Navigating Difficult Requirements
An in-depth look at process control, one of the most-cited IATF 16949 requirements
by R. Dan Reid
The new automotive supplier quality management system (QMS) standard, IATF 16949, was released late last year. The first several hundred third-party certification audits have been conducted, and the International Automotive Task Force (IATF) has released information on the most-cited requirements thus far, many of which are not new. One such requirement is process control.
Process control (IATF 16949 subclause 8.5.1)
Process control has been part of the automotive requirements for many years. Controlled conditions can include several provisions, including:
- Documentation (procedures, work instructions and records). Documented information must define the product
characteristics and results to be achieved. There is a new requirement at the
QMS level, which is to determine the results expected of the QMS. Because the
QMS requires the use of a process approach, this new requirement also extends
to the processes in the QMS.
This means that for each process, the inputs, outputs, sequence and interaction of steps, metrics and controls must be determined.¹ For example, what is the expected outcome of your corrective action process? Where is that documented? To what degree are you meeting that expected outcome and, importantly, how do you know?
Suitable monitoring and measuring resources. Years ago, Chrysler, Ford Motor Co. and General Motors addressed monitoring and measuring resources in the guidance manual Measurement Systems Analysis (MSA).² The International Organization for Standardization (ISO) also has published guidance on the subject.3, 4
Automotive QMSs and process auditors generally do not understand the science of metrology well because of the technical nature of the material and because many have not directly worked in this field. In its new standard, IATF now requires internal and supplier auditors to demonstrate competency in the applicable core tools related to the scope of the audit. Core tools include Automotive Industry Action Group (AIAG) manuals on statistical process control, potential failure mode and effects analysis (FMEA), production part approval process, advance product quality planning and MSA.
Most organizations rely on gage repeatability and reproducibility (gage R&R) to qualify their measurement systems. While this is applicable, it alone is insufficient to prove the suitability of a measurement system. Other studies, such as stability, linearity, bias and precision, also should be conducted to determine the total amount of measurement uncertainty in the system.
This uncertainty must be identified to make good decisions regarding accepting or rejecting product. Without a good understanding of the total uncertainty in the measurement system, you may be accepting nonconforming products or rejecting good products because of errors in the measurement system.
A common problem with gage R&R is that the studies aren’t performed with the operators who will be conducting the measurements in production. This invalidates the results because people are a key part of a measurement system. Going forward, automotive auditors should have evidence of competency (such as training records) in MSA, the other core tool documents and applicable customer-specific requirements related to IATF 16949 and its core tools.
activities. Verification activities, such as inspections or tests,
must be performed at appropriate stages to verify that specified requirements
have been met. Three groups typically specify QMS requirements: customers,
regulatory authorities and the organization itself (engineering and quality
departments, for example).
This should include a final inspection prior to shipment and a formal release to ship to the customer. Some organizations use a product audit process, but this doesn’t meet the intent of final inspection, a verification activity that is part of the production process.
Product audits must be performed because they are random and outside of the production process6—they can detect a problem with the final inspection process so the problem isn’t discovered in the field.
Another common issue with verification activities is that inspection status is not always recorded, especially after some visual inspections. Inspection status must be known throughout the production process, starting when raw materials and components are received.7 The location of materials in the production process is insufficient identification of inspection status.
people. This also has been in the automotive requirements since the
standard was first published, but the emphasis used to be on training, not
competence. An employee’s competence must be determined by a combination of his
or her education, training and experience.
A common problem with this clause is having documentation of the competency requirements for jobs and the records to show that these requirements have been met. Some organizations don’t obtain copies of employees’ degrees as evidence of their education. Instead, they use the employee’s résumé as adequate proof of education. This should not be accepted by an organization or an automotive auditor.
- Validation and periodic revalidation of
special processes. Special processes cannot be verified except
through destructive testing (heat treating, welding, painting, plating and
soldering, for example).
In the ISO 9001 requirements, validation has a separate and distinct meaning from verification. Validation is "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled."9 Verification is "confirmation, through the provision of objective evidence, that specified requirements have been fulfilled."10
Figure 1 shows that verification can be done without the product. Validation can be thought of as doing the right thing, while verification can be thought of as doing it the right way. Organizations should be able to explain for an auditor validation and verification as separate activities and have evidence that both are being performed.
The new ISO 9001 requirement includes periodic revalidation of special processes so it cannot be done only in design and development stages of new product development to meet the intent.
- Actions to prevent human error. This is the first time that error proofing or mistake proofing has been required in ISO 9001. Many organizations in the automotive sector have examples of error-proofing in manufacturing and assembly, but error proofing still is not well implemented when compared to its potential for application.
Other sectors are even further behind. IATF 16949 adds more prescriptive requirements including: documenting processes, detailing methods used in process risk analysis (process FMEA, for example), listing test frequencies in the control plan and verifying error-proofing methods to ensure they are working.11
One common problem with this clause is that too many organizations trust the error-proofing device without periodically verifying that it is working as intended. This does not meet the intent of the requirements.
In addition to process control, there are many other difficult automotive QMS requirements to navigate—maintenance, standard work, special characteristics and difficult ISO 9001 requirements, such as risk and context of the organization. Those may be covered in a future column.
- International Organization for Standardization (ISO), ISO 9001:2015—Quality management systems—requirements, subclause 4.4.1.
- Automotive Industry Action Group, Measurement Systems Analysis (MSA), 1990.
- Joint Committee for Guides in Metrology (JCGM), JCGM 100 series—Guides to the expression of uncertainty in measurement, 2008.
- JCGM, JCGM 200:2008—International vocabulary of metrology—basic and general concepts and associated terms.
- International Automotive Task Force (IATF), IATF 16949:2016—Technical Specification, subclauses 7.2.3.d and 7.2.4.e.
- Ibid, subclause 220.127.116.11.
- ISO, ISO 9001:2015—Quality management systems—requirements, subclause 8.5.2.
- Ibid, subclause 7.2.b.
- ISO, ISO 9000:2015—Quality management systems—fundamentals and vocabulary, subclause 3.8.13.
- Ibid, subclause 3.8.12.
- See reference 5, subclause 10.2.4.
R. Dan Reid is the principal consultant with Management Systems Consulting LLC in Farmington, MI. He is an author of IATF Technical Specification 16949, QS 9000, ISO 9001:2000, ISO IWA-1 (the first International Organization for Standardization international workshop agreement) the Chrysler, Ford, General Motors Advanced Product Quality Planning With Control Plan, Production Part Approval Process and Potential Failure Modes and Effects Analysis manuals and Business Operating Systems for Healthcare Organizations (Automotive Industry Action Group, 2007). Reid was the first delegation leader of the International Automotive Task Force. He is an ASQ fellow, an ASQ-certified quality engineer and a trainer of many other requirements, including ISO 13485, AS9100, ISO 14001, ISO 45001 and the German automotive standard VDA 6.3.