Control of Operations Procedure

Translate approved product and process requirements into controlled instructions

Approved process specifications and manufacturing instructions state the product, process, equipment and food-safety requirements to be applied at the point of manufacture. Product and process parameters are established and approved through the Product Design & Development Procedure before being incorporated into the controlled information used for routine production.

The framework covers recipes and allergen information, mixing conditions, equipment settings, cooking and cooling requirements, applicable critical control points, labelling and coding references, production storage conditions and alignment with agreed finished-product specifications. Where a requirement belongs to another controlled procedure, this document defines the operational interface rather than taking ownership of that separate control.

Production is required to begin and continue only when personnel can access the current approved process specifications, recipes, manufacturing instructions and applicable equipment settings. Missing, obsolete, contradictory or unverifiable instructions prevent process start or changeover from proceeding until the required information is resolved.

Control planned changes before they become routine practice

Planned changes to process specifications or manufacturing instructions are assessed before implementation for their effect on product safety, legality, quality, specification conformity, equipment capability and the food safety plan. Product or process modifications that require development, trial, validation or approval are progressed through the applicable Product Design & Development controls before routine manufacture.

The procedure makes an important distinction between an approved change and an unplanned deviation. A deviation is managed as a deviation and cannot be used to establish a new routine value, range or method. Revised operating conditions become routine only after the required assessment and approval activities are complete and the affected controlled information has been updated.

Protect critical equipment settings from unauthorised alteration

Where an equipment setting is critical to product safety or legality, the procedure requires the approved value or operating range and its critical status to be identified in the applicable process or equipment instruction. Adjustments are limited to trained and authorised personnel acting within defined authority, while Engineering personnel may restore approved settings following maintenance.

Access restrictions are applied where the equipment design, control interface and associated risk require them. The approved method may use password protection, permission controls, keys, locks, seals, restricted tools, supervisor-controlled access or another suitable restriction. Production supervision maintains the restriction during routine operation and records and escalates unexplained, unauthorised or unverifiable changes for product-status assessment.

Use monitoring to demonstrate that approved conditions are maintained

Process monitoring provides continuing evidence that approved operating conditions are maintained during manufacture. The current instruction defines what is monitored, the applicable value, range or limit, the method and point of measurement, the required frequency and the role responsible for completion.

Monitoring frequency is set with regard to the risk associated with loss of control, process and equipment reliability, the frequency of process change, previous performance and the ability of the chosen method and frequency to demonstrate continuing control. Results are recorded when the activity is completed, including results that identify a deviation. Where a required result is missing and control cannot otherwise be demonstrated, potentially affected product is controlled through the Non-Conforming Product Control Procedure.

Where the monitored control is a critical control point, the procedure directs monitoring to the HACCP – Monitoring of CCPs Procedure, preserving the distinction between routine process monitoring and CCP-specific requirements.

Link in-line monitoring devices with defined failure alerts

For an in-line device that controls a process parameter or product-quality characteristic, the procedure requires a suitable failure alert capable of identifying loss of the monitored function, exceedance of the defined parameter or another defined failure condition in time for an effective operational response.

The alert condition, expected responders and form of alert are defined in the applicable equipment or process instruction. Alert testing is carried out at a defined frequency using an approved method and acceptance criteria, taking account of the significance of the monitored control, equipment and alert design, manufacturer guidance and demonstrated performance. A failed or missed test is reported, with product assessment required where correct operation of the monitored function cannot be demonstrated.

Validate variable processing characteristics and verify them in routine production

Where processing conditions can vary across positions, zones or operating space within equipment critical to product safety or quality, the procedure requires the relevant processing characteristic to be validated before routine use and verified thereafter.

Technical or Quality Management defines the characteristic to be assessed, the required product-safety or quality outcome, operating conditions, equipment positions or zones, validation method and acceptance criteria with Quality and Engineering input. For heat or temperature distribution, validation identifies the least favourable position or zone and demonstrates that the required condition is achieved there.

Validated operating conditions and the required verification characteristic, method, acceptance criteria, frequency and responsible role are then incorporated into the applicable process or equipment instruction. Verification results confirm whether routine production remains within the validated conditions. Where compliance cannot be demonstrated, Technical or Quality Management determines whether further verification, technical investigation, adjustment, repair, equipment modification or revalidation is required, while potentially affected product remains subject to the appropriate product-control route.

Separate operational continuation from product-status decisions

Equipment failure and process deviation each trigger an immediate recorded response, but the procedure does not require production to stop automatically. Production or Operations Management decides whether production may continue under controlled conditions or whether process stoppage is required.

Where production continues, Production Supervision applies any temporary controls and maintains monitoring so that the period of continued operation, the point at which approved conditions are restored and the affected product can be identified. Continued operation is not treated as evidence that product remains conforming.

The procedure separates the operational decision from the assessment of product status. Technical or Quality personnel determine food-safety status where safety may have been affected, while quality and specification conformity may be assessed against predefined acceptance criteria by Production Supervision where that assessment is authorised and demonstrable. Where conformity cannot be established, Technical or Quality personnel determine status. Suspected or confirmed non-conforming product remains controlled through the Non-Conforming Product Control Procedure until an authorised outcome is reached.

For equipment failure, the approved setting or operating condition must be restored through the applicable maintenance and return-to-service controls before routine production resumes. For process deviations, approved operating conditions must be restored and significant, repeated or systemic deviations are directed into the corrective and preventive action process where required.

Control out-of-scope products and materials where they could affect in-scope product

Where the site handles products or materials outside the BRCGS audit scope, the procedure establishes controls to prevent those items from compromising the food safety, authenticity or legality of products within scope.

Technical or Quality Management coordinates the assessment of food-safety effects such as shared equipment, exposed-product areas, allergen cross-contact, microbiological transfer, contamination, rework, by-product or waste routes and movement of personnel or utensils. Authenticity controls address identity, composition, provenance, claim status and chain of custody, while legality controls consider unintended incorporation, loss of identity, incorrect composition, coding or labelling consequences, claim impact and market restrictions.

The applicable control route is then applied through the relevant FSQMS procedures, including layout and segregation, allergen management, contamination control, authenticity and chain of custody, traceability, labelling and coding, non-conforming product control and incident escalation where the affected product has left site control.

Allocate responsibility across technical, operational and engineering functions

Senior Management provides the resources and authority required for effective production control. Technical or Quality Management owns the process-control system, approves and controls process specifications and manufacturing instructions, keeps monitoring, validation and verification aligned with approved product specifications, legal requirements and the food safety plan, and determines product status where loss of control may have affected conformity.

The Product-Development function establishes and scales recipes and trial-derived process parameters through the applicable gated process, while the HACCP Food Safety Team determines the food-safety controls, critical control points and hazard-management requirements that must be reflected in production controls.

Production or Operations Management implements the controls and holds the authority to decide whether production may continue under controlled conditions or must stop following a significant failure or deviation. Production Supervision maintains access to current instructions, monitoring completion and restrictions on critical settings, while Engineering supports setting restoration, access restriction, equipment-related failure response, validation, verification and alert testing. Production and Operations personnel follow the approved requirements, complete monitoring records at the time of activity and report failures, deviations or missed checks without delay.

A control-of-operations procedure within the wider FSQMS

Within the Food Industry Hub FSQMS Policies and Procedures Suite, this procedure links approved product and process requirements with the controls used during manufacture. Its interfaces with product development, HACCP, document and specification control, equipment and maintenance management, calibration, labelling and packing, storage, non-conforming product control, corrective action, traceability and incident management show how normal operating control and loss-of-control response remain connected to the wider FSQMS.