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Internal Quality Audit Work Instruction

Author: Mr D Wilson

Source of document: Open University

Date: 25/09/95

GENERAL

This instruction details the procedure to be followed to ensure that all the elements of the assurance system are operating effectively.

PLANNING

The Quality Audit Plan. The QE is to prepare a 12 monthly quality audit plan. The plan takes the form of the matrix (see figure 1) and ensures that all the elements of the quality assurance system are regularly audited.

• Activities / System Elements Subject to Audit. The elements subject to audit are the Dept WI's as detailed.


PROCEDURE
 

• Quality audits will be carried out by QE, QA, QSM or other nominated trained personnel.
• Dept heads are to be informed prior to the audit by agreeing a time and date with the auditor.
   

Note: A copy of the audit plan is to be issued to each Dept, all personnel will be kept aware of their quality audit periods. The date will only need to be confirmed shortly before the audit.
 

• Discrepancies / non-compliancies to the system are documented on the proforma at Annex B and brought to the attention of the relevant Dept heads. One discrepancy / non-compliance per proforma.
• Corrective action and time to rectify are agreed between the auditor and Dept head. The date for a follow-up audit is also fixed at this time. Corrective action should be completed as soon as possible but must not exceed 21 days.
• The QE must be kept informed by the Dept head of any corrective action which is not completed in the agreed time.
• The corrective action taken on any discrepancy / non-compliance must also be aimed at preventing recurrence of the fault.
• Management review. Quarterly management reviews to confirm the effectiveness of the quality assurance system are to be carried out and recorded. Trends of discrepancies will be studied and corrected.
• Evaluation. An independent evaluation of the effectiveness of the Dept quality assurance systems will be carried out during audits of WTI's.

Ser

Sect

Month

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Work Instruction

4

5

6

7

8

9

10

11

12

1

2

3

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(j)

(k)

(l)

(m)

(n)

1

Dept 1

H

B

E

C

G

D

H

B

E

C

G

D

2

Dept 2

A

F

B

D

H

E

A

F

B

D

H

E

3

Dept 3

B

G

C

E

A

F

B

G

C

E

A

F

4

Dept 4

C

H

D

F

B

G

C

H

D

F

B

G

Auditors:

A = IC Dept 1, B = IC Dept 2, C = IC Dept 3, D = IC Dept 4, E = 2IC Dept 1, F = 2IC Dept 2,

G = 2IC Dept 3, H = 2IC Dept 4.

Auditor A will conduct any audits that can not be conducted due to leave or courses.

Fig 1 Example of Quality Audit Plan Matrix

ANNEX A

QUALITY AUDIT REPORT

Dept Audited: Dept Head:                                                                            Activity Audited:

Compliance / Non-compliance / Deficiency (Delete and comment as necessary), details:

Auditor: (Signature) Date:

Corrective Action is as follows:

Target Date (Dept Head):                                                                            Dept Head: (Signature) Date:

FOLLOW UP AUDIT

The corrective action has / has not been completed by the new target date.  Auditor: (Signature) Date:

Comment (Dept Head):

Dept Head: (Signature) Date:                                                                      QE: (Signature) Date: Text starts here

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