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Compiled by ENTC 320 Students: David Ellis, Kyle Kaminski Date: April 5, 2012
To Shawty Management: As we begin our transition into a new line of automotive products, it is imperative that we adopt and change our current quality management system. The introduction of our new line of Low Rider vehicles will certainly bring a large market value to our company, but this can only be achieved if we step up and improve how we handle our production quality. What you will find below is a comprehensive explanation of ISO 9000, its benefits, its costs, and overall how it can make us a leader in the automotive industry. We implore that you consider applying for ISO 9000 standardization and hope that what you read can convince you that it is the right thing for the company.
requirements shall be clearly defined in contracting data and the effectiveness of the subcontractor's quality assurance system shall be assessed. Customer-Supplied Material states that any customer-supplied material shall be protected against loss or damage. Product Identification & Traceability states that the products shall be identified and traceable by item, batch or lot during all stages of production, delivery and installation. Process Control states that the production (and installation) processes shall be defined and planned. The production shall be carried out under controlled conditions: documented instructions, in-process controls, approval of processes and equipment, and criteria for workmanship. And, special processes that cannot be verified after the fact shall be monitored and controlled throughout the processes. Inspection and Testing states that incoming materials shall be inspected or verified before use. In-process inspection and testing shall be performed. A final inspection and testing shall be performed prior to release of finished product. The records of inspection and test shall be kept. Inspection/Measuring/Test Equipment states that the equipment used to demonstrate conformance shall be controlled, calibrated and maintained. One must identify measurements to be made, identify affected instruments, calibrate instruments (procedures and status indicators), periodically check calibration, assess measurement validity if found out of calibration, and control environmental conditions in metrology lab. The measurement uncertainty and equipment capability shall be known. One must know if test hardware or software is used, and it shall be checked before use and rechecked during use. Inspection and Test Status states that status of inspections and tests shall be maintained for items as they progress through various processing steps. Records shall show who released conforming product. Control of Nonconforming Product states that nonconforming product shall be controlled to prevent inadvertent use or installation. The review and disposition of nonconforming product shall be formalized. Corrective Action states that the problem causes shall be identified corrected and the effectiveness of the corrective actions be assessed. Handling, Storage, Packaging & Delivery states that procedures for handling, storage, packaging and delivery shall be developed & maintained. The handling controls shall prevent damage and deterioration. Secure storage shall be provided. Product in stock shall be checked for deterioration. The packing, preservation and marking processes shall be controlled. The quality of the product after final inspection shall be maintained. This might include delivery controls. Quality Records states that the quality records shall be identified,
collected, indexed, filed, stored, maintained and dispositioned. Internal Quality Audits states that audits shall be planned and performed. The results of audits shall be communicated to management and any deficiencies found shall be corrected. Training states that the needs shall be identified and provided. Some tasks may require qualified individuals and the records of training shall be maintained. Servicing states that the servicing activities shall be performed to written procedures and the servicing shall meet the requirements. Statistical Techniques states that the statistical techniques shall be identified and shall be used to verify acceptability of process capability and product characteristics. In order to obtain ISO 9000 certification, which is established by the International Organization of Standardization, an organization must have work procedures in place that help ensure the quality goals. Certification of adherence to those quality objectives can be issued by an organization that has been accredited by the International Organization of Standardization. Certification will help convince customers that a company's products are of high quality. To become a certified ISO 9000 company, the company must select a registrar and prepare for a certification audit by this registrar. The company must prepare for phase 1 audit that checks the present quality management system against the standard. This is usually followed by establishing teams to ensure that all components of the key clause are developed and implemented, training of personnel, developing applicable documentation and developing and installing all new components of the quality system that may be required. Things that must change is that a quality policy is developed that is linked to business and marketing plans. The guidelines are obeyed at every level and every employee has specific goals. The quality policy is met by monitoring 6 basic areas in documents, records, internal audits, control of Nonconforming Products and Services, corrective Action, and preventative action. ISO 9000 has had three revisions since it was instated. ISO 9000:1994 was the first revision and it was based around twenty key elements that companies used to effectively and consistently produce products and services. The standard was originally only geared towards manufacturing companies producing widgets, it was adapted to apply to a wide range of organizations from processing companies to service companies. The primary purpose was to assure customers that the certified company produced products at a consistent level of quality and not be worried about final product. ISO 9000:2000 had a lot of changes from its 1994 counterpart. Instead of twenty key elements, it was based on a process model than an effective enterprise can use whether it processes chemicals, parts or provides services. It dropped from twenty elements to four sections:
Management responsibility, Resource management, Product realization, and Measurement, analysis, and improvement. Each section is more generic than the original twenty key elements allowing it to be adapted to a wide range of industries. ISO 9000:2000 initiated Voice of the Customer, because customers drive the input and customer satisfaction drives the output. Also, continual improvement to remain certified has to be shown. Management responsibility was not a huge factor in ISO 9000:1994, but it is much more important in ISO 9000:2000. Both revisions require management to provide necessary resources. The final revision ISO 9000:2008, continues to enhance the requirements to become and remain ISO 9000 certified. The new standard contains eight principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision making, and mutually beneficial supplier relationships. There are relatively few philosophy changes in the 2000 and 2008 versions, however the changes in process procedures very differently. ISO 9000:2008 emphasizes process approach, requires companies to meet statutory and regulatory requirements applicable to the product, management should be a member of the organization, measuring devices now termed as measuring equipment, and finally customer property includes personal data too. These changes however make no new requirements to become certified, they are merely stated in a way to fully understand the ideals and requirements of ISO 9000.
The length of ISO 9000 certification is directly correlated to how quickly we can convert our processes to ISO 9000 standards. The longer it takes us to adapt, the longer it will take us to become certified. To ensure that it does not take too long, each employee must understand the rules and regulations of ISO 9000 and be willing to incorporate them into their work habits. By expediting our change, we can become ISO 9000 certified quickly and avoid any long term costs or mistakes. Finally, we have determined that the estimated return on investment for becoming ISO 9000 can be very high. ISO 9000 products demand higher prices, and customers are generally fine with paying the higher prices because they understand they will be getting the highest quality products. As long as we work hard on becoming ISO 9000 certified and do it at a relatively quick pace, we can expect the see profits very soon. The cost of ISO 9000 should not be a deterrent because we will make it up as quickly as we spent it.
throughout the life of our company, and we must never lose it. Losing our certification may lead to loss of customer loyalty because it shows something has changed in our quality management system. The biggest hurdle we may face when earning our ISO 9000 certification is employee buy-in. Since ISO 9000 involves the entire company it is imperative that every employee is onboard with the change and will not slack in the future. Another issue with ISO 9000 is the time and cost of certification. We must be absolutely sure we want to pursue ISO 9000 certification before jumping into the process. The cost and time commitment could prove fatal to our company if the right path is not taken. There is no consolation prize for trying to earn the certification and failing to earn it. However, after all of these potential pitfalls, the benefits far outweigh any disadvantage. Our mission is to be a leading Low Rider manufacturer, and without ISO 9000 certification we cannot say we have obtained that goal.
Sources
http://www.qualitydigest.com/feb00/html/measure.html http://www.realquality.com/benefits.htm http://www.inc.com/encyclopedia/iso-9000.html http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm? csnumber=42180 http://www.asq.org/standcert/iso.html