ISO 9000:2K



Shattering QS-9000 Myths

Even after five years of
implementation and the
registration of more than 12,000
companies, misconceptions
about QS-9000 abound

1994 marked the first year that suppliers to Ford Motor Co., General Motors Corp. or Chrysler Corp. (now DaimlerChrysler AG) could register to the Big Three's new collection of automotive quality requirements, known as QS-9000. The newly published QS-9000 requirements combined the entire ISO 9000:1994 standard with a harmonization of the separate quality system requirements utilized by each of the Big Three.

 Now, after five years, the number of QS-9000-registered companies has grown to more than 12,000 worldwide, including more than 2,000 registrations in the first half of 1999 alone. Despite the thousands of companies registered to or in compliance with QS-9000 and the thousands of employees, registrars, auditors and consultants who work with QS-9000 on a daily basis, misconceptions about the requirement abound.

 In an effort to clear up many of the most common QS-9000 misconceptions, Quality Digest asked Plexus Corp., the only sanctioned provider of QS-9000 train-the-trainer programs and developer of QS-9000 training and other sanctioned materials, to document and respond to these subjects. Alex Chong, president of Plexus, researched these misconceptions and, with the help of current and past members of the Big Three's Supplier Quality Requirements Task Force, refutes fiction with fact.

QS-9000 Glossary

AIAG - Automotive Industry Action Group
APQP - advanced product quality planning and control plan
ASQ - American Society for Quality
Cpk - the capability index for stable processes
FMEA - failure mode and effects analysis
OEM - original equipment manufacturer
PPAP - production part approval process
Ppk - the performance index
PPM - parts per million
QSA - quality system analysis
RAB - Registrar Accreditation Board

General misconceptions

QS-9000 is a standard.

 The QS-9000 requirements are not a standard. QS-9000 does utilize the ISO 9001 standard within its elements, but this incorporation doesn't qualify QS-9000 as a standard. Rather, it's a harmonized set of quality system requirements. QS-9000 certificates cannot imply that QS-9000 is a standard (per an RAB advisory).

QS-9000 is just another burden imposed on suppliers by the Big Three.

 Actually, QS-9000 replaced the three separate quality system requirements of Chrysler, Ford and GM. It's simply a streamlined consolidation of the tradi-tional quality system requirements of the subscribing companies.

QS-9000 creates too much paperwork.

 One of the most common mistakes made by companies seeking ISO 9000 registration is to over-document. Over time, quality managers at these companies typically realize that the quality system documentation can be much more concise, clear and user-friendly than they had originally thought. As an efficiency measure, many companies incorporate bulleted lists and flow charts in their documents instead of long sentences. The amount of documentation needed depends upon a number of factors, such as the size and complexity of the business.


QS-9000's benefits

There's no value added in attaining QS-9000 registration.

 The ASQ/AIAG Quality Survey results from 1997 and 1998 indicate that there is about a 3:1 return for all costs (internal and external) and about a 17:1 return on out-of-pocket certification costs for QS-9000 registration. The 1998 survey also indicates that companies save, on average, about 6 percent of sales as a result.

There's no correlation between QS-9000 compliance and better product quality.

 Product quality improvement is traditionally associated with ISO 9000 compliance, but QS-9000 customers also expect a high degree of correlation. Although "sporadic" problems may occur, the "chronic" performance of the quality system in a QS-9000-registered site should meet customer expectations.

QS-9000 is too expensive for small suppliers.

 Simple operations should be able to use simple processes. Documentation should be concise, and the use of consultants should be avoided because their cost is significantly higher than the costs of registration. For example, a North American one-site nondesign-responsible company with 50 employees should expect to pay a registrar about $4,000 to obtain QS-9000 registration and about $2,500 annually to maintain it. In other regions of the world, these figures are much lower and are based upon the daily rates of the local registrars. DaimlerChrysler, Ford and GM have low-cost, locally delivered training in much of the world that can provide implementation support.


Shortcuts to registration

If we just make our quality manual and procedures look good, we'll pass the audit.

 If the practices in the organization do not meet the specified requirements, the registrar is obligated to report this as a major finding in the audit report. The quality system documentation also has to address all the QS-9000 requirements.

I don't really have to show customer performance improvements.

 Effectiveness of the supplier's quality system must be measured and correlated to customer performance requirements. Continuous improvement in key indicators is expected, and if it isn't achieved, it can jeopardize the QS-9000 certification. Part of the evidence of continuous improvement is having improvements implemented through one cycle of internal audit/management review (see QS-9000's Appendix B). Continuous improvement must also give highest priority to special characteristics of greatest importance to the customer.

Because I am a seeking a certificate under a "corporate scheme," I won't have to have all of my manufacturing locations audited.

 All sites that are included in the scope of the registration must be audited; sampling of sites is not allowed.

I don't really have to do internal quality audits on each shift.

 Internal quality audits should cover all shifts, and the third-party QS-9000 audits require all shifts to be audited.



There's no definite distinction between corrective action, preventive action, continuous improvement and innovative improvement.

 Simply stated, preventive action is taken to prevent occurrence of a nonconformity. Corrective action is taken to prevent recurrence of a nonconformity. "Continuous improvement" refers to the small, incremental steps that anyone in the company takes on a regular basis to make improvement where there is no nonconformity but where activities can be improved. Innovative improvement is significant but typically infrequent improvement achieved by research and development personnel or technical experts.

My quality plans must include both short-term and long-term planning for my organization.

 A quality plan should define the specific quality practices, resources and sequence of activities relevant to a particular product or contract. It defines how quality will be achieved for the product. It is normally associated with new product planning and development and is distinct from control plans or business plans. For QS-9000, short- and long-term planning for an organization should be detailed not in the quality plan but in the business plan.

There's no clear distinction between "design verification" and "design validation."

 Notes 10-14 in ISO 9001:1994 provide helpful guidance on the dif- ference. Verification is focused on design reviews and may include such activities as performing alternative calculations or comparing a new design with a similar, proven design. Validation follows verification and is normally performed on the final product under defined operating conditions, generally for each specific use or application.

If I'm not design-responsible, I don't have to worry about the APQP.

 APQP is required of all suppliers. The APQP process starts later, where the supplier doesn't have design responsibility. See the APQP manual for more guidance.

Our customer hasn't identified special characteristics, so I don't have to worry about them.

 Special characteristics are a shared responsibility of both the customer and the supplier. However, it is possible that a part would have no special characteristics.

Records of premium freight must be maintained for the number of instances that premium freight must be paid, but not necessarily for the total costs of premium freight.

 QS-9000 intends that records of the premium freight from subcontractors include all incidences, regardless of whether the supplier or subcontractor pays the charge. The supplier also has to maintain records of all supplier-responsible premium freight shipments to the customer.

The Big Three's expectations of their suppliers with regard to laboratory scope aren't defined.

 The laboratory scope, defined in the QS-9000 Third Edition glossary, is a quality record that contains the specific tests, evaluations and calibrations a laboratory has the ability and competency to perform; a list of the equipment that it uses to perform them; and a list of the methods and standards by which it performs them. The intent is to provide the customer with a record of the activities that the lab can competently perform so the customer can have confidence in the data that is generated. The laboratory scope is a requirement of commercial laboratory accreditation to ISO Guide 25. The function and intent of the laboratory scope in QS-9000 is the same.

QS-9000 doesn't clearly define the objective of a QS-9000 audit.

 The QSA manual defines the on-site audit as the phase of the assessment process that determines the degree and effectiveness of the quality system implementation at the supplier's site and remote locations. The audit is one of three phases of the assessment process defined in the QSA manual; the others are the documentation review prior to the audit and the analysis and report after the audit.

Unlike "shall," "should" does not indicate a requirement.

 This is true in ISO 9001, but not in QS-9000. The third edition of QS-9000 defines "should" as "a mandatory requirement with some flexibility allowed in compliance methodology." The supplier has more options for meeting the "should" requirement than typically exist with a "shall" requirement.

There's no set method for conducting "dock audits" (e.g., how many, how often, to what extent, etc.)

 Final product audits were added to QS-9000's Third Edition to enhance the supplier's quality system where shipment of nonconforming product is made on a "chronic" basis to the customer, which shouldn't happen. When this occurs, the supplier is to conduct final product audits using samples based primarily on customer PPM data and including experience based on past quality performance. The audits should be performed at an appropriate frequency to contain nonconforming material at the supplier facility. Where the customer PPM meets the customer expectation for the supplier, infrequent final product audits are appropriate.



I don't have to submit a PPAP for products introduced prior to 1987 even if the part number, engineering change level, manufacturing location, material suppliers or the production/process environment has changed.

 If any of these factors have changed, then a full PPAP is required. The existing (pre-QS-9000) customer part-approval requirements would apply to PPAP-type situations prior to 1987. PPAPs do have to be completed on the applicable parts with records maintained at the supplier. You must submit a PPAP for parts introduced or modified since 1987.


Cpk and Ppk

I can use either Cpk or Ppk to predict a population's performance.

 Although Cpk and Ppk quality index values will be the same for the same characteristic on the same population if a process is stable over time, there is a difference. Simply stated, Cpk is a predictor of the performance of a population's specific characteristic. You use an indicator (R bar over D2), which is obtained in calculations for a control chart, to make an estimation of the expected performance of the population. You need stability in the process in order to calculate Cpk. However, Ppk uses data from the actual population rather than from the indicator and thus reveals the actual performance of the characteristic. See the PPAP Third Edition for guidance.


QS-9000 elements

According to Clause 4.1.3 -- Management Review, a supplier must hold a separate management review meeting to satisfy this requirement.

 The requirement could be incorporated into management meetings with other agenda items, as long as the requirements for management reviews are met.

According to Clause 4.2.5 -- Continuous Improvement, programs that address the elimination of special causes affecting process stability qualify as continuous improvement.

 These programs are corrective; continuous improvement doesn't begin until processes are stable. The continuous improvement process must address issues over and above process stability.

According to Clause 4.6.2 -- Evaluation of Subcontractors, subcontractors are required to obtain QS-9000 (or ISO 9000) registration.

 Subcontractor registration isn't a requirement at this time; however, the supplier has to perform subcontractor development with the goal of subcontractor compliance to QS-9000.

According to Clause 4.9.1 -- Process Monitoring and Operator Instructions, records and results of process monitoring (e.g., SPC data) are to be maintained to satisfy customer needs.

 Clause 4.9.1 requires process monitoring and operator instructions. These are intended to support the employees performing work. The instructions should define how work is to be performed and what to do when things go wrong. The control plan must be incorporated into the operator instructions to ensure that provisions are made to mitigate the cause of any potential problems not "designed out" of the product as a result of the FMEA exercise in the APQP phase. Data collection for process monitoring is intended to occur under Clause 4.9.2, not under Clause 4.9.1.

According to Clause 4.9.1 -- Process Monitoring and Operator Instructions, operator instructions (work instructions) must be written.

 They must be documented, and they should be recorded in the local language of the operators. In some cases, operators may not be able to read. Operator instructions are only effective when they can be understood, so they should incorporate visuals such as pictures or diagrams wherever possible. The third-party auditors are obligated to assess the effective implementation of all QS-9000 requirements, so the approach taken at a site must meet QS-9000's intent.


 Did we cover all of the myths? Probably not, but we hope that we've helped clarify any confusion you may have had about the QS-9000 requirements. We've learned by experience that many of QS-9000's misconceptions can be cleared up by a careful reading of the requirements and its supporting documents. However, when that doesn't seem to work, you may need some help. Assistance is available from Plexus Corp. at (651) 644-4900 or and from the AIAG at (248) 358-3570.

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