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SO 9000 has taken more than its and GM, who I’ll refer to as original ments and their ability to properly
fair share of criticism, largely due equipment manufacturers (OEMs) in apply their knowledge in a variety of
to the variation in international the rest of this article, when they were given scenarios.
third-party conformity assessment.1 A designing QS-9000 and their recog- Where the testing revealed insuffi-
significant difference in auditor and nized third-party certification process. ciency, the process design required
registrar auditing competence is auditors to take additional OEM sanc-
caused by factors such as education, tioned classes to supplement or
training and experience.2 update their competence to continue
There are also systemic problems. OEM efforts to reduce as OEM recognized QS-9000 auditors.
The oversight function3 design of the variation in conformity This measure required recertification
international third-party conformity every three years.
assessment process has not consistent- assessment make In today’s world, change is one of
ly provided customer organizations the only constants, so it is critical for
with confidence in the overall process. continual learning auditors and registrars to make con-
The system design with respect to essential. certed efforts to keep their knowledge
the revenue stream contributes to the and skills up-to-date.
problem. Companies contract with
registrars for auditing and certifica- Based on responses from a survey Examples of Required
tion services so are viewed as cus- of registrars from around the world, Auditor Skills
tomers. QS-9000 Appendices B, G and H were To add value, auditors should be
Another group of key customers are developed and made a condition of agents for positive change. In addition
the companies purchasing your orga- achieving OEM recognition of the reg- to the requirement of bringing specific
nization’s product. They are the direct istrar ’s certificates. Despite much industry experience to the audit
customers of the quality system certi- OEM work to reduce variation in the process, it is helpful if they are skilled
fication status of their suppliers. Yet, third-party conformity assessment in process engineering or reengineer-
because they are out of the revenue process (such as auditor qualification) ing.4
stream, registrars usually don’t view used to support the launch of QS- An auditor should be able to readily
them as customers of the audit 9000, additional measures became identify the inputs, outputs and
process or results. necessary. requirements of any process and
One of these measures was an audi- determine or confirm the key charac-
Initiatives To Reduce Variation tor recertification process. This was teristics, 5 inputs and outputs of the
These were key concerns of designed first to test the auditors’ process.
Chrysler (now DaimlerChrysler), Ford knowledge of the QS-9000 require- These characteristics can be either
variable or attribute. The OEMs pub-
lished a common statistical process
FIGURE 1 Evaluating Effectiveness control (SPC) reference manual to pro-
vide common methodology for
understanding variation, process
capability or performance, control and
improvement.
Are actions taken to address a Since its release in 1992, a strong
requirement effective in meeting bias toward the use of variable data
or exceeding the intent of the standard?
has resulted in an underutilization of
Requirement process controls for attribute data.
Are the operation and control of processes While OEM and supplier quality has
effective in meeting planned results and continued to improve, many supplier
meeting or exceeding the intent of the caused OEM quality problems today
Process
standard?
result from attribute characteristics.6
Chapter three of the SPC manual is
Is the management system effective dedicated to attribute control charts
in meeting planned arrangements and and should be familiar to QS-9000
System meeting or exceeding the intent of the
auditors.
standard?
Auditors must also review the OEM
customer quality feedback reports ➤
of the auditees.7 Information in these Figure 1, p. 72). They need to deter- spread. The auditor should determine
reports can and should be a major mine whether the: whether characteristic tolerances were
consideration in determining the • Actions taken to address a require- based on statistical methodology. If
effectiveness of the auditee’s process- ment are effective in meeting or not, process capability or performance
es and system. exceeding the intent of the stan- index (Cpk or Ppk) values may not be
dard. much help in determining whether
Evaluating Effectiveness • Operation and control of processes the process (at the characteristic level)
One of the OEM survey questions are effective in meeting planned is, in reality, capable.
asked of auditors in designing the QS- results and meeting or exceeding Regardless, the auditor should look
9000 third-party certification require- the intent of the standard. to downstream process results (scrap,
ments was whether the auditors • The management system is effec- rework and customer complaints, for
evaluated the effectiveness of the tive in meeting planned arrange- example) to determine whether the
actions taken by auditees to address a ments and meeting or exceeding system is capable at a higher level.
requirement. the intent of the standard. Automotive OEM quality expectations
Some indicated they did not because are at high level, less than 25 parts per
they were only to verify whether the Process Capability million for example, at a part number
auditees (the experts) were doing Process controls are widely used in level. Wherever possible, error proof-
what they said they were going to do. industry today. But process design ing methods should be in place rather
Others indicated they made some leading to a process capable of pro- than relying on detection and correc-
evaluation of the effectiveness of the ducing the desired result all the time tion of problems after they occur.
actions taken. The OEMs then made must come before process control or
the latter a QS-9000 Appendix B there will be inherent problems in the Measurement Systems Analysis
requirement to increase confidence in process with no planning for mitigat- The amount of measurement varia-
the eventual audit results. ing potential downstream effect. tion as a percentage of the total toler-
Auditors must be able to evaluate Process capability from a statistical ance spread must be understood to
effectiveness on at least three levels (see point of view is a function of tolerance determine process capability. Auditors
Machine/Process Capability Study supplier on the FMEA form and carried forward to the part
number control plan and appropriate work instructions to
A comprehensive step-by-step
mitigate the effects of a potential failure downstream—in
approach to characterize and opti-
L I T E R AT U R E R E V I E W