ISO 9001 - Tips On Setting Quality Objectives

ISO 9001 - Tips On Setting Quality Objectives

What is the purpose of quality objectives?
The purpose of quality objectives is to determine conformity to (customer and regulatory) requirements, and facilitate the effective deployment and improvement of the quality management system (QMS).

What are the specific requirements in ISO 9001 for quality objectives?
The requirements (clause 5.4.1) for quality objectives are:

· Establish quality objectives at relevant functions and levels
· Include objectives to meet product requirements
· Quality objectives must be measurable
· Keep these quality objectives consistent with the quality policy
· Make all personnel aware of the importance of the objectives and how they
can help to achieve them (clause 6.2.2d).

Where should quality objectives originate from?
Quality objectives must orginate from the organization’s quality policy. Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, starting with establishing the quality policy and objectives.

Your quality policy provides top management’s vision on quality management for the organization. It provides the organization with focused direction, i.e. high level goals and objectives for quality management.

Besides your own organization, requirements for quality policies and objectives (e.g., for product as well as product realization processes) may also come from the customer, regulatory bodies and industry standards or codes.

Your quality policy and objectives must be consistent with the scope of your QMS and must complement other business objectives of your organization such as those related to growth, finance, profitability, the environment and occupational health and safety. Aggressive sales or marketing strategies must not be at the expense of quality management.

The goal of an organization should be to integrate the various management systems (including quality management) used to achieve its strategic business goals and objectives. It is unfortunate that many organizations choose to dis-associate quality management from operational management.

What are these other strategic business goals and objectives?
Top management must integrate and keep quality management policies and objectives consistent with strategies, policies and objectives for other business, areas such as:
· Markets: share and growth, customer base and diversification, competitor information, pricing, sales, etc.

· Organization: size, structure, responsibilities and accountability, etc.

· Product: quality, performance, reliability, maintainability, design technology and innovation, demand, mix, packaging, pricing, warranty, support, etc.

· Processes: facility, capability, capacity, technology, reliability, quality

· Supplier management: quality, delivery, price, consistency, flexibility

· Workforce: labor availability, competence, mix, utilization, compensation, health and safety, etc.

· Capital: sourcing, availability, cost, prioritization of use, return, etc.

· Other: environment, regulatory issues, governmental policies, communications, etc.

What should an organization state in its Quality Policy?
Clause 4.1.a - requires that you document your quality policy and clause 5.3.c requires that you specify your commitment to ‘meet requirements’ and ‘continually improve the effectiveness of your QMS’. Clause 1 specifies requirements for the scope of your QMS. Therefore, it would be logical and useful to use the wording in clause 1 to define your quality policy?

The wording of the quality policy should preferably specify what requirements are being complied with (e.g., customer, regulatory, ISO 9001, etc.). It must also clearly state your commitment to continually improve the effectiveness of the QMS.

Beyond that, you may state other complementary and important policies (business growth; product or manufacturing technology; workforce competence; business flexibility, etc.)

How do quality objectives flow from the Quality Policy?
What you state in your quality policy, must lead to establishing quality objectives, e.g. if you state in your quality policy that you will “meet customer requirements”, then from this, you might derive customer focused objectives for - product defects; customer complaints and returns; on time delivery, etc.

Similarly, for the phrase -“meet ISO 9001 requirements”; from this you might derive process objectives for effectively using ISO 9001 requirements to manage and control your QMS processes to achieve conformity to the standard.

Stating that you will “continually improve the effectiveness of your QMS” in your quality policy - can lead to a number of objectives, as your QMS is comprised of many processes each with related risks; so it is possible to have one or more improvement objectives for each process.

Thus, we can see that each statement in your quality policy may result in one or more quality objectives. These quality objectives do not need to be stated in your quality policy, but top management must clearly be involved in providing direction, establishing and reviewing these objectives.

Who should be involved in setting quality objectives?
Top management must provide the leadership and direction for quality management within an organization. The establishment of quality objectives should be part of the business planning or QMS planning processes.

Top management must establish the organizational structure and internal environment that motivates personnel to achieve the organization's quality management goals and objectives. They must provide adequate resources to develop, implement, maintain and improve the QMS.

Quality objectives may be set at various functional levels of the organization - top management; departments; processes; functional groups; work cells; project teams; individuals; etc. In determining quality objectives, top management must obtain input from these sources. Top management must also ensure that quality objectives from all sources are consistent with each other as well as other business objectives such as sales growth and profitability.

They must ensure also buy-in and ownership of all quality objectives to facilitate their deployment and achievement. The Quality management representative can play a significant role in coordinating the development and deployment of quality policies and objectives.

Input from customers and regulatory authorities must also be considered.

Can you provide some examples of quality objectives for an organization?
Quality objectives may be established to measure the performance of products; processes; customer satisfaction; suppliers; use of resources; and the overall performance and effectiveness of the QMS. Quality objectives may be established for all QMS processes.

Examples of quality objectives:

Product - reduction in defect rates, PPM’s (defective parts per million), scrap rates, rework; improvement in on time delivery (see clause 7.1a).

Process - objectives generally focus on improving process productivity through the elimination or reduction of variation and waste in process - inputs, outputs, conversion activity and related use of resources.

Objectives may be used to monitor and improve process - productivity; reduction of cycle time, errors, omissions and failures; etc. Examples could include objectives for - set-up time; run rates; process cycle time; etc.

Customers - reduction in # of complaints; improvement in customer satisfaction rating; on time delivery; service; support, etc, (see clause 8.2).

Suppliers - material defects; on time delivery; # of complaints with supplier.

Resources - (includes facility; equipment; labor; etc.) - objectives could be established based on availability; capability; maintenance; personnel competency, absenteeism; production rates; efficiency; safety; etc.

For the QMS - customer satisfaction feedback; internal audit results; # of and results of improvement opportunities; etc.

Should quality objectives be measurable?
Quality objectives must be measurable (see clause 5.4.1). Measurement can be done quantitatively or qualitatively. Quantitative measures are generally more objective in determining whether conformity or effectiveness has been achieved. In some situations, the use of qualitative measurements may be appropriate. Objectives based on yes/no criteria, (e.g. - develop new product by June 2006), are also acceptable.

Quality objectives should be specific and relevant, so that the expected outcome is understood and meaningful to personnel responsible for its achievement. The objectives must be realistic and achievable with the resources provided.

The quality objectives must be achieved within a defined time period to ensure accountability. This could be determined by your customer, your management, your head office, regulatory bodies, etc. Your business or quality planning process must establish these time periods and include the communication of objectives and timelines to those responsible for achieving them.

Where should quality objectives be documented?
Quality objectives may be documented in any or all of these documents - your quality manual; QMS processes; procedures; quality plans; etc.
As a quality document, your documented statement of objectives must be controlled by 4.2.3 control of documents.

How many quality objectives must an organization have?
You must be careful not to overwhelm your organization with too many objectives as this may cause more frustration than positive results. Start with objectives that focus on meeting customer requirements and then slowly develop meaningful objectives for key processes and risk prone processes, as initial targets are achieved.

When and how often should quality objectives be reviewed?
ISO 9001 clause 5.6.1 states that top management shall review the QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the QMS, including quality policy and quality objectives. Results of management reviews shall be maintained (see 4.2.4)

Management reviews should be held at least once a year and preferably more often. More organizations are moving to integrate the review of QMS issues at regular business and operational review meetings, usually held monthly.

The review should evaluate to what extent quality objectives have been achieved; obstacles and issues that prevent achievement; outcomes and decisions from such reviews must focus on taking corrective action on problems and continual improvement of the QMS. Records must be kept of such reviews.

What methods should be used to track performance to quality objectives?
Planning for measurement and analyses of performance to quality objectives must consider the methods and resources (time, manpower, computer, software, statistical tool, etc) needed to collect, organize and analyze product, process, supplier, customer satisfaction and QMS performance data.

Your process for data collection and analysis must address the type of data to be collected; how it should be sorted and classified; use of appropriate information systems and data gathering tools and techniques; assignment of responsibility and authority to review and act; competency and training in use of tools and data analysis; that the data is gathered, analyzed and acted upon on a timely basis; communication and awareness of objectives to all personnel responsible for achieving them, etc.

Use your organizations cross-functional knowledge of customer requirements; product; technology; manufacturing processes; etc, to determine what statistical methods to use to measure and track quality objective measurables, and to what extent to use them. Include these methods in your quality plan.

Various statistical methods- process capability studies, control charts; Pareto analysis; variation analysis; spreadsheets; fors; data acquisition and analysis software; business analysis software may be used for effecitive and efficient data collection and analysis.

What are some common mistakes that organizations make in setting quality objectives?
Using quality objectives to improve your QMS and business can be a powerful tool if used the right way. Here are some mistakes that you should avoid:

· Using quality objectives superficially as a way to fulfill ISO 9001 requirements instead of using it as an effective tool for decision making and strategic management.

· Using objectives that do not relate to the organization’s mission and business strategies.

· Using objectives that are not measurable.

· Not assigning specific accountability for achievement of objectives.

· Not providing adequate resources

· Using objectives that are confusing, ill-defined or feel-good.

· Allowing process owners and functional managers to define objectives without guidance and coordination, resulting in objectives that are inconsistent with each other or with other business strategies and objectives.

· Not providing training to personnel in understanding quality objectives and using the measurement tools to achieve them.

· Just collecting the data on performance to objectives; and not using the data.

· Not conducting periodic review of progress and removing obstacles to achieving quality objectives.

Where can I get further help?
This article is an excerpt from my eBook, “Understanding ISO 9001:2000”. 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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