Ames Procedural
Requirements
APR 8735.1
Effective Date: June 8, 2009
Expiration Date: JUne 8, 2014
COMPLIANCE IS MANDATORY
Responsible Office: Code Q, Safety and Mission Assurance Directorate
Title: Control of Nonconforming Products and Services
| Status (Baseline/ Revision/ Canceled) | Document Revision | Effective Date | Description |
|---|---|---|---|
| Baseline | 0 | 6/08/09 | Baseline release |
| Revision | 1 | 8/12/09 | Added Revision History, revised section 1.0 on hardcopy, added definition of residual risk, updated section 5.3.1.2 to discuss residual risk, updated section 5.6.1 PRACA Manager to clarify review function, clarified who assigned PRACA manager Ð it is SMA Director not Associate Center Director, updated flow chart. |
This document represents the Nonconformance Reporting (NCR) element of the quality assurance ensemble of core processes that also includes Corrective Action Requests (CAR)s, and Deviation/Waivers. In total these integrated core processes are intended to ensure that customer requirements are met in the most effective and efficient manner possible.
This procedure defines the requirements and responsibilities for the identification, control, remediation, documentation and disposition of nonconforming products and services, herby referred to as nonconformances (NC)s, discovered before or after delivery to the customer. In addition it establishes the relationships and links between NC and the other elements of the core QA processes; Corrective Actions (CA)s, and Deviation/Waivers.
The Center shall use this procedure to ensure that NC are identified, documented, reviewed for clarity and validity, reviewed for root cause determination, reviewed for severity of impact and need for action and assigned an appropriate corrective action plan. In addition, this procedure shall be used to ensure that any CAs stemming from nonconforming products or services receives validation and verification for its effectiveness.
The Ames Research Center's Problem Reporting and Corrective Action system (PRACA) shall be the only NCR system used to implement this procedure and electronically generate, manage, and archive Nonconformance Reports, Corrective Action Requests, and Deviation and Waiver Requests. In the event the PRACA tool is unable to automate the signature process, manual routing of a signature page and supporting information may be used as long as such page contains all signature authorities required by the specific NCR, CAR, or D/W APR.
This procedure applies to all Civil Servants and Contractors, and is applicable to all materials, hardware (machinery, equipment, subsystems, platforms, parts, and assemblies), software, products of research, services and facilities. It is also applicable to processes and procedures that make up the Ames Management System as well as Project specific plans.
| NPD 1210.1 | Surveys, Audits and Reviews |
| NPD 1280.1 | NASA Management System Policy |
| NPD 8730.5 | NASA Quality Assurance Program Policy |
| NPR 7120.X | Management Series |
| NPR 7150.2 | NASA Software Engineering Requirements |
| NPR 8621.1 | NASA Procedural Requirements for Mishap and Close Call Reporting, Investigating, and Recordkeeping |
| NPR 8000.4 | Agency Risk Management Procedural Requirements |
| APD 8700.1 | Problem, Nonconformance, Preventive and Corrective Action Policy |
| APR 1280.1 | Ames Management System |
| APR 8700.2 | Continuous Improvement Action |
| APR 8700.3 | Internal Assessment of the Ames Management System |
| APR 8735.2 | Deviation and Waiver Process |
| APR 5100.1 | Procurement Initiator's Guide |
| APR 1440.1 | Records Management Procedural Requirements |
| APR 8705.1 | System Safety and Mission Assurance |
| APD 8735.3 | Verification of Products / Services Conformance to Requirements |
| APD 4520.1 | Receival and Inspection Reports |
| APR 8730.2 | Ames EEE Parts Control Requirements |
| Approval Authority | Technical and Programmatic Authorities and Customers. |
| Center-Wide NCR System | PRACA is the Center-Wide NCR system. |
| Concession | Documented (via a Deviation and Waiver request) acceptance or use of a nonconformance, nonconforming product or nonconforming service by a relevant Approval Authority, and where applicable, the customer. |
| Control Board | Either a MRB, PCB, or software change control board. |
| Corrective Action | (CA): An action taken to trace the symptoms of a current problem to its cause, identify solutions for minimizing/preventing the recurrence of the problem, implement the solution(s), and monitor that the solution(s) have been successful. |
| Problem Reporting and Corrective Action System | (PRACA): An interactive, Web-based system used to document and track nonconformances and associated corrective actions. It is the Center-Wide NCR System. |
| Customer | The recipient of an ARC product or service. A customer may be internal, such as another ARC organization, or external to the Center. |
| Defect | Non-fulfillment of a requirement related to an intended or specified use. |
| Disposition | The action taken on a nonconformance. See Rework, Repair, Regrade, Return to Supplier, Use As-Is and Scrap as examples of disposition. |
| Initiator | Any person who identifies a nonconformance, takes appropriate immediate action(s) and documents the nonconformity |
| Interested Parties | Individual or group (e.g. the customer) concerned with or affected by the nonconformity. |
| Material | Raw material, component, hardware, software, or subassembly intended for use in or is used in a product. |
| Nonconformance | (NCR): Resulting condition when a process, product or service does not meet/fulfill a specified requirement. |
| Material Review Board | (MRB): The Material Review Board consists of a Code QS Quality Assurance Representative, cognizant design Engineer(s), and a Project Representative or Responsible Manager who controls and dispositions nonconforming products. |
| Preventive Action | An action taken to trace the symptoms of a potential problem to its cause, identify solutions for minimizing/preventing the occurrence of the problem, implement the solution(s), and monitor that the solution(s) have been successful. |
| Parts Control Board | MRB for EEE parts that is always chaired by the Ames Chief Engineer. |
| Problem | A nonconformance found during qualification or acceptance testing or any issue identified that does not meet specified requirements. |
| Product | The results of ARC activities and processes to include hardware, software, data (including research results), services and processed materials. |
| Responsible Manager | Civil Service project or line manager with responsibility for cost, schedule and technical performance. |
| Remedial Action | Action taken to fix a current problem that might or might not address the root cause or minimize/prevent the reoccurrence of the problem. |
| Regrade | Assign to another application whose less demanding requirements can be met. |
| Repair | Action taken on a nonconforming product to render it acceptable for the intended use. Repair may affect or change parts of the nonconforming product, for example as a part of maintenance. Requires MRB authority. |
| Residual Risk | The remaining risk, exceeding that which would have existed absent the nonconformance, that exists after all mitigation actions have been implemented or exhausted in accordance with the risk management process. |
| Return to Supplier | Action taken to return nonconforming product to the supplier/vendor in accordance with contract provisions. |
| Rework | Action taken on a nonconforming product to make it conform to all original requirements. |
| Root Cause | The most fundamental cause in a causal chain. |
| Scrap | A product's permanent removal or an action which precludes it from its originally intended use. In a nonconforming service situation, use is precluded by discontinuing the service. |
| Use As-Is | Accepting a nonconformity for use or approving the use of a nonconforming product without resort to rework or repair. |
| Validation | Confirmation, through the provision of objective evidence, that the requirements for a specific intended use, application or action plan have been fulfilled. May require a SME to conduct. |
| Verification | Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. |
5.1.1 Ensure that their organizations record and remedy products and services that do not meet documented requirements using the Center-wide nonconformance reporting process defined in Section 6 below.
5.2.1 Identify and segregate nonconforming items to prevent unintended use, and protect nonconforming items with appropriate labeling, packaging and storage, to preclude damage or deterioration.
5.2.2 Notify the Responsible Manager of the nonconformity.
5.2.3 Document and describe nonconformities using the nonconformance reporting process prescribed in section 6 below.
5.2.4 Document any immediate action(s) taken.
5.3.1 Ensure that reports of nonconformances are accurate and submitted, evaluated and acted upon in a thorough and timely manner.
5.3.1.1 For all NCRs stemming from a NPR 7120.X series work effort categorize each NCR's level of criticality according to table 1 (taken from NPRs 8000.4 and 8621.1), such that the NCR is given the criticality level corresponding to the highest level of any of the five impact areas.
Note: For all other work, Table 1 and paragraph 5.3.1.2 may be used but organizations have the option of developing their own three level criticality matrix and accompanying escalation protocol. Alternative protocols shall be documented and approved by the Ames Safety and Mission Assurance Directorate. All other requirements of this APR shall be followed.
Table 1 Nonconformance Criticality Matrix
5.3.1.2 Ensure that the protocol for escalating NCR review and final disposition approval/authorization corresponds to the NCR's criticality level as follows:
5.3.2 Coordinate with the SS&MA division the formation of a Control Board (i.e., MRB, PCB) for NCRs rated above a criticality of Low based on the following2 :
5.3.3 Ensure that identified nonconforming materials and products are controlled as defined in this procedure so that they are not delivered to a customer unless authorized.
5.3.4 Ensure that all stake holders are notified and provided follow-on communications through final disposition of the nonconformity.
5.3.5 Ensure remedial actions for nonconformities are implemented and are based on:
5.3.5.1 Root cause analysis
5.3.5.2 Analyzing of impact on design margins.
5.3.5.3 Evaluating of impact on safety, functionality and customer satisfaction.
5.3.5.4 Considering of cost and schedule impact.
5.3.5.5 Identification of less demanding alternative applications for nonconforming items.
5.3.6 Implement the authorized disposition of the nonconformance to include, when required, obtaining a customer approved deviation/waiver for acceptable nonconformities.
5.3.6.1 Ensure that repair and use-as-is remedial actions (ie. product / service won't meet original requirements) are:
5.3.6.1.1 Approved by the relevant engineering function. And in the case of a repair, alternative acceptance criteria are defined.
5.3.6.1.2 Approved by the relevant safety and mission assurance function. Note: Customers often reserve the right to approve repair and use-as-is remedial actions since they result in delivery of nonconforming items (e.g., NCR's initiated due to a material surface or cosmetic issue that will not impact performance).
5.3.6.1.3 Processed on a Deviation/Waiver in accordance with APR 8735.2.
5.3.7 Ensure the initiation of corrective action or preventive action IAW APD 8700.1 to preclude future similar nonconformities . 5.3.8 Ensure authorized personnel inspect and release nonconforming materials or products after repair or rework.
5.3.9 Ensure Lessons Learned submittal and GIDEP failure reporting, when appropriate.
5.3.10 Ensure nonconformance report closure after authorized remedial actions and final disposition of the nonconformity have been fully implemented, including any reinspection, re-test or re-analysis.
5.3.11 Use the PRACA system to transmit an electronic version of the completed Nonconformance Report and associated documentation to the Center PRACA Manager
5.3.12 Coordinate MRB membership with the SS&MA division
5.4.1 Implement authorized remedial actions.
5.4.2 Validate the effectiveness of the remedial actions, or final disposition of the nonconformity.
5.4.3 Coordinate with the SS&MA division for the verification of the effectiveness of the remedial actions, or final disposition of the nonconformity.
5.4.3.1 After rework (see Definitions)-provide for the verification of conformance to original requirements.
5.4.3.2 After repair (see Definitions)-provide for the verification of conformance to authorized (sometimes alternate) acceptance criteria.
Note: Verification of conformance may include reinspection, re-test or re-analysis.
5.4.3.3 Notify the Responsible NASA and PRACA Managers when the authorized remedial action and verification of conformance are complete.
5.5.1 Collaborate with the Center PRACA Manager to provide independent analysis of the Center-wide NCR Process for trends and potential preventive actions or Continuous Improvement Action.
5.5.2 Report nonconformance trends to the AMS Executive Steering Committee.
5.6.1 Ensure NCR's have the appropriate level of review and disposition approval/authorization corresponding to the NCR's criticality level. This ensures that NCR's are properly filled out and that the proper authority reviews, and approves/disapproves. If the PRACA Manager is not certain as to the proper level, the PRACA Manager shall contact SS&MA and the Ames Chief Engineer to determine proper review and approval level.
5.6.2 Ensure that all deviations/waivers and other stake holder documentation are formally recorded with the nonconformance report.
5.6.3 Hold reviews on a yearly or more frequent if necessary bases to identify patterns or trends in the NCR activity that might indicate a need for a CAR and report findings to the AMS Manager.
5.6.5 Initiate preventive action or Continuous Improvement Action IAW APR 8700.2, where appropriate.
5.7.1 Ensure that the Agency, Center or customer directed requirements for S&MA activities are addressed in all moderate and very high NCRs at the Center.
5.7.2 Provide verification and validation of all moderate and very high NCR dispositions including corrective actions when applicable per APR 8735.3 and authorize closure after all necessary information, signatures and activities have been accomplished.
5.7.3 Complete acceptance of any open test or manufacturing operations that supported the issuance of the NCR.
5.7.5 Appoint the CB Chair and coordinate CB membership with the Responsible Manager .
5.8.1. Include members representing Project, Engineering and Safety and Quality Assurance functions.
5.8.2 Authorize a disposition for each nonconformity, based on evaluations provided by Subject Matter Experts.
5.8.3 Define usage restrictions on the PRACA record when the product is regraded for a less demanding application.
5.8.4 Define processing requirements and reinspection criteria on the PRACA record when a rework or repair disposition is authorized.
5.8.5 Determine whether corrective action should be initiated to preclude/minimize similar nonconformities.
5.8.5.1 Initiate a Corrective Action Request or:
5.8.5.2 Document on the PRACA record why no Corrective Action is required.
5.9.1 Coordinate Control Board activities.
5.10.1 Appoint the PRACA Manager.
5.10.2 Review and approve or disapprove NCRs with a criticality level of very high that they deem applicable to their purview.
Review and approve or disapprove NCRs with a criticality level of very high that they deem applicable to their purview.
5.12.1 Appoint the PRACA Manager.
5.12.2 Review and approve or disapprove NCRs with a criticality level of very high that they deem applicable to their purview.
5.13.1 Review and approve or disapprove NCRs with a criticality level of very high that they deem applicable to their purview
5.14.1 Review and approve or disapprove NCRs with a criticality level above low.
Figure one represents the workflow that shall be followed in exercising the responsibilities of section 5.
| Record | Retained By | Min. Retention |
|---|---|---|
| Nonconformance Report | Center PRACA Manager | 5 years after product delivery, project, service or research completion |
| Deviations/Waivers | Center PRACA Manager | 5 years after product delivery, project, service or research completion |
| Corrective Action Request | Center PRACA Manager | 5 years after product delivery, project, service or research completion |
53.ARC.0013 Control of Nonconforming Products and Services
S. Pete Worden
Center Director
Center lines of Authority fall into four distinct categories: Institutional, Programmatic, Safety, and Technical. Each Center Authority has purview per the list of AMS requirements (not to be considered exhaustive) below:
