NONCONFORMANCE MANAGEMENT SYSTEM

Transcription

1 PROCEDURE NONCONFORMANCE MANAGEMENT SYSTEM This document is stored electronically. Printed version might not be the latest. SAOCOM PROJECT COMISION NACIONAL DE ACTIVIDADES ESPACIALES BUENOS AIRES ARGENTINA

2 SAOCOM PROJECT Number Title Summary SUBCONTRACTOR NONCONFORMANCES MANAGEMENT SYSTEM This document describes the mechanism to be implemented by CONAE-PC and subcontractors for managing non conformances detected during their activities for the SAOCOM Project. Secondary Reference Circulation Level 1 This document is digitally signed Workflow Summary State Assignee Action Completed Date Changes Record Issue Date Author PARA Description HMartirena Creation. This document replaces the document SOG-SMA-PL A PROBLEM & FAILURE REPORTING PLAN Comisión Nacional de Actividades Espaciales (CONAE) from Argentina owns the copyright of this document which is supplied in confidence and which shall not be used for any purpose other than that for which it is supplied and shall be only reproduced, copied or communicated, in whole or in part, for internal use of CONAE, directly or by third parties holding confidentiality agreements with CONAE. Any person other than the authorised holder obtaining possession of this document by finding or otherwise, should send it, together with his name and address, in a sealed envelope to: Comisión Nacional de Actividades Espaciales (CONAE) SAOCOM Project Av. Paseo Colón 751 (C1063ACH) Capital Federal ARGENTINA Letter postage need not be prepaid. Other postage will be refunded. Page 2 of 14

3 INDEX INDEX OBJECTIVE SCOPE APPLICABLE AND REFERENCE DOCUMENTS APPLICABLE DOCUMENTS REFERENCE DOCUMENTS DEFINITIONS AND ABBREVIATIONS DEFINITIONS ABBREVIATIONS AND ACRONYMS DEVELOPMENT DETECTION AND IMMEDIATE ACTIONS- STEP CLASSIFICATION ON NC- STEP DISPOSITION OF MINOR NONCONFORMANCES. STEP 3A DISPOSITION OF SIGNIFICANT/MAJOR NONCONFORMANCES. STEP 3B ANALYSIS OF CAUSES AND CONSEQUENCES. STEP CORRECTIVE AND PREVENTIVE ACTIONS. STEP IMPLEMENTATION OF ACTIONS AND NONCONFORMANCE CLOSE-OUT. STEP RISK ASSESSMENT PARTICIPATION OF THE CCB STATUS OF NC/CORRECTIVE ACTIONS ALERTS OR RED FLAGS EEE COMPONENTS NONCONFORMANCES SOFTWARE NONCONFORMANCES SUB-SUBCONTRACTORS ANNEXES ANNEX A: NC REPORT ANNEX B: CAR REPORT Comisión Nacional de Actividades Espaciales (CONAE) Page 3 of 14

4 1. OBJECTIVE This procedure describes the methodology and responsibilities for managing non conformances identified during the activities of its subcontractors for the SAOCOM Project. 2. SCOPE This procedure is applicable to CONAE-PC and of its subcontractors, from the identification of a non conformance up to its closure. 3. APPLICABLE AND REFERENCE DOCUMENTS 3.1 Applicable documents None. 3.2 Reference documents ECSS-Q-ST C NON CONFORMANCE SYSTEM 4. DEFINITIONS AND ABBREVIATIONS 4.1 Definitions non conformance: non fulfilment of a requirement. Note 1: the term requirement in this definition applies to requirements that will be verified in a Configured Item or in a process during activities such as inspections or audits, according to documents (such as procedures or specifications) issued by contractors or by CONAE, and agreed between both parties, that cover all the applicable requirements. Note 2: terms like failure, problem or anomaly are considered synonymous to non conformance. major nonconformance (rating 3): major degradation or total loss of functional capability of instrument or spacecraft significant nonconformance (rating 2): significant degradation of required functional capability of instrument or spacecraft, such as: significant degradation of functional capability of instrument or spacecraft significant degradation of engineering or science telemetry significant increase in operational difficulties or constraints appreciable reduction in lifetime significant impact on safety of people or equipment significant impacts on reliability, maintainability, availability, appreciable reduction of functional or dimensional interchangeability, impacts on interfaces with hardware or software regulated by different business agreements Comisión Nacional de Actividades Espaciales (CONAE) Page 4 of 14

5 changes to or deviations from approved qualification or acceptance test procedures, the need to scrap project specific items significant impacts of product assurance requirements minor nonconformance (rating 1): negligible degradation of required functional capability of instrument or spacecraft, such as: minor degradation of engineering or science telemetry negligible increase in operational difficulties or constraints negligible reduction in lifetime support, test, or facility equipment problem / failure support, test, or facility operator induced problem / failure random failures, where no risk for a lot related reliability or quality problem exists; if the form, fit or function are not affected; minor inconsistencies in the accompanying documentation. critical non conformance: non conformance that needs urgent actions, either the disposition or the corrective/preventive action or both corrective action: action taken to eliminate the causes of a detected non conformance or other undesirable situation alert: formal notification to users, informing them of failures or nonconformity of items, already released for use or not, which could also be present on other items already delivered [e.g. items with identical design concept, materials, components or processes] preventive action: actions taken to eliminate the causes of a potential non conformance or other potential undesirable situation 4.2 Abbreviations and acronyms CCB: Configuration Control Board CONAE-PC: CONAE acting as principal contractor SAOCOM PLM SOFTWARE: Document management system of the project NRB: nonconformance review board PA representative: person nominated by the subcontractor as responsible for Product Assurance activities. 5. DEVELOPMENT 5.1 Detection and immediate actions- STEP 1 Every person working for CONAE-PC or for its sub contractors that detects a non conformance has the responsibility to inform immediately to the area responsible person and to the PA representative. The non conformities can be detected: - By subcontractor s personnel in its own facilities - By CONAE-PC s personnel in the subcontractor s facilities Comisión Nacional de Actividades Espaciales (CONAE) Page 5 of 14

6 The area supervisor shall perform an immediate preliminary assessment of the nonconformance to establish its extent and cause when it is detected. Based on this preliminary assessment shall take the following actions without delay, as applicable: Provisions for the safety of the personnel and of the equipment. Prevention of unauthorized use of the nonconforming items, by marking and segregating until their disposition. Prevention of the recurrence of the nonconformance on similar or identical items under processing or testing at that time. NOTE: This can lead to the suspension of manufacturing or testing. The person responsible for the activity being performed can apply the following actions to the segregation of nonconforming articles shall: Establish a clearly marked holding area for nonconforming items pending NRB disposition. Limit the access to this area to NRB members or personnel authorized by the NRB. Make provisions to prevent unauthorized removal of any item. For items whose segregation in the holding area is not practicable the person responsible for the activity being performed shall perform the following actions: Mark the item as not to be used. Make sure that the item cannot be used by unauthorized personnel. The person responsible for the activity being performed shall: complete the nonconformance report, and submits it to the NRB via the SAOCOM PLM SOFTWARE. describe the nonconformance clearly, unambiguously and sufficiently detailed that it can be understood by personnel not involved in its detection. ensure the traceability between the NCR and the quality and manufacturing records related to the nonconforming item. Subcontractors shall carry out physical operation of an irreversible nature on the nonconforming item only with prior approval by CONAE-PC. 5.2 Classification on NC- STEP Subcontractor s Nonconformance Review Board The NRB is the sole technical authority for the treatment of nonconformance occurring in the frame of a business agreement. The NRB Chairman is the PA manager and other members are convened form technical areas related to the NC detected. The NRB chairman shall involve higher management levels in case of conflict General classification of NC Immediately after the reporting of a nonconformance, the PA Manager shall convene a NRB meeting. The NRB shall classify nonconformance: Comisión Nacional de Actividades Espaciales (CONAE) Page 6 of 14

7 - as major, significant or minor, based on the severity of their consequences (see definitions), and - as critical and no critical, based on the need to take or not immediate and urgent actions. In case of Problem / Failure during Integration, Testing and Launch operations, the NRB shall perform a preliminary assessment of the certainty that the exact failure cause has been determined and that the corrective action will mitigate the risk of recurrence of the problem / failure in flight. When this preliminary assessment is possible, the NRB shall rate the Failure Cause / Corrective Action as is detailed in the Table in Section 5.8, and activate the Alert System, when a Red Flag is detected, reporting at all major project reviews. If this preliminary assessment is not possible, this rating and the eventual alert are handled according to section 5.8. In case of several different minor nonconformances on the same item, the internal NRB evaluates whether the nonconformance remains minor or is reclassified as significant. In case of doubt, the NRB shall classify nonconformance as significant. The subcontractor shall report the detection of nonconformances to CONAE-PC with their proposed classification for approval, within 24 hours of its detection. The NRB will answer within 48 hours confirming or not the preliminary classification proposed by the subcontractor. During a phase of testing, integration or launch operations, all NC shall be considered at least- major. If the final classification of the NC is minor, the subcontractor is responsible for taking the disposition (see 5.3). If the final classification of the NC is major or significant the subcontractor shall agree the disposition with CONAE-PC (see 5.4). 5.3 Disposition of minor nonconformances. STEP 3A The NRB shall dispose minor nonconformances according to the following criteria: 1. Return to supplier 2. Use as is 3. Rework 4. Repair 5. Scrap Non conformances can also be: - errors in documents - non compliances with procedures - problems during a test - problems during the transport of goods, - etc. In these cases, the disposition of the non conformances can also be: - continue or abort a test Comisión Nacional de Actividades Espaciales (CONAE) Page 7 of 14

8 - review and revise a document - accept the goods even if the transport showed a deficiency. The subcontractor shall report CONAE-PC the disposition to be taken only for critical minor non conformances within 1 week of their detection.. The subcontractor shall: load into the SAOCOM PLM SOFTWARE the disposition to be implemented implement disposition by performing actions defined by the NRB and approved RFWs and RFDs. The PA Manager shall include minor nonconformances in the nonconformance status list managed by the SAOCOM PLM SOFTWARE. 5.4 Disposition of significant/major nonconformances. STEP 3B The NRB shall submit the proposed disposition of major nonconformances reports to the CONAE-PC NRB by means of the SAOCOM PLM SOFTWARE, according to the following time frame: Critical Non critical Significant/Major 48 hours 1 week CONAE-PC NRB shall review the reports of significant/major nonconformances in order to: assess whether the requirements of the higher level customer are impacted and determine the consequences. notify and involve CONAE-Customer in the ensuing NRB, in case of actual or suspected impacts CONEA-PC NRB shall confirm or not the proposed disposition within 48 hours of the recepction of the non conformance report. When determining a disposition, CONEA-PC NRB shall perform the following tasks: Review records of any previous similar or identical nonconformances. Assess the feasibility of the intended dispositions. Assess the applicability of dispositions and corrective actions to existing and in process items. This also may include re inspection and retest. Assess the effect of the nonconformance on the requirements of the business agreement Assess the effect of the nonconformance on the intended use of the item Assess whether the item is identified as critical Assess the need for raising an alert to other users of similar nonconforming items, and activate the related procedures established in the business agreement. CONAE-PC NRB shall identify and recommend the need for a waiver or deviation. Upon request, the subcontractor shall submit: a request for waiver (RFW) for significant/major nonconformances with the use as is or repair disposition for CONAE-PC. a request for deviation (RFD) or a contract change notice, for follow on production of the unit. Comisión Nacional de Actividades Espaciales (CONAE) Page 8 of 14

9 After CONAE-PC s approval, the subcontractor can implement the disposition. 5.5 Analysis of causes and consequences. STEP 4 The NRB shall investigate the cause(s) of all nonconformances. The NRB shall investigate the consequences of the nonconformance The NRB shall document the results of the investigation in the nonconformance report integrated into the SAOCOM PLM SOFTWARE. Then, the NRB shall determine the most appropriate corrective action that may eliminate the identified causes (see 5.6). If the nonconformance is associated with the following equipment: Flight hardware Flight software Electrical Engineering Model hardware Structural and Thermal Models hardware Support Equipment Facility Equipment Safety violations Test software Any qualification model in addition to the cause analysis, a risk evaluation shall be performed in order to consider the possibility of not identifying the real cause (see section 5.8). 5.6 Corrective and preventive actions. STEP 5 The NRB shall determine corrective actions to eliminate the cause(s) of the nonconformance and prevent any recurrence. Typical corrective actions consist of, for instance, changes to tools, equipment, facilities, processes, materials, drawings, specifications, and procedures. The NRB shall determine also preventive actions to avoid the occurrence of the nonconformance on similar items. In the case of significant/major no-conformance, based on the results of the NRB s investigations, CONAE-PC NRB shall decide on the need to perform complementary investigations of causes and consequences and confirm or modify the corrective action recommended by the subcontractor. A NC dispositioned use as is needs not any physical action on the nonconforming item to make it usable, however corrective and preventive actions shall be performed. 5.7 Implementation of actions and nonconformance close-out. STEP 6 The subcontractor shall close-out an NCR only after the following actions have been performed: All related actions have been performed and their results successfully verified. All defined inspections and tests have been performed, and their results verified and reported on or traceable from the NCR. Related RFW/RFD are approved. The PA representative shall close out the NCRs. For significant/major NCRs, the PA representative shall close out the NCR only after CONEA-PC PA endorsement. Comisión Nacional de Actividades Espaciales (CONAE) Page 9 of 14

10 5.8 Risk assessment There may be cases in which there is certain uncertainty on the capacity of a corrective action to prevent the recurrence of the non conformance. In these cases (called red flags ), the acceptance of a corrective action may involve the assumption of certain level of risks, and a detailed and close involvement of the Project Manager and the highest technical levels of the project is necessary. There are 4 levels of risks related to the corrective action: Rating Failure Cause / Corrective Action Rating Failure Cause / Corrective Action Known Cause / Certain Corrective Action. No known residual adverse effect, and / or no possibility of recurrence. Unknown Cause / Certain Corrective Action. No known residual adverse effect, and / or no possibility of recurrence. Known Cause / Uncertainty in Corrective Action. Some known residual adverse effect, and / or some known possibility of recurrence. Unknown Cause / Uncertainty in Corrective Action. Some known residual adverse effect, and or some known possibility of recurrence. This rating is obligatory for non conformances related to the equipment listed in section 5.5 All significant (level 2) and major (level 3) non conformances with risk levels 3 and 4 are to be considered red flags. A preliminary rating shall be assigned at the earliest possible time to determine if there are potential Red Flag issues (See 5.11). 5.9 Participation of the CCB The CCB is convened when the resolution of a non conformance or a corrective action can produce an impact on the configuration control Status of NC/corrective actions The subcontractor shall handle all steps of NC management using SAOCOM PLM SOFTWARE. The amount of information stored should be sufficient to allow statistical and trend analysis. The subcontractor shall periodically review the nonconformance records, in order to: - evaluate the progress of the actions for the correction and prevention of nonconformances and to ensure their close out, - to assess the existence of trends in the occurrence of nonconformances. The subcontractor shall define a frequency of the reviews which is appropriate to the volume of nonconformances, but not less than quarterly. As result of the analysis of the nonconformance records, the subcontractor shall provide as a minimum: - total number per flight configuration, subsystem and equipment as appropriate, - trend of open and closed status, both in terms of disposition and corrective action(s) implementation, and - number by cause of the nonconformance, to identify the areas for improvement and verify the effectiveness of corrective actions. The subcontractor should show the trends separately for hardware, EEE parts and software. For EEE parts, the subcontractor should provide the trend per generic type (capacitors, power transistors, microprocessors, carbon resistors, and diodes). Comisión Nacional de Actividades Espaciales (CONAE) Page 10 of 14

11 5.11 Alerts or red flags The alert system is set up for the prompt interchange of information on failures or nonconformance which can affect more than one user, or can recur in other projects or circumstances, if no preventive actions are taken. The NRB shall determine when failures or nonconformances can result in an alert and record this decision in the NC form. The above is applicable to failure or problems detected by the subcontractors or by one of his lower tier subcontractors. When a failure or nonconformance is to be treated as an alert, CONAE-PC shall communicate all other subcontractors the occurrence of the failure or non conformance. The subcontractors shall: assess the impact of incoming alerts to project work, and definition, implementation and follow up of necessary preventive actions at any contractual level. distribute of incoming alerts to the possible affected users within the project EEE components nonconformances The subcontractor shall process SCC qualified components or components under SCC qualification in accordance with ESCC 22800, prior to delivery to the purchaser. The subcontractor shall apply the basic requirements defined in clause 6.2 to EEE components nonconformances, with the following modifications related to the NRB classification of nonconformances as significant in case of : - lot or batch rejection during manufacturing, screening or testing at the manufacturer s facilities, if the purchaser proposes: o o to use as is the rejected lot or batch, or to continue processing, rework or testing, although the lot or batch does not conform to the specified requirements. - nonconformances detected after delivery from the manufacturer. CONEA-PC shall invite the final customer (CONAE-Customer) to the NRB meeting related to significant/major nonconformances on EEE components. If it is suspected that nonconforming items of the same batch or production have been released to other users, the subcontractor shall submit an alert to the CONAE-Customer, in accordance with the procedures established by the business agreement 5.13 Software nonconformances The subcontractor shall apply the requirements in this procedure to the following software products: - on board software, - verification software (e.g. simulators, and test beds), - mission control software (ground based), and - support software for development of the on board software. Comisión Nacional de Actividades Espaciales (CONAE) Page 11 of 14

12 The subcontractor shall apply the same basic requirements defined in clause to software nonconformances, with the following NRB dispositions modifications: - use as is, when the software is found to be usable without eliminating the nonconformance; - fix, when the software product can be made fully in conformance with all specified requirements, by: o o o correction of the software, addition of software patches, or re design. - return to supplier, for procured software products. o NOTE For example, COTS Sub-subcontractors The subcontractor is responsible for communicating the requirements of this procedure to its subcontractors. The non conformances identified by sub-subcontractors shall be considered NC of the subcontractor. Comisión Nacional de Actividades Espaciales (CONAE) Page 12 of 14

13 6. ANNEXES 6.1 Annex A: NC REPORT NONCONFORMANCE REPORT STEP 1 IDENTIFICATION OF NC Document Number Document Number Project Project that NC refer Title Title of report Informant Person that report the NC Organization Reporting organization Assembly Group Assembly group that compounds the nonconforming item Subsystem Subsystem that the NC item is part of Model Model that compounds the NC item Drawing / Part No. Document that defines the NC item Critical Item Yes No Nonconforming Item NC item identification (part and name) Serial Number Serial number of NC item Supplier Company that supply the NC item, if outsourced Contract /PO Reference to contract or purchase order with which item is provided Procedure/Paragraph Not Fulfilled Identification of requirement that not fulfil the item Observation Date Date of detection of nonconformance Observation Location Location where NC was detected Detected During Activity being performed when NC was detected Description Description of nonconformance STEP 2 CLASSIFICATION OF NC Classification Minor Major Significant Criticality Critical Non Critical Alert Needed? Yes No STEP 3 - INTERNAL DISPOSITION OF NC Proposed Disposition Use As-Is / Continue / Accept Rework / Redo / Return to Supplier Estimated Finish Estimated date to implement the disposition CAR Required Yes No RFD / RFW Yes No CAR/RFW/RFD Reference to RFW/D and/or CAR associated to this NC Repair / Correct Scrap / Dismiss / Abort Comments Reference Documents Final Classification and Disposition Resolution date Approvals Aditional comments Reference documents Evaluation of classification and disposition by CONAE NRB Resolution date of nonconformance AUTHORITY Reporting Organization CONAE-NRB NAME DATE SIGNATURE Comisión Nacional de Actividades Espaciales (CONAE) Page 13 of 14

14 6.2 Annex B: CAR REPORT CORRECTIVE ACTION REPORT Document Number Project Title NCR Cause of NC STEP 4 AND 5 CAUSE ANALYSIS + CORRECTIVE ACTION Document Number Project that NC refer Title of report NCR associated to this CAR Description of cause of NC/failure/problem Corrective/Preventive Actions Description of taken actions Estimated Start Estimated Finish Corrective Action Rating NRB-CONAE (If major/significance) Resolution Date Estimated date to start the resolution Estimated date to finish the resolution 1 Known Cause / Certain Corrective Action 2 Unknown Cause / Certain Corrective Action RED FLAG 3 Known Cause / Uncertainty in Corrective 4 Unknown Cause / Uncertainty in Corrective Action Approval of cause determination and proposed actions by CONAE NRB Resolution date of CAR STEP 6 - VERIFICATION Comments Additional comments Reference Documents Effectiveness Verification Reference documents Verification of effectiveness of corrective actions taken AUTHORITY Reporting Organization CONAE-NRB (Major / Significant) NAME Approvals DATE SIGNATURE Comisión Nacional de Actividades Espaciales (CONAE) Page 14 of 14