Investigation
This must occur at the very start of any corrective or preventative action plan.
What is an investigation?
In this type of request, not all possible elements or activities will apply.
The purpose of this regulatory activity following an adverse event is to go beyond direct and somewhat apparent causes and figure out the underlying reasons for the event.
What is a Root Cause Analysis (RCA)?
This component of an action plan helps to prevent recurrence or drift.
What is a control plan?
This quantifiable element helps ensure a corrective action plan is on track, achievable, and effective.
What are metrics?
The minimum number of "why's" to ask for a thorough investigation.
What is five?
These individuals have relevant information or insight into the issue or solution, understand processes related to their job and interface with suppliers or consumers.
Who are stakeholders?
The question that should be asked to reframe problems and challenges into opportunities using the SPRINT methodology?
What is "how might we?"
Stakeholders are authorized to assist with corrective actions under these circumstances.
What is when necessary and as determined by the Compliance leader coordinating the corrective action plan?
Two primary purposes of an investigation.
What are to clearly identify the problem and gather information?
The first question to ask when a problem is detected.
What happened?
This is done to eliminate the potential cause of an identified nonconformity occurring.
What is a preventative action?
This is meant to capture safety events to identify, correct and prevent unsafe occurrences, and is a regulatory requirement.
What is an incident report?
This portion of a corrective action plan demonstrates commitment and confidence, is written last, and serves as a quick resource for leaders to review.
What is the summary statement?
The failure or refusal to conform to rules or practice.
What is nonconformity?
Determining the importance and urgency of containing a problem with immediate action is one objective of investigating this.
What is a problem or defect?
This is considered reactive problem management.
What is corrective action?
The SPRINT methodology requires interviewing this number of people. Why?
What are five, because these five will help you discover 85% of the issues and any more diminishes returns?
This plays a vital role in identifying the solution and validation of effectiveness for corrective and preventative actions.
What is data analysis?
This methodology helps make processes more efficient.
What is Six Sigma?
Making definitive determinations for the cause of the problem and looking beyond the obvious symptoms are two common reasons for using this analytic or improvement methodology.
What is the Five Whys?
The most commonly overlooked yet critical part of a corrective action plan.
What is identification of documents to create or revise?
This is an important part of a corrective action plan to evaluate for efficacy.
What is monitoring and auditing?
This type of thinking is critical when determining or creating many CAPA.
What is Risk-based Thinking?
What is a nonconformity statement?