ISO 9001 - Is the Payoff Worth The Effort?

Every supplier in the plastics industry supply chain can benefit from some form of documented quality system (QS). The reason: solving similar problems over and over again is costly and counter-productive. Having a QS helps to systematically identify and eliminate problems and clarify procedures. It also is essential to improving product and customer service quality and to continually improving business operations. In addition, it helps set expectations and improves communication.

The system need not be very elaborate but should include at least written product specifications and/or process routings, work instructions, an equipment and gauge calibration system, a training program, controls in quoting and contracts and a system for handling customer complaints and rejected material. After all, problems can arise at any point from design to delivery of a product. Too often, the source of the problem is not where the pain is felt. Instead, those who suffer are the assemblers who deal with bad parts from a supplier or poor design considerations, the shipper who is missing paperwork or details from the sales office that gets the product out the door, or the customer who has to send a product back because of defects. Unsolved problems ultimately equal lost customers and unhappy employees.

That's where ISO 9001 - the international quality standard for quality management and quality assurance - comes into play. ISO 9001 provides a sound framework for achieving quality at every level in a company. It can be used for companies that want full ISO registration or as a roadmap to achieve higher product, process and customer service quality. It is important to understand that third-party registration is not required by the standard, although a company may be compelled by its business partners to obtain third-party registration.

A second-party, industry-specific ISO 9001 certificate of compliance for the plastics industry is the more business improvement approach. It is an independent watchdog that audits for conformance that has a number of added benefits:

• A distinction in the plastics marketplace from other companies.
• Continuing improvement through systematic review of processes by internal audits.
• Improved methods of identifying customer requirements and any changes needed.
• Greater employee involvement, understanding and commitment to achieving quality.
• Fewer audits by customers seeking assurance of quality.

The latest revision, ISO 9001:2000 - which has just been published - has a greater focus on how companies meet customer needs, integrate those needs into the operation and evaluate customer feedback (see table after article). It is the most extensive overhaul of the standard yet and requires top-level management leadership. The new updated standard is based on eight fundamental "best practices" that all organizations should have integrated into their business if they intend to keep up with their competition.

Improved customer relations are only one of a number of benefits of adopting such a company-wide quality system. Following ISO 9001 improves communications both inside and outside the firm. It reduces rework, scrap and product returns. It builds better supplier relationships through improved communications and feedback. An ISO 9001 system helps to create a reliable system for documenting procedures, which helps set performance expectations, promote consistency and can reduce new employee training time.

The greatest obstacle to adopting an ISO 9001 quality system is understanding what compliance to the standard really means, and then implementing the requirements in a simple and easy-to-use system. Because the standard can be applied across all industries, a first step for most companies is deciding what parts of the standard apply and identifying where any system already in place needs to be improved or modified. Many companies get stuck trying to fit the standard to their situation rather than implementing the basic controls and checks/balances that ISO looks for. Here the experience of plastics professionals can help a moldmaker/molder by clarifying which requirements are needed, what areas are to be placed under document control, and the easiest methods to show evidence of quality related activities.

How can moldmakers/molders meet the challenge?

If your shop is considering ISO 9001, there are a number of things you can do to simplify the effort:

Define your company's goal. Obtain top management support. Experience shows that establishing a quality management system that conforms to ISO 9001 is virtually impossible without solid support from top management. Management must understand the costs and benefits of ISO 9001 and how it relates to other business goals and initiatives. Management also must provide the resources needed to implement the quality management system. Identify a project champion. This can be an outside plastics consultant. Someone should coordinate the work needed in order to keep the quality management system implementation moving forward. This individual should be an effective project manager and work well with a variety of people. Experience with management systems and quality issues are an obvious plus. Build a cross-functional team. Virtually every function in an organization can affect quality management and performance. This approach enhances ownership of the quality management system, brings together the people who will need to implement the system and helps to ensure that processes and procedures are practical and effective. Conduct a preliminary review (or "gap analysis"). An outside plastics consultant can be helpful here. This review will help your company understand where its major implementation challenges are likely to be. Develop a plan and schedule. Based on the results of the preliminary review, the project team should be in a good position to prepare a detailed plan and schedule for ISO 9001 implementation. As part of this plan, consider how you will monitor and report on implementation progress. Involve your employees. Employees can make an invaluable contribution to the ISO 9001 development effort and will obviously play a key role in system implementation. Document the quality management system. ISO 9001 requires documentation of certain processes and operating procedures. Keep in mind that the most important audience for this documentation is your own employees. Keep documents simple and clear for users. Conduct employee training. Again, an outside plastics consultant can be helpful. Employees need to be aware of the ISO 9001 and the elements of the system that are relevant to their work, among other topics. Training and communication are often cited as the most challenging aspects of ISO 9001 implementation. Certification of compliance. Obtain logos and a certificate of compliance to ISO 9001 for the plastics industry by a second party. Third-party registration. If your company decides to pursue third-party registration, the selection of the right registrar is a critical part of this process. Keep in mind, their role as a registrar officially starts when a company has in place an auditable quality management system. The responsibility for the integrity of financial reports has shifted to the company's senior management and board of directors. Financial analysts, investors and shareholders want more current, reliable and accurate financial information and, more importantly, operational data. Fortune 500 financial statements are beginning to include ISO 9001 along with external financial auditors' generally accepted accounting principles (GAAP). Quality does not just happen. It requires an intentional effort on the part of top management and employees within the quality system. Obtaining certification to the ISO 9001 standard clearly shows customers and shareholders that consistent quality in products and customer service is important as well as vital for continued success. A Snapshot of ISO 9001:2000 Requirements Quality policy - Develop a statement of your company's commitment to quality. Use this framework for subsequent planning and action. Quality aspects - Identify quality attributes of your company's products, activities and customer services. Determine the attributes that have or could have significant impacts on the quality. Keep this information up-to-date. Legal and other requirements - Identify and provide access to laws and regulations that are relevant to your company (as well as other requirements to which it adheres). Objectives and targets - Establish quality goals in line with your company's quality policy. Consider significant quality aspects, legal and other requirements and the views of interested parties, among other specified factors. Quality management programs - Plan actions to achieve quality objectives and targets. Define "who, what, how and when" in these programs. Structure and responsibility - Establish roles and responsibilities for quality management and provide adequate resources. Appoint a top management representative for the quality management system (QMS) with specific responsibilities. Training, awareness and competence - Ensure that your employees receive proper training, are aware of QMS requirements and are capable of carrying out their quality management responsibilities. Communication - Establish processes for internal and external communications on quality management issues. Consider communicating externally on your company's significant quality aspects. QMS documentation - Maintain information on your QMS and related documents. Document control - Ensure effective management of operating procedures and other quality management system documents. Operational control - Identify, plan and manage your operations and activities in line with your quality policy, objective and targets. Define requirements (as needed) for contractors and suppliers. Emergency preparedness and response - Identify potential emergencies and develop procedures for preventing and responding to them. Monitoring and measurement - Monitor key activities and track performance. Conduct periodic compliance evaluations. Nonconformance and corrective/preventive action - Identify and correct problems and prevent reoccurrence. Records - Keep adequate records of your QMS and its performance. QMS audits - Conduct audits periodically to verify that your QMS is operating as intended. Management review - Periodically review your QMS with an eye to continual improvement of the system.