NON CONFORMITIES REPORTING

Transcription

1 CERN CH-1211 Geneva 23 Switzerland the Large Hadron Collider project LHC Project Document No. CERN Div./Group or Supplier/Contractor Document No. - EDMS Document No Date: Quality Assurance Instruction NON CONFORMITIES REPORTING Abstract This document gives detailed instructions for the reporting of non conformities. Two possible schemes are described: The use of non conformity documents stored in CERN's Engineering Data Management System (EDMS), linked to a Manufacturing and Test Folder (MTF) and making use of the status and approval mechanisms offered by the EDMS to track the evolution of the non conformity. The use of stand-alone non conformity documents stored in the EDMS. Prepared by : M Mottier EST/ISS Marcel.Mottier@cern.ch E. Manola-Poggioli EST-ISS Elena.Manola@cern.ch Checked by : LHC Quality Assurance Working Group

2 Page 2 of 7 History of Changes Rev. No. Date Pages Description of Changes Draft First Draft Released

3 Page 3 of 7 Table of Contents 1. PURPOSE BASIC SCHEMES SCHEME 1: TRACKING USING EDMS SCHEME 2: TRACKING WITHOUT USING EDMS TRACKING USING EDMS PERSONS, LISTS, AND ROLES EDMS CONFIGURATION TRACKING WITHOUT USING EDMS ANNEXES RELATED DOCUMENTATION...6

4 Page 4 of 7 1. PURPOSE This document gives detailed instructions for the reporting of non conformities. Two possible schemes are described: Use of non conformity documents stored in CERN's Engineering Data Management System (EDMS), linked to a Manufacturing and Test Folder (MTF) and making use of the status and approval mechanisms offered by the EDMS to track the evolution of the non conformity. Use of stand-alone non conformity documents. 2. BASIC SCHEMES 2.1 SCHEME 1: TRACKING USING EDMS This scheme is mandatory in all cases where a series production is foreseen or where the production involves many processes and organisations working on complex equipment. In this scheme the complete information about a non-conformity is made up of two sets of information: 1. The technical details of the problem and its solution. They are collected in a document, the non conformity report, stored in EDMS. 2. The details of the decision process, i.e. the record of organisations, groups and individuals participating in defining and approving the way the problem is resolved. They are stored as attributes of the non conformity document. To avoid duplication of effort and data, the record of the decision process into the non conformity report is optional. 2.2 SCHEME 2: TRACKING WITHOUT USING EDMS In cases where the tracking of non conformities cannot be carried out according to the scheme described in section 2.1, a record of the problem, its solution and the decision process still has to be maintained. In this case all the technical details of the problem, its disposition and the decision process must be written in the non conformity report, and the report must be stored in EDMS. 3. TRACKING USING EDMS 3.1 PERSONS, LISTS, AND ROLES The flowchart outlining the steps involved in the resolution of a non-conformity is given in annex 1. This shows the individuals and groups of persons involved and their roles in the process. For the process to work, it is necessary to identify the persons that will fulfil the different roles and to set-up the EDMS configuration for non conformities accordingly. This takes some time and it is recommended to carry out these preparations before production starts. Originator: This can be any person involved in the production process.

5 Page 5 of 7 His/her responsibilities are to complete points 1 to 11 of the NC report, to create the NC document in EDMS, to upload the NC report file, and to create a link to the appropriate MTF step. If the originator is not trained to carry out these tasks, he/she shall seek the assistance of a supervisor. Quality manager: This is the person responsible for the quality control aspects of the contract. He/she can be a representative of the firm in charge of the contract, a representative of a third party with responsibility for quality control, or a representative of CERN or a collaborating Institute. His/her responsibilities are to verify that new non conformities are genuine and not due to defective measuring equipment, use of inadequate testing procedures, error in calibration etc. Once the problem is confirmed to be a non conformity, he/she has to change the status of the NC to NC CHECK, after updating the NC report if necessary. Once a disposition has been approved, he/she has to check that the action plan is carried out, that the failed requirement is met and that corrective and preventive actions have been initiated. If these conditions are fulfilled he/she can then change the status of the NC to CLOSED. Project Engineer: This usually is the CERN engineer, or the collaborating Institute engineer, in charge of the contract. His/her responsibilities are to evaluate the NC, decide whether it is critical or not critical (see ref. [ 1 ]) and to propose a plan of action to solve the problem. In the case of a non critical NC the next tasks are to: complete the NC report (points 13 and 14), change the status to ACTION PLAN and then APPRO CLOSED. In the case of critical NCs the tasks are to: complete the NC report (points 12 and 13), change the status to APPROVAL OPEN to launch an approval procedure, make the final decision on the disposition of the NC and of corrective/preventive actions, change the status to APPRO CLOSED, finally he has to close the NC (status CLOSED ) after ensuring that the disposition has been satisfactorily completed and that corrective and preventive actions have been initiated. List NC check : This list can be used to notify its members and collect their comments or opinion before defining the NC as critical or not, and defining a plan of action. List NC approval : This list is used to notify, collect comments and get the approval or refusal of its members. Care must be taken to ensure that all persons involved by the NC are included in the approval list. Persons can be added to the list for specific cases as necessary. 3.2 EDMS CONFIGURATION Before the NC tracking process can be used the following preparation have to be made: Define under which EDMS node the NC documents will be created. Name the persons for each of the roles defined in section 3.1. Name the members of the lists NC check and NC approval.

6 Page 6 of 7 4. TRACKING WITHOUT USING EDMS In this case it is assumed that the follow up of the NC process is done by some means other than using the EDMS system in the way described in chapter 3. However, at the latest when the NC has been closed, a record of the NC and its disposition has to be made. This is achieved by completing an NC report, including points 14 and 15, and storing this document in EDMS together with the other production follow-up documentation. This is the responsibility of the Project Engineer, who may delegate to the Quality Manager. For non critical non conformities the Quality Manager has the responsibility to set the status of the NC to CLOSED once he has checked that the disposition has been carried out, that the failed requirement is met and that corrective and preventive actions have been initiated. In the case of critical non conformities the responsibility for closing the non conformity rests with the Project Engineer. 5. ANNEXES Annex 1: Non conformity process flowchart Annex 2: Non conformity report template 6. RELATED DOCUMENTATION [ 1 ] LHC-PM-QA Handling of Nonconforming Equipment [ 2 ] LHC-PM-QA Non Conformity Report (the template) [ 3 ] EDMS Release Procedures for NCRs EDMS N o

7 Page 7 of 7 Who Activity Report EDMS Originator NC detected Fill-in NC report points 1 to 10 Create document Doc type: Report Activity: Non conformity Attach to MTF Quality Manager NC not confirmed NC cancelled NC verification NC confirmed Upload modified report NC CHECK All members of list NC check are notified RED Project Engineer Non critical NC Analysis of problem NC critical or not? Fill-in point 11 Critical NC Project Engineer Prepare action plan Prepare action plan Fill-in points 12 and 13 Upload modified report ACTION PLAN REJECTED Prepare new action plan Proposed plan of actions circulated for comments and approval APPROVAL OPEN All members of list NC approval are required to comment/approve the action plan YELLOW Project Engineer Approval or rejection of the proposed plan of action APPROVED APPROVAL CLOSED All members of list NC approval are notified of decision GREEN For non critical NC: Quality Manager For critical NC: Project Engineer Disposition completed corrective and preventive actions initiated CLOSED GREY Annex 1: Non conformity process flowchart