Mary,
Better for the PEARs to be completed by the people responsible for ensuring their processes are effective instead of the internal auditors.
Auditors looking for "opportunities for improvement" suggests that the leaders, their management system and its design process are not enabling the employees to do this for themselves. The leaders may have learned this language from your registrar. Have they established objectives for the audit programme as a whole?
The internal auditor could usefully investigate and report how well the management generates improvements from the design team.
The design process is effective when the design objectives, including the requirements of the customer and manufacturing, are fulfilled by implementing the design plan.
So, take a design plan and audit its completeness against the design inputs. Talk to the people responsible for aspects of the design and listen to how they fulfilled their responsibilities and solved problems as the arose. Look for evidence of collaboration between members of the design team and with reps from manufacturing and QA. Determine if review comments were sought and resolved before the design outputs were verified and then validated. Check the retrievability of the design records and lessons learned to benefit future design plans.
Report on how well your management system helps designers to fulfill requirements including the requirements for improvement.
Do not allow your checklist to constrain your thinking but be clear, before the audit, on what you want to see and why you want to see it.
John
