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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 Document and Data Control within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
Documentation is data presented in a form that is meaningful to the recipient. It adds to knowledge and is relevant to the situation. Two types of documentation are policies and procedures. A document requires control if it provides guidance or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services customers receive. Data becomes documentation when it is transformed to communicate meaning or knowledge, ideas, or conclusions. By itself, data is meaningless. The attributes of an effective sample of documentation include accuracy, form, frequency, scope, origin, and time. Attributes of any set of documentation are relevance, completeness, and timeliness. In the context of contemporary food safety and quality systems, the term documentation may also be used broadly to include records and digital data.
Document control is one of the most critical components of the quality management system. Effective document and data control ensures that a food business can be confident that they are using the current version of a document, and the information contained in these documents has been approved by management. All documents related to operational food safety and quality programs must be managed appropriately and must be accessible for the verification of the operational scope of the program. The general requirement for effective document control is for each page to be authorized, and to include an issue date. All documents and monitoring/verification forms should be available in a digital format and may be photocopied from an original as required. All used forms and documents must be archived, recycled, or destroyed appropriately. Procedural and policy documents must be available for general use in a read-only format. Copies of this material may be printed, but general access to the alteration of such material must be strictly governed. The review of documents and records must be undertaken at programmed intervals to verify the operation of the food safety program.
The Food Safety and Quality Management System should include specific requirements for Documentation and Data Control, which may include:
Document registers and Amendment registers are commonly used to verify documentation control.
In an age where computers play a leading role in the management of data and digital information, systems must be implemented and maintained to ensure digital data is protected against loss or corruption. Such data may be securely managed through the implementation of structured system backups, which include defined contacts and responsibilities.
Where an external contracted data or document storage service provider is used, the service provider should be managed through the approved supplier process to ensure appropriate outcomes.
Documentation and records associated with any food business operation should be maintained and retained for a period that exceeds the shelf life of the product, including where final product customers may extend the product’s shelf life. These may include documentation and records for HACCP monitoring, processing, production, and distribution. Food industry or regulatory standards may also specify the timeframes for document and record retention commensurate with the products or processes involved. Defined timeframes should also be allocated for the retention and control of obsolete or superseded digital data or files.
The requirements of any science-based Food Safety Management System include, but are not limited to the following systemic examples to ensure adherence to relevant legislative requirements and food industry sector guidelines:
Elements that are common to any quality management system include:
Documentation and Record-Keeping requirements for:
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:
A record of training should be kept for every employee that undergoes training no matter how short the employment term is. Each record should detail the type of training given, the date, and a brief outline of content and signatures of both the trainer and the trainee. Copies of any relevant formal training an employee has undergone externally should also be kept in the training record. Training records should be kept on file for the lifetime of an employee.
A training matrix is a useful document to track and summarize all employees against all the different types of training that may be given. Degrees of competency may also be captured in a training matrix.
Signage is an important part of the communicative processes within any food business and can further enhance the consistent application of high-level outcomes. As with other system elements, Signage should also be controlled in a manner that ensures it is accurate and represents current requirements. Signage should be managed similarly to how other system documentation is managed.
Examples of ways in which this may be achieved may include:
External Documentation must also be controlled to ensure available versions are current. This is commonly facilitated by including the Name and Version of External Documentation within site Document Register formats.
Examples of External Documentation may include:
Amendment Registers should also be updated to show where updates to External Documentation have been facilitated.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Document and Data Control 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 Document and Data Control:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Document and Data Control Documentation requirements in relation to their items.
You may wish to visit the Document and Data Control Templates section of haccp.com for examples of Document and Data Control 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 Document and Data Control 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 Document and Data Control do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Document and Data Control 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 Document and Data Control 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 Document and Data Control 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 Document and Data Control 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 Document and Data Control:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Document and Data Control Monitoring requirements in relation to their items.
You may wish to visit the Document and Data Control Templates section of haccp.com for examples of Document and Data Control 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 Document and Data Control related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Document and Data Control 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, Food Safety and Quality 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 Document and Data Control:
To ensure that the document and data control system is effective, an internal audit of the system at least annually is recommended.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Document and Data Control 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 Document and Data Control:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Document and Data Control 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 Document and Data Control must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Document and Data Control should have knowledge including:
Team members who have defined responsibilities regarding Document and Data Control should have skills including:
Team members who have defined responsibilities regarding Document and Data Control 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 Document and Data Control 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.