kept to a minimum.

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 (QMPF 001) 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 process owner to ensure ample time for training (if required) is allotted.

b. When 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 also 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. When revised documents are distributed, the document holder is responsible for destroying the obsolete document(s) being replaced.

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

These documents are issued for information purposes only and are clearly marked with “OBSOLETE” or “FOR INFORMATION PURPOSES ONLY”. Once the intended use has been completed, the document holder is responsible for destroying the document.

8. Publications/External Documents

a. Process owners shall 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 by the document control clerk who ensures the proper revision is available and maintains a master list.

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

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

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 lists individuals having controlled copies of documents.

11. A review of all controlled documents is performed by process owners, the Quality

Manager, and the IH according to the document review matrix listed in Appendix C.

A full review is conducted by the process owner and all necessary personnel. These reviews are documented on the initiation and review form QMPF 001 or on the document review form QMPF 023 and included with the appropriate document.

C. Records Management

1. Records of air monitoring activities and supporting areas are listed in Appendix A of this document.

2. If needed, records may be kept in a redundant manner, but the original document is considered the document of record. This includes hand written or computer-generated data and/or documents.

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 archival time.

5. Records are maintained by the process owner prior to archival. These records shall be 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 according to the schedules listed in the Appendix section of this document.

a. Personnel generating records are responsible for package archival records IAW

CDP policies and procedures.

b. The Quality Manager, or designee, transfers custody of archival records to CDP archival personnel using the record submission section of Form CDP-RM-003.

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

1. Functional areas shall be audited IAW an approved audit schedule; however, anyone may document findings at any time. Internal auditors shall be independent of the areas they are assigned to audit.

2. 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 or designee 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 or designee schedules an internal audit opening meeting to include auditors, process owners and the AD. 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 finding report (QMPF 004). A copy of this form is supplied to the process owner and Quality Manager. Electronic copies are preferred.

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 AD 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 AD. Records of all internal audits are maintained by the quality section and should be archived two calendar years, at a minimum, after the completion of the audit.

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

CAR, action will be IAW section E.3 of this procedure.

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

k. The database is used to track findings and ensure closure. 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 informing the process owner

(usually via email) of the need to revise the document based on audit findings during the review process.

(2) The process 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, independent of internal audits, should be documented on a findings report (QMPF 004). The quality section enters the findings into the Findings Report Log QMPF 026 to ensure proper closure and then entered into the quality database for tracking.

n. 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 other government 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, QMPF 006. 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) Process owner (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 review.

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

c. If action is approved by the AD, the CIA is forwarded to the quality section to issue a CIA number and is entered 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 from the AD.

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 support the initial goals recorded for the improvement of the process.

g. A list of recommended improvement actions developed by the team are documented on the CIA form (QMPF 006). The form is then presented to the process owner and the AD for approval.

h. The process owner coordinates with the AD to 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 ensures implementation of the changes and the procedure is revised IAW section B of this procedure 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, QMPF 006, 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 form, QMPF 006, is circulated for approval signatures listed on the form.

l. When the CIA is closed, an entry is made on the CIA log, QMPF 007, indicating the CIA has been closed.

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

2. Plan- Do- Check and Act Cycle

NOTE: For more information on PDCA cycle see CQAPCAAM Section 2 or AMP

QC Plan Section 2.

a. The Plan-Do-Check Act (PDCA) cycle ensures that processes are resourced and that opportunities for improvement are found and acted upon.

b. PDCA cycle is a quick check on a process anyone can perform.

c. 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.

d. PDCA cycle is a quality process performed to complete an 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: 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/or 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) How was non-conformance discovery made (in-process, internal/external audit, etc.)

(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 findings report form, QMPF 004, are completed by the quality section.

c. The Quality Manager decides whether to issue or not issue a CAR. The decision should be made after consultation with the process owner and the AD.

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 quality section documents the finding on 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 section. The Quality Manager must sign the findings report (QMPF 004) to ensure proper closure.

e. If the decision is made to issue a CAR, the finding is transferred to or completed on CAR form (QMPF 008).

f. The quality section will fill out the following information on the QMPF 008:

(1) Enter date

(2) Assign a CAR number

(3) Enter the author

(4) How the discovery was made

(5) Requirement statement (the requirement source document)

(6 ) Description of the Non-conformance

g. The CAR form is circulated for required signatures which serve as acknowledgement of the non-conformance, and 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 five (5) business days to complete this section and return the CAR to the quality section. In the event that a process owner is unsure or unaware of appropriate immediate corrective action(s) to take, consult the Quality Manager for assistance.

i. The AD must approve the immediate corrective action.

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

Quality Manager establishes a suspense date for completion of the root cause analysis. An established method of root cause determination will be used, e.g.

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 or AD. The identified root cause(s) is documented on the

CAR form, QMPF 008.

k. During the review process, the group shall also determine if similar nonconformities exist, or could potentially occur. These findings should be included in the CAR form (QMPF 008).

l. Once the root cause is determined, the process owner has five (5) 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 Quality Manager.

The CAR form, QMPF 008, 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 Quality Manager establishes the time frame for closing the CAR The date projected for closing the finding is recorded on CAR form (QMPF 008).

n. In the event additional time is needed for implementation, the process owner may request a documented five (5) day extension from the Quality Manager; which is recorded on CAR form (QMPF 008).no more than two extensions will be granted.

If extension time is not requested or exceeded, the quality section will report the violation to the process owner’s supervisor for follow-up.

o. A follow up verification will be conducted by the quality department.

p. 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

Quality Manager’s signature. Procedural changes resulting from corrective actions shall be verified, confirmed and validated in appropriate SOP and/or WI.

If the corrective action has not been implemented and/or is not effective actions needed to close the CAR will be discussed. Actions can include re-verification at a later date, or the CAR can be re-issued to the process owner.

q. When the CAR is closed, an entry is made on the CAR log, QMPF 009, indicating the CAR has been closed.

r. Records of corrective actions are maintained by the quality section and archived

IAW archival schedule (Appendix A & B).

4. Risk Assessment

NOTE: For more information on risk assessment methods refer to Appendix J of

CQAPCAAM or Appendix D of this document.

a. Risk based thinking is critical to the growth of a process.

b. Determining the organization’s risks helps the organization to develop strategies to deal with the challenges and opportunities in their organization.

c. 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).

d. SWOT analysis can be done during QMR meetings and included in the minutes of the meeting.

(1) A SWOT analysis can be performed by anyone and should help the organization determine its strategic direction.

(2) For an example of a SWOT analysis of the COBRATF see SWOT Analysis

Notebook maintained by the quality section.

(3) A SWOT should at a minimum be reviewed annually or contingent upon operational changes be performed again.

(4) Performing a SWOT analysis:

(1.) A SWOT will be reviewed or completed annually by the COBRATF quality team.

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

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

Opportunities.

(4.) Ask questions about each category (examples of questions can be found in

Appendix D).

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

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

NOTE: For a more complex explanation of Decision Authority Matrix refer to

Appendix D.

e. Decision Authority Matrix

(1) 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.

(2) If something is going to occur and would have catastrophic effects, then it may be advantageous to focus on controlling that risk.

(3) 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.

(4) A Decision Authority Matrix is used when performing procedural hazard assessments.

(5) A simplified Decision Authority Matrix is completed for vendor evaluation.

(6) Performing a Decision Authority Matrix for Vendor

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

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

(c.) Follow the instructions on the form to complete the QMPF 015.

(d.) Follow Section H of this procedure to obtain vendor approval.

f. Failure Mode Efects Analysis is a tool used in harazdous assessment anaylsis. A modified FMEA as discussed in Appendix D of this procedure, is used when hazardous analysis (HA) is performed by process owners, and is included with each SOP submitted to document control.

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

NOTE: Requirements for materials, products and services are specified by documents (e.g. 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 IAW section B of this procedure which ensures 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

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

2. Records of non-conformities and subsequent actions taken are maintained by each process owner 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. This analysis provides information in areas relating to:

a. Measurable 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. Continual improvement

3. Measurable 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 measurable. All measurable quality objectives are subject to approval by the AD.

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. Approved Vendors

a. 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.

b. All vendors included on the GSA.gov website (except high risk vendors) and vendors with ISO certifcates are initially considered approved vendors and shall be added to the approved vendor list. All vendors are subject to continuous evaluation.

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

(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.

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

e. 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.

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

g. 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 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 or have a evaluation using QMPF 015 completed by the quality department on file.

(3.) The purchasing clerk verifies the expiration date of the certificates and updates files as necessary. Purchases should not be made from expired vendors.

(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 section.

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

h. Conditionally Approved Vendor Requirements:

(1.) The intent 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.

(2.) 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.) Conditionally aaproved vendors which undergo an evaluation using form

QMPF 015 can have the vendor status changed to approved vendor with the approval of the Quality Manager. The evaluation must be completed annually in order to maintain the approved vendor status.

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

Quality Manager.

i. Conditionally approved vendors may not exceed three transactions within a calendar year without an evaluation being conducted.

(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.

j. Sole Source Vendors:

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

2. Purchases made by federal contract are completed according to the Federal

Acquisition Regulations (FAR).

a. Federal purchases are made using FEMA form 143.

b. This system is monitored under the FEMA asset management regulations.

c. Issues with quality of end product or issues concerning vendor performance should be reported to the COBRATF asset management representative.

d. The issues will be documented and forwarded to a FEMA asset management representative for resolution.

3. Purchase Requests

a. Purchase requests are submitted using a purchase request form (QMPF 012 or other controlled form.

(1.) If form QMPF 012 is used, The requestor completes section one, 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.

(2.) If the product is a service, a description of the service will provide sufficient information to make the purchase.

b. If form QMPF 012 is used, 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.

c. If the vendor is included on the approved vendor list as an approved vendor, purchase requests (using QMPF 012 or other controlled form) are submitted for signatures IAW instrustions on the purchase request form.

d. If the vendor is on the approved vendor list as a conditionally approved or sole source vendor, the QMPF 012 or other controlled form must be sent to the

Quality Manager for review and approval.

e. If the vendor is not on the approved vendor list, follow steps listed in section H.1 of this procedure to place the vendor on the approved vendor list before moving forward with the purchase requisition. Vendors may be hyperlinked to the approved vendor list for quick reference and visibility.

f. If chemicals are purchased, the items are checked against the MINICAMS

Interferent List.

(a.) If the item has been tested and approved, no other action is required.

(b.) If the item has not been tested or has not been approved, request that the product be evaluated IAW OPS SOP 001.

g. If using QMPF 0012 complete sections one through three of the purchase request, and send the purchase request to the purchasing clerk. For AMP purchases section three of QMPF 012 authorizing the purchase must be signed by personnel authorized on AD memo concerning air montoring purchases. All purchases must be approved by the supervisor and/or Project Manager.

h. Purchase Receipt and Inspection

(1.) 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 most current evaluation.

(2.) Inspect all items received from vendors upon receipt to ensure they meet the criteria specified on the QMPF 012 or other controlled purchase request and any engineering specifications, etc. Document inspections on the purchase request form QMPF 012 or other controlled form. Any items rejected are handled as non-conforming material IAW section F of this procedure.

(3.) Document any unusable item(s) purchased and rejected at the fault of the vendor on the QMPF 012 or other controlled purchase request form. Details on actions taken as a result of the rejection shall be documented on the QMPF

012 or other controlled 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 be considered for reinstatement after 90 days. Reinstatement requires approval by the Quality

Manager.

(4.) All results of inspections are documented on QMPF 012 or other controlled purchase request form . The Quality Manager will be notified if an item is rejected. Consult the Quality Manager if inspected items are rejected. Quality

Manager will ensure the items are properly segregated and the issue is resolved in the proper manner.

(5.) All contact with a vendor which has supplied rejected items or has an unresolved issue will be documented on a complaint form (QMPF 024) and sent to the quality section. The quality section conducts a vendor analysis using QMPF 015 to determine actions to be taken, which may include removal of the vendor from the approved list.

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 vendors 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).

4. Calibration frequency is determined using manufacturer’s recommendations and the current calibration date of the item.

a. Calibration Program will email notification to each user fifteen (15) days prior to the month the item is due for calibration

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

c. 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.

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

6. Periodic…