Page 234 - The Handbook for Quality Management a Complete Guide to Operational Excellence

220 P r o c e s s C o n t r o l Q u a l i t y A u d i t s 221

problems according to how serious they are. Product-defect-seriousness
classification schemes are discussed below. Some organizations also apply
seriousness classification to discrepancies found in planning, procedures,
and other areas.
These seriousness classifications (e.g., “critical,” “major,” “minor”)
should be explicitly defined and understood by all parties. Generally, some
sort of weighting scheme is used in conjunction with the classification
scheme and an audit score is computed. Although the audit score contains
information, it should not be the sole criterion for deciding whether or not
the audit was passed or failed. Instead, consider the numerical data as
additional input to assist in the decision-making process.
Most audits are not pass/fail propositions. Rather, they represent an
effort on the part of buyers and sellers to work together for the long
term. When viewed in this light, it is easy to see that identifying a prob-
lem is just the first step. Solving the problem requires locating the root
cause of the problem, which is challenging work. Many times the prob-
lem is treated as if it were a cause; that is, action is taken to “manage the
problem” rather than addressing its cause. Examples of this are inspec-
tion to remove defects or testing software to catch bugs. Wilson et al.
(1993) define “root cause” as that most basic reason for an undesirable
condition or problem, which, if eliminated or corrected, would have pre-
vented it from existing or occurring. Root causes are usually expressed
in terms of specific or systematic factors. A root cause usually is expressed
in terms of the least common organizational, personal, or activity
denominator.
In most cases the auditor is not capable of identifying the root cause
of a problem. The auditee is expected to perform the necessary analysis
and to specify the action taken to address the cause(s) of the problem. At
this point the auditor can sometimes determine that the root cause has
not been identified and can assist the auditee in pursuing the problem at
a deeper level. At other times there is no choice but to validate the cor-
rective action by additional audits, tests, or inspections. The final proof
of the effectiveness of any corrective action must be in achieving the
desired result.

Product, Process, and Materials Control

Work Instructions
Work instructions must establish quantitative or qualitative means for
determining that each operation has been done satisfactorily. These crite-
ria must also be suitable for use with related inspections or tests, because
work instruc tions serve operating personnel, supervisors, inspectors,
managers, and even customers. Compliance with instructions is subject to
review and audit.

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