QUALITY CONTROL INTERNAL AUDIT SOPS

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