Module 4 Flashcards
The common elements of Corrective And Preventive Action are?
Identify the non-conformance or opportunity
Implement immediate corrective actions to secure food safety or quality
Determine what caused the non-conformance using root-cause analysis tools
Determine the appropriate actions to prevent recurrence of the non-conformance
Implement the actions
Verify that corrective and preventive actions have been implemented and are effective.
What are the intentions of corrective actions?
The intentions of corrective actions are to identify problem areas, correct them, and put controls in place to prevent recurrence.
What is recommended to determine if the CAPA process is effective?
An ongoing trend analysis.
Choose all the statements that are true about CAPA.
Corrective actions are documented on the Corrective Action Request (CAR). The CAR includes accountability and tracking details. A formal closure and verification procedure is necessary. Significant corrective action issues should be added to the audit program for future monitoring.
What is the minimal information to be recorded during the audit?
Documents that were reviewed
Personnel interview notes
Observations of equipment, products, and procedures
Statements of conformance and non-conformance
How is an audit finding defined?
An audit finding is substantiated by objective evidence.
An audit finding is a statement of fact made during an audit
FOCUS meaning
Factual, Objective, Concise, Understood, Stand
What do audit findings show?
Whether audit criteria are being met or are not.
Opportunities for improvement or to identify best practices.
Choose all the statements that are true about objective evidence.
It may be based on described observations or interview reports.
It is information that shows or proves that something exists or is true.
Objective evidence is factual
What type of information do you document to make the audit report credible and factual?
Observations must be credible and factual. Always document what was observed, where it was observed, and why it is a poor practice.
What is the timing for implementation of corrective actions dependent on?
The extent of the immediate correction.
The severity of the non-conformance.
What type of information is referred to when preparing the summary report?
Information related to food safety risks and business risk.
Information about costs (preventive cost, assessment cost, correction cost).
Information related to ROI and continuous improvement
Why is the audit report important?
It is an important contributor to the process of initiating corrective action and continual improvement of the food safety and quality system.
What factors are detailed in the corrective action approach?
The procedure reference number (BRC, SQF, GMP clause).
The evidence that supports the non-conformance.
The corrective action to be implemented
What occurs during the closing meeting?
Emphasis on positive elements.
Identify and confirm next steps.
Providing feedback in a non-contentious manner.
Set targets for completion and verification.
