Written corrective action work instructions tend to cluster around the use of a corrective action report (CAR). The CAR is a way to make QS9000 (now TS 16949) your business more efficient. By developing a CARs that applies to all situations, paperwork can be reduced as well as the time it takes to process each CARs. Item 4.13 A central theme in QS9000 (now TS 16949) is error prevention, not just fault detection. To achieve this, you need to have an aggressive program of corrective actions, preventive actions, and a process in place to control the non-conforming goods you discover. Therefore, elements 4.13 and 4.14 (control of non-conforming products and remedial/preventive actions) address this issue. We begin by looking at element 4.13. Finally, you should use cross-functional teams to provide techniques such as FMEA, APQP, PPP, and problem solving. Each of these points has been covered in previous articles and represents a significant extension of the QS9000 (now TS 16949) requirements. It is these techniques that cause QS9000 (now TS 16949) to lose its clearly defined compliance limit. With ISO 9001, every requirement has an end. With QS9000 (now TS 16949), once you enter a technique like APQP, you open a box of related methods. Methods such as designed experiments, team building, problem-solving tools, risk assessment, value analysis, etc.

A good test, measurement, and inspection procedure determines how a meter enters your system, when it is calibrated, how employees are trained to use the meter, what records are kept, and how the meter is removed for repair or decommissioning. QS-9000 certification is a long and tedious process. Keeping these basic concepts in mind will make your journey less cumbersome. Product identification and traceability go hand in hand for most companies. As we will see later in the test and inspection status requirements, the system will be beneficial for other QS9000 (now TS 16949) requirements. Apart from the QS9000 (now TS 16949), a good workflow tracking system is always beneficial for solving manufacturing problems, improving quality, planning a just-in-time system, and finding other similar ways of continuous improvement. The IASG was established in early 1994 to develop interpretations and responses to the QS 9000 criteria, processes and records. The IASG was composed of IRBs and four other registrars, three accreditation bodies, representatives of the Quality Working Group of the Big Three suppliers, and several automotive suppliers. The IASG had expanded to many registrars. The IASG has worked to develop consensus among all parties, balancing interests and constraints to ensure successful interpretation of QS 9000 requirements.

In element 4.3 of QS9000 (now TS 16949), there is the requirement to review contracts to develop a product description of the customer`s requirements. In this briefing, Design Control begins. The design team takes over the mission and adds regulatory, safety and environmental specifications. Some companies are also looking for specifications that the customer did not mention, that are necessary or that add value/competitiveness to the product. The new list of specifications represents design inputs. You should conduct design reviews at regular intervals. Here, a representative from each relevant department is convened to a single meeting to discuss the current state of the design based on the customer`s requirements. They conduct design reviews to ensure that all tasks are done correctly, that you are on time, and that all customer needs are met. Examination sessions should be documented as evidence of compliance. What is missing is the mention of subcontractor documents, special features and the role of quality assurance in verifying customers` technical specifications/standards. Therefore, these missing elements should be added to the procedure to make it ready for QS9000 (now TS 16949) certification.

For example, you may find that a product that does not conform to specifications performs better than the design requires. In this case, you must ask the customer for permission to use the materials outside of the specifications. At the same time, you should investigate why this strange event was possible. Why did the design review not capture this? As usual, ISO 9004-1 and ISO 9000-2 extend these elements through implementation guidelines. For these specific elements, clauses 4.0 and 5.0 of ISO 9004-1 make it clear that compliance with management and quality system requirements is not an easy task. For critical process equipment, the QS-9000 requires a preventive maintenance schedule, including predictive maintenance methods. QS9000 (now TS 16949), Section One, specifies some specific document control requirements for all sales departments. To interpret the requirement, you need a copy of QS9000 (now TS 16949) for details, and a copy of ISO 9000-2 and ISO 9004-1 for guidance on how to apply the requirement. This standard incorporates the ISO 9001 standard of 1994 (now obsolete) with a focus on customer satisfaction and process control.

In addition to the ISO 9001 elements of 1994, it also contains certain requirements that apply specifically to the automotive industry. The QS-9000 was introduced to the industry in 1994 and revised in 1998. QS-9000 Quality System Requirements QS-9000, or simply QS-9000, is an international quality management system (QMS) standard for the automotive industry, originally developed by and for the “Big Three” of the U.S. automotive industry, namely Daimler Chrysler Corporation, Ford Motor Company and General Motors Corporation. This standard incorporates the ISO 9001 standard of 1994 (now obsolete) with a focus on customer satisfaction and process control. In addition to the ISO 9001 elements of 1994, it also contains certain requirements that apply specifically to the automotive industry. The QS-9000 was introduced to the industry in 1994 and revised in 1998. The QS-9000 quality standard must be met by suppliers of automotive production materials, production and service parts, heat treatment, paint, electroplating and other finishing services. Therefore, not all suppliers in the automotive industry need to be certified according to QS 9000 standards.

The QS-9000 is divided into three (3) sections: 1) the twenty (20) ISO 9001 elements plus specific automotive requirements; (2) system requirements defined by the “Big Three” for their own use and referred to in the standard as “Additional Requirements”; and (3) customer-specific requirements that are specific to each automobile or truck manufacturer. The basic requirements of the QS-9000 activity are: 1) Quality System Assessment (QSA); 2) Advanced Product Planning and Quality Control Plan (AQMP); 3) Production Parts Approval Process (PPAP); (4) Analysis of Potential Failure Modes and Effects (FMEA); 5) Measurement System Analysis (MSA); and 6) Statistical Process Control (SPC). The QS-9000 certification includes the following basic steps: 1) Review of the QS9000 document standard and its supporting documentation and software; 2) Organizational preparation and composition of a team to oversee certification; 3) Development of a quality manual that meets QS 9000 requirements; 4) Development of supporting documents for your quality manual; 5) Implementation of the quality management systems defined in your quality manual; 6) Preliminary assessment of your quality systems (optional); 7) QS-9000 certification; 8) Continuously evaluate your quality systems against QS-9000 requirements to maintain your registration. The QS-9000 certification requirements are considered very demanding as only a few selected third-party companies have been duly authorized by the automotive industry to issue QS-9000 certifications. Nevertheless, many large companies certified to QS-9000 standards have saved millions of dollars through reducing errors and waste, improving on-time delivery performance, and of course, increasing market share. The biggest weakness of the QS-9000 is the fact that it is based on ISO-9001:1994, which has been obsolete and replaced by ISO-9001:2000. Therefore, automotive companies should adopt ISO/TS-16949 as a new standard for automotive quality management systems. See also: QS-9000 requirements; Le TS-16949; ISO 9000; ISO 14000; quality systems; document control; HOME Copyright © 2001-2007 EESemi.com. All rights reserved. The guidance for point 4.12 would essentially rewrite the short list of requirements. You would then add who (by job title) is ultimately responsible for ensuring that this system is in place and used correctly. Typically, the plant manager would have this responsibility if included in the process control process.

You would also add any custom requirements for identifying tests and inspections to the requirements of element 4.12. Level II (standard operating procedures) documents for the procurement service should focus on verification and documentation. A procedure should be your method of selecting and approving suppliers. This procedure should explain how to create your list of approved vendors. Vendor approval must include the use of QS9000 (now TS 16949) as the basic management model for quality assurance. The existence of the list and your supplier development method is crucial proof of compliance. Then there`s the issue of measuring customer satisfaction. This is not always an easy task. Their main customers are OEMs or a top-tier supplier.