7 replies to this topic

[QAKat]

Hello, 

 

I am working on our internal audit and from last years audit this was what the auditor said regarding an NC we received for the internal audit:

 

"For Module 11 "no issures observed" does not comply to the SQF requirments, please ensure that this will be corrected and relevant information will be captured goin forward"

 

I looked at the code and it doesn't say "no issues observed" does not comply with the requirements. I understand we need to record evidence of why maybe there is "no issues" but I just want to know where exactly on the code it states that it does not comply and just for module 11.

 

If anyone can help me out and shed some experience on an SQF newbie that would be great!

 

TYIA 

[Tony-C]

Hi QAKat,

 

The SQF Food Safety Code Section 2.5.4 Internal Audits and Inspections (Mandatory) states:

2.5.4.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure:

i. All applicable requirements of the SQF Food Safety Code: Food Manufacturing are audited per the SQF audit checklist or a similar tool;

ii. Objective evidence is recorded to verify compliance and/or non-compliance;

 

Clearly “no issues observed” is insufficient evidence of conformance and this is more common in looking at GMP areas such that other standards advise that tick lists are not acceptable as evidence. It appears that this issue applied to your internal auditing of compliance with Module 11 requirements in your last SQF audit, hence the wording of the NC.

 

The internal auditor needs to record what was checked and what condition it was in (e.g. Filling area: floors clean and in good condition 11:00am 1/1/23). My advice would be to also take photos to include with the audit.

 

Kind regards,

 

Tony

 

[jfrey123]

Two of my plants have been hit for this in the past month.  It's no longer sufficient to say "no issues", they want you to prove your compliance in your responses to the self audit.  Our VP FSQA ended up asking the auditor, "Well hell, why do you we need you here if we can do it ourselves?"

[QAKat]

Hi QAKat,

 

The SQF Food Safety Code Section 2.5.4 Internal Audits and Inspections (Mandatory) states:

2.5.4.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure:

i. All applicable requirements of the SQF Food Safety Code: Food Manufacturing are audited per the SQF audit checklist or a similar tool;

ii. Objective evidence is recorded to verify compliance and/or non-compliance;

 

Clearly “no issues observed” is insufficient evidence of conformance and this is more common in looking at GMP areas such that other standards advise that tick lists are not acceptable as evidence. It appears that this issue applied to your internal auditing of compliance with Module 11 requirements in your last SQF audit, hence the wording of the NC.

 

The internal auditor needs to record what was checked and what condition it was in (e.g. Filling area: floors clean and in good condition 11:00am 1/1/23). My advice would be to also take photos to include with the audit.

 

Kind regards,

 

Tony

Hello Tony, 

 

Thank you for your input. I completely overlooked the "objective evidence" part 

Well now it makes 100% sense lol.

 

Even if there is no issue we still have to note why there was no issue.

 

Appreciate you!

[QAKat]

Two of my plants have been hit for this in the past month.  It's no longer sufficient to say "no issues", they want you to prove your compliance in your responses to the self audit.  Our VP FSQA ended up asking the auditor, "Well hell, why do you we need you here if we can do it ourselves?"

Hi Jfrey123

 

Not sure how long the objective evidence has been on the code but before I was in my current job they had consultants doing the internal audits and for no issues they wrote "no issues" and they never got an NC. I guess it is getting more strict now.

 

I see it as a way of them trying to help us look exactly at what the auditors will be looking for and hence helping us in getting less NCs. BUT yes we are pretty much making their job easier as well lol.

[jfrey123]

Hi Jfrey123

 

Not sure how long the objective evidence has been on the code but before I was in my current job they had consultants doing the internal audits and for no issues they wrote "no issues" and they never got an NC. I guess it is getting more strict now.

 

I see it as a way of them trying to help us look exactly at what the auditors will be looking for and hence helping us in getting less NCs. BUT yes we are pretty much making their job easier as well lol.

 

They made the change going from 8.1 to 9.0:

 

8.1:

2.5.5.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted at least annually. The methods applied shall ensure:

 

i. All applicable requirements of the SQF Food Safety Code for Manufacturing are audited as per the SQF audit checklist or similar tool;

 

 

9.0:

2.5.4.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure:

i. All applicable requirements of the SQF Food Safety Code: Food Manufacturing are audited per the SQF audit checklist or a similar tool;

 

ii. Objective evidence is recorded to verify compliance and/or non-compliance

 

 

 

They changed the code number for the internal audit requirement, added the ii objective evidence requirement, and didn't clearly show that change in their own guidance documents.

 

Code-Change-Summary-Quality-Code-Edition-9.pdf (sqfi.com)

 

Summary of changes:

• Moved 2.5.4 Product Sampling to 2.4.4.

• Added staff conducting internal audits shall be independent of the function being audited.

 

 

I've made the same "no issues" mark in a number of client records over the past few years, and this caught me even completely off guard.  We've had to notify all the plants for the company I work for now aware of the change, and a couple scrambled to make sure the self-audits were properly filled out.  It literally gives the auditor a road map to travel down and make their job easier, and lets them hit us on our own handiwork if something is amiss.

[Scampi]

crap crap crapity crap

 

I list what I looked at (records, programs, work instructions, people performing the task etc.)

 

If everything was compliant, I enter compliant with zero explanation

 

Also, our auditor (2 years running) insists he needs to be on the floor 1/2 of audit time sooooooooooo by the time we got to the IA, he only wanted to see 3

[Tony-C]

crap crap crapity crap

 

Sounds like it applies to your auditor Scampi! 

 

Internal Audits are a mandatory item so I would expect a bit more focus on those by any auditor worth their salt.

 

Also note Inspection reporting (2.5.4.3 Regular inspections of the site and equipment ) isn’t the same as what is expected from an Internal Audit in my experience.

 

Kind regards,

 

Tony