Avoid the Most Common Sources of ISO 9001:2015 Nonconformances with the Process Approach

Penny Ouellette’s “ISO 9001:2015 Implementation: The Good, the Bad and the Trending” (Quality, November 8 2018) provides a valuable list of the most frequent clauses that are cited in ISO 9001:2015 findings. These are:

  • Clause 4.4.1, Quality management system and its processes.
  • Clause 7.2, Competence.
  • Clause 8.4.1 Control of externally provided processes, products, and services.
  • Clause 9.1.2 Customer satisfaction.
  • Clause 9.2.1 Internal audit.
  • Clause 9.3.2 Management review inputs.
  • Clause 10.2.1 Nonconformity and corrective action. CAPA deserves particular attention because, as stated by other references, this is a major source of IATF 16949 findings as well as FDA Form 483 citations. The organization also relies on its CAPA process to address risks and opportunities, as well as resolution of internal and external audit findings.

The article also cited difficulties with clauses 4.1 and 4.2, context of the organization and needs and expectations of interested parties respectively, and also 6.1, actions to address risks and opportunities. These issues are related because context of the organization, and needs and expectations of interested parties, are vital considerations for actions to address risks and opportunities—and they are applicable to processes of the quality management system as well as the organization as a whole.

The article also cites 5.1.1(d) which relates to the process approach and risk-based thinking. This, despite being a seemingly obscure sub-clause, is a key foundation of a modern quality management system. ISO 9001 made it clear, starting with ISO 9001:2000, that the best quality management systems consist of processes as opposed to isolated activities, and this consideration ties in with clause 4.4.1, one of the major nonconformance sources. It is vital to remember that processes include inputs, actions taken on the inputs, and outputs, which implies in turn interactions with and handoffs between other processes. Processes also have suppliers and customers, whether internal or external, and the customers in particular have needs and expectations.

Areas Covered in the Session :

  • Deployment of ISO 9001:2015 clauses 4.1 (context of the organization), 4.2 (needs and expectations of interested parties) and 6.1 (actions to address risks and opportunities) to the process level, and application of the SIPOC (Supplier, Inputs, Process, Outputs, and Customer) model, should address most problems associated with the cited clauses and others. What are the context and scope of the process? That is, what is it supposed to achieve, and what internal and external issues affect its ability to perform? What are the needs and expectations of its customers, whether internal or external? What risks affect its ability to deliver the desired results, and what opportunities exist to improve its effectiveness? AIAG’s Potential Failure Mode and Effects Analysis (4th ed), in fact, suggests addition of columns for variation sources and deliverables side by side with the process flowchart.
  • Customers for a process for competence (clause 7.2, one of the major nonconformance sources) include other processes that need competent people to perform them. Their needs and expectations include requirements for skills and other competencies. The process itself would include, for example, training activities, assessment of competence, and outputs including quality records in the form of proof of training that reflect the competence gained. The management review meeting is, or ought to be, a process with inputs such as audit findings, customer complaints, and key performance indicators, and outputs that include actions to address deficiencies and also opportunities. These outputs can become inputs to yet another process: corrective and preventive action (CAPA).
  • Corrective action (10.2.1) has multiple inputs including not only nonconformity, but also audit findings and outputs from management review meetings. An output from the customer satisfaction process, or a supplier corrective action request (SCAR), also can initiate corrective action for any deficiency. The CAPA process is also, however, usable for realization of opportunities unrelated to audit findings, complaints, poor quality, or other issues related to nonconformity. It is equally applicable to the removal of waste (muda). The importance of the organization’s CAPA process cannot be overemphasized.
  • The presentation will therefore focus heavily on the concept of a process including inputs, resources, handoffs and interactions, and outputs as well as application of clauses 4.2 and 6.1 (in particular) to assessment of processes.

Attendees will receive a pdf copy of the slides and accompanying notes for the presentation.

Who Should Attend:

All ISO 9001:2015 users, including but not limited to manufacturing and quality managers, engineers, and technicians.

William Levinson

William (Bill) A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Pennsylvania State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, TOC World 2004, and other national conferences on productivity and quality.

Mr. Levinson is also the author of several books on quality, productivity, and management. Henry Ford’s Lean Vision is a comprehensive overview of the lean manufacturing and organizational management methods that Ford employed to achieve unprecedented bottom line results, and Beyond the Theory of Constraints describes how Ford’s elimination of variation from material transfer and processing times allowed him to come close to running a balanced factory at full capacity. Statistical Process Control for Real-World Applications shows what to do when the process doesn’t conform to the traditional bell curve assumption.

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