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Kalinzu

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Posted 01 December 2016 - 06:14 AM

Hi All,

 

I would like some help in closing NCs we got at the Stage 1 audit. The NCs would appear obvious things to do before an audit but they came about due to the set up of the company and many other factors (let me not go into specific details). Kindly help out if you can.

 

  1. At the time of the audit it was noted that all documents had not been approved.
  2. The Food Safety policy had not been approved.
  3. Food Safety objectives were not SMART.
  4. Procedure for Emergency preparedness did not address the requirement of the standard.
  5. The organisation had not conducted a Management Review meeting.m
  6. There was no representation from the Human Resources and Sales & Marketing dept in the Food Safety Team.
  7. Raw materials, ingredients and product contact materials characteristics were described within the HACCP Plan. However, the spices formulation had not been described.
  8. Analysis of results of verification activities had not been done.
  9. The procedure under mock withdrawal did not provide the sequence of actions to be taken in the event of a planned withdrawal. (This was actually in the procedure - just an oversight on both the auditee and auditors side)

Most of these are documents that need editing and reviewing as corrections. Would appreciate help in coming up with possible Root Causes and Corrective actions? 

 

Thank you.



Charles.C

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Posted 01 December 2016 - 07:12 AM

Hi All,

 

I would like some help in closing NCs we got at the Stage 1 audit. The NCs would appear obvious things to do before an audit but they came about due to the set up of the company and many other factors (let me not go into specific details). Kindly help out if you can.

 

  1. At the time of the audit it was noted that all documents had not been approved. Have them approved ?
  2. The Food Safety policy had not been approved. Have it approved ?
  3. Food Safety objectives were not SMART. There are examples on this Forum. Search ?
  4. Procedure for Emergency preparedness did not address the requirement of the standard.There are examples on this Forum. search ?
  5. The organisation had not conducted a Management Review meeting. Conduct one. There are examples on this Forum if needed. Search ?
  6. There was no representation from the Human Resources and Sales & Marketing dept in the Food Safety Team. Add 2 people ?
  7. Raw materials, ingredients and product contact materials characteristics were described within the HACCP Plan. However, the spices formulation had not been described. Reason? Add if simple to do. Pls explain if not.
  8. Analysis of results of verification activities had not been done. I deduce the verification activities had been done, So  reason ?
  9. The procedure under mock withdrawal did not provide the sequence of actions to be taken in the event of a planned withdrawal. (This was actually in the procedure - just an oversight on both the auditee and auditors side). Add a cross-reference in the document ?

Most of these are documents that need editing and reviewing as corrections. Would appreciate help in coming up with possible Root Causes and Corrective actions? 

 

Thank you.

 

Hi kalinzu,

 

I asume  this is iso22000, not fssc22000.

 

I have added a few quick suggestions.

 

The last request probably requires you to post the relevant documents on this forum if  specific answers are  required.

Alternatively a likely generic root cause for many of the items listed in yr OP  is simply - "Oversight by XYZ/whoever". This respose has previously been employed by some posters here although its overuse might suggest that the overall FS System is simply unfinished due ABC, ie not yet ready for auditing. Is it ?(another possible root cause)


Kind Regards,

 

Charles.C


Kalinzu

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Posted 01 December 2016 - 08:16 AM

Thanks Charles. C

 

 

I forgot to mention that the documents - procedures, were audited as soft copies. No hard copies at the time of audit.

 

Does approval mean the approving authority's signature has to appear on the documents?

 

The Food Safety policy had been printed out, signed by the FSTL and several copies posted on notice boards.



Charles.C

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Posted 01 December 2016 - 08:42 AM

Thanks Charles. C

 

 

I forgot to mention that the documents - procedures, were audited as soft copies. No hard copies at the time of audit.

 

Does approval mean the approving authority's signature has to appear on the documents?

 

The Food Safety policy had been printed out, signed by the FSTL and several copies posted on notice boards.

 

Hi Kalinzu,

 

By soft copy I presume you mean digital electronic on a PC.

 

Files can be uploaded on this forum. Click the "more reply options" button and follow the directions.

 

Documents are formatted as per yr Documentation Procedure. The details are as required by the Standards involved.

 

I suggest you have a look at some examples on this Forum if unsure.


Kind Regards,

 

Charles.C


Charles.C

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Posted 01 December 2016 - 08:07 PM

addendum

 

Regarding “approval” (eg sec 4.2.2.a) these 2 forum threads may be of interest (there are others) –

 

http://www.ifsqn.com...ocument-review/

http://www.ifsqn.com...edure-approval/

 

The range of possible interpretations of “approval” for iso22000 is probably similar to that for  iso9001. For the latter examples of  2 current viewpoints are linked below, one based on detailed “approval” information on the document itself  and another noting  alternative  methods of  “approval”. Both styles would presumably be auditor acceptable provided they are elaborated in the Document Control Procedure and compliant with the additional items (b-g)  in 4.2.2

 

http://www.qualitysy...ol-of-documents

http://www.cgbusines...falls-to-avoid/

 

The choice may depend on factors such as Structure of FS System/Operational Styles/available digital technology/etc.

 

PS - IMEX the Quality/FS Policy is more commonly associated to the MD of the Company, ie the top of the ISO-Pyramid. Supports Top Management Commitment.


Kind Regards,

 

Charles.C


instantina

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Posted 06 June 2023 - 07:25 AM

Hi

 

Just commenting on this thread to receive some solution to similar problem We had a Stage 1 audit few weeks back on ISO22000:2018. The internal auditor/FSTL was not competent as she is not trained on this version of ISO 22000. This was given as an NC by the auditor. Since the company is a startup so there was not budget allotted to provide the training which is the root cause of this NC and the same was mentioned in the CAP as well and submitted to the auditor. But the auditor has asked to review and change the root cause.

 

So can someone think of any other probable root cause to this point. Giving the context, the organization is pretty new and just started with the business . The team is very small with only one technical person handling all responsibilities related to quality, production, documentation, R&D, etc. We are in the process of growing and will get more people on board in coming years but as of now wants to implement the FSMS at the starting level only. Due to budget constraints, cannot appoint a consultant too.

 

Looking forward  to responses from the smart people of this forum. :)



Nellie

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Posted 06 June 2023 - 05:48 PM

Hi

 

Just commenting on this thread to receive some solution to similar problem We had a Stage 1 audit few weeks back on ISO22000:2018. The internal auditor/FSTL was not competent as she is not trained on this version of ISO 22000. This was given as an NC by the auditor. Since the company is a startup so there was not budget allotted to provide the training which is the root cause of this NC and the same was mentioned in the CAP as well and submitted to the auditor. But the auditor has asked to review and change the root cause.

 

So can someone think of any other probable root cause to this point. Giving the context, the organization is pretty new and just started with the business . The team is very small with only one technical person handling all responsibilities related to quality, production, documentation, R&D, etc. We are in the process of growing and will get more people on board in coming years but as of now wants to implement the FSMS at the starting level only. Due to budget constraints, cannot appoint a consultant too.

 

Looking forward  to responses from the smart people of this forum. :)

 

Hi,

 

I am not one of the smart people on the forum :cheezy: IMO the root cause was spot on. More important would be the CA that you have identified in the CAP. Will there be a budget / finances available for IA to at least get transition / bridging training on ISO 22000:2018? If not, this may be a recurring finding, and even snow balling to other areas. Regards.



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instantina

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Posted 07 June 2023 - 05:32 AM

Hi

 

Thank you for responding. Yes, actually an online training would work since the IA is already trained on the 2005 version. So there is budget for a group training.

:)





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