20 replies to this topic

[ShaunD]

Hi all,

 

I'm after a bit of advice here after receiving a non-conformance during a retail audit.

 

I know BRCGS 6.4.2 states "Any equipment used to monitor CCP's must be protected from damage, deterioration or misuse".

Interprtation guidelines simply state this can be "through good design or the training of staff".

 

My question is, do the test packs used to carry out the checks on the metal detectors need to be locked up when not carrying out the checks?

 

We use the standard test sticks, not card. We have a signout sheet for the test pieces used for each line, checks are for damage etc., these are then returned, inspected and signed back at the end of shift and placed in locked boxes.

 

 

The n/c was raised against the BRCGS standard, not the customer requirements. The BRCGS standard has remained the same since at least issue 7 so we have had at least 7 BRCGS audits since then and this has never previously been raised as an issue.

 

Any advice would be appreciated.

 

 

 

[Scampi]

so what exactly was the NC?

[kconf]

Your procedure of storing test pieces seems appropriate. 

BRCGS 6.4.2 v9 is about frequency and accuracy. Is it validated and calibrated? Any deviations? 

[Dorothy87]

hi  

 

Not sure what you checking but 6.4.2 is about calibration 

 

6.4.2 All identified measuring devices, including new equipment, shall be checked and, where necessary, adjusted:

• at a predetermined frequency, based on risk assessment

• to a defined method traceable to a recognised national or international standard where

possible. Results shall be documented. Equipment shall be readable and be of a suitable accuracy for the measurements it is required to perform.

 

this sounds more like 4.10.1.3 , 4.10.3.3 and 4.10.3.4

 

The site shall ensure that the frequency of the testing of the foreign-body detection and/or

removal equipment is defined and takes into consideration:

• specific customer requirements

• the site’s ability to identify, hold and prevent the release of any affected materials, should

the equipment fail. The site shall establish and implement corrective action and reporting procedures in the event of a failure of the foreign-body detector and/or removal equipment. Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.

 

For Tesco, M&S and JS (Sainsburys)  you must specify in your MD procedure how you store your test pieces when not in use / between tests. Usually, they should be locked in the metal detector rejection box - but double check with retailer requirements. Considering the fact that they will be in use hourly (sometimes even more often - 4.10.3.3) , some factories introduced metal cages next to lines to keep samples with test pieces separately. 

 

 

[ShaunD]

so what exactly was the NC?

 

Hi Scampi,

 

The n/c was for the test packs, when not in use between the hourly checks, were not locked up. Auditor used the BRCGS clause 6.4.2, stating that "misuse" means they should be locked away when not actually being used i.e. between the hourly checks. 

[ShaunD]

 

hi

 

Not sure what you checking but 6.4.2 is about calibration 

 

6.4.2 All identified measuring devices, including new equipment, shall be checked and, where necessary, adjusted:

• at a predetermined frequency, based on risk assessment

• to a defined method traceable to a recognised national or international standard where

possible. Results shall be documented. Equipment shall be readable and be of a suitable accuracy for the measurements it is required to perform.

 

this sounds more like 4.10.1.3 , 4.10.3.3 and 4.10.3.4

 

The site shall ensure that the frequency of the testing of the foreign-body detection and/or

removal equipment is defined and takes into consideration:

• specific customer requirements

• the site’s ability to identify, hold and prevent the release of any affected materials, should

the equipment fail. The site shall establish and implement corrective action and reporting procedures in the event of a failure of the foreign-body detector and/or removal equipment. Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.

 

For Tesco, M&S and JS (Sainsburys)  you must specify in your MD procedure how you store your test pieces when not in use / between tests. Usually, they should be locked in the metal detector rejection box - but double check with retailer requirements. Considering the fact that they will be in use hourly (sometimes even more often - 4.10.3.3) , some factories introduced metal cages next to lines to keep samples with test pieces separately. 

 

 

 

 

Your procedure of storing test pieces seems appropriate. 

BRCGS 6.4.2 v9 is about frequency and accuracy. Is it validated and calibrated? Any deviations? 

 

Apologies, it should have been 6.4.1:

"BRC 6.4.1 - Test pieces used for CCP Metal Detection were kept on desk in packets - All test equipment used for control of CCP steps must be stored securely. Locked storage box required."

[Dorothy87]

Apologies, it should have been 6.4.1:

"BRC 6.4.1 - Test pieces used for CCP Metal Detection were kept on desk in packets - All test equipment used for control of CCP steps must be stored securely. Locked storage box required."

 

6.4.1 The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality. This shall include, at a minimum:

• a documented list of equipment and its location

• an identification code and calibration due date

• prevention from adjustment by unauthorised staff

• protection from damage, deterioration or misuse.

 

ok, now make a sense - protection from damage/misuse etc . Staff shouldn't leave packets on desk. Update your procedure, re-train staff, collect signatures, provide root cause, corrective actions and close NC :)

[ShaunD]

 

6.4.1 The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality. This shall include, at a minimum:

• a documented list of equipment and its location

• an identification code and calibration due date

• prevention from adjustment by unauthorised staff

• protection from damage, deterioration or misuse.

 

ok, now make a sense - protection from damage/misuse etc . Staff shouldn't leave packets on desk. Update your procedure, re-train staff, collect signatures, provide root cause, corrective actions and close NC :)

 

 

Thanks Dorothy87,

 

I understand what you are saying, and we are actioning the n/c as you have written.

 

I just don't agree with the n/c, as mentioned the test pieces are signed in and out to each shift supervisor (checked for condition), only the relevant test pieces are available on the line. These are stored on the supervisor's desk, with their PC/tablet used to record production details, when not in use.

These are test sticks with the metal sphere totally enclosed in plastic, how can these be misused or damaged when physically in/attached to packs of product?

Condition of test pieces checked when signed in and out by shift supervisors.

 

Does everyone keep their test packs locked up between checks?

[kconf]

We don't keep them locked up. They just stay in a closed container, and used by trained staff members only. 

I don't see either how they can get damaged the way you are describing you store them. 

I would tell the auditor what you are telling us and show all the records. 

Good luck! 

[Dorothy87]

Thanks Dorothy87,

 

I understand what you are saying, and we are actioning the n/c as you have written.

 

I just don't agree with the n/c, as mentioned the test pieces are signed in and out to each shift supervisor (checked for condition), only the relevant test pieces are available on the line. These are stored on the supervisor's desk, with their PC/tablet used to record production details, when not in use.

These are test sticks with the metal sphere totally enclosed in plastic, how can these be misused or damaged when physically in/attached to packs of product?

Condition of test pieces checked when signed in and out by shift supervisors.

 

Does everyone keep their test packs locked up between checks

 

 

I do..  and between checks. 

We bought a simple lockable metal box, plus sign in /out records  and god knows what else they wish to see in the future requirements... 

[kingstudruler1]

I think I am with you.   This seems like a stretch.  Were their words "locked storage box required" or are those your words?

 

My intrepretation is that clause is for equipment that monitors / measures.   This would not include other items / stanadrs used to conduct calibrations or verify such as calibration weights, test pieces, etc.  

 

I would ask the CB if this is the correct application of the clause.  Declaring "locked storage box required" also seems inappropriate.   How you meet the standard is up to you, not them.  

[G M]

 

6.4.1 The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality. This shall include, at a minimum:

• ...

• protection from ... misuse.

 

...

 

 

...

 

Does everyone keep their test packs locked up between checks?

 

A locker seems a bit overboard, but yes, they have a designated place when not in use.  Partly to help prevent cross contamination, but also to prevent them from becoming FM themselves (they are relatively small and un-tethered).

[kingstudruler1]

A locker seems a bit overboard, but yes, they have a designated place when not in use.  Partly to help prevent cross contamination, but also to prevent them from becoming FM themselves (they are relatively small and un-tethered).

 

 

This risk seems like a more significant risk to me as well.  IE - im missing a test piece is difficult to hear.    Maybe more appropriate finding in a different clause.  

[ChristinaK]

I'd been through several BRCGS audits at my previous place, and we never locked up our test wands in-between checks. NC was never received for anything with our MD program except that we didn't include documenting the checks we did to ensure the MD bandages were rejected by the machine.

 

We kept our test wands in 64oz plastic jars with plastic lids. Jar and Lid had been marked with bright blue electrical tape so that neither would accidentally be used on the line for a food product. Each production room had a dedicated set, and there was an emergency backup set in my office. The wands themselves were bright yellow, pink, and blue plastic with the "contaminant" embedded within a clear portion of the piece. Each was placed in its own tied clear glove. That's how they would be placed in a sample of product to test the rejection mechanisms. If the test piece were to be damaged, the pieces would be contained in the glove to prevent a FM contamination incident. At the end of the day, they would be taken back the the QA lab, which was locked.

 

They used to be kept in plastic bags until my first QA tech "lost" a set. That's when I made the switch to using a large clear jar. Never happened again after that! 

[Tony-C]

Hi ShaunD,

 

Clause 6.4.1 is about measuring equipment: The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality.

So I’m with kingstudruler1 on this: ‘ask the CB if this is the correct application of the clause’.

 

It is good practice to control these test pieces and a ‘simple lockable metal box’ as Dorothy87 has posted is quite common and a simple solution to your NC.

 

Kind regards,

 

Tony

[ShaunD]

Thanks all.

 

I think I am with you.   This seems like a stretch.  Were their words "locked storage box required" or are those your words?

 

 

 

That was the n/c copied from the audit summary.

 

The test pieces, once signed out from the locked box in the production office, are attached to product that has been passed through the metal detector. These are labelled accordingly. The only time they are removed from the product is when there has been a change in pack size, so little to no chance of being a foreign body risk. When the packs are not being used to runs the tests, they are stored at the supervisors work station. 

 

We supply all the major retailers in the UK and have had numerous audits, including our annual unnanounced BRCGS audits, and this has never (until now) been raised as an issue.

 

My understanding of the clause is that the metal detector, in this case, is the equipment that needs to be protected from "misuse", so is password protected to prevent unauthorised changes etc.

 

I am getting tired of having to put in place corrective actions to close off n/c's raised because of an auditors' interpretation, or should that be misinterpretation, of a specific clause even if it is an easy fix, as in this case.

 

We once had an issue raised because we had not reviewed or carried out a gap analysis on a code of practice that covers ambient stable products, the scope cleary stated only applicable to ambient stable products, we do not produce any ambient stable products so the requirements are obviously not applicable. Wrong, we had to complete the gap analysis and cover the requirements.

 

I could go on but.....

I thank everyone for their input.

 

 

 

[chrisrushworth]

We just keep ours in a white tub by the side of the MD.

The re-start key, is locked away incase of a +ve alarm....

 

I agree, very weird, the test pieces are part of start up checks, they are checked start, hourly & end of runs and then re-checked at EOD checks....

 

I get any restart keys, but not test pieces, as per procedure if the test pieces are damaged or do not activate the MD, the failure procedure kicks in, thus product safety is maintained?

Did you have any history or malicious intent towards your test pieces? Customer complaints about parts of pieces in product? Loss of a wand?

 

... dependant on how many NCs you received, may be worth arguing.. assume you did with the auditor on the day?

[ShaunD]

 

Did you have any history or malicious intent towards your test pieces? Customer complaints about parts of pieces in product? Loss of a wand?

 

... dependant on how many NCs you received, may be worth arguing.. assume you did with the auditor on the day?

 

No, no history of malicious intent or customer complaints or loss of test pieces.

 

Only 4 n/c's in total. Unfortunately, the n/c only became apparent at the closing meeting (which I didn't attend), the auditor had questioned it at the time but didn't make a big deal of it.

[chrisrushworth]

No, no history of malicious intent or customer complaints or loss of test pieces.

 

Only 4 n/c's in total. Unfortunately, the n/c only became apparent at the closing meeting (which I didn't attend), the auditor had questioned it at the time but didn't make a big deal of it.

 

Well done for only 4 NC's... just take it as constructive...

 

Once the close outs are done, no need to worry for 12m.

[ChristinaK]

My understanding of the clause is that the metal detector, in this case, is the equipment that needs to be protected from "misuse", so is password protected to prevent unauthorised changes etc.

 

Oh jeez. I get that then...although I feel like people focus too much on the password-protection for the MD software, when that's not what a line worker will tamper with, in my experience.

We had a MD with a pneumatic reject arm mechanism. Instead of calling for QA to inspect, line workers would turn off the pneumatic switch for the arm so there was no physical rejection (the MD had a screen indicator but no audio alarm). Eventually the switch was broken from constant misuse and we had to have a temp QA stand at the machine and physically remove indicated rejects for 2 weeks until we could replace the part. Then we had a lock box put around the thing. Of course the software was password-protected, but when this occurs, passwords don't do much. 

 

Anyway! Congrats on only 4 NC's. Not bad! 

[Rick Reyes]

Good morning all, I am not audited to BRCGS but it seems to me like this clause may be referring CCPs other than metal detection, possibly microbial control.