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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 Good Laboratory Practices within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
It is not uncommon for food businesses to conduct their testing of raw ingredients, work in progress, or finished products, particularly for testing against microbiological or chemical criteria. It is important that these and other related activities do not have an impact upon the safety of the foods being produced onsite, and that the results are accurate. It is also important to ensure that any contracted laboratory services are also operating within the confines of established Good Laboratory Practices.
Good Laboratory Practices commonly include requirements for:
Systems should be developed, documented, and implemented to ensure appropriate outcomes regarding the organizational structure covering the scope and purpose of the laboratory facility. This should ideally include a defined organizational structure showing reporting channels and a clear definition of requirements for the covering of absences within key positions. Position descriptions should also be developed, displaying clear nominations for the qualifications and experience of key personnel participating in laboratory activities.
Management responsibilities should be defined to include requirements for:
A quality assurance program should be developed, documented, and implemented to include requirements for:
The responsibilities of the quality assurance personnel should include, but not be limited to, the following functions:
Requirements for laboratories and testing facilities and amenities should be defined to include:
Requirements for laboratory testing equipment and materials should be defined to include:
Requirements for testing systems should be defined to include:
Requirements for test and reference substances should be defined to include:
Standard operating procedures should be developed, documented, and implemented, including the following requirements:
Reporting of testing results must be appropriately structured to include general and specific information regarding the scope and purpose of the testing conducted.
Testing results reports should include:
As with any management system, Good Laboratory Practices rely on well-developed document and record control procedures to ensure traceability and appropriate outcomes.
The following requirements should be considered regarding the storage of testing records and reports;
– Record and report archives should be designed and equipped for the accommodation and the secure storage of all relevant notes, data, and outcomes of tests conducted, including final reports, quality assurance verification activities, and samples and specimens where applicable. Materials stored in such archives should be appropriately indexed to facilitate orderly storage and rapid retrieval when required;
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Laboratory Practices 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 Good Laboratory Practices:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Laboratory Practices Documentation requirements in relation to their items.
You may wish to visit the Good Laboratory Practices Templates section of haccp.com for examples of Good Laboratory Practices 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 Good Laboratory Practices 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 Good Laboratory Practices do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Good Laboratory Practices 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 Good Laboratory Practices within 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 Good Laboratory Practices 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 Good Laboratory Practices 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 Good Laboratory Practices.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Laboratory Practices Monitoring requirements in relation to their items.
You may wish to visit the Good Laboratory Practices Templates section of haccp.com for examples of Good Laboratory Practices 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 with 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 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 Good Laboratory Practices related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Laboratory Practices 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.
Good Laboratory Practice Corrective Action and Preventative Action Key Points
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 Good Laboratory Practices:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Laboratory Practices 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 Good Laboratory Practices:
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 Good Laboratory Practices must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Good Laboratory Practices should have knowledge including:
Team members who have defined responsibilities regarding Good Laboratory Practices should have skills including:
Team members who have defined responsibilities regarding Good Laboratory Practices 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 Good Laboratory Practices 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.