ISO 9001 Consulting, Training
        and Auditing Services

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 9001:2008”. 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.

 Call us today at 905-593-8867 or email us at artjlewis@rogers.com for a no obligation review of your specific needs.

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