ISO 9001 Continual Improvement

Everything You Need To Know About Meeting ISO 9001 Requirement For Continual Improvement

What is Continual Improvement?
Continual improvement is a recurring activity that seeks to increase the organization’s effectiveness and efficiency in fulfilling the requirements of the organization as well as its stakeholders - customers; suppliers; employees; investors; community; etc. The aim of a Continual Improvement program is to improve your capability to meet requirements and satisfy customers.

What are the ISO 9001 requirements for Continual Improvement?
Clause 8.5.1, states:
The organization shall continually improve the effectiveness of the quality management system (QMS) through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action, and management review. 

Yes, improvement can and should be made throughout an organization, but from an ISO 9001 requirements perspective, the focus of continual improvement must be on improving the effectiveness of the quality management system. Now this may not necessarily be restrictive. It depends on what the scope of the QMS is. Increasingly, organizations are widening the scope of their QMS to include just about all business activities.

The rationale is that by improving the effectiveness and efficiency of the QMS, the organization will indeed directly and indirectly improve in other areas, such as product quality and cost; profitability; competitiveness; employee relations and work environment; customer satisfaction; etc.

Why is Continual Improvement important?
The business world is highly competitive and dynamic. Customers increasingly demand better quality products, service, support and costs. They will go elsewhere, if your organization cannot keep pace with their expectations and requirements.

The expectations of other shareholders are equally demanding in terms of increasing profitability and rewards. If businesses stand still, they will lose their competitive edge, so improvements must be made to keep pace with stakeholder demands and expectations; and to be viable and grow.

How is ISO 9001 Continual Improvement brought about?
The continual improvement process can be conducted by:

1. Significant breakthrough projects that either revise or improve existing processes
    or lead to new processes. These are usually done by cross-functional teams
    outside routine operations.

2. Small-step ongoing improvement activities conducted by personnel within
    existing processes.

What are the recurring activities or tools that the ISO 9001 standard requires for Continual Improvement?
The CI tools or recurring activities referred to in the standard (clause 8.5.1) include: quality policy, quality objectives, audit results, analysis of data, corrective and preventive action, and management review. 

How can the ISO 9001 Quality Policy and objectives be used for Continual Improvement?
If you recall clause 5.1 required top management to establish the quality policy and clause 5.3.e required them to review it for continuing suitability. If your quality policy and related quality objectives (clause 5.4.1) are not being achieved, then opportunities for CI exist. These opportunities should surface at management review and operations meetings when quality measurement results are reviewed to quality objectives. 

Changes in product, customer base, organization ownership, management, technology, QMS standards, etc., may require changes to your quality policy and objectives. As a tool for continual improvement, it requires top management to review and understand these changes; make changes, if necessary, to the quality policy and objectives and use these changes to continue further improvement of the QMS and customer satisfaction.

How can Audit Results be used for CI?
Results of product, process and QMS audits (clause 8.2.2) 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 for management review. 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. You will be amazed at what you will find and improvement opportunities you will uncover.

 Call us today at 905-593-8867 or email us at artjlewis@rogers.com to discuss your specific needs to discuss your specific needs.  

How can Analysis of Data be used for Continual Improvement?
Analysis of QMS data (clause 8.4) may provide significant information on operational performance and improvement opportunities. Management must review and make decisions and take actions on the results provided by such data.

Examples of areas where data is gathered that may lead to improvement projects include: machine set-up, die change, machine changeover times; process cycle time; scrap; non value-added use of floor space; variation in process parameters; less than 100% first run capability; process averages not centered on target values; testing requirements not justified by accumulated results; waste of labor and materials; difficult manufacture, assembly and installation of product; excessive handling and storage; etc.

How can Corrective Action be used for CI?
Corrective action (clause 8.5.2) is action taken to eliminate the cause of a detected nonconformity to prevent recurrence. Most business experience problems on a day to day basis (nonconformities in quality management lingo) that may relate to - products; QMS processes; resources; suppliers and outsourced work; product shipped to customers; customer complaints; etc.

They must define a process for analyzing these nonconformities and use problem-solving techniques to eliminate their root cause(s) to prevent them from occuring again. They should apply succcessful solutions to other similar situations, where the same or similar problem might occur.

Corrective action is your day to day tool to improve the effectiveness of your QMS by tackling and eliminating problems and their root cause as they occur.

How can Preventive Action be used for Continual Improvement?
Preventive action (clause 8.5.3) is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence. Sources of for finding potential QMS nonconformities may include - analyses of data; audit results; cost of quality reports; quality records; service reports; supplier performance; customer satisfaction feedback; FMEA’s; management review records; lessons learned from past experience; SPC charts and analyses.

Organizations must define a process for analyzing these potential nonconformities and use problem-solving techniques to eliminate their root cause(s) to prevent them from occuring at all. Preventive action is your proactive business planning and risk reduction tool to improve organizational capability in order to enhance stakeholder satisfaction.

While preventing potential QMS nonconformities is our focus for ISO 9000, it might be more useful to think of preventive action in a wider context, i.e. the entire business. Think in terms of actions needed to prevent - loss of market share; loss of product profitability; loss due to lack of product diversity; loss of business opportunities due to lack of capacity, inadequate or older facilities, production equipment, technology or information systems; loss of key or competent personnel; inadequate business financing; inadequate staffing, etc.

These issues may have far more serious consequences than QMS issues. Consider a process that involves developing a business plan covering these issues, based on - gathering relevant research data on these issues; use of appropriate risk evaluation and management methods; developing proactive strategies and action; monitoring and reviewing performance against the business plan. This would constitute the ultimate CI process.

How can Management Reviews be used for Continual Improvement?
The purpose of conducting management reviews (clause 5.6) of the QMS is to gauge the health of the QMS. The review must determine QMS suitability, adequacy and effectiveness. Are the QMS resources and controls that were planned and implemented, suitable and adequate for the QMS to be effective in achieving customer and regulatory requirements; and in achieving quality objectives? Are changes needed to improve product, processes and use of resources? 

Top management must evalute qms data to answer these questions and then take appropriate actions to improve products, processes, resources and customer satisfaction, based on opportunities identified through such review. Clause 5.6 requires that top management must perform these reviews at planned intervals.

Are there other tools that are also useful for CI?
Other tools that are often used to continually improve, include: capability studies; design of experiments; risk analysis; SPC; FMEA’s; fishbone analysis; supplier evaluation; test and measurement technology; 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.

How might the effectiveness of the ISO 9001 CI process be measured?
Performance indicators to measure the effectiveness of the CI process may include - quality objectives being met sooner than planned;; achieving and exceeding business and quality objectives; improved efficiency in use of resources; cost reduction; improved product quality; etc.

Who in the organization, should be responsible for Continual Improvement?
Everyone in the organization has a contributing role. Top management must provide the leadership, support and resources and prioritize CI projects. Process owners and functional managers must organize and focus the resources and efforts, and review progress. Employees may identify opportunities as well as participate in CI implementation projects.

CI programs are most often carried out by teams that either - identify problems, find solutions, or implement changes. These teams may be from within processes or cross-functional. An organization may often use external expertise to facilitate the process and project. However, top management must provide the leadership, visibility, involvement, resources to direct the teams towards their goal, and above all, provides the environment for success.

What are useful steps for an ISO 9001Continual Improvement process?
The following steps provide a practical approach to undertaking CI:

1. Identify the opportunity - using the tools identified above

2. Evaluate the current situation - existing controls, resources, risks, etc.

3. Select appropriate diagnostic and problem-solving tools

4. Analysis - the root cause of the problem should be identified and evaluated.

5. Where possible, do a cost/benefit analysis to establish economic feasibility

6. Obtain management and process owner commitment, adequate resources; and
    define the improvement objective.

7. Identify solutions and implement the optimal solution to achieve improvement
    objective

8. Evaluate the effects of the implemented solution - has root cause been
    eliminated and improvement objective achieved?

9. Standardize and formalize the change - implement new technology, training,
    communication, documentation, records, change management, etc.

10. Apply successful improvements to other similar products, processes and
      situations in the organization.

Where can I get further help?
This article is an excerpt from my eBook, “Understanding ISO 9001:2008”. This book provides a complete and in-depth coverage of all ISO clause requirements and well as key quality management principles and concepts. It is an excellent guide for QMS development, maintenance or improvement.

Need Training or Consultancy help?
Ask Art Solutions has significant expertise in all of the implementation steps and can help you fast track your way to an effective and profitable QMS.
If you need help in developing or implementing your ISO 9001:2000 QMS, please call us at 905-593-8867 for a no obligation review of your needs.

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