Elements and Performance Criteria
- Establish the scope of the QA system
- Define the enterprise needs and expectations in product quality
- Detail existing systems and requirements for incorporation into the QA system
- Define the scope of the CCP-based quality system to encompass production system and product requirements
- Design the system to prevent and control identified hazards
- Conduct hazard analysis and assessment
- Assess every step in the production process for potential food safety hazards
- Establish CCPs to identify where each significant hazard can be prevented or controlled
- Assign a measurable or recognisable standard for each CCP to define the critical limits
- Validate the critical limits technically and scientifically
- Ensure all documents, work procedures and processes required for the system are developed, available and in use
- Describe all products and processes covered by the QA system in a standardised format defining product characteristics relevant to food safety
- Review work instructions and standard operating procedures (SOPs) for accuracy, relevance and sufficiency to prevent hazards
- Implement documented procedures for monitoring CCPs
- Implement documented procedures to ensure any CCPs that are outside critical limits are brought back within limits, and affected product is suitably handled
- Implement documented procedures to ensure the QA system is regularly verified and audited as working effectively
- Maintain the availability and data storage of all records and documents for the system
- Respond to non-conforming product or processes
- Identify procedures for taking corrective action
- Implement corrective and preventative measures to prevent recurrence
- Develop or revise procedures to support control measures
- Identify processes or conditions that could result in a breach of procedures, and take corrective action
- Introduce process changes and control so that quality assurance requirements are accomplished
- Review product sampling and test results
- Audit, verify and validate the system
- Revise, verify and validate safety plans to reassess hazards, CCPs, critical limits, testing methods and all related procedures of the QA system to ensure they are appropriate to the enterprise requirements
- Follow up and act on internal or external audit findings
- Investigate and act on reported quality hazards and non-conformances
- Review the CCP-based QA system to take account of any process changes or product specifications