QMS Internal Audit Record

PROCESS AUDITED: ____Corrective & Preventive Actions______________________________________ AUDIT DATE: __________________________

AUDITOR: ____________________________________________________________________ DEPARTMENT: _________________________

No Check List Auditee Comments & Evidences Comply

Yes No
1 By Whom: (6.2.1, 6.2.2, 6.2.2.2, 6.2.2.3, 4.2.4,
4.2.4.1, 5.5.1, 7.6.1)
- Who is the person-in-charge?
- Any JD for the QC personnel who handle
corrective & preventive actions process?
- Is this person competent to carry out the the
tasks? Check competency records (training
records, resume, etc.)

2 Process Indicators: (5.4.1, 8.4.1)

- What is the KPI?
- Show me the data. Is it achieving the
target?
- If not, what is the root cause and corrective
action? Show me.

3 By what (6.3, 6.3.1, 6.3.2, 6.4, 6.4.1, 6.4.2, 7.5.1.4,

7.5.1.5, 7.6)
- Email; phone

4 How: (4.2.1, 4.2.3, 4.2.3.1, 4.2.4, 4.2.4.1)

- Refer to SOP 11, Appendix 4.1 & Appendix
4.2
- Check whether the SOP 11 is up-to-date.

5 Input: (8.5.2, 8.5.3)

- Customer complaint cases
- Internal quality problems
- Identify potential failure modes during the
new product development. Sample the
PFMEA.
1)
 QMS Internal Audit Record
PROCESS AUDITED: ____Corrective & Preventive Actions______________________________________ AUDIT DATE: __________________________

AUDITOR: ____________________________________________________________________ DEPARTMENT: _________________________

6 Output: (8.5.2, 8.5.3)

- Verify that the Appendix 4.1 of the SOP 11
is followed as follows:
a) Check the CAR (QC-F06) of the
complaint cases. Sample a few cases
of CARs
b) Check the root causes analysis is
carried out
c) Check the correction and corrective
actions are taken.
d) Check the effectiveness of the actions
taken.
- Verify that the Appendix 4.2 of the SOP 11
is followed as follows:
a) Verify that the preventive actions stated
in the PFMEA are implemented.