Ask Art Solutions Com Continual Improvement Tips HTML

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ISO 9001 - Tips on Continual Improvement (CI)

What is CI?

Continual improvement is a recurring activity that seeks to increase theorganization 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 CI program is to improve your capability

to meet requirements and satisfy customers.

What are the ISO 9001 requirements for CI?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 mustbe on improving the effectiveness of the QMS. 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 allbusiness 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, suchas product quality and cost; profitability; competitiveness; employee relations

and work environment; customer satisfaction; etc.

Why is CI 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 andrequirements.

The expectations of other shareholders are equally demanding in terms of

increasing profitability and rewards. If businesses stand still, they will lose theircompetitive edge, so improvements must be made to keep pace with stakeholder

demands and expectations; and to be viable and grow.

How is CI brought about?

The continual improvement process can be conducted by:

1. Significant breakthrough projects that either revise or improve existingprocesses

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 standard requires for

CI?

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e oo s or recurr ng ac v es re erre o n e s an ar c ause . .

include: quality policy, quality objectives, audit results, analysis of data,corrective and preventive action, and management review.

How can the Quality Policy and objectives be used for CI?

If you recall clause 5.1 required top management to establish the quality policyand 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 resultsare 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 furtherimprovement 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 manyopportunities 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 theseopportunities 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 veryproductive 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 improvementopportunities you will uncover.

How can Analysis of Data be used for CI?

Analysis of QMS data (clause 8.4) may provide significant information onoperational performance and improvement opportunities. Management must

review and make decisions and take actions on the results provided by suchdata.

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 inprocess 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 experienceproblems 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 similarsituations, 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 CI?

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; managementreview 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 marketshare; 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 theseissues, 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 CI?

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 thentake 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 CI process be measured?

Performance indicators to measure the effectiveness of the CI process may

include - quality objectives being met sooner than planned;; achieving andexceeding business and quality objectives; improved efficiency in use of

resources; cost reduction; improved product quality; etc.

Who in the organization, should be responsible for CI?

Everyone in the organization has a contributing role. Top management must

provide the leadership, support and resources and prioritize CI projects. Process













owners an unc ona managers mus organ ze an ocus e resources anefforts, 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, andabove all, provides the environment for success.

What are useful steps for a CI 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 9001:2000. Thisbook 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 forQMS development, maintenance or improvement.

Need Training or Consultancy help?

Ask Art Solutions has significant expertise in all of the implementation steps andcan 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, pleasecall us at 905-593-8867 for a no obligation review of your needs.

Your Feedback is valuableIf this article was informative or if you would like to provide feedback, do send us

an email with your comments.If you feel this article could help your supplier, customer or other business

associate, feel free to refer our website to them








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