This procedure defines the authority, responsibilities, and quality system used to ensure that all customer complaints are received, documented, assessed and responded to in a timely basis
4.9.2 Definitions
A non-conformance is any analytical result, which may be outside acceptable error due to the use of an incorrectly calibrated instrument or an instrument found to be out of range of acceptable deviation during a quality assurance test. In other words, a system that is
not compliant to its normal operating specifications outside of regular maintenance.
A non-conformance is a deviation from an established protocol or plan, such as:
° failure of resources (i.e. personnel, equipment, facilities, work instructions) to meet performance requirements or other specified requirements;
° failure of personnel to comply with documented work instructions or operational
procedures;
° failure of test data to meet required standards due to:
- failure (or suspected failure) to meet all conditions necessary to ensure the integrity and representatives of the sample, i.e. sample history deficiencies exist;
- failure (or suspected failure) to comply with the test method SOP's; - failure (or suspected failure) in method performance as demonstrated by
results provided by quality control samples;
- inherent property of a sample that compromises the testing, e.g. as verified
by the method of standard additions;
Relevant evidence provided by data validation e.g. as a result of comparison with expected values, ranges or relationships.
If any of these causes is due to circumstances outside the control of GLIER, then it is termed a deficiency. Deficiencies are handled through the use of a Sample
Submission/Reception form, at the sample receiving area. The client is contacted and the problem resolved before the samples are processed.
GLIER - Analytical Laboratories
ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 3 of 5 Revision 08 Issued: October 2008 4.9.3 Non-Conforming Test Data
Test data will be considered to be nonconforming, if any of the following conditions exist:
° failure (or suspected failure) to meet all conditions necessary to
ensure the integrity and representativeness of the sample, i.e. sample history deficiencies exist;
° failure (or suspected failure) to comply with the test method or supporting work
instructions;
° failure (or suspected failure) in method performance as demonstrated by results provided by quality control samples; inherent property of sample that
compromises the testing, e.g. as verified by the method of standard additions; ° relevant evidence provided by data validation, e.g. as a result of comparison
with expected values, ranges or relationships.
Non-conformance logs are initiated using the Non-Conformance Report (form 4.9) located in the appendix binder. Each Laboratory Supervisor shall ensure that records of non-conformances and the actions taken are kept. If applicable, in the case of a non- conformance applies to both labs the Quality Manager ensures that the record is kept and actions are followed up. It is also the responsibility of the Quality Manager to have the CAR reviewed at year end during QA and or management review.
Manual flags are assigned to nonconforming test results. They shall exist at the following steps in the data management process:
° sample reception; ° sample analysis; ° data validation.
The provision shall exist for each assigned flag to be accompanied by an explanatory comment. Prior to reporting nonconforming or suspected nonconforming data, the Laboratory Supervisor shall advise the client and seek further instructions.
If for any reason it is suspected that nonconforming data may have been reported, i.e., as a result of audit findings, proficiency testing, client feedback or any other circumstance, the Laboratory Supervisor shall immediately notify any client whose data may have been affected. After conferring with the client work may be recalled and followed by a
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ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 4 of 5 Revision 08 Issued: October 2008
4.9.4 Procedure for Remedial Action of Non-conformance
The Laboratory Supervisor ultimately assumes responsibility for ensuring any non- conformance identified in the laboratory is identified and corrected. The Quality Manager is responsible for ensuring all necessary resources are made available to the laboratories for the maintenance of the Quality System.
The Lab Supervisor authorizes a resume work (start up) when non-conformance is corrected.
If an instrument or piece of testing equipment is found to be out of calibration, and is deemed to possibly impact the quality of the data reported to the customer, an
investigation into the root cause and evaluation of the significance of the non- conformance is initiated. As soon as the non-conformance has been identified, the following procedure is conducted:
° The instrument will be identified as out of service. Any other instrument or piece of equipment that may have be adversely affected by the nonconformity, or is subject to similar fault, will also be evaluated in the same manner.
° The reporting of any future results generated by the instrumentation will be withheld until the root cause and net analytical effect can be determined.
° Any further work on the instrument will be halted until the extent and significance of the non-conformance is determined. A decision on the acceptability of the results produced since the last calibration will be made to determine if non-conforming results may have been generated and reported between calibrations.
° If the possibility exists, client(s) whose data have been affected by the non- conformance are notified in writing, and individual concerns and the significance of potential deviations are determined.
° As soon as remedial action is taken, the Laboratory Supervisor authorises the instrument to be placed back into service. If the instrument cannot be returned to service immediately, and an acceptable backup method exists, results may be generated using the backup method.
° After the instrument has been returned to service, its performance shall be monitored regularly to ensure corrective action taken was effective. If doubt exists concerning the ability of the instrument to continue to produce reliable results, the Laboratory Supervisor will devise a long-term strategy for the repair, replacement, or acceptance of an alternative method.
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ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 5 of 5 Revision 08 Issued: October 2008
APPENDIX A REVISION HISTORY
Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.9 Appendix A Approval
Change rev.no. to follow Q.M.2003 add revision table
add approval/authorization page
07 Dec. 8, 04 JC All text 4.9.3 4.9.4 Title page
Lab manager to Supervisor
Clarify responsibility of CAR to Lab Supervisor and Quality Manager
Lab Supervisor authorizes work start up after non- conformance
Lab Director approval 08 Oct. 2008 JC Barrette Header 4.9.2 4.9.3 Remove 2001 from 17025
A simplified definition of non-conformance Clarify client notification and work recall
GLIER - Analytical Laboratories
ISO/IEC 17025:2001 Quality System Procedures Section 4.10
Corrective Action Page 1 of 4
Revision 07 Issued: December 2004
4.10 Quality Manual Authorisation and Approval
The following section of this Quality Manual has been reviewed and approved for issuance by the commissioned management personnel. This is a controlled document, and unauthorised printing or photocopying is prohibited. Copies not showing the original signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
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ISO/IEC 17025:2001 Quality System Procedures Section 4.10
Corrective Action Page 2 of 4
Revision 07 Issued: December 2004 Management Requirements 4.10 Corrective Action 4.10.1 General 4.10.1.1 Purpose
This procedure outlines a system for identification and correction of existing quality non- conformities within the operations of GLIER Laboratories. Outlines for specific
programs and procedures are addressed, with the objective of monitoring these corrective actions to achieve prevention of any recurrences.
4.10.1.2 Definition
Corrective Action: A corrective action is a measure taken to rectify conditions that compromise the quality of a product or system, or in response to a customer complaint, and where possible, to preclude its recurrence. It usually identifies a response to an existing problem.
4.10.2 Cause Analysis
Corrective actions are often carried out in response to a non-conformance (Section 4.9) and may include;
° an investigation of potential causes of nonconformity, and an analysis of possible contributing factors to determine the root cause.
° Potential causes can be assessed from various sources of information, including client feedback, sample specifications/condition, methods and procedures, training requirements for staff, or equipment calibrations. 4.10.3 Selection and Implementation of Corrective Actions
It is the policy of GLIER Laboratories to initiate immediate action(s) to control or correct a non-conformance identified to affect the quality procedure. The Laboratory Manager assumes responsibility for investigating the problem and determination of the root cause, as well as assigning responsibility for the implementation of a corrective action
procedure.
The corrective action processes are maintained under document control procedures using Corrective Action Reports (Appendix 4.10), and required changes are implemented by the
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ISO/IEC 17025:2001 Quality System Procedures Section 4.10
Corrective Action Page 3 of 4
Revision 07 Issued: December 2004 Laboratory Supervisor with assistance from the Quality Manager and/or Laboratory Heads as required.
Specific procedures are defined in Section 4.9, the laboratory standard operating procedures and work instructions, and may include;
° determining and initiating a preventative action to eliminate or control the
problem or prevent its re-occurrence.
° implementation of the necessary corrective action and assessment of its
effectiveness.
° Applying controls to prevent re-occurrence.
° Implementing and documenting changes resulting from the corrective action, as well as documenting its effectiveness.
4.10.4 Monitoring of Corrective Actions
In the case of an internal method audit, proficiency testing, or any other corrective action, the following procedures are followed:
° An audit report is submitted from the Laboratory Head to the appropriate
Laboratory Supervisor;
° A final decision is taken by management regarding the remedial action and a written reply is submitted from the responsible Laboratory Supervisor to the Laboratory Head within 15 days.
4.10.5 Additional Actions
The necessity of initiating additional, follow-up, audits, in cases where a serious, persistent issue has not been solved using the above procedures may occur.
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ISO/IEC 17025:2001 Quality System Procedures Section 4.10
Corrective Action Page 4 of 4
Revision 07 Issued: December 2004
APPENDIX A REVISION HISTORY
Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.10 Appendix A Approval
Change rev.no. to follow Q.M.2003 add revision table
add approval/authorization page
All text
4.10.3 Title page
Lab Manager terminology to Supervisor
Lab Supervisro implements CAR required changes Lab Director approval
GLIER - Analytical Laboratories
ISO/IEC 17025:2001 Quality System Procedures Section 4.11
Preventative Action Page 1 of 3
Revision 08 Issued: August 2006
4.11 Quality Manual Authorisation and Approval
The following section of this Quality Manual has been reviewed and approved for issuance by the commissioned management personnel. This is a controlled document, and unauthorised printing or photocopying is prohibited. Copies not showing the original signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
GLIER - Analytical Laboratories
ISO/IEC 17025:2001 Quality System Procedures Section 4.11
Preventative Action Page 2 of 3
Revision 08 Issued: August 2006
Management Requirements
4.11 Preventative Action, Continual Improvement