CHKL4.02 Quality System

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

5.2 Procedure format & contents

• 1) Show me that each procedure contains a cover & contents page

  Yes

  No

  N/A

• 2) Show me that the cover page is accordance with form doc. 4.2-001/1 & completed with the following information;<br>Company name<br>Document description<br>Heading containing - Document no., issue status, page no., document title

  Yes

  No

  N/A

• 3) Show me that the cover page is always identified as page 1

  Yes

  No

  N/A

• 4) Show me that an approved procedure is maintained on the personal drive of the QA Manager's computer

  Yes

  No

  N/A

• 5) Show me that the above mentioned header appears on every page (excluding the appendices) of a procedure along with the company name

  Yes

  No

  N/A

• 6) Show me that the contents page records the contents of the procedure and the six main sections are as listed:<br>Purpose <br>Scope<br>Reference<br>Definitions<br>Actions<br>Documentation <br>numbered from 1-6 respectively. Other main points covered in section 5 are numbered to one decimal place. (eg. 5.1)

  Yes

  No

  N/A

• 7) Show me that procedures take the following general format:<br>Purpose: outlines the objective of the procedure<br>Scope: applicability of the procedure including to which personnel it effects<br>Reference: lists any documentation which have a bearing on the activities within the procedure <br>Definitions: defines any terms which may have a specific interpretation within the procedure<br>Actions: present and describe the main steps of the procedure. This section shall identify whenever possible, who does what, when, where, how and why<br>Documentation: lists any documents necessary to implement the procedure and/or which are attached to the procedure. Each attachment shall be given an appendix number.<br>Auditors signature:

  Yes

  No

  N/A

5.3 Presentation of procedure

• 8) Show me that procedures are presented in a clear and legible manner

  Yes

  No

  N/A

5.4 Issue of procedures

• 9) Show me that the QA Manager ensures that an authorised procedure contains the correct issue number along with all the other above mentioned details

  Yes

  No

  N/A

• 10) Show me that the QA Manager retains the master copy of the procedure on personal computer drive

  Yes

  No

  N/A

5.7 Copying procedures

• 11) Show me that the issued copies of procedures are retained in their original condition and are protected against accidental alterations or deletions

  Yes

  No

  N/A