Audit Check Points for Design

Auditee :- Auditor:-
9001 System Rating
Sl. No ISO 9001:2015 & ISO 14001:2015 Wt Score
14001 0 1 2 3 4 5
RESULT or OUTPUT(A)

1.1 Bill of material(BOM)

1.2 List of Drawings for- Assembly & Parts drg.

8.5.1
1.3 Product specifications & Instruction manuals

1.4 Design validation report

1.5 Master list of revised designs & drawings 45

1.6 Project number Register

1.7 Design Activity Monitoring chart

4.4.2
1.8 Evidence as per documented information -Maintain/Retain
6.2.2
1.9 Functional objectives data filled & updated?

PROCESS (B)
7.4
2.1 Internal & External communication determined?
6.1.1
2.2 Identification of Risks & Opportunities
8.3.1
2.3 Detailing design/Pattern making
8.3.5
2.4 Approval of final design
`
8.3.5
2.5 Preparation of validation plan
8.3.4
50
2.6 Verification of design outputs
`
8.3.4
2.7 Conducting validation tests
8.2.4
2.8 Updating design/drawings/change parts/BOM
`
8.3.4
2.9 Drawing issue process
6.2
2.10 Planning to achieve Functional Objectives ?

INPUT(C)
7.5
3.1 List of Documented information (Maintain/Retain)
8.5.3
3.2 Property belonging to customers (Competitor Catalogues)
8.5.4
7.2
3.3 Necessary Competence of persons determined?
9.1.2
3.4 Internal/service/field feedback data 35
8.5.2
3.5 Identification & traceability of old & revised design
8.3.2
3.6 Design Activity planning
7.1.6
3.7 Determined the knowledge necessary for operation.?

Contd...
 Audit Check Points for Design
Auditee :- Auditor:-
9001 System Rating
Sl. No ISO 9001:2015 & ISO 14001:2015 Wt Score
14001 0 1 2 3 4 5
OUTPUT(A)
RESULT orInformation
Documented (D)
4.4.1 Documented information address all requirements of
4.1
A to H clause 4.4.1 (a to h) (Department manual)
5.1.1
4.2 How process owner demonstrate leadership & commitment?
6.1.2
4.3 Actions to address Risks & signfact aspect
8.3.4
4.4 List of Old & Revised Drawings (Design controls & Changes) 35
8.3.6
8.3.5
4.5 Master list of Design & Drawings
8.3.3
4.6 Applicable standards for Design & Inputs
5.3
4.7 Relevant roles are assigned,communicated & understood

Support , Performance Evaluation & Improvement(E)

7.3
5.1 Functional members trained on Objectives ?
9.3
5.2 Status of actions from previous MRM completed?
10.1
5.3
10.3
No of CIP's/suggestions Implemented? 25
9.2
5.4 Internal & Process audit findings closed?
10.2
5.5 CAPA implemented to eliminate Internal NCR's?

Total = A+ B+ C+ D+ E 190
XXX-MR-03 R1
Criteria for Rating 01-01-2017
0 System not Established

1 System Established, Poor Adherence

2 System Established, Moderate Adherence

3 System Established, Good Adherence, Not Effective

4 System Established, Good Adherence, Effective

5 System - Established, Adhered to, Effective, Constantly Improved upon

Date:- Collect the Auditor Evaluation from Auditee Signature of Auditor