11 replies to this topic

[QAKat]

Hi everyone!

 

We recently did our SQF audit and got an NC for not having a public notification notice or a customer letter (did not know we needed this   )

I found the public notification templates from FDA but I can't find a template for the customer letter. 

 

Does anyone have a template they can share? 

 

Thank you in advance. 

[Tony-C]

Hi QAKat,

 

See Michigan Department of Agriculture Food Product Recalls Guidance For Industry

There is an Example Customer Notification Letter on page 10.

 

What clause did the auditor refer to in the NC?

 

Kind regards,

 

Tony

[Scampi]

Assuming the NC was for this

2.6.3 Product Withdrawal and Recall (Mandatory) 2.6.3.1 The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall:
i. Identify those responsible for initiating, managing, and investigating a product withdrawal or recall;
ii. Describe the management procedures to be implemented, including sources of legal, regulatory, and expert advice, and essential traceability information;
iii. Outline a communication plan to inform site personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate about the nature of the incident; and
iv. Ensure that SQFI, the certification body, and the appropriate regulatory authority are listed as essential organizations and notified in instances of a food safety incident of a public nature or product recall for any reason.

[SQFconsultant]

We gave an example of the "letter"  which for us is a simple email that would go to customers - WWWW and that sufficed.

 

I doubt that we would ever use it but it keeps the auditors happy. 

 

Just like a free lunch does. 

[G M]

 

Assuming the NC was for this

2.6.3 Product Withdrawal and Recall (Mandatory) 2.6.3.1 The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall:
i. Identify those responsible for initiating, managing, and investigating a product withdrawal or recall;
ii. Describe the management procedures to be implemented, including sources of legal, regulatory, and expert advice, and essential traceability information;
iii. Outline a communication plan to inform site personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate about the nature of the incident; and
iv. Ensure that SQFI, the certification body, and the appropriate regulatory authority are listed as essential organizations and notified in instances of a food safety incident of a public nature or product recall for any reason.

 

 

Not having a pre-written form letter drafted seems like a bit of a stretch for an NC on those grounds. 

 

If there is a policy that describes what kind of information needs to be communicated, and who is responsible (maybe give yourself a default timeline), the majority of the predictable content is covered.  

[Scampi]

Not having a pre-written form letter drafted seems like a bit of a stretch for an NC on those grounds. 

 

 

Then you've never had one of our auditors!   

[MDaleDDF]

Not having a pre-written form letter drafted seems like a bit of a stretch for an NC on those grounds. 

 

If there is a policy that describes what kind of information needs to be communicated, and who is responsible (maybe give yourself a default timeline), the majority of the predictable content is covered.  

I agree, and I don't have one either.   I have our response well covered in our documents, but a pre-drafted letter seems over the top as situations will vary so much.   If they ask for a letter I'll show um my letterhead, and tell um I fill the rest in depending on the situation.

Literally never had an auditor ask for such a thing, but perhaps it's a scope difference?

I don't see any HARM in having a letter, but I think it's totally possible to satisfy the clause Scampi cited above without one as well.

Edited by MDaleDDF, 28 August 2024 - 03:57 PM.

[QAKat]

Hi QAKat,

 

See Michigan Department of Agriculture Food Product Recalls Guidance For Industry

There is an Example Customer Notification Letter on page 10.

 

What clause did the auditor refer to in the NC?

 

Kind regards,

 

Tony

Hi Tony, 

 

Thanks so much!

 

On the report it cites 2.6.3.2. The NC was for not following up on one of our mock recalls after I opened a CAPA for some gaps we found. Everything was done correctly we just didn't conduct another recall to verify corrective actions had worked. The other part was "some aspects of the mock recall simulation were missing (i.e. public notification, customer letters, etc.)"

[QAKat]

 

Assuming the NC was for this

2.6.3 Product Withdrawal and Recall (Mandatory) 2.6.3.1 The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall:
i. Identify those responsible for initiating, managing, and investigating a product withdrawal or recall;
ii. Describe the management procedures to be implemented, including sources of legal, regulatory, and expert advice, and essential traceability information;
iii. Outline a communication plan to inform site personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate about the nature of the incident; and
iv. Ensure that SQFI, the certification body, and the appropriate regulatory authority are listed as essential organizations and notified in instances of a food safety incident of a public nature or product recall for any reason.

 

Hi Scampi,

 

All of that is documented on our SOP but when we did our actual mock recalls we didn't have the public notification or customer letters with the rest of the documents

[QAKat]

We gave an example of the "letter"  which for us is a simple email that would go to customers - WWWW and that sufficed.

 

I doubt that we would ever use it but it keeps the auditors happy. 

 

Just like a free lunch does. 

Hi SQFconsultant, 

 

Unfortunately we didn't have any example of such letters and moving forward he wants us to do the public notifications and customer letters and add them to our mock recall records. I mean, I get it. We are supposed to do the exercise as if it were a real thing.

[jfrey123]

I've always had a template, and I think the whole point is for the SQF auditor to be able to verify your template meets FDA requirements for what will be communicated to the consumer or customer.  It's one thing to have a program that states what you're going to tell the public, but in the heat of the moment under a recall I think trying to figure out what to put into the letter causes an unnecessary delay.

 

Because FDA requires specific information within your recall communications, SQF knowing that your recall letter will contain the proper information becomes a regulatory compliance issue.  FDA recall notice requirements described here:

eCFR :: 21 CFR 7.49 -- Recall communications.

 

(b) Implementation. A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: “drug [or food, biologic, etc.] recall [or correction]”. The letter and the envelope should be also marked: “urgent” for class I and class II recalls and, when appropriate, for class III recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the above methods and/or documented in an appropriate manner.

(c) Contents.

(1) A recall communication should be written in accordance with the following guidelines:

(i) Be brief and to the point;

(ii) Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;

(iii) Explain concisely the reason for the recall and the hazard involved, if any;

(iv) Provide specific instructions on what should be done with respect to the recalled products; and

(v) Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm.

[Tony-C]

Hi Tony, 

 

Thanks so much!

 

On the report it cites 2.6.3.2. The NC was for not following up on one of our mock recalls after I opened a CAPA for some gaps we found. Everything was done correctly we just didn't conduct another recall to verify corrective actions had worked. The other part was "some aspects of the mock recall simulation were missing (i.e. public notification, customer letters, etc.)"

 

Hi QAKat,

 

That makes more sense, as jfrey123 has posted above I was thinking it was probably more related to legislation requirements given the SQF Food Safety Code doesn't specify the need to have template public notification notice or a template customer letter and they aren't mentioned in SQF Product Withdrawal & Recall Edition 9 Guidance Document either.

 

Anyway it is generally regarded as good practice to have them and an easy fix to close out your NC.

 

Kind regards,

 

Tony