In Part 3 of the BRCGS Issue 9 series, we discuss the major changes under Requirement 3 (the Food Safety and Quality Management System).
The Food Safety and Quality Management System requirement consists of 11 clauses (sections) and has 4 fundamental requirements.
The following clauses are fundamental requirements:
3.4 Internal audits
3.5.1 Management of suppliers of raw materials and packaging
3.7 Corrective and preventive actions
A complete list of the clauses under Requirement 3 (The Food Safety and Quality Management System). The clauses marked with * are discussed in this article:
3.1 Food safety and quality manual
3.2 Document control
3.3 Record completion and maintenance
3.4 Internal audits*
3.5 Supplier and raw material approval and performance monitoring*
3.7 Corrective and preventive actions*
3.8 Control of non-conforming product*
3.11 Management of incidents, product withdrawal and product recall*
Clause 3.4 – Internal Audits
Clause 3.4 – Change on the Internal Audits statement of intent
Clause 3.4 is about Internal audits and remains a fundamental requirement. There is a slight change to the statement of intent where “the site’s Food Safety and Quality Management System” has been added. It now reads as follows:
“The company shall be able to demonstrate that it verifies the effective application of the food safety plan, and the implementation of the requirements of the Global Standard Food Safety and the site’s food safety and quality management system.”
Clause 3.4.1 – Internal audit coverage of the complete system at least once a year
The following has been added under Clause 3.4.1. It reads as follows:
“All activities that form a part of the site’s food safety and quality systems, including those relevant to food safety, authenticity, legality and quality, shall be covered at least once each year.”
Clause 3.4.3 – Review of the audit nonconformity results
Under Clause 3.4.3 the summary of the audit nonconformity results shall be reviewed during the management review meeting(s).
Clause 3.4.4 – Reporting of fabrication inspections to the responsible person
Under Clause 3.4.4 it is now required that fabrication inspections shall be reported to the person responsible for the activity or area audited. Corrective actions, and timescales for their implementation, shall be agreed and their completion verified.
A summary of the results must be reviewed during management review meetings.
The frequency of the inspections shall be based on risk and on any changes that may affect Food Safety but shall be not less than once per month in open product areas.
Clause 3.5 – Supplier and Raw Material Approval and Performance Monitoring
Clause 3.5.1 – Raw material approval and performance monitoring
Clause 3.5 is about supplier and raw material approval and performance monitoring. The first change is under Clause 3.5.1, with the addition of the term “authenticity”.
Clause 126.96.36.199 – Extension on the scope for supplier audits and initial approval questionnaires
There are also slight changes under Clause 188.8.131.52, where the supplier approval procedure has been better clarified on what it can be based on.
Changes are mostly on the extension of the scope for supplier audits and the scope of the initial approval questionnaire for low-risk suppliers.
Clause 184.108.40.206 – Product safety consultants
Under Clause 220.127.116.11, product safety consultants and providers of product safety training have been added as part of suppliers that need to be approved and monitored.
Clause 18.104.22.168 – Performance review of suppliers of services
The addition of Clause 22.214.171.124 requires ongoing performance reviews of suppliers of services and ensuring that the records of the review are maintained.
Clause 3.5.4 – More clarification on outsourced processing
Clause 3.5.4 has been largely dedicated to the clarification of outsourced processing.
The BRCGS Issue 9 has attempted to clarify what the term actually means, including stipulating clear requirements with respect to outsourced processes.
This is aimed at ensuring that the outsourced process does not compromise the safety of the product and that the controls for the outsourced process are similar to the ones implemented by the certificated site.
Clause 3.7 – Corrective and Preventative Actions
Clause 3.7 – Corrective and preventive actions statement of intend change
Under Clause 3.7, which is a fundamental requirement dealing with corrective and preventive actions, the statement of intent has been slightly changed to read as follows:
“The site shall be able to demonstrate that it uses the information from identified issues in the food safety and quality management system (e.g., non-conforming products, internal audits, complaints, product recalls, product testing, second- and third-party audits and online reviews) to complete necessary corrective actions and prevent recurrence.”
Clause 3.7.1 – Root cause analysis and preventive action
Under Clause 3.7.1 a lot more emphasis has been placed on the root cause analysis and better explains what should happen when there is an apparent failure of the food safety management system.
In other words, the site must have procedures that include the completion of root cause analysis and implementation of preventive action.
Clause 3.7.2 – Investigation and recording of non-conformities
Under Clause 3.7.2 there are also additions and where the term “authenticity” has been added, as well as “where there is an adverse trend in quality” this shall also be investigated and recorded.
In addition to the existing recording requirements, the following was also added:
- “the “corrective” action to address the immediate issue
- completion of root cause analysis to identify the fundamental cause (root cause) of the non-conformity
- appropriate timescales for corrective and preventive actions
- the person(s) responsible for corrective and preventive actions
- verification that the corrective and preventive actions have been implemented and are effective.”
“The root cause analysis shall also be used to prevent recurrence of non-conformities, and to implement ongoing improvements when analysis of non-conformities for trends shows there has been a significant increase in a type of non-conformity”
Clause 3.8 – Control of Non-conforming Product
Clause 3.8.1 – Management of products returned to the site
Clause 3.8 deals with the control of nonconforming products. There is only one change and that is in Clause 3.8.1 with the addition of the following:
“Management of any product returned to the site” (as part of the nonconforming product procedure).
Clause 3.9 – Traceability
Clause 3.9.1 – Traceability legal compliance of country of sale or intended use
Clause 3.9.1 requires that the traceability system must comply with the “legal requirements in the country of sale or intended use”.
Clause 3.9.3 – Mass balance and quantity check
Clause 3.9.3 provides clarity in what instances a mass balance or quantity check is required where the traceability includes raw materials and final products.
Clause 3.11 – Management of Incidents, Product Withdrawal and Product Recall
Clause 3.11.1 – Management of incidents
Under Clause 3.11.1 the word “authenticity” was added twice in the first paragraph of the clause.
There is also an addition of “product contamination indicating a product may be unsafe or illegal” as part of incident management procedures.
Clause 3.11.4 – Informing certification bodies of significant incidents, product recalls, product withdrawals, etc.
Clause 3.11.4 compels sites to provide as much information as possible to the certification body to enable it to determine if the incident has any impact on the site’s certification status. This would be done within 21 calendar days.
At a minimum, this shall include corrective action, root cause analysis, and a preventive action plan.