CAPA Management Part 2 – Continued from CAPA Management Part 1
Corrective Action Objective
To generate a plan of action that will that will eliminate or reduce the incidence of the root cause of the deviation, failure, or breakdown.
Developing the Corrective Action
Consider the following elements when preparing and documenting the corrective action plan
•Decide the means to implement the action
–Training or Retraining
–Implementation of automation or new equipment
Decide on the implementation time-frame
Determine the method of CA communication
Determine staff involved in carrying out the CA
Scope Of Corrective Action
Do not expand the corrective action beyond the identified root cause unless directly linked to another factor
The corrective action must match the root cause of the deviation.
If possible, build the corrective action upon existing or known barriers.
Remember that continuous correction is not quality improvement!
The objective of the Effectiveness Evaluation is to generate documentation that proves or disproves the following two statements:
The Corrective action was completed and implemented as planned
The corrective action was effective in the reduction or halt of recurring deviations.
Verify that corrective action was properly implemented
Determine data source for Effectiveness Evaluation
Determine when to perform Effectiveness Evaluation
Determine evaluation period
Consider impact of learning curve
Determine success criteria
Who Carries out the Effectiveness Review?
Operations management is responsible for the planning, completion and reporting of the effectiveness evaluation.
Reporting of the Effectiveness Evaluation consists of documented evidence of the effectiveness of the corrective actions taken for the event.
Timeframe for Evaluation
In most cases, the evaluation should be started no earlier than 30 days. This ensures that the staff is competent
and familiar with the corrective action submitted. Depending on the organizational SOP, the evaluation for
effectiveness should begin within 60 days of the corrective action plan implementation date.
Depending on the organizational SOP, the evaluation should be completed no later than 120 days after corrective action implementation.
Observe staff directly involved in the execution of the corrective action alongside a small sample of other staff members (one to five) not directly involved in the corrective action.
Review source documents involved in the corrective action for one to three months post implementation. Look for omissions, corrections, or completion attributes that reflect a recurrence of the original deviation.
Staff may be interviewed individually or as a group to ensure understanding of the process
in question. Role playing exercises using corrective action scenarios may also be used
to ensure understanding.
Operations or Quality Assurance may perform a post corrective action audit to determine overall effectiveness.
Generate a presentation or internal document to ensure understanding of the process change initiated for the corrective action. Ensure that key stakeholders in the organization can articulate the problem. Run an update session with all teams and seek questions from team members about the issue and the investigation. If required make this memo part of the mandatory training for people affected. Supply a list of employees that have completed, including the date completed
For each effectiveness evaluation performed, a memo should be generated to document and summarize what was done for the evaluation and the resultant outcome.
Details including the date range, persons performing the operation, and specific root cause being evaluated should be documented in the memo.
In the Event of a Failed Evaluation
Issue a new deviation or nonconformity. The Root Cause Analysis will need to be redone.
Items to consider:
There may have been multiple root causes that were not initially discovered.
There may have been significant contributing factors that were not discovered.
To summarize an Effective CAPA Process
1. Define the problem.
2. Gather data/evidence.
3. Ask why and identify the causal relationships associated with the defined problem.
4. Identify which causes if removed or changed will prevent recurrence.
5. Identify effective solutions that prevent recurrence, are within your control, meet your goals and objectives and do not cause other problems.
6. Implement the recommendations.
7. Observe the recommended solutions to ensure effectiveness.