BRCGS Section 4.6 risk assessments for version 9
I am looking for something regarding Section 4.6 of the new BRC, please if anyone willing to share any risk assessments that are needed for version 9 of the BRC standard, please do source, share and/or discuss. Thank you very much in advance
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Hi @nalysisstaffskillsacademy,
Welcome back!
I presume that you are asking about risk assessments required as per BRCGS Global Standard for Food Safety Issue 9 Section 4.6 Equipment.
If we look at the BRCGS Global Standard for Food Safety Issue 9, first of all clause 4.6.1
requires a documented purchase specification for any new equipment detailing the site requirements for the equipment. This is clearly a starting point as if your equipment is specified correctly then risks are minimised.
Clause 4.6.2 requires that the design and construction of equipment shall be based on risk, to prevent product contamination. For example, the use of the correct seals, impervious surfaces or smooth welds and joints, where they are exposed to product and could otherwise result in foreign- body, microbiological or allergen contamination of the product.
Clearly if equipment is for food contact then it should be specified correctly and inspected prior to use.
The need for further controls is covered in clause 4.6.3 which requires:
A documented, risk-based commissioning procedure shall be in place to ensure that food safety and integrity is maintained during the installation of new equipment to site.
Installation work shall be followed by a documented hygiene clearance procedure.
New equipment to site shall be inspected by an authorised member of staff before being accepted into operation.
The commissioning procedure shall include the update of any other site procedures that are affected by the new equipment, for example, training, operating procedures, cleaning, environmental monitoring, maintenance schedules or internal audits.
I use a Process Change Approval form for New Equipment with an assessment of risk involved in the change. This risk assessment will need to consider the severity of any potential hazards and the amount of product that could be potentially affected.
From the BRCGS Guidelines:
Risk assessments and resultant controls must be proportionate to the likely risk to the product; for example, the equipment’s proximity to product (e.g. use in production areas or open product areas), its significance to the production process, and its complexity (for example, a new production line or part of a production line will need significantly more consideration than a small item such as a plastic scoop).
Clearly a comprehensive Commission Checklist will be required for a new production line with new filling equipment (high risk).
This checklist is likely to include:
Specification sign off
Initial inspection
Plan and precautions for installation
Installation & monitoring of installation
Inspection & release for trials
Production trials
Training
Plus a sign off of:
Operation
Product Quality/Safety
Health & Safety
Hygiene including cleaning validation/verification
Engineering & Maintenance including calibration if necessary
Documented procedures for production, operation, maintenance, monitoring etc.
An item such a plastic scoop may be regarded as relatively low risk but if it is for food contact, it will still need to be specified for intended use, have relevant procedures issued & trained in such as usage/cleaning and inspected prior to use.
Kind regards,
Tony
Tony Thank you very much
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Hi Tony your analisys is very cool.
I have simplify it describing in the procedure this kind of risk:
1. Structural work (possible dangers: foreign bodies) = intervention only when production has stopped or with suitable segregation of the area
2. Dirt on equipment (physical and microbiological hazards) = cleaning work before bringing equipment into area and subsequent cleaning and if necessary disinfection of equipment
3. Connection work on company equipment (possible dangers: foreign bodies and microbiological contamination of surfaces) = intervention only when production has stopped or with appropriate segregation of the area. Cleaning and if necessary disinfection of equipment at end of operation.
4. External personnel (physical-chemical-microbiological hazards) = compliance with hygiene behaviour practices.
What do you think about my simple analysis?
In Italy we have the Reg. CE 852-2004 where describe the principes about the allocation of new equipment.
Hello, does anyone have an example of a risk assessment they could share? Purchase specification checklist for supplier to provide prior to supply?
Hello, does anyone have an example of a risk assessment they could share? Purchase specification checklist for supplier to provide prior to supply?
Following on this.
We use this. It's basically a restatement of the requirements in 21 CFR 117.40.
Marshall