Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 60

Table 4.2: Suggested Annual Design Audit Procedure (for a Center with 10 Design Teams)

Month Activity Agenda Participants Evidence Produced

2 1st bimonthly

design review

All design team
leaders

- Review previous NCs
- Review design activity
- Receive review report of
2 teams
- Identify NCs
- Produce action plan

- Report
- Action plan
- Signed off NCs

4 2nd bimonthly

review

All design team
leaders

- Review previous NCs
- Review design activity
- Receive review report of
2 teams/projects
- Identify NCs
- Produce action plan

- Report
- Action plan
- Signed off NCs

6 3rd bimonthly

review

All design team
leaders

- Review previous NCs
- Review design activity
- Receive review report of
2 teams
- Identify NCs
- Produce action plan

- Report
- Action plan
- Signed off NCs

8 4th bimonthly

review

All design team
leaders

- Review previous NCs
- Review design activity
- Receive review report of
2 teams
- Identify NCs
- Produce action plan

- Report
- Action plan
- Signed off NCs

10 5th bimonthly

review

All design team
leaders

- Review previous NCs
- Review design activity
- Receive review report of
2 teams
- Identify NCs
- Produce action plan

- Report
- Action plan
- Signed off NCs

12 Annual design

audit

All internal
auditors

- Review previous audit's
NCs
- Annual review of design
activity
- Bimonthly reviews
- Identification of areas for
improvement

- Annual audit
report
- Action plan
- Signed off NCs