6 replies to this topic

[liberator]

Hi all, I recently conducted an audit on one of our packaging material suppliers. As part of the audit I'd identified that the set of scales they use: 

• "to assist with product processing, troubleshooting, and trending of product grammage."

I'd checked that the scales are calibrated and could confirm the scales are calibrated on an annual basis. However they do no other calibration checks between the annual calibrations. I'd raised this as a minor non conformance. As the question I had is how do they know the scales are accurate and what would happen if it was found the scales were out of calibration at the next annual check? I was assessing this requirement as part of the BRC standards. I'd said they need to do some monitoring of the scales, daily/weekly/monthly - at least something to ensure scales are within calibration between the calibrations.

 

The scales are used for quality monitoring - checking of weights of containers being manufactured. With the NC they advised that 

• Deviation in grammage that would begin to register as a quality issue would become apparent at both the visual / physical product QC inspection, as well as the topload measurement stage. There are a number of interrelated inspections that together would indicate a decrease in product quality.
• historical review of grammage data is not something critical to our process

I'm still not sure that this is an appropriate response/action. They are relying on other QC checks to show that there is an issue in the injection molding process and not just the scale check. Surely a simple one point mass check on the scales on a predetermined frequency would also be a proper corrective action? If their weight check is not critical and there are other qc aspects that can indicate issues - then why bother? I know why the do hence them doing the check - so it has to be important - so a simply one point check would be to their advantage as well? They are FSSC certified for packaging - I'd be interested to know if anyone else who works in the manufacture of packaging for bottles etc have a QC weight check and how they monitor this and their scales calibration. Also what is the FSSC packaging requirement for calibration and monitoring?

 

 

 

[SQFconsultant]

I rarely see once a year.

What I do see for packaging companies is average of every 6 months.

[Scampi]

If you are not PURCHAING BY WEIGHT  they have zero obligation to calibrate the scales  From BRC issue 6 auditing checklist    

 

If they have not determined it to be a "critical control point" and only an assessment tool the scale can be omitted from the list of equipment

 

Clause

Requirements

5.5.1

The site shall identify and control in-line and off-line measuring equipment used to monitor critical control points (where applicable) and product safety, quality and legality. This shall include, as 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 and misuse.

5.5.2

All identified measuring equipment shall be checked and adjusted at a predetermined frequency, based on risk analysis. This shall be carried out by trained staff to a defined method to ensure accuracy within defined parameters. All results shall be documented.

Where possible, calibration shall be traceable to a recognised national or international standard. Where a traceable calibration is not possible, the site shall demonstrate the basis by which standardisation is carried out.

[liberator]

Thanks Scampi, note the BRC Version you have quoted has been updated to 8 and the above section been expanded and changed to below

 

6.4 CALIBRATION AND CONTROL OF MEASURING AND MONITORING DEVICES

The site shall be able to demonstrate that measuring equipment is sufficiently accurate and reliable to provide confidence in measurement results

 

CLAUSE REQUIREMENTS 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.

 

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.

 

6.4.3

Reference measuring equipment shall be calibrated and traceable to a recognised national or international standard and records maintained. The uncertainty of calibration shall be considered when equipment is used to assess critical limits.

 

6.4.4

Procedures shall be in place to record actions to be taken when the prescribed measuring devices are found not to be operating within specified limits. Where the safety or legality of products is based on equipment found to be inaccurate, action shall be taken to ensure at-risk product is not offered for sale.

 

They are monitoring their manufacturing process quality using the scales which they only calibrate annually They meet clauses 6.4.1, 3 and 4. It's the 6.4.2 clause  that I've questioned.

 

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

• at a predetermined frequency, based on risk assessment

 

They are checking - yes - annually.

 

The section on calibration of equipment they use to monitor the quality of the product they are producing. The standard clearly states the point above, that the device shall be checked and at a frequency based on a risk assessment. They have not provided evidence of a RA to show that an annual calibration is sufficient. Again, if the device is calibrated today, then fails tomorrow but you don't know because you're not doing any checks, and the error is found 12 months later when its calibratied again - what does that mean for the product manufactured between the two dates?

 

It's no different to a laboratory who uses scales each day to weigh samples for testing completing a  daily scale check to ensure its reading accurately before using. If I'd audited a lab and found they don't do daily checks then they'd get a non conformance for that as well.

 

It's irrelevant that "PURCHASING BY WEIGHT " decides if its  a non conformance or not. I'm not buying anything purchase based on temperature either - but if I'm auditing a site that makes product that has to be pasteurised then I need to know that the thermometer is checked daily and calibrated based on their RA.

Edited by liberator, 16 April 2021 - 04:55 AM.

[beautiophile]

I think Scampi was referring the BRC for Packaging, which currently remains in Issue 6 and makes more sense to audit packaging suppliers.

 

Again, if the device is calibrated today, then fails tomorrow but you don't know because you're not doing any checks, and the error is found 12 months later when its calibratied again - what does that mean for the product manufactured between the two dates?

By using measuring devices, there are many terms to need to be clearly interpreted: checking, adjustment, calibration, verification and validation. I suggest to look at VIM's terminology. Concerning scales being mentioned, a common practice is (in a lab, AFAIK):

- to check and adjust (if needed) before every measurement

- to calibrate on every day of use or at least weekly

- to validate every 6-months or yearly (with stamp & expiry).

Such practice is based the fact that a scale likely loses its responding consistency quickly. Its indicator often doesn't return accurately to zero after lifting weight. (the TARE button in electronic scale exists for reasons). This failure factor together with FS hazards take part in a risk assessment.

The risk assessment here is to decide the frequency of checking & adjustment, not calibration and validation; according to BRC. Outside BRC, the frequency of calibration usually depends on workload and times of adjustments. The one of validation is usually fixed to semi- or annually.

[TimG]

Good morning Liberator,

Were you auditing them to the FSSC standard, or do you have your own set of company standards? If you are going off of what you posted above:

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

 

If I am understanding that correctly, wouldn't the minor be more for them not having a risk assessment than for them not conducting accuracy checks on your preferred frequency? If they have a risk assessment and it bears out their assertation that an annual certified calibration is sufficient because of X, Y, Z would you know their process enough to dispute their assessment?

 

I went through something similar (not a minor, I proved my side in the discussion phase with the auditor) at the location I am now with pH meters. Our pH checks have nada to do with food safety, or even quality. They are entirely a process monitor to help the smooth transition of ammonia+acid= final product. The final product is still the same regardless and this is verified with assay (purity) analysis. I tell this story to caution that sometimes an industry 'rule' (in my case pH monitors and meters being srsbzns) doesn't always apply to every manufacturing process.

[Charles.C]

I deduce the OP relates to a packaging supplier for a BRC8 certificated food processor.

 

is the approval of the packaging supplier controlled by BRC Food clause 3.5.1.2  which includes -

 

3.5.1.2
The company shall have a documented supplier approval procedure to ensure that all suppliers of raw materials, including primary packaging, effectively manage risks to raw material quality and safety and are operating effective traceability processes. The approval procedure shall be based on risk and include either one or a combination of:
•  a valid certification to the applicable BRC Global Standard or GFSI-benchmarked standard. The scope of the certification shall include the raw materials purchased.

 

etc

 

 

afaik FSSC2200 is a gfsi-benchmarked safety standard and I assume the FSSC (product) scope was GFSI/BRC8  "appropriate".

 

Re BRC8 = Q.E.D. ?

 

I suppose it is an unrelated issue as to why-oh-why do BRC include weight control (and "Quality")  in a Food Safety Standard which consequently involves  the calibration of weight scales ? (I anticipate the answer is "Due Diligence").

Offhand, for GFSI, FSSC22000 presumably focuses strictly on Safety-related aspects, not Quality. However If  the packaging  weighing function  does overlap product safety there may be a reason to also involve for FSSC. Does it ?

 

Regardless of all the above nuances, IMEX,  an accuracy "check" (eg  using reference weights) of all, to be utilised, scales is typically a preliminary daily exercise as stated in an appropriate SOP. Weight = money.