1 reply to this topic

[cafammbah]

Hello everyone,

This is my first time posting in this forum. I am currently updating our documents to align with SQF requirements while also reducing unnecessary paperwork, as we are a small company with a seriously understaffed quality team.

A quality consultant informed me that under ISO 9001:2015, the concept of preventive action has been removed from CAPA. Instead, a risk-based quality management system now addresses preventive actions, making CAPA somewhat redundant. According to him, the entire quality management system is designed to prevent issues, so asking for preventive action following a deviation or non-conformance would imply an overhaul of your food safety management system. He mentioned that only corrective actions are necessary.

Given this, should I change our CAPA to CAR (Corrective Action Request), or am I misunderstanding something? I noticed that SQF still refers to CAPA in section 2.5.3 of Edition 9.

[jfrey123]

Perspectives will vary, but I think your consultant is breaking this down a little too narrowly.  I've always recorded my CAR's where they apply directly:  it could be on a batch record, employee disciplinary form, sanitation record, internal audit form, etc.  I've always reserved CAR's for small breaks or deviations from my program, such as an employee caught with jewelry or a form being filled out incorrectly, a customer complaint based on a quality only issue, minor infractions that do not impact food safety but require correction.  We aren't going to adjust the program for every single minor infraction discovered, but we still need to record where a CA occurred.

 

CAPAs, for me, are reserved for larger, wider reaching infractions, especially where food safety is directly impacted.  I have always maintained a separate investigation form using fishbone or 5 Why's or other tools to perform a full root cause analysis to determine if a preventative action is required moving forward.  Say I've got a large number of those employee GMP infractions showing in trend analysis, or customer discovered my product contained metal past my MD process, or EMP monitoring is showing an increase in sanitation deficiencies.  Those are situations where you'll want a form and process to review, investigation, and determine whether your process needs to be changed to better handle a hazard.

 

SQF allows for this distinction in 2.5.3 in stating "The responsibility and methods outlining how corrective and preventative actions are determined, implemented, and verified..."  I've always distinguished a corrective action from a preventative action as dependent on how it can affect food safety, reserving the option to escalate to a preventative action where we've discovered a failure in our system.