Principle

A procedure must be provided for appropriate action to be taken in the event of product or service non‐conformity that could impact on product safety, legality or other specified quality characteristics. This procedure needs to provide for the corrective actions to be taken on identification of non‐conformance, determining the extent and the implications of that non‐conformance and the appropriate actions to be taken. Preventive actions are those activities undertaken as a result of identification of a weakness in the management system that has yet to lead to non‐conformity, but could if not addressed lead to non‐conformity in the future.

General

28.1 Major non‐conformance is defined as a food safety management system (FSMS), food integrity management system (FIMS) or quality management system (QMS) failure or fault that could give rise to a food safety hazard, integrity threat or major product quality defect. However, if minor non‐conformance persists or if a trend is noted in a series of minor non‐conformance, this sequence of events could be deemed major.

28.2 A procedure should be developed and implemented by the quality control manager to ensure that, once identified, non‐conforming items are clearly identified, segregated and/or otherwise controlled so that unauthorised or inadvertent use is prevented and disposal is formally agreed and recorded (see Chapters 27 and 29). The procedure should also ensure that all events of non‐conformity are fully and adequately recorded.

28.3 Routine inspection, monitoring or verification activities, incorporated within the QMS, FSMS or FIMS, may identify instances of non‐conformance. Routine inspection, monitoring or verification procedures must identify the actions to be taken in the instance that non‐conformance of product or service is identified.

28.4 Corrective action procedures should be established not only for the manufacturing process, but also during receipt, storage and distribution, including the transport of raw, part‐processed and finished products.

28.5 All corrective action should be documented on the appropriate records that identify:

• the date the form is completed;
• details of the actual nature of the non‐conformity;
• product details, including traceability information, so that the batch(es) involved can be identified;
• how much material and/or product is affected;
• location of the material and/or product, for example on‐site or through the distribution chain;
• the root cause of the non‐conformity (see 28.7);
• the required action to be taken, including the need for product recall or product withdrawal;
• the timescale for the required action;
• who is responsible for undertaking that action;
• that all parties have accepted the non‐conformity and agreed the appropriate corrective action;
• who is accountable for the decision on the corrective action necessary; and
• who is responsible for ensuring corrective action has been undertaken and is effective.

28.6 Internal audits may identify evidence of non‐conformity and necessitate the requirement for corrective action. If there are a number of corrective actions, the auditor should develop a corrective action plan (see 11.9–11.14).

28.7 Corrective action plans should address the following:

• ensuring all raw materials, ingredients, processing aids, packaging and part‐processed and finished products are safe, legal and comply with specifications;
• minimising any impact on the customers and ensuring the non‐conformity does not occur again;
• the importance of the non‐conformity, i.e. whether the non‐conformity is minor, a one‐off incident, a repeated minor incident or a major system failure; and
• the resources required to implement corrective action in terms of financial resource, training, personnel and the development of documentation and follow‐up activities to ensure it has been effective.

Corrective action plans need to be reviewed by the quality control manager or designate to ensure that the required actions are undertaken by the designated date and the actions are effective. The corrective action plan needs to take into account both the immediate corrective action to ensure that the non‐conforming product is brought back under control and the longer‐term corrective action that addresses the root cause of the non‐conformance. Root cause analysis can take many forms and follow specific mechanisms, but essentially it is a structured management approach that identifies the factors that resulted in the non‐conformance in order to determine the most appropriate corrective or preventive action. The factors that could be considered include the actual nature of the non‐conformance, the magnitude (major or minor) and the consequences of the problem in order to identify the actions, conditions or behaviours that need to be changed to prevent reoccurrence and/or other similar problems from occurring. Conditions can include processing parameters, procedures, protocols or standards implemented in the manufacturing operation.

28.8 Areas of non‐conformity and the status of corrective actions as well as the effectiveness of previous corrective actions provide input to the management review process (see Chapter 11).

28.9 Corrective action must be followed up at an appropriate interval to ensure that the corrective action has been implemented and has been effective. Verification activities to assess effectiveness of corrective action include:

• review of monitoring results, giving feedback on the effectiveness of the corrective action;
• product testing, for example shelf‐life testing and microbiological testing; and
• follow‐up audits to ensure that the non‐conformity identified is now under control.

Customer Complaints/Depot Rejections

28.10 Corrective action arising as a result of customer or consumer complaints (see Chapter 27) and/or customer depot rejections needs to be formally controlled. The quality control manager should develop procedures that define how all quality aspects of distribution activities will be coordinated (see Chapter 32).

28.11 The quality control manager, or designate, should make a formal assessment of the product on its return to determine the correct disposal. The quality control manager should develop an appropriate documented procedure with associated forms to control this process, including the responsibilities of key individuals in the formal decision making. Routine analysis of the records should be undertaken to determine trends and any additional corrective action that may be required.

28.12 If product is reworked or regraded and then redistributed, records must be maintained to ensure traceability to the original batch details and associated records (see Chapter 29).

Preventive Action

28.13 Preventive action arises following identification of a weakness in the FSMS, QMS or FIMS as a result of inspection, monitoring or verification, including audits and management review processes, trend assessment and risk analysis. Preventive action is designed to eliminate the cause of a potential non‐conformity and prevent it occurring in the first place. Preventive action is a proactive rather than a reactive activity, and a preventive action plan forms part of the manufacturing organisation’s continuous improvement plan. Preventive actions also can be implemented to improve production efficiency, assess new technology or new methods or procedures, improve skill levels and staff knowledge or to reduce repetition in the formal documented systems. Preventive action plans should be established, formally agreed and reviewed at designated intervals to ensure that the preventive actions have been completed and are effective.

28.14 Preventive action is especially important when considering potential criminal activity that could be perpetrated on the manufacturing site (see Chapter 7). Preventing and reducing the risk of criminal activity is more effective than reacting to crime should it occur.

28.15 Corrective and preventive action (CAPA) is a term often used in good manufacturing practice (GMP), hazard analysis critical control point (HACCP) and threat analysis critical control point (TACCP) to describe the processes organisations undertake to eliminate non‐conformity and to develop a continuous improvement programme that is appropriate to the products manufactured and the processes employed. Essential within a CAPA process is the use of root cause analysis in terms of potential and actual non‐conformity associated with materials, products, processes, people and the formal management systems (see 28.7). The steps of the CAPA process can be described as:

1. Identify the problem, failure or weakness.
2. Determine the root cause.
3. Determine the corrective or preventive action.
4. Implement the action.
5. Review and audit: follow up to ensure action is effective.
6. If the action is ineffective then follow previous steps and implement additional corrective action.
7. Analyse the system for further areas requiring CAPA.

The CAPA process should be fully documented, including maintenance of all records of actions undertaken and their effectiveness. There are multiple tools available to assist in root cause analysis, including Ishikawa or fishbone diagrams, the 5 Whys approach, Pareto analysis and so on.