JPR_1281.14.pdf

Johnson Space Center Procedural Requirements

JPR No.: 1281.14E

Effective Date: 07/28/2015

Expiration Date: 07/28/2025

(Formerly SLP 4.14)

Verify correct version before use at: https://cdms.nasa.gov/ JSC Form JF2420B (Revised January 21, 2020) (MS Word August 28, 2006)

Verify correct version before use

Compliance is Mandatory

Corrective and Preventive Actions, and Continual Improvement

Revalidation, July 2020

Responsible Office: Safety and Mission Assurance Directorate https://cdms.nasa.gov/

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JPR No.

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TABLE OF CONTENTS

CHANGE HISTORY LOG

P. PREFACE

P.1 PURPOSE

P.2 APPLICABILITY

P.3 AUTHORITY

P.4 APPLICABLE DOCUMENTS

P.5 MEASUREMENT/VERIFICATION

P.6 CANCELLATION

CHAPTER 1 OVERVIEW

1.1 Types of Actions

1.2 Criteria for Determining Type of Action to Take

CHAPTER 2: RESPONSIBILITIES

2.1 Manager of the Office of Knowledge and Quality Management Systems

2.2 JSC Corrective Action Manager

2.3 Directorate Level Organizations (DLOs)

2.4 JSC Audit Manager

CHAPTER 3: PROCEDURE

3.1 Audit Corrective Action

3.2 DLO Self-Initiated Corrective Action

3.3 Audit Preventive Action

3.4 DLO Self-Initiated Preventive Action

3.5 Procedure for Corrective and Preventive Actions tracked outside of QPID or for actions being tracked in OASIS………………………………………………………….. 33

3.6 Continual Improvement

CHAPTER 4: RECORDS

APPENDIX A. Acronyms, terms and definitions

APPENDIX B. Corrective action plan approval timeline

APPENDIX C. SLP 4.14 Change Record

APPENDIX D. Flow Diagram

LIST OF FIGURES

Figure 1-1 Criteria for Determining Type of Action in a Product/Service Life-cycle….….18

Figure 1-2 Criteria for Determining Type of Action in a Management Review…………..19

Figure 1-3 Criteria for Determining Type of Action from an Audit…………………………20 Figure 1-4 Criteria for Determining Type of Action from an External Audit/Assessment.21

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CHANGE HISTORY LOG

Revision Date Originator Description of Changes

Baseline 1/2008 NA/Cheryl Andrews 483-5979

Converted SLP 4.14 to JPR format with the following requirements changes:

2.1: Changed responsibility of JSC CAM to ensuring verification of effectiveness occurs;

and to assist DLO CAMs with process

2.2: Added requirement on DLO to assign POC (aka DLO CAM); and to assign owners to actions; and to use QPID, whenever possible.

2.3: Added responsibilities of DLO CAM

3.1.1/3.2.1: Added DLO responding to audit findings per JPR 1281.17

3.1.3/3.2.3: Clarified who performs verification and closure for audit findings

3.1.4: Defined responsible persons for closure of CA/PA;

3.3.1: Changed basis of CI from greatest resources to greatest value to org. or customers

A 7/2010 NA/Cheryl Andrews 483-

Changed office references from Management Integration Office to Office of Knowledge and Quality Management Systems

P.1: Defined purpose of CA/PA/CI process

P.2: Clarified Scope and Applicability

P.4: Added JPR 1700.1 Safety and Health Handbook; deleted JPR 1281.1 Management Responsibility; Changed NPR 8000.4 to JPR

8000.4 Risk Management Plan

P.5c: Changed JPR1281.1 to 1280.2

1.0 Re-title as “Overview”

1.1 Overview: Merged with 1.0; deleted

redundant sentences.1.2: Renumbered as 1.1;

deleted “in the JSC Management System”

1.3: Renumbered as 1.2, 1.2.1, 1.2.2

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Revision Date Originator Description of Changes

2.1: Inserted separate responsibility of Director to appoint JSC CAM

2.2, 2.3 and 3.1.2: Added new steps to address Major Audit N/C (QPID 2053)

2.2a: Inserted ‘JSC’;

2.2f: add “work with the owning organization to update plan”

2.2i: Added responsibility to manage external HQ audit findings

2.3b: Change “fix” to “address”; corrected reference to 1.1 Type of Actions

2.3h: Delete “preventive”; insert “Notify JSC CAM” and “update corrective action plan”.

2.3l: Rewrote to address review of all actions, not just CA/PA/CI.

2.3m: Change from “provide QMS review results to JSC CAM” to “document status of actions in QMS review minutes”.

2.4b: Add responsibility of escort during int/ext QMS audits

2.4c: Add requirement to concur on and enter QPIDs

2.4d: Insert “notify JSC CAM when not timely and update CAP”

2.4e: Clarified that DLO CAM closes self-initiated CA/PA

Add 2.4g: Identify DLO CAM as responsible for managing CA/PA from HQ audits.

3.1.4, 3.2.4: Delete section. Requirements are in 2.2

3.3.1i: Delete requirement – resides in JPR 1280.2.

3.3.1h, B3: Changed reference to JPR 1280.2 from JPR 1281.1 – document deleted.

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Revision Date Originator Description of Changes

4.0: Section added to meet requirements of JPR 1410.2 for Records identification

Appendix B: Inserted Acronyms List which moved Flow Diagram to Appendix D.

B 8/2011 NA/Cheryl Andrews/483-

Changes made to reflect clarifications made and new requirements in AS9100 Rev C:

P.1(b): Clarify that effectiveness should be reviewed, not just the actions.

P.2(b): Clarify that corrective actions are flowed to contractors when they are responsible for nonconformance, not just the root cause.

P.4(b): Inserted reference to JPR 2310.1 JSC Org Learning Program and added requirement in 2.4a(6)

1.2a(6): Added note from AS9100 standard for sources for continual improvements

1.3 and Figure 1-3: Deleted guidance in example sentence to take preventive action on all audit Observations. Clarified Figure 1-3 showing that Observations should be assessed for potential nonconformance and impact.

2.3a(5): Clarify that corrective actions are flowed to contractors when they are responsible for nonconformance, not just the root cause.

2.3a(12): Clarify that effectiveness should be reviewed, not just the actions.

2.4a(5): Clarify that effectiveness is to be verified prior to closure.

2.4a(6): Added requirement to identify lessons-learned to Learning Representative

3.3.1(g): New requirement that effectiveness is to be evaluated.

Appendix A: Remedial Action: Clarified that remedial action also includes actions taken based on the causes found to identify other product which could have been affected.

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Revision Date Originator Description of Changes

Other changes: Corrected title of JPR 1440.3

OPR changed from AK/Jeanie Engle to NA/Terrence Wilcutt.

Page Change 1

4/2013 NA/Cheryl Andrews/483-

P.3: Moved JPR 1280.2 to P.4.

P.4: Corrected numerical order of documents.

Modify 3.3.1(g) to be consistent with AS9100C, 8.5.1(b)

Remove 3.3.1(h) requirement to include in Management Review benefits/effectiveness of improvements. Conflicts with JPR 1280.2.

C 8/2013 NA/Cheryl Andrews/483-

P.4 Added AS9100 as Applicable Document

Deleted sentence in Chapter 1. Overview.

Adjusted Chapter 1 numbering accordingly.

Corrected Chapter 2 numbering.

Changed Section 2.3 to cover all DLO roles.

Inserted 2.3.1.h: Director approves CAP

2.3.2.g: Replaced HQ/IPS audits with QAAR audits

Deleted “Procedure” from title of Sections 3.1,

3.2 and 3.3

3.1.1.a: Inserted ‘preventive’

3.1.1.c: Clarified what constitutes Immediate action.

3.1.2a: Clarified requirement to take Immediate Action

3.1.2b: Inserted requirement to take Remedial Action

3.1.2.c: Added ‘and document’

3.1.2.d: Added requirement to document scope of root cause analysis

3.1.2.e: Added ‘and document’ and ‘to ensure it does not recur’

Deleted previous 3.1.2 e. Interim Action

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Revision Date Originator Description of Changes

3.1.2h: Simplified to “Submit the CAP to DLO

CAM”

3.1.2i: Inserted “the approved”

3.1.2j: DLO CAM to verify actions completed

3.1.3a: Added “and submit for approval”

3.1.3b: Added DLO CAM to verify actions completed

3.2.2.a: Changed interim action to immediate and remedial actions and clarified meaning of preventive action.

3.2.2 b: Inserted step to determine cause of potential nonconformance.

3.2.2.c: Corrected definition of preventive action from simply an observed condition

3.2.2.f: Simplified to “Submit the CAP to DLO

CAM”

3.2.2.h: DLO CAM to verify actions completed

3.2.3.b: Added DLO CAM to verify actions completed.

4.2: Changed AK to NA14

Merged Appendices A and B: Changed to Appendix A. Acronyms, Terms and Definitions

Removed numbering from Appendix A.

Appendix A Deleted Interim Action, added Immediate Correction, modified Remedial Action, added Scope of Root Cause Analysis

Added new Appendix B. Corrective Action Plan Approval Timeline

Admin Change 1

2/2014 NA14/Cheryl Andrews/483-

Appendix B: Added * note at bottom of table.

Appendix A: Defined AM

Page 2: Inserted missing header.

D 7/2014 NA/Cheryl Andrews/483-

TOC: Revised Section titles

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Revision Date Originator Description of Changes

P.2 Applicability: Changed reference for “critical and complex work” from AS9100 to NPD 8730.5.

P.4 Applicable Documents: Added NPD 8730.5 and moved AS9100 to Appendix A. Acronyms

1.2: Updated Figures 1-1, 1-2 and 1-3

2.2 and 2.2.1: Changed title to JSC Corrective Action Manager

2.2.1h: Added reference to Appendix B and removed “effectiveness”.

2.3.1f: JSC CAM no longer serves as A-Code

CAM.

2.3.2: Removed “preventive” from title of DLO CAM and corrected numbering.

2.3.2.1c: Added requirement for DLO CAM to ensure timeliness of actions in response to audit findings using Appendix B as a guide

Added 2.3.3: Moved relevant DLO Personnel responsibilities from Sections 3.1.1 and 3.3.1 and renamed as Corrective Action Owner.

Added 2.4 Audit Manager responsibilities as they apply to audit CA/PA

Converted previous Section 3.1 Corrective Action into two separate sections with detailed steps – 3.1 for audit corrective action and 3.2 for DLO self-initiated corrective action.

Converted previous Section 3.2 Preventive Action into two separate sections with detailed steps – 3.3 for audit preventive action and 3.4 for DLO self-initiated preventive action.

3.1 – 3.4: Added step to perform risk analysis and assessment for corrective/preventive actions using JSC Risk Scorecard from JPR

8000.4. Renumbered paragraphs accordingly.

3.1 – 3.4: Added requirement for CA Owner to determine completion dates based on risk for immediate and remedial actions.

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Revision Date Originator Description of Changes

3.1 – 3.4: Added requirement for CA Owner to provide objective evidence for all actions

3.1 – 3.4: Added requirement for DLO CAM to attach all evidence to the QPID.

3.1.13 and 3.3.13: Clarified that Audit Manager closes audit findings.

Appendix A: Added acronyms and definitions for AS9100, Corrective Action, IRMA, Preventive Action, Risk, Risk Analysis, Risk Assessment and System Level Procedure.

Appendix B: Added risk assessment and providing completion dates to containment step in timeline. Changed “emails” Root Cause to “enters”

Change 1 11/2014 NA/Cheryl Andrews/483-

P.2(b): Removed requirement to specify this directive on contracts for critical and complex work. This directive is already applicable for those contracts required to “follow the JSC QMS”. Contractors must meet the intent of this JPR even though they cannot specifically follow it.

1.1(c): Added “includes containment actions”

Appendix A: Added definition of “containment.”

E 7/2015 NA/Cheryl Andrews/483-

Editorial changes: P.1 formatting and order, P.2(e), P.6, change “nonconformity” to “nonconformance”, 1.1(c), replaced “immediate action” with “immediate correction” consistently, P.1(a) & (b): Re-wrote to establish requirements in (a) and define process in (b). Added missing requirements from 8.5.2 of AS9100C. Clarified that JPR applies to all CA/PA, regardless of tracking tool used.

P.2(b): Clarified contractor use of their corrective action process.

P.2(f): Broadened by eliminating reference to mishaps and close calls.

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Revision Date Originator Description of Changes

P.4(a): Deleted. No citation found.

P.4(c): Added JPR 1281.6 as Applicable Document, cited in 2.3.1 DLO Responsibilities.

1.1(c) and (d): Added examples of when to take

CA/PA.

1.2.1: Added “shall” to reflect criteria in flowchart.

1.2.2: Included problems identified during monitoring and measurement activities and data analysis

1.2.4 & Figure 1-3: Added external assessments as sources for corrective action, preventive action, and continual improvements.

2.1(b): Added responsibility to resolve matters pertaining to CAP ownership, approval, and closure.

2.3.1: Added “or a member of their senior staff”

2.3.1(l) : Added requirement to ensure that CA issued to contractors per JPR 1281.6 meet intent this JPR.

2.3.1(k): Added “inspections and assessments”

2.3.1(n): Reworded to be consistent with JPR

1280.2 QMS Reviews and deleted requirement

to include status of CA in the QMS Review minutes.

2.3.2(f): Deleted parenthetical exclusion of audit CA and note on delegation.

2.3.2(i): Deleted as it is redundant.

2.3.2(i): Moved steps pertaining to external audits to new step (j).

Added 2.3.2(j): Focus is external audits hosted by a DLO. Addressed CAP submittal timeline for external audits. Clarified Functional Review findings use QPID, corrected title of EEFR, and added note on use of SAARIS by the Agency.

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Revision Date Originator Description of Changes

3.1: Re-titled as “Internal and NQA Audit Corrective Action”.

3.2: Added statement that timeline for DLO Self- Initiated CA is managed by DLO.

3.3: Re-titled as “Internal and NQA Audit Preventive Action” and added statement referencing steps and timeline in Appendix B.

3.4: Added statement that timeline for DLO Self- Initiated PA is managed by DLO.

3.5: Added new section defining requirements for CA/PA not documented in QPID (e.g.

NSC/SAARIS, contractor CA/PA systems, etc.).

4.3: Delete. Not relevant to the procedure.

Appendix A: Added definitions of “objective evidence” and “systemic issue”.

Administra tive Change 1

01/06/20

NA/Walter Marker/ 483-0117

2.3.3: Administrative change to clarify corrective action owner response to an audit observation.

4.1: Changed AFS/NRRS from 8/101 to 8/114.

The retention schedule does not change.

Page Change 1

3/2017 NA/Walter Marker 483-0117

Appendix B: Replacement of Timeline for CAP submission and completion to support times required by Registrar.

Chapter 4: Updated 4.1 and added 4.2 to be conformant with update of JPR1440.3.

Administra tive Change 2

8/2017 NA/Jessica McLaughlin

Appendix B: Added words to address reassignment of CAPs, updating risks associated with CAP, flow down of CAPs to external providers, and plan if CAP is not completed within 60 days.

Appendix B: Updated Time for CAP submission to captures Effective of CAP

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Page Change 2

10/2018 NA/Jessica McLaughlin 281- 483-8057

Figure 1-3: Removed wording “or External Audit/Assessment” from title

Added Figure 1-4, Criteria for Determining Type of Action from an External Audit/Assessment

Section 2.2: added (l), (m), and (n)

Section 3.5: Added wording “or for actions being tracked in OASIS” to heading title

Section 3.5.1: Added (f), (h), and re-alphabetized

Appendix A: Added OASIS

Revalidati on

07/2020 NA/Walter Marker 281-483-0117

Changed signatory from William S. McArthur to William R. DeLoach.

Corrected Table of Content to include Section 3.5

Section P.4. (h) Change “JSC Organizational Learning Program” to “JSC Knowledge Management Strategy”,

(j) inserted reference to JPR 7120.3 “Program/Project Management and Systems Engineering,

(k) inserted reference to JPR1281.7 “Control of Customer Property”

Section 1.1.f: Change (section3.3) to (section 3.6)

Figure 1-!: Redrew entire figure to include Yes/No decision paths

Figure 1-2: Redrew entire flowchart and corrected reference of continual improvement JPR 1281.14, section 3.5 to 3.6

Figure 1-3: Redrew entire figure to cover only Internal Audits

Section 2.3.2.b: add “as well as support to virtual audits of the DLO.”

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Section 2.3.2.i: Change “NSC/SAARIS” to

“NSC/STAR”

Section 3.5.1: Change “NSC/SAARIS” to

“NSC/STAR”

Appendix A: Corrective Action System Definition- delete “The tool used is QPID”

Objective Evidence Definition delete “per clause 3.8.1of ISO 9000:2005” replace with

ISO9000:2015, 3.8.3

Added Virtual Audit Definition

Appendix B: Changed the timeline for corrective action development for internal audits from 60 to 120 days.

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P. PREFACE

P.1 PURPOSE

a. Establish the JSC requirement to eliminate the causes of nonconformances and potential nonconformances in order to prevent recurrence or occurrence by taking corrective and preventive actions. JSC shall take corrective or preventive actions appropriate to the effects of the nonconformances when processes or products and services either have not or will not meet requirements of the JSC Management System, customer requirements (including customer complaints), Agency requirements, regulatory requirements, and certification standards.

b. Document the criteria for determining what type of action to take, based on the nature of the problem to be solved, and the responsibilities and procedures to be used for taking corrective, preventive, and continual improvement actions.

c. Define the process for: reviewing nonconformances to requirements (including customer complaints), determining the causes of nonconformances, evaluating the need for action to ensure that nonconformances do not occur (preventive) or recur (corrective), determining the appropriate actions needed, reviewing the effectiveness of preventive and corrective actions taken, and taking action to ensure timely and effective corrective actions, including determining if additional nonconforming product exists, when applicable. This process applies regardless of the tracking tool being used.

d. Establish the requirement to continually improve the effectiveness of the management system.

P.2 APPLICABILITY

a. This directive is applicable to all organizations at JSC, including Ellington Field and the Sonny Carter Training Facility, except for the following:

(1) White Sands Test Facility,

(2) Office of Inspector General.

(3) NASA Engineering Safety Center (NESC)

b. JSC directives may apply to contractors or grant recipients only to the extent specified or referenced in the appropriate contracts, grants, or agreements. If so, the contractor shall follow its corrective action process and the intent of this directive when it is determined that the contractor is responsible for the nonconformance, or for site activities with environmental impact.

c. In this directive, all mandatory actions (i.e., requirements) are denoted by statements containing the term “shall.” The terms: “may” or “can” denote discretionary privilege or permission, “should” denotes a good practice and is recommended, but not required, “will” denotes expected outcome, and “are/is” denotes descriptive material.

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d. In this directive, all document citations are assumed to be the latest version unless otherwise noted.

e. This directive does not apply when responding to mandated statutory audits by local, state, or federal authorities, including Inspector General and Government Accounting Office

(IG/GAO).

f. For the procedures required to address safety and health related problems, see JPR

1700.1 JSC Safety and Health Handbook.

P.3 AUTHORITY

JPD 1280.1, Quality Policy

P.4 APPLICABLE DOCUMENTS

a. JPR 1280.2, Quality Manual

b. JPR 1281.6, Procurement

c. JPR 1281.9, Process Control

d. JPR 1281.13, Control of Nonconforming Product

e. JPR 1281.17, JSC Audits

f. JPR 1440.3, JSC Records Management Procedural Requirements

g. JPR 1700.1, JSC Safety and Health Handbook

h. JPR 2310.1, JSC Knowledge Management Strategy

i. JPR 8000.4, JSC Risk Management Plan

j. JPR 7120.3, Program/Project Management and Systems Engineering

k. JPR 1281.7, Control of Customer Property

P.5 MEASUREMENT/VERIFICATION

a. Processes and procedures shall be measured and monitored as prescribed by JPR 1281.9.

b. Audits, as prescribed in JPR 1281.17, shall be used to verify conformance with requirements.

c. Results shall be reviewed by Directorates and the Center as prescribed by JPR 1280.2.

P.6 CANCELLATION

This directive cancels JPR 1281.14E, Corrective and Preventive Actions, and Continual Improvement, effective July 28, 2015.

Original Signed By:

Nigel Packham for William R. DeLoach Director, Safety and Mission Assurance

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Distribution:

JDMS

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CHAPTER 1: OVERVIEW

1.1 Types of Actions

One or more of the following types of action shall be taken to address problems:

a. Management action is a task assigned by management to analyze a situation or to develop additional information, and to report status and results obtained to the manager making the assignment (no formal procedure).

b. Correction is action taken to fix or eliminate a detected nonconformance (see JPR

1281.13 for control of product nonconformances).

c. Corrective action is action taken to eliminate the cause(s) of a detected nonconformance or other undesirable situation (such as a significant process escape, systemic issue, or significant safety/health/environmental effects) to avoid recurrence. The corrective action process includes containment actions.

d. Preventive action is action taken to avoid a potential nonconformance or other undesirable situation (such as a negative trend or potential significant safety/health/environmental issue).

e. Risk management is an organized, systematic decision-making process that efficiently identifies, analyzes, plans, tracks, controls, communicates, and documents risk to increase the likelihood of achieving program/project goals (see JPR 8000.4).

f. Continual improvement is a recurring activity taken to increase the ability to fulfill requirements (per Section 3.6). [Note: Continual improvement opportunities can result from lessons learned, problem resolutions and the benchmarking of best practices.]

1.2 Criteria for Determining Type of Action to Take

1.2.1 The type of action required is problem dependent. Not all problems require corrective action, and some problems may require more than one type of action. Problem solving is taking action appropriate to and commensurate with the severity of the problem encountered.

Corrective Action or Preventive Action shall be taken when the criteria defined in Figures 1-1 through 1-3 is met.

1.2.2 Criteria for determining what type of action to take for problems occurring within a product or service life-cycle, identified during product and process monitoring activities (such as inspections, process reviews, self-assessments, etc.), or as a result of data analysis shall be as follows:

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Figure 1-1 Criteria for Determining Type of Action in a Product/Service Life-cycle

1.2.3 Criteria for determining what type of action to take during a management review shall be as follows: [Note: Each metric reviewed would be processed accordingly.] (See Management Reviews, JPR 1280.2)

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Figure 1-2 Criteria for Determining Type of Action in a Management Review

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1.2.4 Criteria for determining what type of action to take for findings resulting from an internal audit, or external audit/assessment shall be as follows:

Figure 1-3 Criteria for Determining Type of Action from an Internal Audit

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Figure 1-4 Criteria for Determining Type of Action from an External Audit/Assessment

Non-conformance to documented requirement

Results of external audit

Potential non-conformance documented requirement

Recommenda tion for improvement

Data input for Management Review

JPR 1280.2

Track in

QPID

IS there a documented requirement

Audit Corrective Action Section 3.1

Audit Preventative Action Section 3.3

Evaluate for Preventative Action Section 3.3

Evaluate for Continual Improvement Section 3.6

No NoNo

Yes Yes

Yes Yes

Minimum Procedure Section 3.5

No

Yes

Track in OASIS

Track in QPID and assign responsible JSC organization

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CHAPTER 2: RESPONSIBILITIES

2.1 Manager of the Office of Knowledge and Quality Management Systems

The Manager of the Office of Knowledge and Quality Management Systems shall:

a. Designate a JSC Corrective Action Manager (JSC CAM).

b. Resolve matters pertaining to Corrective Action Plan (CAP) ownership, approval, and closure.

2.2 JSC Corrective Action Manager

The JSC CAM shall have responsibility and authority to:

a. Operate, maintain, measure, improve, and report on the JSC corrective/preventive action process.

b. Work with the human resources training organization to provide periodic training in the methodologies and techniques availalble for use in problem solving.

c. Operate, maintain and improve center-wide tools (i.e., Quality Process Improvement Database (QPID)) used to implement system procedure as well as to track and report the status of corrective and preventive actions, and assist Directorate-level Organization Corrective Action Managers (DLO CAMs) with the use of center-wide tools.

d. Request and obtain corrective, preventive, and continual improvement action measurements and information from DLO.

e. Concur on root cause analyses (RCA) for audit findings.

f. Assist DLO CAMs in the development of corrective/preventive action plans (CAPs) and execution of other problem solving techniques, as needed.

g. Concur on CAPs for audit findings.

h. Monitor corrective and preventive actions for timely performance of the corrective action steps as defined in Appendix B, Corrective Action Plan Approval Timeline, and work with the owning organization to update plans when timeliness is not achieved.

i. Ensure verification of effectiveness occurs prior to closure of corrective and preventive actions. Performing verification may be delegated to a DLO CAM for external HQ audit findings.

j. Analyze measurements and information received and characterize center-wide system status, performance and effectiveness, and report as part of the semi-annual management review of the management system (JPR 1280.2).

k. Work through the Quality Systems Panel (QSP) to form working groups, as applicable, to perform corrective and preventive action for center-wide problems or issues, or to perform actions to improve center-wide system performance.

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l. Input CA plans and supporting documentation which have been developed by responsible DLO CAMs into OASIS. Once the CAP is complete, submit documentation into OASIS and NC submit for closure.

m. The AM or JSC center-wide Corrective Action Manager shall enter any non-conformances resulting from Registrar audits of AS9100 into the IAQG (International Aerospace Quality Group) OASIS database.

n. Input NCRs resulting from an IAQG audit into QPID and assign applicable JSC organizations.

2.3 Directorate Level Organizations (DLOs)

2.3.1 Directors, DLOs

Directors of DLOs or a member of their senior staff shall:

a. Ensure that measurement and monitoring activities needed to determine, collect and analyze information to demonstrate the conformance and effectiveness of its products, services, and processes are established throughout the organization.

b. Ensure that the appropriate type of action is taken to address problems as they occur based on the definitions and criteria prescribed in Section 1.2 Types of Actions.

c. Ensure that data generated as a result of monitoring and measurement, and from other relevant sources, are analyzed and that opportunities for continual improvement are identified.

d. When required action spans more than one organization, ensure that the organization responsible for taking action is the one with control of the content that has to be fixed, and that concurrence has been obtained.

e. Ensure flow-down of requirements for corrective action to a contractor performing critical or complex work when it is determined that the contractor is responsible for the nonconformance.

f. Designate a primary point-of-contact to manage corrective/preventive actions initiated by or assigned to the organization (aka DLO CAM). [Note: ‘A’ Codes may share a DLO CAM.]

g. Assign an owner to each corrective and preventive action.

h. Approve CAPs.

i. Monitor corrective and preventive actions for timely performance and effectiveness.

j. Ensure that persons managing and performing actions are trained in the methods and techniques of problem solving.

k. Ensure the DLO utilizes center-wide procedures and tools (i.e., QPID) when self-initiating corrective/preventive actions or when required for audit, inspection, and assessment findings.

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l. Ensure that corrective and preventive actions issued to contractors by the Contracting Officer on behalf of the organization as part of contract surveillance in accordance with JPR

1281.6 meet the intent of this JPR and include the CA/PA steps defined in Section 3.5.

m. Provide resources to participate on working groups formed by the QSP to perform corrective and preventive action for center-wide problems or issues, or to perform actions to improve center-wide system performance, including tools.

n. Include status of corrective and preventive actions as part of the DLO Quality Management System (QMS) Reviews (per JPR 1280.2).

2.3.2 DLO Corrective Action Manager

The DLO Corrective Action Manager (DLO CAM) is the primary point-of-contact for corrective and preventive actions initiated by or assigned to the organization. The DLO CAM understands the JSC corrective and preventive action and continual improvement procedure and assists the organization in the implementation of the process. The DLO CAM shall:

a. Attend training scheduled by the JSC CAM.

b. Escort internal and external QMS auditors during audits of the DLO, as well as support to virtual audits of the DLO.

c. Ensure appropriate actions are taken in response to audit findings according to the time period specified during the audit closing meeting (using Appendix B as a guide for Internal and NQA Audits).

d. Concur on and enter CAP into QPID and maintain or modify schedule, as appropriate.

e. Provide a status of corrective/preventive actions owned by the DLO to the JSC CAM, as requested, notifying the JSC CAM when corrective actions are not timely or effective, and updating the corrective action plan.

f. Review, verify effectiveness, and close corrective action plans self-initiated by the DLO.

g. Identify lessons-learned to Directorate Learning Representative per JPR 2310.1 as appropriate.

h. Participate in working groups formed by the QSP to address center-wide problems or to improve center corrective action system performance. [Note: This task can be delegated to other knowledgeable DLO personnel, as needed.]

i. For external audits/assessments by NASA Headquarters and third-party accreditation bodies hosted by the DLO (ex. Procurement Management Review, Energy Functional Reviews (EEFR), etc.), enter findings into QPID unless otherwise specified by auditing entity, including those assigned to other DLOs. Follow CAP submittal timeline specified by external auditing entity.

Perform verification of effectiveness when delegated by the JSC CAM. [Note: Some Agency audits (ex. Quality Audit, Assessment, and Review (QAAR) and Institutional/Facility/Operational Safety (IFO) require CA response in the NSC/ STAR tool. See Section 3.5 for requirements.]

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2.3.3 Corrective Action Owners

Corrective Action Owners shall:

a. Respond to an audit nonconformance, written against documented requirements they own, by taking corrective action in QPID.

b. Respond to an audit observation by discussing the observation at the Quality System Panel to determine, by majority vote of the Directorates attending the QSP, if the observation requires formal preventive action in QPID.

c. Identify negative trends or a repeat problem and initiate preventive action.

d. Take action appropriate to the severity of the problem requiring action.

2.4 JSC Audit Manager (per JPR 1281.17)

a. The JSC Audit Manager (JSC AM) shall ensure that:

(1) Actions are taken appropriate to the audit finding.

(2) The action taken follows controlled procedures (i.e., JPR 1281.14).

(3) The corrective and preventive actions taken are tracked through closure.

b. The JSC Audit Manager shall:

(1) Lead follow-up audit activities that verify the implementation and effectiveness of the corrective action plan. However, verification of the effectiveness of corrective actions may be delegated.

(2) Close corrective actions for audit findings following verification.

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CHAPTER 3: PROCEDURE

3.1 Audit Corrective Action

The steps and audit response timeline for the Internal and NQA Audit Corrective Action process are specified in Appendix B. If not using QPID, see Section 3.5.

3.1.1 Corrective

Action Owner shall:

a. Analyze and assess the severity of risk posed by the problem utilizing the JSC Risk Scorecard in JPR 8000.4. Determine and document Likelihood and Consequence ratings and risk category.

Contact the DLO Risk POC when the Risk Severity is identified as High or Moderate for consideration for entry into IRMA.

b. Determine and perform immediate correction (including immediate communication) with appropriate completion dates necessary to stop, control, or fix the nonconforming condition and commensurate with the assessed risk. Document results as objective evidence along with actual completion dates.

c. Determine and perform remedial action with appropriate completion dates to mitigate the impact of the risk of the nonconformance, if any, and determine if the problem exists in other locations or similar processes. Document results as objective evidence along with actual completion dates.

3.1.2 DLO CAM

shall:

a. Enter risk assessment, and containment actions with estimated completion dates in QPID.

b. Attach objective evidence for containment actions with actual dates once completed.

3.1.3 CA Owner

shall:

a. Perform and document a root cause analysis to determine the cause and effect reason(s) for the nonconformance utilizing working groups and methodologies and tools, as appropriate, ensuring involvement of all knowledgeable parties.

b. Document the scope/extent of the root cause analysis.

3.1.4 DLO CAM

shall:

a. Review and enter root cause analysis in QPID.

b. Obtain concurrence on the RCA from the JSC CAM. [Note:

Concurrence should be obtained from JSC CAM before proceeding to next step to avoid rework and delay of CAP approval.]

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3.1.5 CA Owner

shall:

a. Define and document action(s) to be performed to eliminate the cause(s) of the nonconformance to ensure it does not recur. This includes flowing down the corrective action requirement to a supplier or contractor, when it is determined that the supplier or contractor is responsible for the root cause.

b. Define schedules for completing action implementation.

c. Submit the CAP to the DLO CAM for review.

3.1.6 DLO CAM

shall:

a. Review CAP for compliance with this procedure.

b. Define the steps and associated schedule that will be used to verify that the action taken to eliminate the cause(s) of the subject nonconformance was effective in accomplishing its purpose. [Note: The JSC Audit Manager will refine the Verification Plan following CAP submittal, if needed].

c. Submit the CAP in QPID for JSC CAM and JSC AM concurrence.

3.1.7 JSC CAM

and JSC AM shall:

a. Review and provide feedback to the DLO CAM on the CAP until concurrence is obtained.

3.1.8 JSC AM

shall:

a. Modify the Verification Plan if needed.

b. Inform DLO CAM of CAP concurrence.

3.1.9 DLO CAM

shall:

a. Obtain DLO Management approval of the CAP and enter objective evidence into QPID.

b. Obtain DLO Management approval for any substantive changes to the CAP, including extensions to the QPID estimated completion date, and enter objective evidence into QPID.

3.1.10 JSC Audit

Manager shall:

a. Change the status of the QPID to CAP Approved.

b. Send approved CAPs to the external registrar, as required.

3.1.11 CA Owner

shall:

a. Implement the approved CAP according to the defined schedules and retain objective evidence of completion.

b. Notify DLO CAM that all planned actions are completed and provide objective evidence.

3.1.12 DLO

Corrective Action Manager shall

Attach objective evidence for all actions in the CAP. Enter actual completion dates for actions and change status of QPID to Actions Completed. [Note: Closure of audit findings requires verification by JSC CAM and JSC AM per JPR 1281.17.]

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3.1.13 JSC CAM

shall:

a. Verify completion and effectiveness of actions taken.

b. Notify JSC AM that QPID is ready for closure verification.

3.1.14 JSC Audit

Manager shall:

Close corrective action following verification and change status to Closed-Verified. If there is insufficient evidence of effectiveness, the QPID may be Closed-Pending Verification until sufficient evidence is available.

3.2 DLO Self-Initiated Corrective Action

The response timeline is managed by the Directorate.

3.2.1 Corrective

document Likelihood and Consequence ratings and risk category.

Contact the DLO Risk POC for any Risks that have been identified as High or Moderate for consideration for entry into IRMA.

b Determine and perform immediate correction (including immediate communication) with appropriate completion dates necessary to stop, control, or fix the nonconforming condition and commensurate with the assessed risk. Document results as objective evidence along with actual completion dates.

c. Determine and perform remedial action with appropriate completion dates to mitigate the impact of the risk of the nonconformance, if any, and determine if the problem exists in other locations or similar processes. Document results as objective evidence along with actual completion dates.

3.2.2 DLO CAM

shall:

a. Enter risk assessment, and containment actions with estimated completion dates in QPID.

b. Attach objective evidence for containment actions with actual dates once completed.

3.2.3 CA Owner

shall:

a. Perform and document a root cause analysis to determine the cause and effect reason(s) for the nonconformance utilizing working groups and methodologies and tools, as appropriate, ensuring involvement of all knowledgeable parties.

b. Document the scope/extent of the root cause analysis.

3.2.4 DLO CAM

shall:

Review and enter root cause analysis in QPID.

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3.2.5 CA Owner

shall:

a. Define and document action(s) to be performed to eliminate the cause(s) of the nonconformance to ensure it does not recur. This includes flowing down the corrective action requirement to a supplier or contractor, when it is determined that the supplier or contractor is responsible for the root cause.

b. Define the steps that will be used to verify that the action taken to eliminate the cause(s) of the subject nonconformance was effective in accomplishing its purpose.

c. Define schedules for completing action implementation and for verification.

d. Submit the CAP to the DLO CAM for review.

3.2.6 DLO CAM

shall:

a. Review CAP for compliance with this procedure and submit the CAP in QPID.

b. Obtain DLO Management approval of the CAP, enter objective evidence into QPID and change status of QPID to CAP Approved.

c. Obtain DLO Management approval for any substantive changes to the CAP, including extensions to the QPID estimated completion date, and enter objective evidence into QPID.

3.2.7 DLO CAM

shall:

a. Attach objective evidence for all actions in the CAP, enter actual completion dates for actions and change status of QPID to Actions Completed.

b. Verify that all planned actions were effective in preventing recurrence of the nonconformance and close the QPID. [Note: The DLO CAM may delegate this task, as appropriate.]

c. Close corrective action following verification and change status to Closed-Verified. If there is insufficient evidence of effectiveness, the QPID may be Closed-Pending Verification until sufficient evidence is available.

3.3 Audit Preventive Action

The steps and audit response timeline for the Internal and NQA Corrective Action process are specified in Appendix B. If not using QPID, see Section 3.5.

3.3.1 Preventive

Action Owner shall:

a. Analyze and assess the severity of risk posed by the problem utilizing the JSC Risk Scorecard in JPR 8000.4. Determine and document Likelihood and Consequence ratings and risk category.

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Contact the DLO Risk POC for any Risks that have been identified as High or Moderate for consideration for entry into IRMA.

b. Determine and perform any immediate correction (including immediate communication) required to prevent the observed condition or other potential nonconformance from worsening and becoming a nonconformance. Document results as objective evidence along with actual completion dates.

c. Determine and perform remedial action with appropriate completion dates to mitigate the impact of the risk of the potential nonconformance, if any, and determine if the condition exists in other locations or similar processes. Document results as objective evidence along with actual completion dates.

3.3.2 DLO CAM

shall:

a. Enter risk assessment, and containment actions with estimated completion dates in QPID.

b. Attach objective evidence for containment actions with actual dates once completed.

3.3.3 PA Owner

shall:

a. Perform and document a root cause analysis to determine the cause and effect reason(s) for the potential nonconformance utilizing working groups and methodologies and tools, as appropriate, ensuring involvement of all knowledgeable parties. [Note: Some level of investigation may be required in order to understand the nonconformance that is being prevented.] and

b. Document the scope/extent of the root cause analysis.

3.3.4 DLO CAM

shall:

a. Review and enter root cause analysis in QPID, and

b. Obtain concurrence on the RCA from the JSC CAM. [Note:

Concurrence should be obtained from JSC CAM before proceeding to next step to avoid rework and delay of CAP approval.]

3.3.5 PA Owner

shall:

a. Define and document action(s) to be performed to eliminate the cause(s) of the potential nonconformance to ensure it does not occur.

This includes flowing down the preventive action requirement to a supplier or contractor, when it is determined that the supplier or contractor is responsible for the root cause.

b. Define schedules for completing action implementation and for verification.

c. Submit the CAP to the DLO CAM for review.

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3.3.6 DLO CAM

shall:

a. Define the steps and associated schedule that will be used to verify that the action taken to eliminate the cause(s) of the potential nonconformance was effective in accomplishing its purpose. [Note:

The JSC Audit Manager will refine the Verification Plan following CAP submittal, if needed].

b. Review CAP for compliance with this procedure.

c. Submit the CAP in QPID for JSC CAM and JSC AM concurrence.

3.3.7 JSC CAM

and JSC AM shall:

Review and provide feedback to the DLO CAM on the CAP until concurrence is obtained.

3.3.8 JSC AM

shall:

a. Modify the Verification Plan, if needed.

b. Inform DLO CAM of CAP concurrence.

3.3.9 DLO CAM

shall:

a. Obtain DLO Management approval of the CAP and enter objective evidence into QPID.

b. Obtain DLO Management approval for any substantive changes to the CAP, including extensions to the QPID estimated completion date, and enter objective evidence into QPID.

3.3.10 JSC Audit

Manager shall:

a. Change the status of the QPID to CAP Approved.

b. Send approved CAPs to the external registrar, as required.

3.3.11 PA Owner

shall:

a. Implement the approved CAP according to the defined schedules and retain objective evidence of completion.

b. Notify DLO CAM that all planned actions are completed and provide objective evidence.

3.3.12 DLO

Corrective Action Manager shall

Attach objective evidence for all actions in the CAP. Enter actual completion dates for actions and change status of QPID to Actions Completed. [Note: Closure of audit findings requires verification by JSC CAM and JSC AM per JPR 1281.17.]

3.3.13 JSC CAM

shall:

a. Verify completion and effectiveness of actions taken.

b. Notify JSC AM that QPID is ready for closure verification.

3.3.14 JSC Audit

Manager shall:

Close corrective action following verification and change status to Closed-Verified. If there is insufficient evidence of effectiveness, the QPID may be Closed-Pending Verification until sufficient evidence is available.

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3.4 DLO Self-Initiated Preventive Action

The response timeline is managed by the Directorate.

3.4.1 Preventive

document Likelihood and Consequence ratings and risk category.

Contact the DLO Risk POC for any Risks that have been identified as High or Moderate for consideration for entry into IRMA.

b. Determine and perform any immediate correction (including immediate communication) required to prevent the observed condition or other potential nonconformance from worsening and becoming a nonconformance. Document results as objective evidence along with actual completion dates.

c. Determine and perform remedial action with appropriate completion dates to mitigate the impact of the risk of the potential nonconformance, if any, and determine if the condition exists in other locations or similar processes. Document results as objective evidence along with actual completion dates.

3.4.2 DLO CAM

shall:

a. Enter risk assessment, and containment actions with estimated completion dates in QPID.

b. Attach objective evidence for containment actions with actual dates once completed.

3.4.3 PA Owner

shall:

a. Perform and document a root cause analysis to determine the cause and effect reason(s) for the potential nonconformance utilizing working groups and methodologies and tools, as appropriate, ensuring involvement of all knowledgeable parties. [Note: Some level of investigation may be required in order to understand the nonconformance that is being prevented.]

b. Document the scope/extent of the root cause analysis.

3.4.4 DLO CAM

shall:

Review and enter root cause analysis in QPID.

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3.4.5 PA Owner

shall:

a. Define and document action(s) to be performed to eliminate the cause(s) of the potential nonconformance to ensure it does not occur.

This includes flowing down the preventive action requirement to a supplier or contractor, when it is determined that the supplier or contractor is responsible for the root cause.

b. Define the criteria that will be used to verify that the action taken to eliminate the cause(s) of the subject nonconformance was effective in accomplishing its purpose.