An annual overall auditing plan will cover all relevant sections of the
organization, all procedures followed and emphasize attention on those elements which are
known to be weakest.
The auditor will set up a checklist for the procedure which is to be
checked. For each of the elements which are checked a compliance or non-compliance
statement shall be reported. There is no in-between opinion possible in the compliance
statements.
Should non compliances be found then another test can be made in order
to check if it is actually a systematically non-compliance or only incidental. Agreed
non-compliances will then have to be corrected for which another official requesting
system can be introduced.
This procedure in particular will be treated with the utmost importance
as the not responding to a corrective action request, holds the danger of undermining the
whole of the QA system.
7. Auditors
The actual process of auditing requires very skilled auditing
personnel. A combination of personal qualities, perception and objectivity is required. A
number of issues have to be remembered when performing the auditing:
audit the procedure, not the person
use both open and closed questions
objectivity has to be assured which can be difficult for internal
auditors
the auditor cannot be part of the audited section
avoid discussion
maintain confidentiality.
Due to the importance of the auditing process it should be clear that
an auditor has to be prepared and trained for his task, while needless to say that the
more the auditor knows of the process he will audit, the better it is.
This auditor training should comprise the principles of QA, devising
procedure checklists, identification of compliance and non-compliance, preparing and
closing corrective action requests, monitoring corrective action, questioning techniques
and handling of difficult auditees.
8. Role of management
As stated from the very beginning the committment of the management to
implement the QA system is one of the keys to succes. The main elements which are required
are setting of the quality policy, organizing the QA system, reviewing the quality system
in its total.
In the quality policy this will necessarily include:
the organizations' mission
a description of the QA management system
the general staff responsibilities
how the QA system is documented
the range of functions for which there are procedures
