Approval and Performance Monitoring of Manufacturers and Packers of Traded Products Procedure

Part of Food Industry Hub’s FSQMS Policies and Procedures Suite.

The Approval and Performance Monitoring of Manufacturers and Packers of Traded Products Procedure forms part of the Food Industry Hub FSQMS Policies and Procedures Suite.

It defines how traded-product suppliers and the manufacturers or packers of traded products are assessed, approved, monitored and periodically reviewed. The procedure gives Technical / Quality Management a risk-based framework for deciding whether approval can be granted or continued, and gives Procurement / Purchasing a clear basis for sourcing only where the required supplier and manufacturer or packer approval is current.

The document is specific to traded products. It works alongside the common supplier approval process, but preserves the additional traded-product risk assessment, approval evidence and ongoing review requirements needed for the supplier, manufacturer or packer, manufacturing or packing site, and traded product or product range concerned.

Base approval on the traded product, supplier and manufacturer or packer risk

The procedure requires approval and ongoing monitoring to be based on a documented risk assessment relevant to the product, supplier and manufacturer or packer. Product-safety risks identified through the traded-product food safety plan are taken into account, with the assessment also considering the nature of the product, customer-specific requirements, legislation in the country of sale or importation, source or country of origin, potential adulteration or fraud, supply-chain risk up to receipt, and product brand identity.

That risk assessment determines the approval method or combination of approval methods required, the frequency of ongoing manufacturer or packer review, and the performance criteria and information relevant to continuing review. Where sufficient information is not available to complete the assessment or determine the approval requirements, approval is not granted or continued until the required information has been obtained and assessed.

Keep supplier and manufacturer or packer approval identifiable for each traded product

The procedure extends the certification, supplier-audit, questionnaire, approval-status and performance-monitoring methods established under the Supplier & Raw Material Approval and Performance Monitoring Procedure to traded-product suppliers and manufacturers or packers, as applicable. It also makes clear that raw-material-specific exceptions, intermediary-purchase controls and alternative measures under that common process do not replace or modify the approval requirements defined for traded products.

Initial and ongoing approval must cover each traded-product supplier and the manufacturer, processor or last manufacturer or packer associated with each traded product. The approval applying to the supplier, manufacturing or packing site, product or product range remains identifiable, so that the organisation can establish the applicable approval status before a source is relied upon for supply.

Define the evidence that can support manufacturer or packer approval

Manufacturer or packer approval may be supported by certification, supplier audit or questionnaire evidence, singly or in combination, according to the traded-product risk assessment and the procedure’s conditions.

Where certification is used, the certificate must be valid to the applicable BRCGS Standard or a GFSI-benchmarked standard and must include the traded products purchased within scope. Where supplier audit is used, the audit scope must include product safety, traceability, HACCP review and good manufacturing practices, and the auditor’s product-safety competence must be demonstrable. If a second- or third-party audit is relied upon, the full audit report is obtained and reviewed before the audit is used for approval.

Questionnaire-based initial approval is restricted to low-risk situations with a valid risk-based justification. The questionnaire must cover product safety, traceability, HACCP review and good manufacturing practices, and must be reviewed and verified by a demonstrably competent person. This distinction keeps questionnaire approval within the limits set by the risk assessment and the procedure’s approval conditions.

Make continued approval dependent on satisfactory evidence and review

Technical / Quality Management determines whether the evidence obtained through the applicable approval method is satisfactory and sufficient for the manufacturer or packer and traded products concerned. Approval is granted or continued only where the required evidence supports the decision.

Where certification, audit or questionnaire evidence cannot be demonstrated, the approval method is not accepted and approval is not granted or continued until approval has been completed using an acceptable method. Where supplier-audit findings require corrective or preventive action by the supplier, Technical / Quality Management confirms satisfactory closure and reviews supporting evidence before approval is granted or continued.

Use performance information to review manufacturer or packer status

The procedure extends the performance-monitoring process to manufacturers and packers of traded products. Review frequency and content are determined by the traded-product risk assessment, and ongoing review uses defined performance criteria at a frequency that reflects the assessed risk.

Relevant information may include complaints, available product-test results, regulatory warnings or alerts, customer rejections and customer feedback. Where complaint or product-test information is used, the activities generating that information remain governed by the relevant complaints handling or traded-product inspection and laboratory testing procedures.

Technical / Quality Management reviews the relevant performance information and determines whether continued approval remains acceptable. Where review supports continued approval, the existing approval status remains current; where it no longer supports continued approval, continued approval is not extended until the risk assessment and supporting approval evidence have been reassessed.

For questionnaire-based approvals, the procedure also requires questionnaires to be reissued at least every three years and requires suppliers to notify significant changes between reviews, including changes in certification status. Technical / Quality Management assesses notified changes to determine whether the risk assessment or approval requires review.

Review manufacturing or packing site issues before continued approval is extended

Any issue identified at a manufacturing or packing site with the potential to affect food products traded by the company is reviewed against the existing risk assessment and approval status. The review determines whether the risk assessment remains appropriate, whether the evidence supporting approval remains satisfactory, whether continued approval remains acceptable and whether further assessment or follow-up is required before continued approval can be confirmed.

Where the issue means that continued approval can no longer be supported, continued approval is not extended until the required follow-up has been completed and Technical / Quality Management has reassessed the manufacturer or packer’s approval status. If the issue identifies traded product that may not meet specified requirements, product control is managed through the Non-Conforming Product Control Procedure. If it indicates a potential incident, or that unsafe or illegal product may have been placed on the market, escalation is managed through the Incident Management, Product Withdrawal & Recall Procedure.

Allocate responsibility across approval, monitoring and sourcing decisions

Senior Management provides the resources and organisational support needed for effective approval and performance monitoring. Technical / Quality Management owns the risk assessment, approval decision, evidence review, closure of relevant audit findings, ongoing manufacturer or packer performance review, site-issue assessment and maintenance of identifiable approval status and supporting evidence.

Procurement / Purchasing is responsible for sourcing traded products only where the required supplier and manufacturer or packer approval has been established and remains current. All employees are required to report information or concerns that may affect the approval or continued acceptability of a traded-product supplier, manufacturer or packer. That allocation connects technical approval authority with the purchasing discipline and reporting routes needed to keep sourcing decisions aligned with current approval status.

Maintain evidence within the wider traded-products control framework

Approval records identify the approval method used and the evidence supporting each manufacturer or packer approval decision, including applicable audit reports or verified certification evidence confirming the product-safety status of manufacturing or packing sites supplying the traded products. Ongoing review records and manufacturing or packing site issue follow-up records provide evidence of continued assessment.

The procedure interfaces with the Traded Products HACCP Procedure, Traded Product Specifications Management Procedure, Inspection and Laboratory Testing of Traded Products Procedure, Legal Compliance for Traded Products Procedure, complaints handling, non-conforming product control, incident management and record control. These interfaces keep traded-product approval connected with the risk, specification, legal, testing, complaint and escalation information that may affect whether continued approval remains justified.

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