2.5.3 Corrections & Preventive Actions, Policy, Procedure or Both?

Hello Fellow Food Safety Warriors,

 

I am slowly (very slowly) starting the path towards an SQF certification for my facility.  There many policies, procedures, and documents that I will have to modify or create but I want to start with a solid CAPA program.  I have been battling myself on whether this should be a policy or a procedure or maybe both??  I know what needs to be done but not sure how to start off.

 

I am curious to see what you guys think about this and possibly how you've structured yours (if anyone would like to share).  I need a good, solid base.

 

- Lou

You would need both.

A policy and procedure also stating the responsibile personnel (SQF practitioner) and a Corrective action investigation form/log

What are the scopes of your facility?


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It needs to be both , a Policy that states what you will do and procedure on how to do it along with the record 

You would need both.

A policy and procedure also stating the responsibile personnel (SQF practitioner) and a Corrective action investigation form/log

What are the scopes of your facility?


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Metal detection and allergen control are our biggest concern.  Would Non-conformance also be included in the CAPA program?

that depends on how you write your program....I think a CCP should be included in the CAPA, as you would want to investigate a CCP failure anyway so you prevent it from happening again....a routine non-conformance can turn into a paperwork nightmare for every little thing

 

Example: cook chicken to 165F hold for 2 mins..........you discover time was ok but temp was only 145.....how did this happen at a kill step

 

Handwash sink was cold water...program says warm....employees still washed hands and the next check water was ok.....could have been a million causes but the risk level did not increase

 

I hope that helps

that depends on how you write your program....I think a CCP should be included in the CAPA, as you would want to investigate a CCP failure anyway so you prevent it from happening again....a routine non-conformance can turn into a paperwork nightmare for every little thing

 

Example: cook chicken to 165F hold for 2 mins..........you discover time was ok but temp was only 145.....how did this happen at a kill step

 

Handwash sink was cold water...program says warm....employees still washed hands and the next check water was ok.....could have been a million causes but the risk level did not increase

 

I hope that helps

 

I agree that our CCPs will be included in the CAPA but do I need to just brave the paperwork storm and also log minor non-conformance like your hand washing scenario?  In y'alls experience, how have auditors seen this?

NO!!!!  You will spend all of your time reviewing non conformance.....the non conformance for water temp should be noted on the daily GMP record-with follow up being next check temp was good

 

You need to ensure that your procedures ALL include deviation procedures.....then you can specifically note if it requires a CAPA or not

 

Out of curiosity, why are you starting with the CAPA program and not the run of the mill day to day procedures?

Hi Louie,

 

There are numerous threads on this Forum discussing/arguing the difference(s) between "Policy" and "Procedure". This extract from a summary on the IT covers a variety of the aspects involved -

 

 

Key Differences Between Policies and Procedures

The difference between policies and procedures in management are explained clearly in the following points:

1. Policies are those terms and conditions which direct the company in making a decision. Procedures are the sequential steps which direct the people for any activity.
2. Policies are not hard and fast rules as they permit any extraordinary and unconventional situation. Conversely, Procedures are strict in nature, which needs to be followed in the series.
3. Policies reflect the ultimate mission of the organisation. Unlike Procedures, that are made to show the practical application of the policies.
4. Policies are made to support the strategies while Procedures are helpful in the implementation of programs.
5. Policies are decision oriented, but Procedures are action oriented.
6. Policies need to be thoroughly accepted by the people who are influenced by them. On the other hand, there should be a methodical process in the Procedure.

 

pl1- Difference Between Policies and Procedures.pdf   828.82KB   285 downloads

 

The SQF8 Manufacturing Code requests very few specifically named Policies but it seems (not a SQF user myself) that in practice, a large number are sucked in via its introductory paragraphs, eg -

Document the SQF System – prepare policies, procedures, work instructions and specifications that meet the system elements and GMP Modules of the SQF Food Safety Code for Manufacturing.  In other words, “say what you do.”

 

 

Similarly this NSF (2018) Food Manufacturing Audit Standard has an increased number of  named Policy requirements but  supplemented by another encyclopedic generalisation -

The plant shall have documented policies and procedures covering all aspects of ingredient receipt, food manufacture, and storage and shipping. These policies and procedures shall be well organized, available, current, dated and approved by an authorized person.

pl2 - NSFsupplier assurance manual,2018.pdf   703.35KB   325 downloads

 

To give some ideas of textual possibilities, a collection of basic Quality-FS System/Process Policy Statements is attached.

The specific details would require matching to yr own Facility/FS Standard/Situation. For example, Company FS Policies as posted in other threads here  usually include an assurance of compliance with legal aspects.

 

pl3 - FS Policy Manual.doc   194.5KB   412 downloads

NO!!!!  You will spend all of your time reviewing non conformance.....the non conformance for water temp should be noted on the daily GMP record-with follow up being next check temp was good

 

You need to ensure that your procedures ALL include deviation procedures.....then you can specifically note if it requires a CAPA or not

 

Out of curiosity, why are you starting with the CAPA program and not the run of the mill day to day procedures?

 

This is a "hand-me down" program.  It has been stitched by a couple different hands and I am trying to unravel it.  There some policies and procedures in place and then there are some day to day activities that are done but no policy or procedure exists.  The reasoning behind my question is that since the inception of this program they have been taught to log ALL non-conformance and deviations in one log with a corrective action for each individual event.  I know better than that but since they have had successful GMP audits since the get go, I was a bit hesitant to change the program.  If I am to move forward then I feel that I have to change their thinking by creating a solid CAPA program that will designated exactly what to do.  Hope that makes sense.   :helpplease: :smile:

Hi Louie,

 

There are numerous threads on this Forum discussing/arguing the difference(s) between "Policy" and "Procedure". This extract from a summary on the IT covers a variety of the aspects involved -

 

pl1- Difference Between Policies and Procedures.pdf

 

The SQF8 Manufacturing Code requests very few specifically named Policies but it seems (not a SQF user myself) that in practice, a large number are sucked in via its introductory paragraphs, eg -

 

 

Similarly this NSF (2018) Food Manufacturing Audit Standard has an increased number of  named Policy requirements but  supplemented by another encyclopedic generalisation -

pl2 - NSFsupplier assurance manual,2018.pdf

 

To give some ideas of textual possibilities, a collection of basic Quality-FS System/Process Policy Statements is attached.

The specific details would require matching to yr own Facility/FS Standard/Situation. For example, Company FS Policies as posted in other threads here  usually include an assurance of compliance with legal aspects.

 

pl3 - FS Policy Manual.doc

 

Thank you so much for this wealth of info!!!

This is a "hand-me down" program.  It has been stitched by a couple different hands and I am trying to unravel it.  There some policies and procedures in place and then there are some day to day activities that are done but no policy or procedure exists.  The reasoning behind my question is that since the inception of this program they have been taught to log ALL non-conformance and deviations in one log with a corrective action for each individual event.  I know better than that but since they have had successful GMP audits since the get go, I was a bit hesitant to change the program.  If I am to move forward then I feel that I have to change their thinking by creating a solid CAPA program that will designated exactly what to do.  Hope that makes sense.   :helpplease: :smile:

 

How does one make the determination of whether or not to include a non-conformance/deviation on a CAPA log? We have also taken the approach of including every event in a CAPA log.