07/07/2020 AS9003A Process-Based Audit Plan XACTIV

4.1 Business Planning & Requiremts

8.2 Nonconforming Product

7.6 Measuring Equipmenty
7.5 Control of Production
7.2 Cust Contract Review
7.1 Plan Product realiztn
4.2 Documents, Records
Timing (mo.s between)

5 Mgmt Responsibility
6.1 Human Resources

8.1 Measure Product

8.3 Corrective Action

6.2 Work Environmt
to be

8.4 Internal Audit

updated to AS9100
Elements

7.4 Purchasing

Priority
Impact
Process
Core Process
Raw Materials L 18 x x x 3
Outside Processing L 18 x x x x 4
Production Planning L 18 x x x x x 5
Ink Production H 6 x x x x x 5
Print Production M 12 x x x x x 5
Product Measurement M 12 x x x 3
Product ID & Control H 6 x x x x x x x 7
Pack & Ship L 18 x
Support
Executive Leadership L 18 x x x 3
Quality Management H 6 x x x x x x x x x x x 11
Technical Leaderhip M 12 x x x x x x x x 8
Office Management L 18 x x x 3
XACTIV AS9100D Audit Questions R-840-004

Status can be recorded on a sliding scale:

0. Not started; needs effort. 0
1. Procedure /forms exist 1
2. Procedure/ forms adequate for purpose 2
3. Procedure/ forms in ad hoc use 3
4. Procedure/ forms used uniformly 4
5. Records exist and are readily accessible 5
6. Records are used to control the process. 6
7. Evidence that process is reviewed & maintained 7
8. Records show requirement fulfilled. 8

4.0 1 CONTEXT OF THE ORGANIZATION Updated Evidence and reference used Status
Last
4.1 2 the organization and Its context 0.0

External & internal issues determined, relevant to

organization's purpose and direction and affect ability to 0
a 3 achieve the intended results of QMS;

Information about external and internal issues

monitored and reviewed.
b 4 See 3 notes on pg 12.
Needs and Expectations of Interested parties - 0.0
4.2 5 organization shall determine:
a 6 Interested parties relevant to the QMS; 0
the requirements of relevant interested parties relevant
b 7 to
the QMS;
info on interested parties and requirements monitored
8 and reviewed;
4.3 9 Scope of the QMS 0.0

Boundaries and applicability of QMS, considering:

external and internal issues, requirements of interested 0
10 parties, products of the organization ;

all requirements are applicable within the determined

11 scope ;

scope of the QMS is available and maintained as

doc/info. Exceptions must be carefully documented (see
12 pg 12).
4.4 13 QMS and its processes 0.0

QMS is established, implemented, maintained, and

continually improved, including processes needed and 0
4.4.1 14 their interactions;

QMS addresses customer and applicable regulatory

15 QMSrequirements.
Processes needed for QMS and their application
16 throughoutare determined, and shall include:
inputs required and the outputs expected from these
a 17 processes;
b 18 the sequence and interaction of these processes;
criteria and methods (including M&M and related KPIs)
c 19 needed for effective operation and control;
resources needed for these processes and ensure
d 20 availability;

document assignment of responsibilities and authorities

e 21 forthese processes;
f 22 address risks & opportunities according to 6.1;

printed 07/07/2020 Page 2 of 3

XACTIV AS9100D Audit Questions R-840-004

evaluate these processes and implement any changes

g 23 needed;

improve the processes and QMS;

h 24

To the extent necessary

4.4.2 25 (note: may be a quality manual):
maintain doc/info to support the operation of its
26 processes

retain doc/info to have confidence that the processes

27 carried out as planned

printed 07/07/2020 Page 3 of 3