QUALITY
CONTROL INTERNAL AUDIT SOPS
|
1.0 PURPOSE
|
To provide a procedure for Internal
Audit of Quality Control Laboratory.
|
2.0 SCOPE
|
It is
applicable to Quality Control Department.
|
3.0 RESPONSIBILITY
|
Ø Assistant Manager QC
|
4.0 PROCEDURE
|
Procedure:
1.
Assistant QC Manager/ Deputy Quality
Manager will schedule an audit plan and
send to Quality Manager for approval.
2.
After approval of the audit plan, it is
distributed to auditors and
Laboratory personals.
3.
Assistant Manager QC/ Deputy Quality
Manager will inform through letter to auditors and Laboratory personals for the
audit before 10 to 15 days with the approved check list which address
thoroughly all the requirements of management and technical clause of ISO 17025
standard.
4.
Auditors thoroughly evaluate the
Laboratory according to approved checklist.
5.
After audit, auditors conduct a closing
meeting and briefly discuss their positive and negative findings, and
nonconformities.
6.
Auditors submit their report with
nonconformities within three working days and give the time to Laboratory to
submit corrective action plan (CAP) within maximum of two weeks.
7.
The Laboratory submits their CAP within
in specified time. If The Laboratory is unable to submit CAP within time, due
to one or more reason, must inform to the audit team for the next date.
8.
The audit team will arrange a Follow up
audit against CAP on their due date and gives their remarks in written form.
9.
If satisfactory actions were taken by
the Laboratory then closes out the observations/non conformities.
10.
If the Laboratory doesn’t provide the
satisfactory evidence of their actions against CAP, then fix a new date and follow
the next date till OK.
|
5.0 DISTRIBUTION
|
Ø Q.A Manager
Ø Q.C Manager