Note About ISO 9001:2000
This edition of ISO 9001 is one part of a consistent pair of quality management system standards. The second part of the pair is ISO 9004:2000. They are designed to be used together; however, ISO 9004:2000 is not a guideline for carrying out ISO 9001:2000 and it is not part of certification.
ISO 9001:2000 defines specific quality management system requirements necessary for certification. ISO 9004:2000 offers guidance about many quality management system objectives for overall organizational performance.
ISO 9004:2000, Section 4 Quality Management System Guidelines, Item 4.3 - Use of quality management principles identifies eight quality management principles the International Standard is based on:
- Customer focus
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision-making
- Mutually beneficial supplier relationships
ISO 9004:2000 also provides (Annex A) a self-assessment guideline for quality management system criteria. A performance maturity levels table is provided for your evaluation scoring from Maturity Level 1 - No formal approach, to Level 5 - Best-in-class performance. The introduction to this section addresses the Baldrige National Quality Program and regional quality award models as those most recognized. The intent is to move in this direction. Comparing ISO 9004:2000 with the Baldrige criteria - 2000 shows similar categories.
ISO 9001/2 is the beginning of and forms the foundation for quality system excellence. It is easier for employees to bridge the cultural gap starting with ISO than with Baldrige. ISO is fact-based - say what you do and do what you say, and of course document it. Baldrige is more subjective, although the criterion now contains many fact-based requirements (Section 7 Business Results). Of course, this opinion is based on your state of corporate readiness, and level of training and understanding about quality, systems, process, people and other fundamentals. There are many articles arguing cart before the horse and vice versa. Does it matter? No matter how you started, with Baldrige, state award criteria or with ISO requirements, you are on the way to continued excellence. The intent is clear with the introduction of ISO 9004:2000. Is this the best direction to take? Only time will tell.
Element 4.20 Statistical Techniques
4.20.1 Identification of needs:
You shall identify the needs for statistical techniques required for establishing, con-trolling and verifying process capabilities and product characteristics.
The requirement is focused on identifying the need for statistical techniques. It is directed at process capability and product characteristics. The standard does not mandate that you use statistical techniques. It's up to you.
Needs are identified by:
A. The customer clearly calling out statistical data reporting as a contract requirement. During Contract Re-view, this requirement is reviewed and decided upon (i.e. - Do we have the ability to meet the customer contract needs?)
B. Internally imposed requirements. You can develop and use process capability studies, Design of Experiment (DOE), and/or use SPC during production to measure and control product characteristics. The quality department most often uses statistical techniques for both variable and attribute data analysis. Include identification of these practices in your procedure and also document records requirements.
C. Receiving material requirements. Most organizations have developed receiving inspection sampling plans. If you use a sampling plan, be sure to include it in a procedure for 4.20.1. Use of sample plans can be directed toward specific vendors for qualification, based on poor history, current nonconformance, or receipt of critical materials. Receiving procedures will identify which material/product requires use of the sampling plan.
Some companies start by training operators about capturing data based on operational guidelines or procedures. This data is reviewed and analyzed by the quality department for action. The quality department also may talk with operators and setup personnel to use press computer technology with built-in SPC capabilities. Once operators are trained and a statistical program is set up, the operators become responsible for understanding the charted data and authorized to make adjustments or stop production. At the least, operators notify the lead person or supervisor about conditions beyond set limits.
You shall establish and maintain documented procedures to implement and control applications of statistical techniques identified in 4.20.1.
Simply stated: If you use it, document it in a procedure. Develop a procedure for each application clearly defining what technique is to be used, where used, when applicable, and detailed instructions about recording data and analyzing results.
Training is an understood requirement for 4.20.2. Your training program(s) must include sampling, sample size, data collection and frequency, basic statistics, re-cording of data and evaluation of results from charts, plots or graphs. If you use this data real-time, specify when a press or line can be shut down by the operator, lead person, supervisor or quality technician.
Article 20 Statistical Techniques completes the ISO 9000-1994 Series. This column will continue to focus on the Draft International Standards (DIS) as proposed for adoption. DIS is the third draft stage to be evaluated. It then becomes the Final DIS planned for the third quarter of this year. FDIS is planned for publication as the revised ISO 9000, 9001 and 9004-2000 standards in the fourth quarter of this year.
Guidance and opinions about how to update your existing quality system documentation or develop new documentation also will be provided.