6 replies to this topic

[Avryl]

Hi there, I am writing a procedure for the SQF section 2.4.5 Non-conforming product or equipment. I need some help with the procedure as I am not sure if the procedure I wrote make any sense or it is good enough. Any comment or feedback would be much appreciated! 

Attached Files

•  2.4.5.A Non-Conforming Product & Equipment Policy & Procedure.docx   51.77KB   344 downloads

[matthewcc]

Do you have a specific area that is a secure quarantine?  Non-conforming product is usually put there.  I would put that in Procedures under A. 2).

 

Under Disposition, I would specifically disallow the use as-is of a product if it did not meet specifications.

 

Also, I think I would make a separate section for criteria for determining whether something can be released again.  What industry regulations apply here, and is a material review required?

[Charles.C]

Hi there, I am writing a procedure for the SQF section 2.4.5 Non-conforming product or equipment. I need some help with the procedure as I am not sure if the procedure I wrote make any sense or it is good enough. Any comment or feedback would be much appreciated! 

What kind of Product / Process is involved ? Can be relevant.

 

A Few Comments

 

I'm not a user of SQF but IM(personal)EX,  I usually generate "Procedures" without detailing all the minutiae of operational content which  I put into Work Instructions (ISO-type layering). However the exact approach employed is subjective and i doubt that SQF care one way or the other.

 

I suggest you study the SQF Guidelines material to see/compare the SQF specifically mentioned items with your Procedure.

 

I thought the main body was quite good.

 

In segment "1 Purpose" I suggest replacing "record" by "document".

 

2.4.5.1.(iii) seems to have been "missed" in the introductory segments (eg Policy) ?.

 

I don't think segregation is "optional" as yr text (<<when possible>>) implies ? (See the Guidelines)

 

IMO the Forms/Records Section should contain a (fully numbered) list of relevant documents.  Details as relevant should be specified within the Procedure, ie the detailed itemisations as currently provided are superfluous.

 

I did not comprehend the meaning of text in D (c) (RCA-related)

Edited by Charles.C, 14 November 2020 - 04:18 AM.
added

[Avryl]

Do you have a specific area that is a secure quarantine?  Non-conforming product is usually put there.  I would put that in Procedures under A. 2).

 

Under Disposition, I would specifically disallow the use as-is of a product if it did not meet specifications.

 

Also, I think I would make a separate section for criteria for determining whether something can be released again.  What industry regulations apply here, and is a material review required?

Hi matthewcc, we are a small bakery manufacturer that makes tarts, frozen RTE frozen tarts, frozen fruit tarts and etc. We don't have a specific area to put our product in quarantine since the space is limited. 

 

Thanks for suggesting to include the criteria for releasing, I am planning to make one for the product release program. However, we do not do any micro test for our finished products. Is meeting product specification and verifying CCP sufficient for a product release?

 

May I ask what a material review is?

[Avryl]

What kind of Product / Process is involved ? Can be relevant.

 

A Few Comments

 

I'm not a user of SQF but IM(personal)EX,  I usually generate "Procedures" without detailing all the minutiae of operational content which  I put into Work Instructions (ISO-type layering). However the exact approach employed is subjective and i doubt that SQF care one way or the other.

 

I suggest you study the SQF Guidelines material to see/compare the SQF specifically mentioned items with your Procedure.

 

I thought the main body was quite good.

 

In segment "1 Purpose" I suggest replacing "record" by "document".

 

2.4.5.1.(iii) seems to have been "missed" in the introductory segments (eg Policy) ?.

 

I don't think segregation is "optional" as yr text (<<when possible>>) implies ? (See the Guidelines)

 

IMO the Forms/Records Section should contain a (fully numbered) list of relevant documents.  Details as relevant should be specified within the Procedure, ie the detailed itemisations as currently provided are superfluous.

 

I did not comprehend the meaning of text in D (c) (RCA-related)

 

Hi Charles.C, thanks for taking your time reading and giving me useful feedbacks. I will move all the details of the forms/records to the procedure and have a list of the documents listed instead. 

 

2.4.5.1.(iii) seems to have been "missed" in the introductory segments (eg Policy) ?. 

You meant to include the forms/records in the policy?

 

I did not comprehend the meaning of text in D (c) (RCA-related)

For the Section D, I wanted to briefly mention and do a cross-referencing of the CAPA in the procedure for documenting all the non-conformities and the RCA, corrective actions and preventative action.

Do you have any suggestion for doing a cross-reference in the procedure (like the CAPA, release procedure and etc.) so it does not look confusing or complicated? 

[matthewcc]

Hi matthewcc, we are a small bakery manufacturer that makes tarts, frozen RTE frozen tarts, frozen fruit tarts and etc. We don't have a specific area to put our product in quarantine since the space is limited. 

 

Thanks for suggesting to include the criteria for releasing, I am planning to make one for the product release program. However, we do not do any micro test for our finished products. Is meeting product specification and verifying CCP sufficient for a product release?

 

May I ask what a material review is?

 

Hi Avryl, the purpose of putting non-conforming product in a secure quarantine area is so that it cannot get used accidentally.  It is important for this reason, and it would also show regulators/inspectors that you have taken appropriate action to isolate the non-conforming product and ensure that it will not go further in processing or distribution.

 

What I mean by criteria for releasing is, after you had initially determined that there is a problem with a product, or could be a problem with a product, what are the objective criteria that you use for determining it is acceptable to re-release it?  This would vary based on the reason you had put it on hold in the first place.  If an employee finds a mistake on a label, for example, then the criteria for re-release would be not only ensuring it meets specifications and verifying the CCP process was handled appropriately, but verifying that the label is truthful and not misleading, has the right certification(s), etc.  Thus, it would be good to have written criteria for verifying that the problem that was initially identified was addressed.

 

A material review is essentially a review and investigation that Quality Control does on the product and its issue to determine what disposition decision (e.g., release, reject, re-work) should be made, based on a scientifically valid reason.  I'm not sure what CFR's require a material review other than 21 CFR Part 111 (where it's mentioned 30 times), but this is what we have to do for dietary supplements when certain problems are found.  Oddly enough, FDA doesn't seem to give a definition of the term though, but that is my definition.

 

Matthew

[Charles.C]

Hi Charles.C, thanks for taking your time reading and giving me useful feedbacks. I will move all the details of the forms/records to the procedure and have a list of the documents listed instead. 

 

2.4.5.1.(iii) seems to have been "missed" in the introductory segments (eg Policy) ?. 

You meant to include the forms/records in the policy?

Regarding sub-clause's text, I was thinking of "Training"

 

I did not comprehend the meaning of text in D (c) (RCA-related)

For the Section D, I wanted to briefly mention and do a cross-referencing of the CAPA in the procedure for documenting all the non-conformities and the RCA, corrective actions and preventative action.

Do you have any suggestion for doing a cross-reference in the procedure (like the CAPA, release procedure and etc.) so it does not look confusing or complicated? 

I suggest perhaps something like - <<< Where appropriate, root cause analyses are carried out in accordance with Clauses 2.5.3.1 and 2.6.3.2 respectively.>>>

(+ have a look at the relevant "Audit Guidance" sections).(also, peripherally, relates to 2.5.5)

 

Hi Avryl,

 

See ^^^(blue)