23 replies to this topic

[QSDA]

Hi
Im new here so excuse me if I am in the wrong place.
I have just completed a disasterous BRC audit and am trying to get my responses ready.
One minor non-conformance is against clause 5.5.2.4 which requires procedures in place to ensure accuracy of third party lab results.
I stated that we ensure accuracy etc by using UKAS accredited labs (full schedule was availavble on site and the UKAS standard includes all the verification requirements) but the auditor expected us to arrange for ring tests etc to be carried out by sending multiple samples and possibly even same samples to different labs!!

How do I address this or should I appeal against the non-conformance

Thanks for any help, Bit out of depth as we have been A grade for 4 years and suddenly the wheels have fallen off.

Regards

[Charles.C]

Dear QSDA,

Sorry for yr headaches.

It might help/prompt people to comment if you (briefly) informed what kind of products/process you are involved with.

Rgds / Charles.C

[QSDA]

Dear QSDA,

Sorry for yr headaches.

It might help/prompt people to comment if you (briefly) informed what kind of products/process you are involved with.

Rgds / Charles.C

Hi Thanks for the response


The products are either low risk sugar confectionery or chocolate products, there is no question of testing regimes etc, it is the confirmation of the accuracy of the results which are supplied by a UKAS accredited lab.


Non-conformance states No procedure in place to verify reliability of laboratory results


We considered that UKAS certification was suffcient to verify lab results (this is the criteria for appropriate supplier selection) and for us to undertake ring testing, blind testing etc would br prohibitively expensive.

Thanks again

[Charles.C]

Dear QSDA,

I deduce you are saying that yr previous audit for BRC under identical requirements (ie sections 5.5.2.1 – 5.5.2.4) generated no nonconformances.

If so, this now appears illogical.

Does UKAS laboratory accreditation necessitate compliance with all the BRC requirements mentioned in sections 5.5.2.1-2.4 ?
(added - I had a brief look around the net and could not find any explicit confirmation of such a correlation ?)

It would seem logical to me that the question of available ring-testing data etc as mentioned in 5.5.2.4 would be applied to your chosen laboratory rather than yourself. If not available from the laboratory, then i could understand some difficulty might be possible. (Not my direct field but I thought most laboratories certified to 17025 hv had to perform such testing ?.)

Normally i would hv thought aspects like the above would be clarified after the audit ?

Rgds / Charles.C

[Foodworker]

If the situation is as you describe, you should not have received a non conformity.

Clause 5.5.2.3 requires that any sub-contracted laboratories operate in accordance with ISO171025

Clause 5.5.2.4 requires procedures to ensure the validity of results OTHER than those specified in 5.5.2.3

This requirement only comes into force if you are either have a laboratory yourself or are using an unaccredited laboratory. Even then, the requirement is only for analyses critical to safety or legality

[Charles.C]

If the situation is as you describe, you should not have received a non conformity.

Clause 5.5.2.3 requires that any sub-contracted laboratories operate in accordance with ISO171025

Clause 5.5.2.4 requires procedures to ensure the validity of results OTHER than those specified in 5.5.2.3

This requirement only comes into force if you are either have a laboratory yourself or are using an unaccredited laboratory. Even then, the requirement is only for analyses critical to safety or legality

Dear Foodworker,

Interesting comments and many thks for yr input. I am not a current implementer of 5th version but I hv been slightly surprised that (seemingly) no other users hv encountered such problems as QSDA. Maybe yr post is the reason.

I hv seen 5.5.2.4 quoted as stating -

Procedures shall be in place to ensure reliability of laboratory results,
other than those specified in 5.5.2.3. These shall include:
use of recognised test methods, where available
documented testing procedures
ensuring staff are suitably qualified and/or trained and competent to
carry out the analysis required
use of a system to verify the accuracy of test results, e.g. ring or
proficiency testing
1. use of appropriately calibrated and maintained equipment.

(2. etc ?? )

IMO the text as above is ambiguous (if written as "Procedures, other than those specified in 5.5.2.3, shall be in place ...results", the meaning would be clear IMO) however I had interpreted it exactly opposite to yourself since the discussion in 2.3-2.4 seemed (to me) to be focused on "procedures", not results. Also it seems logical to me that some of the above list would apply to all valid results (eg No.1)?. Or maybe my quoted text is incorrect / incomplete ?

This requirement only comes into force if you are either have a laboratory yourself or are using an unaccredited laboratory

I can certainly see the potential logic in yr comment but I don't see any justification as per the text in the standard. If you are correct, it is rather crucial information IMO.

It is not clear what the debated "results" referred to ( @QSDA ??). I had assumed they were for "analyses critical to safety or legality" otherwise, as you say, the auditor's criticism was automatically irrelevant. (Surely such an error would hv come out in any post-audit ? ).

I had presumed UKAS would automatically require an accredited laboratory to be certified to ISO 17025 ??

Are the details of yr above comments (particularly regarding 2.4) based on any official/accessible source ? I'm sure QSDA would like to know.

No other BRC5 users encountered such subtleties as above ?

Rgds / Charles.C

[Charles Chew]

If the situation is as you describe, you should not have received a non conformity.

Clause 5.5.2.3 requires that any sub-contracted laboratories operate in accordance with ISO171025

Clause 5.5.2.4 requires procedures to ensure the validity of results OTHER than those specified in 5.5.2.3

This requirement only comes into force if you are either have a laboratory yourself or are using an unaccredited laboratory. Even then, the requirement is only for analyses critical to safety or legality

Spot on Foodworker. I believe the auditor clearly misinterpreted the application of clause 5.5.2.2. This may be a huge embarrassment and I hope it will not lead to a disqualification as it could affect previous audits. Frightening!

[GMO]

Hi
Im new here so excuse me if I am in the wrong place.
I have just completed a disasterous BRC audit and am trying to get my responses ready.
One minor non-conformance is against clause 5.5.2.4 which requires procedures in place to ensure accuracy of third party lab results.
I stated that we ensure accuracy etc by using UKAS accredited labs (full schedule was availavble on site and the UKAS standard includes all the verification requirements) but the auditor expected us to arrange for ring tests etc to be carried out by sending multiple samples and possibly even same samples to different labs!!

How do I address this or should I appeal against the non-conformance

Thanks for any help, Bit out of depth as we have been A grade for 4 years and suddenly the wheels have fallen off.

Regards

Oh that is totally wrong! Completely outside the remit!

I would check your lab are working to ISO17025 and get a copy of their procedures stating they do proficiency testing etc. Also if they can say this is a requirement of UKAS (which I think it might be), all the better. Then you have a basis on which to appeal that non conformity.

What an eejit. That's extreme nit picking. Can I ask what certification company it is???

[Madam A. D-tor]

How do I address this or should I appeal against the non-conformance

Dear QSDA,

As is said by members before me, the auditor did misunderstand the requirement and the NC should not have been made.
you should eather complain to your CB or appeal.
However if you appeal, you still need to correct the NC (which is IMO not possible, because there is nothing to correct)

It will be interesting to know the reaction of the CB.

[Tony-C]

What an eejit.

Couldn't have put it better

[Tony-C]

Hi
One minor non-conformance is against clause 5.5.2.4 which requires procedures in place to ensure accuracy of third party lab results.
I stated that we ensure accuracy etc by using UKAS accredited labs (full schedule was availavble on site and the UKAS standard includes all the verification requirements) but the auditor expected us to arrange for ring tests etc to be carried out by sending multiple samples and possibly even same samples to different labs!!

How do I address this or should I appeal against the non-conformance

Thanks for any help, Bit out of depth as we have been A grade for 4 years and suddenly the wheels have fallen off.

Regards

Appeal. 5.5.2.4 refers generally to Laboratories but not contracted Laboratories. It does require ring/proficiency testing or equivalent but your auditor had no evidence that your contracted Laboratory does not do ring or proficiency testing. I am sure they do, so ask them for evidence of ring/proficiency testing and send it with your appeal.

Regards,

Tony

[Charles.C]

Appeal. 5.5.2.4 refers generally to Laboratories but not contracted Laboratories. It does require ring/proficiency testing or equivalent but your auditor had no evidence that your contracted Laboratory does not do ring or proficiency testing. I am sure they do, so ask them for evidence of ring/proficiency testing and send it with your appeal.

Regards,

Tony

Hi Tony,

I getting bit confused.

5.5.2.4 refers generally to Laboratories but not contracted Laboratories.

I guess you mean refers to in-house / unaccredited labs only ? (ie as per Foodworker)

if so, the next bit then seems not relevant ?

but your auditor had no evidence that your contracted Laboratory does not do ring or proficiency testing. I am sure they do, so ask them for evidence of ring/proficiency testing and send it with your appeal.

I am interested in QSDA's response as to whether the (claimed accredited) laboratory was also demonstrably certified to 17025 ? (see post#4) (although the iso requirement is obviously not a rigid necessity either )

(I am beginning to wonder if the auditor simply did not believe the contracted laboratory was accredited ? )

Rgds / Charles.C

[GMO]

I am interested in QSDA's response as to whether the (claimed accredited) laboratory was also demonstrably certified to 17025 ? (see post#4) (although the iso requirement is obviously not a rigid necessity either )

(I am beginning to wonder if the auditor simply did not believe the contracted laboratory was accredited ? )

Rgds / Charles.C

It is interesting if that is the case because that is more a requirement of version 6 not version 5 to have some written agreement about standards etc, in which case, it's still a point for appeal. UKAS accreditation should be good enough for version 5 IME.

[QSDA]

It is interesting if that is the case because that is more a requirement of version 6 not version 5 to have some written agreement about standards etc, in which case, it's still a point for appeal. UKAS accreditation should be good enough for version 5 IME.

Hi all

Thanks for the input, the CB has now removed this plus two other minors from the list and downgraded a major. (indication of standard of audit?)

The lab certificate and scope was provided at the audit but the auditor indicated that we should be sending blind samples and possibly the same samples to different labs to confirm the results. I thought I had lost the plot but even though I challenged the point it appeared in the final meeting (less than 5 minutes and NO discussion) as a minor. Too tired at that point to challenge and auditor had train to catch!!



Thanks again

[GMO]

Hi all

Thanks for the input, the CB has now removed this plus two other minors from the list and downgraded a major. (indication of standard of audit?)

The lab certificate and scope was provided at the audit but the auditor indicated that we should be sending blind samples and possibly the same samples to different labs to confirm the results. I thought I had lost the plot but even though I challenged the point it appeared in the final meeting (less than 5 minutes and NO discussion) as a minor. Too tired at that point to challenge and auditor had train to catch!!



Thanks again

That's still beyond what version 6 asks for. Does that take you back to an 'A'? I'd put in a complaint about the auditor on this. 3 minors removed plus one major downgraded is a big deal.

[QSDA]

That's still beyond what version 6 asks for. Does that take you back to an 'A'? I'd put in a complaint about the auditor on this. 3 minors removed plus one major downgraded is a big deal.

No chance, just dragged us up from a fail to a C, never had an aidit like it, the auditor was being assessed and the two got heads together for their writting up of the report.
Re-visit by same auditor next week (solo), not looking forward to it as we still have three non-conformances which I cannot correct as they were already correct, (CB said they cannot do anything until after re-visit), not easy to convince an auditor that they are wrong. If I have any more problems it will have to go to BRC.

Sorry ranting





QSDA

[GMO]

No chance, just dragged us up from a fail to a C, never had an aidit like it, the auditor was being assessed and the two got heads together for their writting up of the report.
Re-visit by same auditor next week (solo), not looking forward to it as we still have three non-conformances which I cannot correct as they were already correct, (CB said they cannot do anything until after re-visit), not easy to convince an auditor that they are wrong. If I have any more problems it will have to go to BRC.

Sorry ranting





QSDA

No, understandable! Well a fail to a C is a big deal anyway. You might find the auditor is already fairly tame as they will have surely been given a slap on the knuckles! Can you ask for them to be accompanied by someone else who could be a more 'neutral' party? I could understand perhaps one downgrade from a major to a minor in an audit but to have had 4 non conformances removed or changed does not suggest the audit was fair or balanced.

[Charles.C]

Dear QSDA,

Thks for the feedback. I presume by “lab. certificate” you meant UKAS certificate rather than ISO 17025 certificate.

I think the last chunk of para. 5.5.2.4 (inc. ring test etc) is new to ver5 while the preceding text of same para. was essentially identical in vers 3,4 (although in different paragraphing format). Don’t recall experiencing/hearing of any in-depth auditor probing like this for those versions.

It sort of appears that after finding some (uncontested?) NCs, things auditorial somehow got a bit out of hand somewhere hence the back-tracking. How much “retrieval” room you currently have will IMO depend on the additional details and yr assessment of the forthcoming “atmosphere”.

Regarding yr comment of a change from (previous) “A” > “C”, I hv to assume that compared to previous audit, there were some other significantly different auditor interpretations in current audit also?. (I presume the grading system is still similar to this post –
http://www.ifsqn.com...dpost__p__45682 )
(post#6 of above thread is also possibly of some, slightly OT, interest)

Good luck.

Rgds / Charles.C

[QSDA]

Dear QSDA,

Thks for the feedback. I presume by “lab. certificate” you meant UKAS certificate rather than ISO 17025 certificate.

I think the last chunk of para. 5.5.2.4 (inc. ring test etc) is new to ver5 while the preceding text of same para. was essentially identical in vers 3,4 (although in different paragraphing format). Don’t recall experiencing/hearing of any in-depth auditor probing like this for those versions.

It sort of appears that after finding some (uncontested?) NCs, things auditorial somehow got a bit out of hand somewhere hence the back-tracking. How much “retrieval” room you currently have will IMO depend on the additional details and yr assessment of the forthcoming “atmosphere”.

Regarding yr comment of a change from (previous) “A” > “C”, I hv to assume that compared to previous audit, there were some other significantly different auditor interpretations in current audit also?. (I presume the grading system is still similar to this post –
http://www.ifsqn.com...dpost__p__45682 )
(post#6 of above thread is also possibly of some, slightly OT, interest)

Good luck.

Rgds / Charles.C

hi Charles

Comment on uncontested, as earlier the auditor did not have time at the end to hold a real closing meeting and these NCs were effectively just dropped on us. They had been some comments during the audit and discussion around some topics, but it was never indicated that these had not been acceptable or that the auditor considered tham serious enough to include as an NC or a recommendation.

If the auditor had indicated this we could have addressed at least 40% of those raised, e.g. Organisational chart not updated with currect struture - which was incorrect the document reviewed was less than 2 months old and currect!, independence of internal auditor - two trained auditors on site at time of internal auditors (one since left, but no internal audits since that date), uncontrolled notice (accepted NC) but then uncontrolled change to this document (two separate NCs), unidentified insect trap (it had become detatched from identified bait point during enthusiastic cleaning) and then second because it was not secured (while this is to the letter it does not indicate open mind).

Just giving a taste of the audit.



QDSA

[GMO]

hi Charles

Comment on uncontested, as earlier the auditor did not have time at the end to hold a real closing meeting and these NCs were effectively just dropped on us. They had been some comments during the audit and discussion around some topics, but it was never indicated that these had not been acceptable or that the auditor considered tham serious enough to include as an NC or a recommendation.

If the auditor had indicated this we could have addressed at least 40% of those raised, e.g. Organisational chart not updated with currect struture - which was incorrect the document reviewed was less than 2 months old and currect!, independence of internal auditor - two trained auditors on site at time of internal auditors (one since left, but no internal audits since that date), uncontrolled notice (accepted NC) but then uncontrolled change to this document (two separate NCs), unidentified insect trap (it had become detatched from identified bait point during enthusiastic cleaning) and then second because it was not secured (while this is to the letter it does not indicate open mind).

Just giving a taste of the audit.



QDSA

It sounds like they raised at least two minor non cons where an experienced auditor would normally have rolled both issues into the one minor (it doesn't seem worth raising as a major in the examples you gave.) For example, there was an uncontrolled notice (hmm, in itself I've known many a factory get away with this) and two separate non cons for changing it? Surely that is one non conformance for lack of document control and a minor one at that? It's not like changing a CCP record in an uncontrolled way?

The lack of proper closing meeting though and communication during the audit, is in itself an issue and a reason to complain as it didn't give you a chance to wade through the reems of non cons! Tough if the auditor has a plane to catch, they should allow time for a proper closing meeting and inform you as you go where they have found issues. It's like appraisals, you should know how you are performing before you walk into an appraisal meeting; likewise you should know roughly whereabouts you are in terms of grade before walking into a closing meeting in an audit. Anything else is just shoddy and rude!

[Charles.C]

Dear QSDA,

Just giving a taste of the audit.

Based on yr comments, I am inclined to agree with GMO. This sounds like an "unfortunate" audit in numerous ways.

I am particularly surprised that the likelihood of forthcoming Major NCs was not apparent during the audit since I presume these did the primary Grading damage. Frankly I would hv thought (guessing) that for an auditor to leave without informing/discussing such issues (as a minimum) is incorrect basic procedure.

Unless there is a blatantly obvious error (eg I once had a Dalek auditor who demanded that any cooking CCP must eliminate every bacterium), a (small) handful of Minors is best tactically/grudgingly accepted IMO. Such is the “Name of the Game”. Of course, if we are talking about >10 and/or a host of sillinesses/contrivances, the situation may change (possibly like yr trap example). I am aware that some people prefer to ferociously argue every possible criticism, this can be counter-productive IMO.
But the choice obviously first demands that the appropriate opportunity is provided !.

Things like controlled documents can be iffy IMEX depending on significance / multiple cases or not / existing audit history etc. If you read through the forum encyclopedia of audit case histories posted on the Net, this is predictably a favourite auditor pouncing-point.

It would be interesting to know what the typical “audit handling proprieties” imposed on a qualified auditor actually are.?

Rgds / Charles.C

[Tony-C]

It is interesting if that is the case because that is more a requirement of version 6 not version 5 to have some written agreement about standards etc, in which case, it's still a point for appeal. UKAS accreditation should be good enough for version 5 IME.

Please explain

5.5.2.3 Issue 5
Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory, or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025. Documented justification shall be available where accredited methods are not undertaken.

5.5.2.3 Issue 6
Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025. Documented justification shall be available where accredited methods are not undertaken.

Regards,

Tony

[Tony-C]

Hi Tony,

I getting bit confused.
I guess you mean refers to in-house / unaccredited labs only ? (ie as per Foodworker)
if so, the next bit then seems not relevant ?


Rgds / Charles.C

Hi Charles

No I mean it is a general requirement for laboratories

Regards,

Tony

[Ian R]

Hi Had a similar problem a few years ago.

I now ensure that every year (just before BRC) I ask my lab for their Proficiency tests. All that will come is streams of paperwork, sign and date them and put them in your micro file. The lab has to do these (if accredited) to validate their own testing procedures.

If the lab cannot produce these change your lab!

Happy Christmas / Holidays