This document discusses anomalies, complaints, non-compliances, and corrective and preventative actions as required by ISO 17025. It outlines the process laboratories must follow to investigate problems, determine the root cause, consider and select options to immediately correct the problem and prevent reoccurrence, and then review the effectiveness of the actions. This includes using tools like fishbone diagrams and SMART criteria to aid the investigation and ensure corrective actions sufficiently address the root cause. Preventative actions focus on proactively improving processes rather than reacting to identified problems. Effective corrective and preventative actions can help laboratories continually improve and reduce future issues.

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
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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
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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
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13. Thank you
Dr. Tim Sandle