ISO 9001:2015 CLAUSE 10 IMPROVEMENT - PRETESH BISWAS (2023)

by Pretesh Biswas

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ISO 9001:2015 CLAUSE 10 IMPROVEMENT

Occasionally undesired things occur; now it’s time to address nonconformity and corrective action. And to make things better there’s continual improvement. The requirements here are familiar and well understood. But what about preventive action? It does not appear. As some have argued for many years, one of the objectives of a management system is preventive action. The requirements in clause 4.1 to “…determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s) of its quality management system” and in clause 6.1 to “determine the risks and opportunities that need to be addressed to assure the Quality management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.” not only address preventive action but go beyond. And in the end, auditors will look back at the management system established in clause 4.4, reviewed in clause 9.3, and now continually improved. Finally, although there remains a requirement for processes, there is no mention anywhere of procedures, documented or otherwise. If a discipline considers that they are required then they will appear in clause 8 – Operations. However, if they are not a requirement but the organization themselves consider they need them then that will be their decision

ISO 9001:2015Clause 10, Improvement, has three sub-clauses:

10.1 General
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement

10.1 General

The organization must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These actions must include improving products and services to meet requirements, as well as, address future needs and expectations; correcting, preventing, or reducing undesired effects; improving the performance and effectiveness of the quality management system. Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation, and reorganization.

The phrase “opportunities for improvement” is only mentioned in ISO 9001:2008 at clause 5.6.1 (Management Review – General). The phrase has been repeated in ISO 9001:2015 at clause 9.3.2.f (Management Review Inputs) and added to clause 5.3.c (Organizational Roles, Responsibilities, and Authorities) and clause 10.1 (Improvement – General). Although “meet customer requirements” and “enhance customer satisfaction” are expressed in several places in ISO 9001:2008, they aren’t mentioned in the old clause 8.5 under Improvement. Clause 10.1 in ISO 9001:2015 adds that improvement actions are taken to meet customer requirements and enhance customer satisfaction. ISO 9001:2015 adds that organizations are to not only improve products and services to meet known requirements, but also to address “future” needs and expectations.

We use the term “improvement system” to mean the approaches, methodologies, tools, and technologies that organizations use to bring about improvements in how the organization operates. These are management approaches for isolating issues and finding solutions, and they are often the catalyst for specific changes to technologies, processes, job roles or organization structures. A systemic and humane approach for improving an organization that makes a difference to the customer and provides a lasting effect has three components:

1. how a product or service is delivered,
2. the product or service design, and
3. a management system toenable improvements.

Process Improvement

The reality for fulfilling the needs of the customer consists of an overwhelming number of factors. Requirements are imposed from multiple sources or customers, each with their own needs and wants. As requirements are cascaded through the organization, the requirements are translated into actionable items. Sometimes with clear connections, sometimes the connections are not obvious. Some benefits are immediately obvious and some benefits are obscure to the local workforce. Each requirement has ramifications far beyond the immediate area. Many Process Improvement methodologies are created to improve operational efficiency and effectiveness. Each provides a disciplined approach for improving how a product or service is delivered. Their primary technique is to expose incongruities in the execution of tactical plans, bringing into the open some of the assumptions and misdirected focus of dedicated professionals. Once incongruities are exposed and understood, people inherently strive to correct them. No one deliberately creates unnecessary work or bad quality. Most processes are created with the best of intentions, focusing on performing the task at hand, with the resources at hand, in the environment where they exist. It uses a structured approach to understanding the existing conditions, generates improvement ideas, then implements the changes.

Product Improvement

The design activity consumes five percent of the product cost, while it has a 70 percent influence on the final cost. On the other hand, material and labour costs can consume 65 percent of product costs, while only influencing the final cost by 25 percent. Where would you invest your capital and human resources to produce the largest return: Improving the 25 percent influence on product costs, or the 70 percent? Value Engineering (VE) has been evolving for the last 60 years as a way to remove unnecessary cost from the product design before, during, and after the fact. VE first identifies the intent or function and understands the context, then develops alternatives and implements a plan. Value Engineering studies bring marketing, finance, operation, design, customers, and suppliers together to systematically explore how the product performs the function the customer needs.

Management Practices Improvement

All human activities and efforts of any organization are based upon management practices. Practices that govern how people interact within the organization, as well as, how people interact between the organization and the rest of the world. The practices may be consciously created and based on theory or may have simply emerged as the organization grew and matured. Management’s job in the area of improvement is to create and facilitate an environment for learning and cooperation. One area to start is to remove policies and barriers that inhibit people from doing a good job. At the same time, encourage communication between functional areas and different levels of the organization. Another aspect of management’s obligation to improvement efforts is to encourage the exploration of data and theory. Finding the context for which data is used for improvement and how it helps align improvement efforts towards the aim of the system. Data, information, and knowledge are not the same. Data is just that, data. Measurements and observation counts are two examples. When data is placed in a context, information is created. Understanding how data is classified and interpreted based on the concepts in which it was created, along with how the data is used for action are just a few factors of converting data and information into knowledge.

Creating a systemic approach toimprovement

Process improvement, productimprovement, and management practicesimprovement must work together towardsimproving the organization as a whole,working towards a common aim. Everybody
doing their best is not sufficient. Functional areas of a system must be aware of how their actions impact other groups and the entire system. Each group must investigate to understand how their actions will benefit the whole, and identify the dangers of how their actions introduce risks to the whole. Also, each group may have to accept less than optimal performance of their functional area in order for the entire system to improve. Selecting where to start is not a question of one area or the other. All three areas are codependent on each other. No group exists in isolation. Every organization is a system. When improvement is begun in any single area, the first issues addressed are usually the issues that can be corrected by the local workforce. However, as these immediate and local issues are corrected, new issues become visible. Issues that are beyond the scope of immediate influence. This causes conflicts as improvement efforts start to influence other areas. Between the unbridled enthusiasm of one area, and another area not understanding the reasons for the change, conflict arises. This conflict causes change efforts to have several adverse effects. First, it negatively affects the morale of people and organizations. Second, conflict leads to reduced performance of other groups in the system. People are not against change, they are against being changed. People need to understand the need for change from their perspective. Functional workgroups are not receptive to outside groups telling them how they must change. Communication and collaboration are the best way to overcome resistance. Management practices must provide an environment where people are given a voice in how change is going to happen and share operational definitions about each other’s improvement projects. Using language that is common or easily understood by most people, without jargon. The organization must learn individually and collectively. Only through cooperation and collaboration will collective learning take place. Collaboration in pairs is an interim step. Eventually, production, product design, and management practices will need to work together.

Below is a simple breakdown of the ADKAR elements for the change, “implementing a new improvement system”.

10.2 Nonconformity and Corrective Action

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization must react to the nonconformity and, as applicable take action to control and correct it; and deal with the consequences. The organization must also evaluate the need for action to eliminate the causes of the nonconformity so it does not recur or occur elsewhere, by reviewing and analyzing the nonconformity,determining the causes of the nonconformity, and determining if similar nonconformities exist, or could potentially occur. The organization must implement any action needed and review the effectiveness of any corrective action taken; It must update risks and opportunities determined during planning, if necessary, and make changes to the quality management system, if necessary. The corrective actions must be appropriate to the effects of the nonconformities encountered.

10.2.2 The organization must “retain” documented information as evidence of the nature of the nonconformities and any subsequent actions taken and results of any corrective action.

Use of “retain” indicates the documented information refers to “records” kept as evidence.

The ISO 9001:2015 requires that the organization must react to nonconformity by first controlling and correcting it, as well as, dealing with its consequences. It also adds a requirement to determine if similar nonconformities exist, or could potentially occur. A new requirement is to update the risks and opportunities determined during planning, if necessary. Another new requirement is to make changes to the quality management system, if necessary. Clause 10.2.2 adds that the documented information retained as evidence must now indicate the nature of the nonconformity and any subsequent actions taken.

Corrective action is the action taken to eliminate the cause of a detected nonconformity to prevent a recurrence, whereas preventive action is the action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence. The procedurefor your corrective action process must address the following control requirements:

• Identify detected nonconformities that relate to your products, QMS processes, resources, suppliers and outsourced work, product shipped to customers, customer complaints, cost of quality reports, and Things Gone Wrong reports.
• Define your process for identifying nonconformities and consider using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity
• Problem-solving tools may include analysis of failure mode, capability studies, correlation diagrams, data collection, fishbone diagram (Ishikawa diagram), histograms, Pareto analysis, probability charts, stratification of data, graphic representations, etc. Ensure that personnel applying these tools are competent and trained.

Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to the product, process, resources, documentation, controls, etc., or any combination of these. Conduct follow-up tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented a recurrence. You must keep appropriate records of these actions and follow-up activities. You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of the root cause may have been incorrect or incomplete. Keep appropriate records of all corrective action steps. Ensure timely completion of any open corrective action or be prepared to provide evidence to justify its continued open status. Make your corrective action records available on request to customers and provide a summary report for management review. All nonconformities may not necessarily result in corrective action. Evaluate the significance of nonconformities in terms of their impact on operating costs, cost of nonconformity and its correction, product performance, safety, dependability, regulatory requirements, the effect on customer’s products and processes, any other risks, and customer satisfaction. Consider using cross-functional teams in such decision-making, including the involvement of your organization’s designated customer representative. Performance indicators to measure the effectiveness of the corrective action process may include a reduction in – cycle time for the correction actions, problem re-occurrence, open corrective actions, costs, and improvement in QMS productivity.

10.3 Continual Improvement

The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system.The organization must consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that must be addressed as part of continual improvement.

ISO 9001:2015 requires that the results of analysis and evaluation (clause 9.1.3) and the outputs of management review (clause 9.3) are to be considered for needs or opportunities that must be addressed as part of continual improvement. Improving the “effectiveness” of the quality management system is a requirement of ISO 9001:2008, clause 8.5.1. The ISO 9001:2015 standard adds in clause 10.3 that the organization is to also improve the “suitability” and “adequacy” of the quality management system.

Continual improvement is defined as a recurring activity to increase the ability to fulfill requirements. The ‘ability to fulfill requirements’ refers to both conforming as well as nonconforming products/processes. Conforming processes can be further improved, and nonconforming processes must be improved by taking corrective action to prevent a recurrence. Recurring activity refers to the quality improvements includes audit results, results of analysis and evaluation, and the outputs from management review, etc. The continual improvement process can be conducted by:

• Significant breakthrough projects either revise or improve existing processes or lead to new processes. These are usually done by cross-functional teams outside routine operations (Business Process Re-engineering).
• Small-step ongoing improvement activities conducted by personnel within existing processes (Kaizen Events).

Use of the continual improvement tools includes:

• Audit Results – Results of product, process, and QMS audits usually provide many opportunities to improve QMS effectiveness and efficiency. Opportunities may relate to communications, information systems, processes, controls, use of resources, technology, etc. The management representative must report these opportunities to top management as included as part of the management review agenda. They can also be reported and reviewed at regular operational meetings, etc.
• Other Audits – Besides product, process, and QMS audits, you might find it very productive to conduct financial, health and safety, environmental, technology, product profitability, social responsibility, information, and communication systems audits.
• In using ‘result of analysis and evaluations as a tool for continual improvement, use the things gone right and Things Gone the Wrong approach to classifying your data for decision-making.
• Examples of situations that might lead to improvement projects include machine set-up, die change, machine changeover times, cycle time, scrap, value-added use of floor space, variation in process parameters, less than 100% first run capability, process averages not centred on target values, testing requirements not justified by accumulated results, waste of labour and materials, difficult manufacture, assembly and installation of the product, excessive handling and storage, etc.

Useful tools that are often used to continually improve, include capability studies, design of experiments, risk analysis, SPC, supplier evaluation, test and measurement technology, the theory of constraints, overall equipment effectiveness, technology, benchmarking, analysis of motion/ergonomics, and error-proofing. Ensure that personnel applying these tools are competent and trained. Performance indicators to measure the effectiveness of the continual improvement process may include quality objectives being met sooner than planned, achieving and exceeding business and quality objectives, improved efficiency in the use of resources, cost reduction, improved product quality, etc.

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PublishedMay 11, 2019May 3, 2023