Evidence is important to the verification of the effectiveness of the implemented plan. Seek objective, factual documentation that the cause of the problem has been eliminated. It is not always possible to have availability of sufficient evidence for 100% confirmation of effectiveness. A sampling of data to demonstrate effectiveness is acceptable. Types of evidence will vary from case to case, but common examples may be:
- Ordering requisitions
- Accessioning records from the laboratory information system
- Instrument calibration and QC records
- Evidence of review of records
- Meeting minutes
- Training records
- Competency records
- Trend analysis data
- Procedures
- Follow-up with customers
Again, the amount of evidence needed should match the scale of the actions taken.
