Product Inspection, On-site Testing & Laboratory Analysis Procedure

Build testing around product risk and defined technical controls

The procedure establishes a scheduled product testing programme covering microbiological, chemical, physical and organoleptic testing where Technical Management determines that those tests are required according to product, process, history, customer expectation or risk assessment.

Each testing activity is defined before samples are collected, submitted or tested. The procedure requires the testing location or provider, test method, sample-handling requirements, competence requirements, reliability checks and result-review requirements to be identified so that testing is controlled consistently whether it is performed by an external laboratory, an internal laboratory, or within production or storage areas.

Sampling arrangements extend beyond the act of taking a sample. They include product or batch identification, sample integrity, traceability to the tested product, labelling where required, storage before testing, delivery to the laboratory where applicable and communication of the testing requirements to the laboratory.

Review results in context before product or process decisions are made

Testing and inspection outcomes are recorded, retained and reviewed so that results are available for assessment and follow-up. Quality Management reviews results against acceptance criteria, action limits or legal limits, identifies trends and assesses the significance of results generated on site, internally or externally before those results are relied upon for product or process decisions.

Where results require follow-up, the procedure distinguishes the response route. Unsatisfactory results affecting product, process or control are addressed through the non-conforming product and corrective and preventive action arrangements where applicable. Adverse trends are directed into corrective or preventive action, while legal-limit exceedances are escalated according to whether affected product remains under site custody or may have entered the supply chain.

For quantitative laboratory results used to determine conformity with a legal limit, safety limit, specification limit, action limit or acceptance criterion, measurement uncertainty is considered where it may affect the conformity decision. The procedure also preserves an important boundary: measurement uncertainty is not used to avoid action needed to protect consumers or maintain legality where a critical safety or legal parameter is affected.

Control shelf-life validation and ongoing verification

Shelf-life control is developed through both validation and ongoing verification. Validation confirms that the shelf life assigned to the product is supported by relevant testing, inspection, analytical or technical evidence, while ongoing verification checks that the assigned life remains supported during continued production.

Technical Management determines the shelf-life evidence required according to product characteristics, process controls, storage conditions and known product hazards. The evidence base may include sensory analysis, microbiological testing and relevant chemical factors such as pH and water activity where those factors affect product performance or control.

Where shelf-life validation or verification indicates that the assigned life is no longer supported, the procedure requires Technical Management to assess the significance of the result and determine whether product control, process review, product design review or labelling review is required. Changes affecting product design, declared shelf life, labelling or artwork are then managed through the relevant FSQMS procedures rather than being treated as isolated test outcomes.

Define how external and subcontracted analysis can be relied upon

Before samples are submitted or testing is commissioned, Technical Management confirms that the external laboratory or subcontracted analysis provider has the technical capability required for the analysis. Where recognised laboratory accreditation is relied upon, the accreditation scope is checked against the relevant analysis, method or testing activity before results are used for product safety, authenticity, legality or quality decisions.

For analyses critical to product safety, authenticity or legality, the procedure requires the subcontractor to hold recognised laboratory accreditation or operate in line with the requirements and principles of ISO/IEC 17025. Where accredited methods are not used, justification must be available before the analysis is commissioned, and proficiency testing forms part of the assurance arrangements where applicable.

Prevent laboratory activity from becoming a contamination route

The procedure gives specific attention to laboratory location, design and operation where testing laboratories are present on the manufacturing site. Site Management, Technical Management and Laboratory Personnel share responsibility for ensuring that laboratory placement, layout, services, access, security and routine operation do not create product safety risk.

For on-site laboratories, the documented controls address containment, drainage, ventilation, access, security, personnel movement, hygiene, protective clothing, movement of laboratory materials, laboratory waste and laboratory equipment. These controls connect laboratory activity with the wider site arrangements for layout and segregation, chemical and physical contamination control, waste disposal, equipment management and maintenance where those interfaces are affected.

Internal pathogen testing is treated as a higher-risk condition. It is permitted only where the laboratory facility is physically segregated from production and storage areas and operated under documented controls that prevent contamination risk to products and production areas.

Control testing performed in production or storage areas

Where testing is carried out in production or storage areas rather than in a separate laboratory, the procedure requires the location, design and operation of the activity to be compatible with the area and controlled so that product contamination risk is not created.

Technical Management defines or approves the location and design of the testing activity, while Laboratory Personnel or designated personnel control the use and removal of equipment, materials, samples or reagents introduced into the area. This preserves the distinction between laboratory-based analysis and controlled testing undertaken inside operational areas.

Maintain confidence in internal and non-critical laboratory results

Where analyses critical to product safety, authenticity or legality are undertaken internally, the site laboratory must have recognised laboratory accreditation or operate in line with ISO/IEC 17025 principles. The procedure links this to controls for document control, defined responsibilities, staff competence, documented methodology, suitable calibrated equipment, quality assurance activity and internal review where required.

Laboratory results outside critical safety and legality controls are also managed for reliability. The procedure requires recognised test methods where available, documented procedures or test instructions for site personnel, appropriate qualification, training and competence, defined accuracy checks such as proficiency testing where applicable, and equipment that is calibrated, maintained and reviewed before return to analytical use where necessary.

Allocate responsibility across management, site and laboratory functions

Senior Management is responsible for providing the resources, facilities, internal or external laboratory capability and organisational support needed to implement and maintain the controls. Technical and Quality Management establish the programme, define risk-based testing requirements, assess results, maintain shelf-life controls, confirm suitability of laboratories and define contamination and reliability controls.

Site Management supports the suitability of on-site laboratory facilities, including design, access, security, services and segregation where internal pathogen testing is conducted. Laboratory Personnel carry out sampling, testing, inspection and result recording in accordance with the defined programme and apply controls for sample handling, materials, movement, hygiene, protective clothing, waste and equipment use. Employees are required to follow the controls relevant to their work area and report conditions, practices or results that could compromise product safety, authenticity, legality, quality or result reliability.

Connect testing evidence with the wider FSQMS

The procedure sits at the point where product testing evidence, shelf-life evidence, laboratory reliability and product-status decisions meet the wider FSQMS. It interfaces with document control, record completion, supplier and laboratory approval, specifications, corrective and preventive action, non-conforming product control, incident management, layout and segregation, equipment management, calibration, product design and labelling controls.

For technical and quality teams, that structure provides a developed framework for demonstrating how inspection, on-site testing and laboratory analysis are planned, technically controlled, interpreted and acted upon rather than being treated as disconnected testing records.