5 replies to this topic

[NorCalNate]

I was updating our CAPA Policy and CAPA Training and had a few questions which I sent to our consultant who responded back in red:

 

Q1: Do NCs from Inspections (e.g., Monthly Facility Inspections) require CAPAs?   No as most are corrections.  If the NC needs capital then it becomes a CAPA.

Q2: If a NC noted on an internal audit is not a repeat offender, determined not to be a food-safety or quality risk, does it still require a CAPA?   No CAPA required again unless again it requires a capital project.

 

His answers didn't add up with my understanding of CAPA or the SQF CAPA Guidance document and I'm left even more confused than I started. I thought risk determined when CAPA was required, not necessarily when a NC required capitol expenditure. 

 

I'm now not sure if I have the correct understanding of a "Correction". For example, do corrections require CAPAs, or are corrections part of CAPA? I thought "corrections" were basically fixes which didn't require RCAs or PAs due to being a non-food safety risk or not a repeat offender. 

 

I've attached the SQF CAPA Guidance document which I was using. 

 

Insights appreciated.

[Scotty_SQF]

I agree with the answers from your consultant to some degree.  Been in SQF for over 10 years, and the terms sometimes seem to get murky to say the least.  For internal audit and inspection findings, if they do not require capital investment, are not multiple repeat findings or are not high risk, you need a corrective action on how you fixed it, but you do not need a CAPA for it.  Basically you do not have to go through the whole root cause corrective action process.  You only need to show that you have documented corrective action to those findings.  SQF sometimes uses the terms corrections and corrective action interchangeably.  The one they always differentiate and stick to when it is needed is Root Cause Corrective/Preventative Action (RCCPA).  This would be used for major projects, high risk findings, multiple repeat findings, etc.  So in a way depending on the risk of your finding, it could sometimes go through the  RCCPA process.  

 

That's my insight at least.  I'm sure I missed some other circumstances to use it.  Interested to hear others insights.

[jfrey123]

What Scotty said (especially on the murky part).  Capital doesn't dictate a CAPA, the type of NC is what will dictate your level of response.  For the plants my team oversees, they report their internal audit NC's and usually list details with their correction for us, and these are mostly effective and accepted.  For NC's that have significant food safety concerns, or repeated issues we discover in trend analysis, it escalates to the full root cause with preventative action. 

 

Having something defined in your program as to when you escalate it to needing a preventative action is what auditors will look for.  Goes to the whole "say what you do, and do what you say."  Lots of low level NC's will need capital but won't require preventative actions.

 

 

 

2.5.3 Corrective and Preventative Action (Mandatory)

2.5.3.1 The responsibility and methods outlining how corrective and preventative actions are determined, implemented, and verified, including the identification of the root cause and resolution of non-compliance of critical food safety limits and deviations from food safety requirements, shall be documented and implemented. Deviations from food safety requirements may include customer complaints, non-conformances raised at internal or external audits and inspections, non-conforming product and equipment, withdrawals and recalls, as appropriate.

2.5.3.2 Records of all investigation, root cause analysis, and resolution of non-conformities, their corrections, and the implementation of preventative actions shall be maintained.

 

 

From the guidance document:

There are typically three types of actions that should be considered in your problem-solving process:

1. Corrections are considered short term fixes, i.e., a quick action taken to remediate a specific problem or adjustments made to regain immediate control.

2. Corrective actions are long term fixes designed to eliminate the root cause of the problem and to minimize the risk that the situation will occur again.

3. Preventative actions are designed to prevent the same deviation or event from occurring on similar product(s) or process(es).

Corrective-and-Preventative-Action-Guidance-Document.pdf (sqfi.com)

[QAKat]

Hello, 

 

I.      When is a CAPA required? 

o   Whenever there is an identified non-conformance triggered by a deviation from the requirements of any relevant module(s) of the SQF Food Safety Code a CAPA must be initiated. Identify the supporting element, description and the extend of the non-conformance. 

 

o   You need to take appropriate corrective action for every non-conformance identified by the SQF food safety auditor (corrective action is the action you take to eliminate the cause of a detected non-conformance to prevent its recurrence).

 

o   Below I have added what as a minimum is required to start a CAPA’s per SQF Code.

 

2.1.3 Complaint Management (Mandatory)

2.1.3.3 Corrective and preventative action shall be implemented based on the seriousness of the incident and the root cause analysis as outlined in 2.5.3. Records of customer complaints, their investigation, and resolution shall be maintained.

 

2.4.5 Non-conforming Materials and Product

2.4.5.2 Quarantine records and records of the handling, corrective action, or disposal of non-conforming materials or product shall be maintained.

 

2.4.8 Environmental Monitoring

2.4.8.3 Environmental testing results shall be monitored, tracked, and trended, and preventative actions (refer to 2.5.3.1) shall be implemented where unsatisfactory results or trends are observed.

 

2.5.4 Internal Audits and Inspections (Mandatory)

2.5.4.4 Records of internal audits and inspections and any corrective and preventative actions taken as a result of internal audits shall be recorded as per 2.5.3. 

 

Changes implemented from internal audits that have an impact on the site's ability to deliver safe food shall require a review of applicable aspects of the SQF System (refer to 2.3.1.3).

2.3.1.3 A food safety plan shall be validated and verified by the site food safety team for each new product and its associated process through conversion to commercial production and distribution or where a change to ingredients, process, or packaging occurs that may impact food safety.

 

2.6.3 Product Withdrawal and Recall (Mandatory)

2.6.3.3 Records shall be maintained of withdrawal and recall tests, root cause investigations into actual withdrawals and recalls, and corrective and preventative actions applied.

 

11.1.7 Equipment and Utensils

11.1.7.9 Non-conforming equipment shall be identified, tagged, and/or segregated for repair or disposal in a manner that minimizes the risk of inadvertent use, improper use, or risk to the integrity of finished product. Records of the handling, corrective action, and/or disposal of non-conforming equipment shall be maintained.

 

11.6.2 Cold Storage, Freezing, and Chilling of Foods

11.6.2.3 The site shall have a written procedure for monitoring temperatures, including the frequency of checks, and corrective actions, if the temperature is out of specification.

Freezing, chilling, and cold storage rooms shall be fitted with temperature monitoring equipment that is located to monitor the warmest part of the room and be fitted with a temperature measurement device that is easily readable and accessible. Records shall be kept of frozen, cold, and chilled storage room temperatures.

 

11.7.4 Detection of Foreign Objects

11.7.4.4 Records shall be maintained of the inspection of foreign object detection devices, of any products rejected or removed by them, and of corrective and preventative actions resulting from the inspections.

 

II.      CAPA Record, Verification and Follow-up Requirements 

o   Evidence of all corrective actions is required (supporting documentation).  

o   A close out time frame must be established for all CAPAs.

o   I recommend that all CAPAs classified as a “Minor and / or “Major” must be verified and closed out at least within thirty (30) calendar days after the date of initiation. 

 

Hope it helps 

[kingstudruler1]

I think the advise you have been given is incorrect.    A CAPA would be required in both situations.   

 

A finding on a GFSI audit requires a rc and capa - why wouldn't an internal audit / inspection?

 

Whats the harm in doing every step - root cause, corrective action, and preventative action?

[jfrey123]

I think the advise you have been given is incorrect. A CAPA would be required in both situations.

A finding on a GFSI audit requires a rc and capa - why wouldn't an internal audit / inspection?

Whats the harm in doing every step - root cause, corrective action, and preventative action?

I don’t know anyone who is doing a full preventative action each time they catch an employee wearing a hair/beard net incorrectly. This is why the guidance docs differentiate between corrections, corrective actions, and preventatives.