Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Our CAPA SOP states a CAPA will be generated when repetitive or systemic errors occur.  Our industry makes patient specific devices based on a doctor Rx. We are trying to associate percentages to the number of complaints or internal rework that would fall into the category of repetitive or systemic. Does anyone have guidance on how to define when a CAPA is warranted?

Thanks in advance for any help you can provide.

Corrective Action (CA) or Preventive Action (PA) need(s) to be triggered commensurate with risk.  This is expected to be your primary mechanism for determining the need for CA or PA.

Specifically, if the observed (or potential) frequency of harm and severity of harm from a nonconformity exceed(s) the risk acceptance criteria set up in the subject device's Risk Management Plan, then CA or PA is/are to be initiated.

Typically there are multiple risk analysis methods that need to be employed to realize a full risk profile for the subject device.  For example, PHA to help flush out consequent user-centric risks plus process FMEA for the manufacturing process and quality system processes to help flush out consequent process-centric and/or device-centric risks.

I generally recommend avoiding unqualified/undefined subjective trigger terms like "repetitive" or "systemic".  Instead, such terms need to be defined in relation to the acceptance criteria set up in the Risk Management Plan.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 15-Sep-2022 22:28
From: Anonymous Member
Subject: CAPA SOP

This message was posted by a user wishing to remain anonymous

Our CAPA SOP states a CAPA will be generated when repetitive or systemic errors occur.  Our industry makes patient specific devices based on a doctor Rx. We are trying to associate percentages to the number of complaints or internal rework that would fall into the category of repetitive or systemic. Does anyone have guidance on how to define when a CAPA is warranted?

Thanks in advance for any help you can provide.

First, understand that there is no such thing as a CAPA. There are two process, corrective action and preventive action, that address different  issues. The confusion comes from, I believe, the title of 820.100.  Use the definitions in ISO 9000:2015.

I infer that your SOP does not have definitions for repetitive errors or systemic errors and you are looking for suggestions to help update the SOP.

A repetitive error means the same error more than one time over an analysis time interval. For internal errors, I recommend you code nonconformances in some way, using a simple coding scheme. (The disposition of the error is not relevant to this analysis.) I recommend you code them using some simple system. This helps with the variation of patient specific devices. For the analysis, draw a Pareto chart over some reasonable time interval, such as six months. You may want to update it every three months. Implement corrective action for the left most bar. Continue working from left to right until get no more than one occurrence of any problem in the time interval. You have, consequently, eliminated the repetitive errors.

For external errors, such as complaints, use a similar approach. The coding system may be different since it should use codes from the patient or user point of view. I recommend using the IMDRF coding system.

A systemic error means that the errors result from some issue in your QMS. For systemic errors, I recommend coding the results of internal audits. You need a robust internal audit program with an orientation to identifying non-conformances. An example is that somebody doesn't follow an SOP but has a "better" way. This suggests a systematic problem in writing SOPs. Your analysis time interval may need to be twelve months since most companies cycle through the audit program once a year. Three month updates are still reasonable.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 15-Sep-2022 22:28
From: Anonymous Member
Subject: CAPA SOP

This message was posted by a user wishing to remain anonymous

Our CAPA SOP states a CAPA will be generated when repetitive or systemic errors occur.  Our industry makes patient specific devices based on a doctor Rx. We are trying to associate percentages to the number of complaints or internal rework that would fall into the category of repetitive or systemic. Does anyone have guidance on how to define when a CAPA is warranted?

Thanks in advance for any help you can provide.