Corrective & Preventive Action Procedure

Control non-conformances from identification to formal closure

Non-conformances can arise through audits, inspections, monitoring, verification, complaints, incidents, trend analysis or routine operational activity. The procedure requires each non-conformance to be recorded with the source and date of identification, the affected area, process, product or activity, an assessment of potential impact on food safety, legality, authenticity or quality, and details of any immediate corrective action.

That impact assessment is carried out by suitably competent and authorised personnel. Where a non-conformance or unsafe situation is identified, immediate corrective action is required to control the issue and prevent further impact. Depending on the circumstances, this may include control or isolation of affected product or process, suspension of activities or equipment, temporary controls, or initiation of the separate Non-Conforming Product Control Procedure.

Immediate action does not replace investigation or any further corrective action that the findings require.

Apply root cause analysis where risk or trend requires it

All non-conformances are investigated to determine their cause and significance. Root cause analysis is mandatory where a non-conformance places food safety, legality or authenticity at risk, or where an adverse trend in quality or compliance is identified. In other cases, the need for root cause analysis is determined according to severity, frequency and professional judgement.

Where required, the analysis must be structured and proportionate to the nature and impact of the issue, with recognised techniques such as Five Whys or cause-and-effect analysis used as appropriate. The outcome is documented so that the identified causes and the rationale for subsequent corrective and preventive actions remain clear.

Separate corrective action from preventive action

The procedure distinguishes corrective action from preventive action rather than treating them as interchangeable.

Corrective actions address identified non-conformances and restore effective control of the affected process, product or system. They may be evident without formal root cause analysis or may arise from root cause findings, but they must be appropriate to the risk and impact of the issue, address the non-conformance and proximal contributing factors, and have defined responsibilities and completion timescales.

Preventive actions arise from root cause analysis, identified weaknesses in processes or controls, or adverse trends. They are systemic in nature and focus on removing the conditions that allowed the non-conformance to occur, strengthening the effectiveness of the FSQMS and reducing the likelihood of recurrence.

Place responsibility where investigation, action and closure are controlled

Technical or quality management owns the corrective and preventive action process. Its responsibilities include timely identification and recording of non-conformances, arranging competent impact assessment, deciding when root cause analysis is required, defining and documenting actions, assigning responsibilities and timescales, verifying effectiveness, confirming formal closure, analysing trends and escalating significant non-conformances or adverse trends to senior management in accordance with defined criteria.

Senior management provides the resources needed for effective investigation and action, reviews significant non-conformances, adverse trends and systemic issues, and makes business-level decisions where risks affect product, customers or the business.

Department managers and functional leads implement immediate and assigned actions within their areas and ensure affected personnel are informed of resulting changes. Employees are required to report non-conformances, incidents and unsafe situations promptly, cooperate with investigations and follow updated controls or instructions.

Verify effectiveness before an action is formally closed

Corrective and preventive actions are implemented within agreed timescales and are not formally closed simply because the assigned task has been completed. The procedure requires effectiveness to be verified first.

Verification confirms that the non-conformance has been adequately addressed, root causes have been eliminated or controlled, and the likelihood of recurrence has been sufficiently reduced. Evidence may come from record review, follow-up checks, audits or performance monitoring. Formal closure follows only once that effectiveness has been verified.

Use trend analysis and controlled interfaces to strengthen the FSQMS

Corrective and preventive action records are reviewed for recurring issues, adverse trends and systemic weaknesses. Outputs from that analysis support continual improvement and are reported through management review where appropriate.

Where actions change procedures, specifications, training or other controls, the resulting changes are managed through the relevant document, record, specification and competence procedures. The Corrective & Preventive Action Procedure also maintains clear boundaries with separate controls for non-conforming product, internal auditing, and incident management, product withdrawal and recall.

These interfaces allow corrective and preventive action to operate as an improvement mechanism within the wider FSQMS without absorbing the responsibilities of the procedures that identify, contain or manage other types of event.