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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 Validation Activities within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
Many processes within food safety and quality system require both validation and verification to ensure the ongoing status of food safety and quality. Validation of a process is the pre-production checking of that process to ensure that the requirements of a product can be met, for example, shelf life. The following information is provided as a guideline covering validation steps, validation process, and requirements for re-validation.
It is important to consider that validation processes are often defined against the responsibilities of food businesses and regulatory bodies. The scenarios for applications are defined as follows:
Validation within food businesses is primarily focused on the collection and evaluation of scientific, technical, and observational information to determine whether control measures are capable of achieving their specified hazard control purpose. The validation process involves measuring performance against the desired outcome, target, or measurable parameter. The validation process is generally applied at the time new control measures are applied within a food safety system, or when the product or process changes require re-validation. Validation of control measures for food safety management systems are generally intended to be applied before the actual implementation of production under the food safety system involved.
The key defining difference between validation and verification is that verification takes place after the validated control measures have been implemented through a food safety system. Verification is the tool used to assess the effectiveness of the validated control measures and to ensure that the validated control measures are controlling potential hazards as anticipated.
Verification activities are applied during or after the food operation to determine that the validated control measures have been effectively implemented to achieve ongoing control of the relevant identified hazards. Common verification methods include a review of records to ensure the applied control measures have been applied according to the defined critical limits or procedures. This differs from the act of completing the monitoring activities and records themselves, in that the verification element is to confirm that the control measures were monitored and recorded at the specified frequency according to the nominated procedures.
Verification activities can target single or multiple control measures in their application. Examples of this are provided as follows:
A structured validation process may include the following steps:
Application of the HACCP Methodology to determine CCPs, Critical Limits, and Control Measures. HACCP Plans, by their nature, will identify control measures and their associated critical limits where applicable.
Identification of the required food safety outcome. For example, a regulatory limit on a specified pathogenic micro-organism might be a count of 1000 per gram; your food business may decide to set your internal limit for the pathogenic micro-organism at 100 per gram, giving you more control over conforming outcomes. In defining the food safety outcomes applicable to your business operation, it is important to consider the financial, human, and premises, and equipment resources at your disposal to ensure realistic outcomes are set. In instances where no regulatory limits are set, the food business may be required to define a limit that is achievable and is not likely to result in food-borne illness within consumers.
Identify which control measures require validation, considering the importance of each control measure to the expected control of the relevant hazard and whether the control measure should be validated by itself, or whether combinations of control measures should be validated together. In most cases, steps identified as CCP’s within a HACCP Plan will require some form of validation.
Identify whether the control measure has been validated previously with appropriate outcomes, or whether the control is well established and supported by relevant validation materials. In either scenario, it is important to ensure that the process inputs, process flow, process equipment, and product and process conditions were the same for the previous validation of relevant validation materials.
Apply a risk-based approach to the application of validation. Dependent on the financial and human resources available to complete validation activities, your food business may or may not be able to complete a comprehensive activity for each control measure. For example, you may wish to prioritize the validation of control measures, which if not appropriately validated are likely to result in a food-borne illness outbreak. Control measures with less severity significance can be validated at a later time. In cases where a significant control measure is related to a new product or process variant that has no accompanying historical food safety performance data, validation must be completed. In cases where historical data is used to support a control measure validation; it is of utmost importance that the data used is applicable to the current status of emerging pathogens or identified food-borne illnesses occurring in similar products occurring since the historical data was published.
The actual application of any validation activity depends heavily on the nature of the hazards being controlled through the application of control measures and their critical limits. Considerations also need to be made for the consistency of the control measure and the required ongoing accuracy of hazard control required. Whilst the methods of application for validation may vary significantly, the goal of such activities is the same; to ensure the control measure is capable of facilitating safe food.
The following references are commonly used as elements of the validation process:
Re-validation should be scheduled and conducted where:
The consideration of the Worst-Case Scenario is of utmost importance for any Validation Activity, as this provides a framework through which Validation outcomes can provide a high degree of confidence in the control of potential hazards. When considering Validation Worst Case Scenario, it is important to be aware of the relevant potential hazard, and any associated Critical Limits and Control Measures applied to that potential hazard at any step within the process flow. The ultimate goal is to ensure that your Validation activity is conducted in a manner that demonstrates the effectiveness of your implemented process controls to ensure any potential hazard does not occur.
Examples of applications of Worst-Case Scenario considerations may include:
Details of the Worst-Case Scenario considerations should be referenced within related Validation documentation to support product and process compliance outcomes.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Validation Activities 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 Validation Activities:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Validation Activities Documentation requirements in relation to their items.
You may wish to visit the Validation Activities Templates section of haccp.com for examples of Validation Activities documentation, record, and resource formats commonly applied within food safety and quality systems.
We have developed a methodology to ensure Food Safety and Quality Programs retain a sense of relevance among today’s vast business management systems… We call it the “SoLFS” Method. SoLFS stands for Sequence of Logical Food Systems!
You’ll see the SoLFS method used throughout haccp.com, including our one-of-a-kind Food Safety and Quality Program Manual functionalities. The use of the SoLFS methodology from Development, through to the Formatting and Training of Food Safety and Quality Programs provides a consistent framework that facilitates consistent application and consistent outcomes.
We’ve defined what we believe to be the most logical manner of facilitating the Development, Formatting, and Training of Food Safety and Quality Programs:
Validation (as a Food Safety and Quality Program concept) commonly comes logically before Verification. Our rationale for listing Validation after Verification is to ensure food businesses are aware of their capability (and associated required human and financial resources) for their required Verification Activities. We prefer to ensure food businesses are aware of their Verification requirements before establishing their Validation references, as this allows for flexibility in the saving of time and resources.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Validation Activities 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 Validation Activities do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Validation Activities 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 Validation Activities 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 Validation Activities 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 Validation Activities 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 apply to Validation Activities:
The outcomes of Validation Activities are commonly displayed as a Validation Study. This format is commonly inclusive of the applied validation steps and their outcomes, including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Validation Activities Monitoring requirements in relation to their items.
You may wish to visit the Validation Activities Templates section of haccp.com for examples of Validation Activities 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, preventive action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action is 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 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 Validation Activities related to non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Validation Activities Corrective 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 apply to Validation Activities:
It is important to consider that Validation Activities themselves require Verification to ensure their ongoing effectiveness and appropriateness. In this context, Verification of Validation Activities is commonly termed as re-validation.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Validation Activities 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 validation 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 Validation Activities:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Validation Activities 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 specified job-related task.
Training and competency requirements for Validation Activities must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Validation Activities should have a knowledge including:
Team members who have defined responsibilities regarding Validation Activities should have skills including:
Team members who have defined responsibilities regarding Validation Activities 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 Validation Activities 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.