A. Background & Definitions
Internal Assessment: Alignment check of implemented measures of the action plan with the corresponding EQIPD directive by qualified member outside the RU but within the organization
B. Guidance & Expectations
The Internal Assessment (IA) is performed by:
- Quality assurance unit or
- Personnel trained in internal assessments (by the organization)
The aim of the Internal Assessment is to:
- Check completion of the Action Plan
- Check the compliance with solutions
- Judge effectiveness of implemented measures
- Identify processes which need to be improved, altered, substituted or deleted
The Internal Assessment is performed on the basis is the Action Plan.
- The internal assessor has been made familiar with EQIPD QS either by the RU or by material from the EQIPD website
- The internal assessor had prior, confidential access to the Action Plan of the RU and the corresponding measures of the RU
- The internal assessor checks whether there are Action Plan items for which no measure has been entered.
- The internal assessor randomly selects between 10 and 15 items from the Action Plan. Five of the items must come from core requirements. The selection process is concealed and independent from the RU.
- The selected items are transferred to the IA list (link/document to be provided here) and the assessment on these items is performed within the RU.
- Do the measures contain appropriate metrics, threshold definitions and wherever applies frequent checks?
- Is the measure implemented in the RU or does it only exist on paper?
- Do members of the RU know the item and the matched measure?
- The findings are documented in the IA list and the list saved in the folder 4.1.2 in the Dossier with the date and indicated in the Action Plan
- After the IA is concluded a final discussion with the members of the RU takes place and the findings are presented
- If required by the assessor, improvement must be set in motion.
- Reconstruct data and check critical items (checklist) by selecting a sample and track it back to the methods, equipment and freezer storage
- Validation of a method: Who and how to use the SOP => Comparison of the individual steps => Description of where problems occurred => Compare how to document and evaluate them
- Once to several times per year (should be defined in advance by the Process Owner)
- When needed
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