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Anomalies,
Complaints and
Non-compliances
Dr. Tim Sandle – in the ISO 17025 context
ISO 17025 CA Requirements
 Investigate the problem
 Determine root cause
 Consider options to
correct problem
(immediate correction)
 Consider options to
prevent re-occurrence
(corrective action)
 Select an option and
implement
 Monitor for effectiveness
Investigate
Determine Root
Cause
Consider options to
address Root Cause
and preventing
reoccurrence
Select an option
and implement
Review for
effectiveness
Changes to process
 Updated our SOPs to bring Institute definitions in line with
ISO Standards
 Removal of requirement for preventive actions to be
considered as part of anomaly, complaint and non-
compliance – what is expected by the Accrediting /
Certificating Bodies
 New version of forms will require:
 Immediate Correction
 Corrective Action
Definitions
Corrective Action - CA Preventative Action - PA
Reactive process Pro-active process
Action taken to address the
immediate problem AND how it
could be prevented from
reoccurring
Action taken to improve a
process / procedure or to
prevent a problem from
occurring
Action taken to target the root
cause and resolve the anomaly,
non-compliance or complaint
Identifies opportunities for
improvement, rather than a
reaction to problems identified
or complaints received
Key Questions to aid
Investigation
 When recording an anomaly or complaint ask yourself:
 What happened?
 When did it happen?
 Where did it happen?
 Why did it happen?
 Extent / Impact?
 Is it a local issue?
 Is it happening on a wider scale?
Root Cause Analysis –
Fishbone diagram
 Investigate the problem
 Anomalies
 Complaints
 Non-compliances
Equipment
• Out of calibration
• Not fit for purpose
Process
• Not following validated
method
People
• Lack of training
• Lack of concentration
Environment
• Temperature in lab
Materials
• Not stored correctly
• Incorrect reagents
Immediate Correction
 Action or actions that will resolve the problem
immediately - based on the root cause
 Anomaly - Invalid assay due to out of calibration pipette
used:
 What can we do to rectify the issue now?
 Immediate correction
 Calibrate pipette or use another calibrated pipette
 Repeat assay
Corrective Action
 Action or actions to prevent the problem reoccurring
Corrective Action (CA)
 What needs to change?
 Where, when and to what extent?
 Anomaly - Invalid assay due to out of calibration pipette used:
 Corrective Action
 Re-train staff on importance of calibration
 Ensure calibration status is clearly displayed
8
Corrective Actions – Common
Pitfalls
 Decision is not always conveyed clearly to those expected
to carry out the action
 Root causes are identified but not adequately addressed
through corrective actions
 Corrective actions are identified, but not implemented
 Corrective actions implemented but not documented
 Corrective actions don’t think about how to prevent the
issue happening again
9
Reviewing the Effectiveness
 Corrective Actions easier to review for effectiveness when using
SMART
 Specific – What, Why, Who, Where, Which?
 Measurable – How much, How many, How will I know when it is
accomplished? Indicators should be quantifiable.
 Achievable – How can it be accomplished, How realistic is the goal?
 Relevant – Is it worthwhile, Does it meet our needs?
 Timely – What timeframe?
 Effectiveness can be measured through:
 Audit
 Testing the system
PA Requirements in ISO 17025
 Over and above
addressing a problem
 Pro-active
 Trying to identify
potential future sources
of issues
 Introducing new
processes
 Separate to Corrective
Actions
Potential source of non-
conformance identified
Develop Action Plan to
prevent / decrease likelihood
of non-conformance
Monitor effectiveness
Advantages of effective CAPA
 Lessons learned prevent recurrence which in turn
reduces future workload (as not having to deal with
same anomaly or complaint repeatedly)
 Can learn from each other – cross Divisionally
 Allow for continual improvement to the system
 Gives additional assurance to our customers that we
strive for the best results
12
Thank you
Dr. Tim Sandle

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Anomalies, complaints and non-compliances

  • 1. Anomalies, Complaints and Non-compliances Dr. Tim Sandle – in the ISO 17025 context
  • 2. ISO 17025 CA Requirements  Investigate the problem  Determine root cause  Consider options to correct problem (immediate correction)  Consider options to prevent re-occurrence (corrective action)  Select an option and implement  Monitor for effectiveness Investigate Determine Root Cause Consider options to address Root Cause and preventing reoccurrence Select an option and implement Review for effectiveness
  • 3. Changes to process  Updated our SOPs to bring Institute definitions in line with ISO Standards  Removal of requirement for preventive actions to be considered as part of anomaly, complaint and non- compliance – what is expected by the Accrediting / Certificating Bodies  New version of forms will require:  Immediate Correction  Corrective Action
  • 4. Definitions Corrective Action - CA Preventative Action - PA Reactive process Pro-active process Action taken to address the immediate problem AND how it could be prevented from reoccurring Action taken to improve a process / procedure or to prevent a problem from occurring Action taken to target the root cause and resolve the anomaly, non-compliance or complaint Identifies opportunities for improvement, rather than a reaction to problems identified or complaints received
  • 5. Key Questions to aid Investigation  When recording an anomaly or complaint ask yourself:  What happened?  When did it happen?  Where did it happen?  Why did it happen?  Extent / Impact?  Is it a local issue?  Is it happening on a wider scale?
  • 6. Root Cause Analysis – Fishbone diagram  Investigate the problem  Anomalies  Complaints  Non-compliances Equipment • Out of calibration • Not fit for purpose Process • Not following validated method People • Lack of training • Lack of concentration Environment • Temperature in lab Materials • Not stored correctly • Incorrect reagents
  • 7. Immediate Correction  Action or actions that will resolve the problem immediately - based on the root cause  Anomaly - Invalid assay due to out of calibration pipette used:  What can we do to rectify the issue now?  Immediate correction  Calibrate pipette or use another calibrated pipette  Repeat assay
  • 8. Corrective Action  Action or actions to prevent the problem reoccurring Corrective Action (CA)  What needs to change?  Where, when and to what extent?  Anomaly - Invalid assay due to out of calibration pipette used:  Corrective Action  Re-train staff on importance of calibration  Ensure calibration status is clearly displayed 8
  • 9. Corrective Actions – Common Pitfalls  Decision is not always conveyed clearly to those expected to carry out the action  Root causes are identified but not adequately addressed through corrective actions  Corrective actions are identified, but not implemented  Corrective actions implemented but not documented  Corrective actions don’t think about how to prevent the issue happening again 9
  • 10. Reviewing the Effectiveness  Corrective Actions easier to review for effectiveness when using SMART  Specific – What, Why, Who, Where, Which?  Measurable – How much, How many, How will I know when it is accomplished? Indicators should be quantifiable.  Achievable – How can it be accomplished, How realistic is the goal?  Relevant – Is it worthwhile, Does it meet our needs?  Timely – What timeframe?  Effectiveness can be measured through:  Audit  Testing the system
  • 11. PA Requirements in ISO 17025  Over and above addressing a problem  Pro-active  Trying to identify potential future sources of issues  Introducing new processes  Separate to Corrective Actions Potential source of non- conformance identified Develop Action Plan to prevent / decrease likelihood of non-conformance Monitor effectiveness
  • 12. Advantages of effective CAPA  Lessons learned prevent recurrence which in turn reduces future workload (as not having to deal with same anomaly or complaint repeatedly)  Can learn from each other – cross Divisionally  Allow for continual improvement to the system  Gives additional assurance to our customers that we strive for the best results 12