|Best Practices for Implementing and Utilizing a Standards-based QMS|
|by Lee Pfennigwerth, SRI Quality System Registrar|
|Industry Spring 2007|
As the plastics industry grows increasingly competitive, it is important for companies, large and small, to certify to certain quality standards, such as ISO 9001 or sector-specific standards such as ISO/TS 16949 and AS9100. As companies consider registering to these standards, the challenge becomes how to best implement and utilize a quality management system.
A few general questions need to be asked when undertaking what could be a complex, and somewhat costly, effort. Why does a company need to implement a quality standard? How will this standard fit that company’s particular business? What type of return on investment can be expected?
Why Implement a Quality Management System?
Benefits go beyond retaining existing customers or qualifying for new contracts. Implementing a quality management system that is ISO 9001 compliant also provides discipline, improves processes, and increases the productivity and effectiveness of a company’s operations. Consistent, reliable, and well-documented management systems result in reduced scrap and waste, less human errors, and as a result, increased profitability and customer satisfaction.
One way to determine the value of a quality management system is to learn from those that have successfully implemented and certified their own systems. Over 20,000 companies have gone through the process and will openly discuss the results with suppliers and customers, as well as in user forums. Similarly, companies that are certified can answer important questions regarding measurable benefits, costs, timing, and challenges. In support of quality management systems, those that have undergone the process often will point out the following:
Effective Utilization of a Quality Management System
Organizing existing information under these processes will facilitate an understanding of and ideally, the implementation of the process approach. Many companies find it extremely beneficial to form a team and have each team member read the standard several times. This will ensure an overall understanding of the intent of the standard and the process approach.
After a company identifies its processes, it must take a general look at its business operations by mapping the processes in the logical sequence in which they occur. Processes that rely on input and output from one operation to another must be connected in sequence, relating the processes to key support and management processes previously identified. It also is important to show how existing records, procedures, work instructions, and documents relate to one another. This will help to ensure each of the processes is followed and the company is meeting the requirements of the chosen standard.
Once operations have been mapped, the system must be tested by completing audits in the process approach. Interview those implementing the requirements and observe each process and requirement. Revisit, revise, improve, or supplement those processes that do not meet the standard, and those that are not flexible, fluent, feasible or efficient, given the nature of the particular business.
Prior to accepting an order from a customer, a review of what the customer has ordered will need to be performed, deciding such factors as whether or not the product can be manufactured or the service provided as expected, what the terms of the offer will be, and what are the associated costs. This is a typical customer-related process per ISO 9001:2000.
In conjunction with this customer-related process, a company also will select a supplier of material or other commodity, train employees, and discover the best methods to administer and implement the process in order to obtain the desired results. Along this path, companies maintain records of customer orders, invoices, purchases, and schedules. These activities may meet ISO 9001:2000 requirements, when formalized, for competence, awareness and training, control of records, and purchasing information.
Following receipt of a customer order, the realization of the product must be planned. In other words, plan the design of the product, the purchasing of materials or other commodities, and verify that the item meets what has been ordered. Other points to consider include the manufacture of material, component, or part to specific criteria and requirements that will provide a product acceptable to the customer, including identifying, tracking, preserving, packaging, measuring, testing, delivering, and correcting any work in progress.
Measurement, Analysis, and Improvement
Objectives and targets should be set for other ROI measures, such as levels of scrap, re-work, and customer rejects (spills in automotive). The objectives and targets should be reviewed periodically for adequacy, suitability, and effectiveness. Adjustments, redefinition, and changes should be made where the targets or overall objectives are not consistent with the business environment. Likewise, corrective and preventive actions should be taken where expectations are not met or do not progress at a pace that meets the schedule for achievement.
Once targets are met and progress is satisfactory, continual improvement of the process should begin. The objectives and targets may need to be redefined or moved and additional objectives and targets identified. In the overall picture, a company’s ROI should be consistent and correlate with the effect of quality management on its financial performance, and internal and external customer satisfaction levels.
Success is a matter of discovering where a company’s policies, requirements, and processes best fit the clauses of the standard. Defining, monitoring, measuring, redefining, adjusting, and changing the processes will lead to achievement of the financial goals of the business.
Lee Pfennigwerth is the senior staff auditor for ISO 9001, ISO 14001, ISO/TS 16949, and OHSAS 18001 at SRI Quality System Registrar. SRI has been involved with Mid-America Plastics Partners, Inc. (MAPP) for several years. SRI is a full-service, accredited, U.S.-owned and –operated, international registrar for ISO 9001, 14001, 27001, 13485, ISO/TS 16949, AS9100, PED Compliance, and RC14001. SRI offers registration services and training to manufacturing and service companies in over 40 industries. The company’s senior experienced auditors, one-on-one customer care, and consistent, thorough audits deliver value at every event.