The Management Representative

ISO 9001 section 5.5.2 states: "Top management shall appoint a member of the organization's management" [to oversee the quality management system(QMS)].  The responsibilities of the 'management representative' are:

• Assuring that the QMS is developed and the processes of the QMS are maintained
• Reporting to management on the performance of the QMS
• Promotion of awareness of customer requirements

In moderate and large sized organizations, this person is typically the individual responsible for the quality function, but this is not necessarily the case.  In smaller organizations , there may be no formal quality organization.  In this case any member of management who is prepared to take on the  responsibilities above can assume the position.  It is common for the selected individual to interface with customers and suppliers on quality matters.

For the management representative to be successful, he or she must have the support of top management, and must understand the ISO 9001 standard.  There are instances where decisions must be made about the acceptability of product.   Sometimes the correct decision is unpopular for cost or other reasons.  The management representative must be supported when difficult issues arise, and must be willing to make the right decision.

To implement the standard, it is common for the management representative to form a team.  A quality team should include one or more members of the following groups:

• Manufacturing
• Purchasing
• Engineering
• Sales

Other groups such as accounting, inventory management, and warehousing may also be possible contributors.

If the management representative is not a quality professional, he or she should receive training in ISO 9001, and have access to a quality assurance consultant.  The elements of the standard only cover 14 or so pages, but the wording is pithy.  An experienced quality professional will understand the wording and its interpretation in the context of business practice, but the representative inexperienced in quality will likely gloss over key points in the standard.

For assistance or more information visit www.rosehillsystems.com.

Quality Objectives

ISO 9001 segment 4.2.1 General states that the quality management system documentation must include documented statements of quality objectives.  It leaves it to management to determine what those objectives are.

Quality objectives should be in alignment with the quality policy, so it’s important to decide what the organization’s quality policy is.  For each QMS process, quality objectives should be established.  The objectives should be SMART.  That is Specific, Measurable, Achievable, Realistic and Timely.

For example, consider a quality policy that states:  ‘We will achieve zero defects in product shipped’.  If the organization is shipping 10% defective product, a SMART objective might be: ‘Achieve a 10% reduction in defects shipped in the next fiscal year’.  It doesn’t reach zero defects, but the objective heads in the direction the organization needs to go to achieve zero defects, so it is in alignment with its objective.

Each organizational unit that can affect the quality of the product should have metrics that show whether the department is meeting goals which drive the organization toward achieving its objectives.  Metrics should measure both efficiency and effectiveness. 

Efficiency measures the amount of resources consumed.  Effectiveness measures the success of the organizational unit in achieving its objectives.  In the example above, man-hours consumed to appraise product quality might be an efficiency metric.  Number of defective units shipped could be an effectiveness metric.  Achievement goals for each metric can be established and achieved within a period.  Achievement of these goals drives the organization toward the achievement of its objective.

I like to have at least one overall metric which tells the organization how it is doing.  For manufacturing operations a metric like first pass rejection rate, or warranty return rate are meaningful metrics. 

Consider measurements which can be quantified in dollars.  One organization I worked with had 20% late deliveries.  For that organization this represented $8 million in sales shipped late to customers.

I have provided some ideas to consider when establishing quality objectives.  An external auditor will view the organization’s metrics in the light of its objectives.  Establish SMART goals that are in alignment with the organization’s objectives, and be able to show that they are being achieved.

For more information visit www.rosehillsystems.com

 

Training Presentations

ISO 9001 Implementation requires that employees be trained in the standard.  Over the years I have done many training sessions in the standard.  These sessions typically take one to two days to conduct.  After a few hours going through the standard,  I find students eyes glossing over.   Either I or the material tends to put people to sleep.  In short I don't believe that a one or two day training session is particularly effective.

To address this training effectiveness issue, I have been developing PowerPoint presentations on specific elements of the standard.  The idea is that a segment can be covered completely in an hour or less, and can keep people's attention long enough to retain the material.  It also makes sense to train in an element as implementation of that element is about to start.

At www.rosehillsystems.com, in the Tools section, you will find a link these presentations.  They cover various elements of the standard with some added insight into implementation.  At this point there are a dozen or so presentations.  I will be adding to these presentations over time, so check back periodically.