Mastering Corrective and Preventative Actions (CAPA) Best Practice
Eldin Rammell, Chairman of the Board of Directors, HSRAA delivered excellent insights at GCP Inspection Readiness 2018 where in which we exploring best practice for Corrective and Preventative Actions (CAPA). We are thrilled to be welcoming Eldin back again this year to facilitate our pre-conference data integrity training day on the 16th September - more info on this here.
Firstly, how do you NOT write a CAPA? We've got a couple of examples here:
- “We request the agency to be not too harsh on us”
- “Noted. It was not realised as being an issue until your inspection ”
- “The resources we have available prohibit these activities”
- “The need for XXX will be placed on the agenda for consideration by the QA group”
Now we've covered what you shouldn't do, here's some points for best practice - broken down into six steps:
Review the finding
Do you really understand what the issue is?
Discuss the issue with those that the issue involves...
- Get their perspective
- How did the issue arise?
- Were people aware of the issue?
- Are there related issues that were not specifically noted or even identified?
Root cause analysis
Refer to Opening Keynote presentation!!
So what else?
- Think “outside the box”…. the cause may lie in unexpected places
- In most cases, avoid citing “training” as a root cause
- Most issue have multiple root causes…. assess them all (aim for at least 4 initial causes)
- Include 4 Ps: Policies, Procedures, People, Plant (systems, tools) or
- Include 4 Ms: Man, Machinery, Methods, Materials
- Do not rush / give it priority
Assess the impact and risks
Consider using standard assessment methodologies e.g. Failure Mode and Effect Analysis (FMEA)
- Understand the potential impact of identified failures (from best case to worst case)
- Consider impact on Data, Safety, Regulatory Compliance, Timelines, Cost*
- For each issue, assign score for Severity, Occurrence, Detection (1 – 10)
Consider using standard assessment methodologies e.g. Failure Mode and Effect Analysis (FMEA)
- Understand the potential impact of identified failures (from best case to worst case)
- For each issue, assign score for Severity, Occurrence, Detection (1 – 10)
- Multiply the score S x O x D = Score out of 1,000
Assess whether the issue is systemic
Try to find additional occurrences:
- Other examples
- Other trials
- Other systems
Refer to root cause analysis data…. this will help to identify systemic issues
Consider corrective actions
Take previous 4 steps into account!
- Your understanding of the issue, the root cause, the impact and the risk will drive what corrections you need to make
- Beware of only correcting the specific failure cited in the inspection report but
- Beware of promising to correct everything !!!
- Be clear and succinct but
- Provide additional background information or rationale
- Be realistic…. don’t over-promise
“It was not appreciated fully that timeframes given for corrective actions needed to be accurate and adhered to exactly and thought more leeway existed than was actually the case. Responses were in fact possibly overly optimistic in their timings […] and for future responses we will endeavour to make more realistic and achievable times.”
Consider preventative actions
Base your preventative actions clearly on the root causes identified in Step 2
- (Re)Training is rarely the root cause…. is the system or process fit for purpose?
- “We’ll make best efforts to prevent this recurring”…. not acceptable
- “The SOP will be updated”…. may be OK if the SOP revision describes a change in practice
Have you assessed the likely effectiveness of your proposals?
Effective implementation of CAPA
“A number of major findings from the previous systems inspection in 2010 had not been implemented and as such resulted in repeat issues arising and critical findings. It is disappointing that there was lack of oversight and implementation of the CAPA and there was no reasonable justification provided for why the CAPA was not implemented.
As such, the organisation will be expected to ensure there are robust mechanisms in place for oversight of the CAPA implementation and given the recent critical findings, will be required to provide quarterly reports on CAPA progress alongside the development of the Quality System.”
To Conclude - Best practice: Critical success factors
Oversight / tracking…. this is an ongoing activity
Address previous CAPAs… contact agency if not done!
- Document the rationale and the reason(s) for action taken (or inaction)
- Revisit the CAPA
- Communicate with the agency
Process governance
- Understand how your processes work and how they inter-relate
- Never change a process without assessing the impact on other processes
- Consider using process experts if you do not have an in-house Process Management function