14 replies to this topic

[Kamwenji Njuma]

Dear All,

Like risk assesments, the BRC standard requires documented Justifications in many occasions e.g why you should not have foreign body detector like metal detector ,etc,can someone please advise on how you do and write a justification.

Regards,
Jeremy

[Simon]

Dear All,

Like risk assesments, the BRC standard requires documented Justifications in many occasions e.g why you should not have foreign body detector like metal detector ,etc,can someone please advise on how you do and write a justification.

Regards,
Jeremy

Can anyone provide an example for Jeremy?

[cazyncymru]

an example would be something like bottling

although a screw could work loose and fall into a hopper, there are 100 micron filters in the line, and also the apeture of the filling nozzle is only 250 microns.

pieces of metal that can pass through these filters would not be picked up by a metal detector )typically 2.5mm)


obviously you would need to show some evidence that you've looked at this, and word it a bit more technically!

[Kamwenji Njuma]

Dear Cazy

Thanks for the info

Regards,
Jeremy

[Simon]

Thanks Caz.

[Tony-C]

Dear All,

Like risk assesments, the BRC standard requires documented Justifications in many occasions e.g why you should not have foreign body detector like metal detector ,etc,can someone please advise on how you do and write a justification.

Regards,
Jeremy

To follow up on Caz's points.

Your packaging makes the sensitivity of the metal detector ineffective e.g. foil lids.

Complaint history e.g never had a metal contamination complaint

Regards,

Tony

[Cathy]

I use a form to be sure I document concerns...it's just a template, but it helps keep me on track. Maybe it will be helpful to you. I have used it for many different decisions or risk assessments. It is a place to document a summary. You may need to attach data as well depending on the circumstance.

Attached Files

•  Decision__Form.doc   29KB   189 downloads

[Charles.C]

Dear Jeremy,

I presume we are specifically talking about something like -

Foreign body detection equipment shall be in place unless it can be justified as not necessary. This justification shall be documented.

Surely it is sufficient here to simply state that X is required/not required by HACCP" with a xref as appropriate (I presume yr HACCP does not require it )

Seems to me the word "justification" is almost synonymous with "validation" in this case.

Yet another example of BRC trying to mystify / irritate people via the English Language.

Rgds / Charles.C

[Cathy]

Saying something is not required by HACCP and so doesn't need justification seems like a bit of a diconnect to me. HACCP requires a good hazard analysis which includes justifications for all food safety decisions. Sometimes, the decisions aren't easy to explain in a small space - like in a hazard analysis table. That's when additional justification documents (a.k.a. decisions making documents) can be useful. BRC asks for a lot of risk assessments - it seems to be another way of saying the HACCP plan hazard analysis must be more thoroughly documented.

[Charles.C]

Dear Cathy,

I did forget to say that my opinion wud also depend on the actual product/process which hv not so far been mentioned in this thread.

As far as I cud see, the only appearance of the word “justification” in the BRC standard is with respect to “documents” issues and my quoted item. Maybe I’ve missed something somewhere ? I based my attempted shortcut on the logic that any factory seeking a BRC audit must have developed a HACCP plan. The associated documentation should then usually include details of the topic under discussion via the validation / verification aspect. It’s true, as you say, that I have encountered instances of unbelievably concise HACCP plans which had passed auditorial inspection, this simply should not happen IMHO. I liked the attachment form you added previously however I personally expect to see all the info. which you mention included within the HACCP plan itself, or referenced in the validation.

I deduce from the BRC text that they routinely expect foreign body (eg metal) detectors in all process flows (BRC originally targetted only retail products I think). I find this illogical. There are many cases, eg intermediate raw process items, where a HACCP plan can “justify” / “validate” the use of alternative procedures. Sadly, IMO, most auditors do seem to agree with BRC and are distinctly nervous / unhappy if there is no metal detector standing in the line, regardless of the process.

@ Jeremy, apologies that this is perhaps getting a bit off-topic since you were requesting a general method for “justification”.For the current query it still seems close to validation IMO.

Rgds / Charles.C

[Kamwenji Njuma]

Dear Charles,

Thanks for the input,apart from the Haccp plan drawn from the process line,the other justifications are not captured in the Haccp and i presumed they needed to be documented also like the example u gave me for the foreign bodies.

[Charles.C]

Dear Jeremy,

Ah, I see.
Well, I noticed "justif" in 2.6.3, 3.7.3.2 and 5.5.2.3 plus the foreign bodies one. Maybe more. Seems to hv at least quadrupled compared to ver4.

My suggested handling wud be -

2.6.3 > normally part of the HACCP plan, > JEV (justification is equivalent to validation), eg a ref. of some sort.
5.5.2.3 > as per 2.6.3 or similarly done in the QA manual if not safety related. Most private labs are compelled to get iso 17025 these days.
3.7.3.2 > this is reminiscent of document control in iso 9001 which I seem to remember expects a "reason for change" column in every procedural "history" form. I think many people simply filled in "update" . For BRC perhaps a signed appendation adjacent to the specific correction, eg WE (writing error !). I presume the aforementioned "change" column is also expected by 3.7.1.3 even if not required to be justified (> ver 6?).

I suppose one cannot strictly protest these well-mentioned requests, the main problem is the time taken. Hv seen endless forum arguments over these documentation issues, eg specimen ripostes to the auditor, "show me where it specificly states this, and this etc,etc " AFAIK, most auditors do not transfer the ISO fascination with minutiae over to BRC although it seems that BRC are now encouraging such developments.

Rgds / Charles.C

[Allsafe]

Your justification can be written down in a number of formats just like a typical risk assessment.
For metal detection you simply need to refer to other steps in the process or agreements with customers for further processing which take out the need for you to metal detection. So clearly have a heading of justification / Evidence to support your reasoning and decision.
Remember you need also to justify your CCP crtical limits and control measures in the same way. Wherever you can refer to some reliable evidence such as codes of practice, industry guidelines, legislation and also your historical data.
Good luck
Russell.

[Kamwenji Njuma]

Dear Charles and Rusell,

Thanks alot.

Regards,
Jeremy

[Tony-C]

Dear Jeremy,

My suggested handling wud be -

2.6.3 > normally part of the HACCP plan, > JEV (justification is equivalent to validation), eg a ref. of some sort.
5.5.2.3 > as per 2.6.3 or similarly done in the QA manual if not safety related. Most private labs are compelled to get iso 17025 these days.
3.7.3.2 > this is reminiscent of document control in iso 9001 which I seem to remember expects a "reason for change" column in every procedural "history" form. I think many people simply filled in "update" . For BRC perhaps a signed appendation adjacent to the specific correction, eg WE (writing error !). I presume the aforementioned "change" column is also expected by 3.7.1.3 even if not required to be justified (> ver 6?).

Rgds / Charles.C

Agreed Charles:
2.6.3 relates to validation of acceptable level of hazards in finished product.
5.5.2.3 Is quite normal in that when standard methods are not used some sort of validation of the test method would be required.

I believe 3.7.3.2 relates to corrections rather than changes to record templates.

Happy New Year,

Tony