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LHC Quality Assurance Working Group - M.

Mottier September 2000


Nonconformance Tracking

Objectives
To provide an on-line system to report,
analyze,and correct non conformities as
required by ISO 9001 and the LHC Quality
Assurance Plan:

 To enable the reporting of non conformities, on-


site and off-site, detected in production, assembly
and installation.
 To provide a comprehensive view of the state of
non conformities at part level, equipment level, and
project level.
 To provide for searching, reporting and statistical
analysis.

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

Method
 Use the EDMS and its web interface.
 Use a document, the nonconformance
report.
 Use a specific document type, QN.

The nonconformance report (NCR) is used to


document the history from detection to
implementation of the solution.
The document status is used to display the main
steps in the nonconformance evolution

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

NC Status

Initiates NC process OPEN (IN WORK)


Inspecto Completes first part of NCR
r There is a problem
Stores NCR in EDMS Waiting for a solution

Production
Makes analysis
Manager Proposes solution, including
UNDER APPROVAL
corrective action There is a problem
Solution found
Waiting for approval
Project Engineer Verifies and
Project Management Approves solution ACCEPTED (RELEASED)
There is a problem
Solution approved
Production Implements solution
Manager Correction in-progress

CLOSED (OBSOLETE)
Production Manager Implementation complete There was a problem
Project Engineer Stops NC process It has been corrected

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

NC process step by step


 Inspector (on production site)
 Discovers a non-conformity.
 Completes the IDENTIFICATION part of the NCR.
 Stores the NCR in EDMS (status OPEN).
 Production Manager (on production site)
 Makes analyses and proposes a solution.
 Updates NCR, point 13, possibly point 16.
 Changes NCR status to UNDER APPROVAL.
 Project Engineer/Project Management (at
CERN)
 Verifies and approves or rejects the proposed solution.

 Decides whether management approval is required.

 Finally changes status to ACCEPTED or REJECTED.

 Production Manager (and PE if necessary)


 Implements the solution.
 Changes status to CLOSED when complete.
LHC Quality Assurance Working Group - M. Mottier September 2000
Nonconformance Tracking

Confidentiality
 Inspector and Production Manager
 May only see NC’s related to their contract
 Project Engineer
 May see NC’s related to all his contracts and to
all related equipment
 Project Management
 May see all NC’s related to the project

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

Web interface
 Specific form to store and search for
NC’s:
 To clearly segregate NC’s, as processes, from
documents.
 To display NC status and hide the NCR document
status.
 To automatically assign the doc type.
 Pre-defined search as for ECR’s
 Search by status, like ECRs.

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

Production sites without Internet


(1)
 Inspector:
ce s s !

e b a c
Fills points 1 to 12 of the form and sends it to Production
Manager
v e a W
 Production Manager: u s t h a
t o r s m
t r a c Fills point 13 of the form and faxes to PE at CERN
Con

 PE (or secretary)
 Completes point 14 or 15 of the form and faxes it to
Production Manager
 Creates an empty (no file attached) NC Report
 Changes the status of NC to IN-PROGRESS
When Implementation is completed:
 Scans the completed form and stores it in EDMS
 Change status to CLOSED

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

Production sites without Internet


(2)
In cases where it has been demonstrated that
communication via the web is not possible:
 Use the nonconformance report as a paper
document.
 Communicate via telephone, fax and mail.
 Scan and store the nonconformance report
when the nonconformance has been
resolved, with the status OBSOLETE.

LHC Quality Assurance Working Group - M. Mottier September 2000


Nonconformance Tracking

LHC-PM-QA-509.00

LHC Quality Assurance Working Group - M. Mottier September 2000

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