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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
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:
The application of Corrective Action within any food business relies on a structured process to consider the 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:
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:
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:
This step includes the verification of the effectiveness of the applied Corrective Actions. Corrective Action verification commonly includes a 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 processing element may include the defining of timeframes for full implementation of Corrective Action and Preventative Action.
This step includes analyzing 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:
This step includes the documentation of the details of the defined root cause.
This step includes the application of Preventative Action to prevent the reoccurrence of the initial non-conformance.
Common applications for Preventative Action may include:
This step includes the documentation of the details of the applied Preventative Actions.
Requirements commonly considered for the documentation of Corrective Actions include:
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.
A waiver is a common change management tool used within food businesses where unavoidable 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:
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 a process or product, providing that:
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 a non-conforming product to be segregated from conforming product stock to ensure no ‘mix-ups’ can occur. Non-conforming products are commonly labeled with brightly colored signage or labels to ensure they are easily identifiable. The control of non-conforming products is often linked to procedures for the 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.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Corrective Action and Preventative Action:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Documentation requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action Templates section of haccp.com for examples of Contract Review documentation, record, and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Corrective Action and Preventative Action within any food business requires genuine commitment from senior management, staff, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcomes of Corrective Action and Preventative Action do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Corrective Action and Preventative Action must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing Corrective Action and Preventative Action within the food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored and or self-adjusted when variances are identified. Regardless of the system used; The goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional Corrective Action and Preventative Action monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
Common monitoring activities and record formats may be applicable to Corrective Action and Preventative Action:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Monitoring requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action Templates section of haccp.com for examples of Corrective Action and Preventative Action documentation, record, and resource formats commonly applied within food safety and quality systems.
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.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure that any identified non-conformance issues are documented, investigated, and rectified within appropriate time frames. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability. Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Corrective Action and Preventative Action related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans, and their operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may be applicable to Corrective Action and Preventative Action:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing. The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of the limits of control or acceptability for Corrective Action and Preventative Action:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specific job-related task.
Training and competency requirements for Corrective Action and Preventative Action must be ongoing, including regular scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Corrective Action and Preventative Action should have knowledge including:
Team members who have defined responsibilities regarding Corrective Action and Preventative Action should have skills including:
Team members who have defined responsibilities regarding Corrective Action and Preventative Action should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Corrective Action and Preventative Action Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.