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Notes For Internal Auditors

Author: Mr D Wilson

Source of document: Open University

Date: 12/10/95
Read / understand the WI to be audited.

• Research WTI's, QA Regs, Standing Orders, Standing Instructions, Health and Safety at Work, etc.

• Select 10-20 key points and prepare questions. Below are the four areas to audit with example question areas:

• Person (those involved with the process):

• • Do they understand the process.
  • Are they qualified / trained.
  • Do they follow the documented process.
  • When was the last time they looked at the documented process.

• Item (the subject of the process). Is it; suitable, labelled, in date, stored correctly.

• Equipment (that used to perform the process). Is it; serviceable, labelled, in date, stored correctly.

• Documentation (the documented process and the forms / books used during the process):

• • Is it available.
  • Is it in date.
  • How is it kept up to date.
  • Does it comply with regulations.
  • Is it in a usable condition.
  • If forms are used:

• • • Are they completed correctly.
    • Are they stored correctly.
    • Is the data used or distributed.

• Agree time, date and place of audit with sect head. Be friendly and helpful. Make short observations and stick to the audit.

• Auditors tools:

• Questioning, Listening, Observing, Conducting (control, assist, be concise).

• Investigate non compliancies and determine the cause if possible. State weather the cause is:

• • Sporadic. Sudden change in the status quo, requiring remedy through restoring the status quo.

• • Chronic. Long standing adverse condition requiring a change in the status quo.

• Identify if the non conformance is:

• • Critical. The non compliance is likely to result in hazardous or unsafe conditions or prevent the tactical performance of the end product of the process.

• • Major. The non conformance is likely to result in failure or reduce the usability of the end product of the process.

• • Minor. The non conformance will have little bearing on the effective use or operation of the end product of the process.

• A follow up audit is to be conducted in the same way as a normal audit only on a smaller scale concerning only non compliance area's identified in the original audit.
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