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Corrective Action and Preventative Action

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Training participants will gain a basic understanding of Corrective Action and Preventative Action and its applications within food safety and quality systems. Basic knowledge competency will be verified through successful completion of the accompanying Corrective and Preventative Action assessment activity. Basic skill competency can be verified through the Corrective Action and Preventative Action competency checklist available as a resource for this training activity.

Key Definitions For Corrective Action and Preventative Action
- Corrective Action: Corrective action is mandatory action to be taken when a deviation to the Quality System occurs, particularly in relation to a Critical Control Point. Examples of corrective action could be: Removal of foods from a broken down chiller and organizing for the chiller unit to be repaired or further heat treatment to a product which did not reach the required cooking temperature defined as a critical limit.
- Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place. Examples of preventative action are: Maintaining correct storage conditions for food products; Ensuring that food products are properly rotated in storage and Regular scheduled maintenance of equipment and premises.
- Root Cause: The source of the problem or reason from which a non-conformance has occurred.


Corrective Action and Preventative Action Development
When considering the development, documentation and implementation of Corrective Action and Preventative Action within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

About Corrective Action and Preventative Action
The application of Corrective Action within any food business relies on a structured process to consider root cause of an identified non-conformance, and the applications of measures to ensure food safety and quality parameters are maintained on an ongoing basis.

Corrective Action processes commonly include the following elements, which are presented in a logical sequence for a scenario in which a non-conformance has been identified:
- Apply Corrective Action;
- Corrective Action Documentation;
- Corrective Action Verification, Review and Notification;
- Root Cause Analysis;
- Root Cause Documentation;
- Apply Preventative Action;
- Preventative Action Documentation;
- Preventative Action Review and Notification.

Apply Corrective Action
This step includes the immediate application of ‘physical’ Corrective Actions to bring the process back into control, to ensure the safety and quality of foods produced.

Common Corrective Action applications may include:
- Segregation, identification and evaluation of suspect and confirmed affected food products;
- Ceasing production until ‘control’ has been re-established;
- Following specific Corrective Action requirements nominated within the HACCP plan where the non-conformance is related to a CCP or QCP;
- Initiating 'non-conforming product' procedures and protocols.

Corrective Action Documentation
This step includes the documentation of details of the non-conformance and applied Corrective Actions.

Requirements commonly considered for the documentation of Corrective Actions include:
- Date, time and area of the non-conformance;
- Person who identified the non-conformance;
- Person responsible for the non-conformance;
- Person responsible for Corrective Action;
- Details of the related non-conformance and reason for the Corrective Action;
- Immediate actions taken, applied or implemented, and by whom;
- Details of recommended Preventative Actions with timeframes for completion where applicable.

Corrective Action Verification, Review and Notification
This step includes the verification of the effectiveness of the applied Corrective Actions. Corrective Action verification commonly includes s structured review process to ensure key positions within the food business are aware of the non-conformance and its associated Corrective Actions.

Corrective Action review and notification elements may include contacting relevant parties, including Senior Management, Customers and Regulatory Bodies where applicable. This process element may include the defining of timeframes for full implementation of Corrective Action and Preventative Action.

Root Cause Analysis
This step includes the conducting an analysis to define the root cause of the non-conformance. A root cause analysis activity must be used as an objective tool to determine and document the cause of the non-conformance for which Corrective Action has been applied.

Root cause analysis must be applied in the holistic sense, including a review of potential causes such as:
- Staff interactions, including effectiveness of training and competency for required tasks related to the identified non-conformance;
- Resource allocations, including those for financial and human resources;
- Premises and equipment failures;
- Raw material failures, including inputs such as ingredients and packaging;
- Failures of pre-requisite programs;
- Failures of approved suppliers or service providers;
- Failures of the HACCP systems to identify significant hazards, appropriate control measures and documented Corrective Actions;
- Failures of previous Corrective Actions and Preventative Actions;
- Failures of organizational structure or position descriptions;
- Failures of Senior Management against the documented Food Safety and Quality Policy.

Root Cause Documentation
This step includes the documentation of the details of the defined root cause.

Requirements commonly considered for the documentation of root cause include:
- Date, time and area of the root cause;
- Person who identified the root cause;
- Person responsible for the root cause;
- Details of the root cause in relation to the applied Corrective Action;
- Details of recommended Preventative Actions with timeframes for completion where applicable.

Apply Preventative Action
This step includes the application of Preventative Action to prevent re-occurrence of the initial non-conformance.

Common applications for Preventative Action may include:
- Permanent rectification of the root cause through considered and approved applications;
- Delegation and release of financial or human resources to ensure the non-conformance does not occur again;
- Staff training to ensure general and specific awareness of the non-conformance, Corrective Action and Preventative Action;
- Management review of the ongoing outcomes following finalization of the non-conformance through Corrective Action and Preventative Action.

Preventative Action Documentation
This step includes the documentation of the details of the applied Preventative Actions.

Requirements commonly considered for the documentation of Corrective Actions include:
- Person who identified the Preventative Action;
- Person responsible for the Preventative Action;
- Details of the related non-conformance, Corrective Action and reason for the Preventative Action;
- Details of decided Preventative Actions with timeframes for completion where applicable.

Preventative Action Review and Notification
This step includes a review of Corrective Action and Preventative Action outcomes with relevant parties, including Senior Management, Customers and Regulatory Bodies where applicable.

A review of applied Corrective Actions and Preventative Actions should also be conducted as elements of the scheduled Management Review process to ensure general and specific awareness of related issues and incidents.

Waivers
A ‘waiver’ is a common change management tool used within food businesses where un-avoidable temporary allowances are made to a defined and documented process or product.

A waiver commonly takes the form of a document that includes the following information:
- Date, time and area for the waiver or 'change' to process or product;
- Person who identified the requirement for the waiver or 'change' to process or product;
- Person responsible for the waiver or 'change' to process or product;
- Details of the proposed waiver or 'change' to process or product;
- Details of potential impacts to the product through the proposed waiver or 'change' to process or product;
- Details of potential impacts to the process through the proposed waiver or 'change' to process or product;
- Details of potential impacts to safety through the proposed waiver or 'change' to process or product;
- Details of potential impacts to quality through the proposed waiver or 'change' to process or product;
- Details of potential impacts to the food business through the proposed waiver or 'change' to process or product.

Once formatted, waivers are commonly approved by documented signatures by key senior management and those responsible for food safety and quality.

It is generally considered appropriate to apply 'waiver' managed changes to process or product, providing that:
- A rational risk assessment methodology has been applied to ensure no un-acceptable negative impacts or outcomes are achieved from their application;
- Senior management and key personnel officiate over the decision to approve a ‘waiver’;
- Key customers and stake holders are also appropriately involved within the process to approve a ‘waiver’. Where Customer Specifications are defined for finished products or processes to which a ‘waiver’ is to be applied, it is important to consider that documented approval may also be required from such customers prior to the actual application of such a ‘waiver’.

Non-conforming Product
It is important to ensure that items identified as non-conforming, whether they be raw materials, work in progress or finished products, are specifically covered within the Product Identification and Traceability procedures. It is common for non-conforming product to be segregated from conforming products stock to ensure no 'mix-ups' can occur. Non-conforming products are commonly labelled with brightly coloured signage or labels to ensure they are easily identifiable. The control of non-conforming products is often linked to procedures for hold and release of such products.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Development requirements in relation to their items.


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