107 6 ISO 9001:2000 Initiatives Syed Imtiaz Haider, Ph.D. 6.1 INTRODUCTION In most commercial organizations, products or services are intended to satisfy a user’s need or requirement. Such requirements are often incorporated in specifica- tions. However, technical specifications may not in themselves guarantee that a customer’s requirements will be consistently met if there happen to be deficiencies in the specifications or in the organizational system that designs and produces the product or services. Consequently, system standards and guidelines that complement the relevant product or services requirement are given in the technical specifications. The series of International Standards ISO 9001:2000 includes a rationalization of the many and various national approaches. ISO 9001:2000 has been prepared by the ISO/TC 178 Quality Management and Quality Assurance, subcommittee 2, “Quality System.” Transposition into a Euro- pean Standard has been managed by the CEN Central Secretariat with the assistance of CEN/BT WG 107. EN 29001:EN 29002 and EN 29003 were superseded by EN ISO 9001:1994, EN ISO 9002:1994, and EN ISO 9003:1994, respectively, which in turn are now superseded by EN ISO 9001:2000. The title of ISO 9001 has been revised in the latest edition and no longer includes the term, “quality assurance.” This reflects the fact that quality management system requirements specified in this edition of ISO 9001, in addition to quality assurance of product, also aim to enhance customer satisfaction. The concept of end product is a global concern for every business, profession, occupation, or enterprise regardless of whether it is a consultancy, a service, or a manufacturing or processing activity. Well-planned design is one of the major contributing factors to achieving quality within a product or service. It is necessary, therefore, to carefully control critical elements and a company’s documentation system with particular reference to each phase of design, to ensure that effects on end product or services are not disastrous and are based on customer requirements. To be successful, an organization must offer services or products that meet well- defined purposes or needs. User satisfaction includes delivery timelines. It should be ensured that applicable standards, statutory requirements, and specifications are in compliance. The offered products or services should be within budget and provide value for the cost, ensuring that the firm’s total operations are carefully reviewed before implementation to reduce the occurrence of error, and to apply quick correc- tions for inadvertent problems. Control should be demonstrated on changes through SL3003Ch06Frame Page 107 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC 108 The Manufacturing Handbook of Best Practices proactive communication and feedback loops between the company and the external interfaces. Trainings needs should be identified to promote efficiency and cost effectiveness. Over the past decade, we have seen drastic changes in the world around us. There has been more competition in terms of quality; organizations are bound to do more work, accomplish higher targets, and be proactive rather than reactive, all with fewer people. And the quality must be the better than ever, due to competitive forces and consumer demands. From the beginning of the new millennium, it is evident that we are working in a global village where survival without offering quality in products and services is impossible. The quest to achieve excellence in products and services should be the organi- zation’s mission, and that can only be achieved with a vision to implement a documented quality system based on a standard that is globally acceptable to over- come the economic barriers. Compliance with global International Standard ISO 9001:2000 will lead a company to • Supply products that are totally fit for use • Satisfy its customers’ expectations and contractual requirements • Yield profits on the invested resources • Achieve and sustain a defined level of quality • Comply with applicable standards and specifications • Focus on prevention of defect, rather than detection • Provide value for the cost • Supply products within delivery timelines agreed on or required by the customer • Comply with environmental requirements • Work in harmony within the organization without productivity losses 6.2 THE BASIC CHANGES The third edition of ISO 9001 cancels and replaces the second edition, ISO 9001:1994, together with ISO 9002:1994 and ISO 9003:1994. Those organizations that have used ISO 9002:1994 and ISO 9003:1994 in the past may use this international standard by excluding certain requirements in accordance with clause 1.2. The revised and adopted module ISO 9001:2000 makes the quality system management requirements extremely clear. The quality system requirements in ISO 9001:2000 are comprehensively grouped under clause 7, with additional emphasis on customer satisfaction and internal communication, where exclusions are made. Claims of conformity to this international standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability or responsibility to provide product that fulfills customer and applicable regulatory requirements. The quality management principles stated in ISO 9004 have been taken into consideration during the development of this international standard. This interna- tional standard promotes the adoption of a process appropriate when developing, implementing, and improving the effectiveness of a quality management system to SL3003Ch06Frame Page 108 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC ISO 9001:2000 Initiatives 109 enhance customer satisfaction by meeting customer requirements. The following eight management principles are integrated into the ISO 9001:1994 standard and revised as the third edition ISO 9001:2000. • Customer satisfaction • The role of leadership • The involvement of employees • The business process approach • A systematic approach to management • Continual improvement • A factual approach to decision making • Mutual beneficial relationship with supplier It is important for the organization to understand current and future needs and expectations to quantify customer satisfaction and act on it. Leadership should take the lead in deploying policies and verifiable objectives, establishing vision, and giving direction to shared values. Management should set challenging goals and implement strategies to achieve them and empower qualified employees within the documented system. The standard emphasizes creating personal ownership of an organization’s goals by using the experience and knowledge of qualified and trained personnel with identified authority and responsibility to continuously work toward process improve- ment. A system should be established for identifying internal and external customers and suppliers of processes. Process activities should be focused to adequately use the people, materials, machines, and methods to demonstrate control. All processes within a system should be identified and aligned for their inter- dependencies with measurable organization goals and objectives. Continuous improvement should be ensured with realistic and challenging goals; resources should be provided as adequate to the company needs in terms of the people and equipment needed to accomplish customer requirements. Continual improvement should be ensured through management services, internal and external audits, and corrective and preventive actions. Analysis of the data and information such as customer complaints, nonconforming products, and audits should be conducted on a continuous basis to enhance productivity and to minimize waste, rework, and rejections. Cost improvement projects should be implemented. Efforts should be made to establish strategic alliances to ensure joint develop- ment and continuous improvement of products, processes, and systems. The com- pany should ensure that subcontractors are meeting the customer requirements through review and evaluation of their performance. ISO 9000 defines “system processes” as activities that use resources to transform inputs into output. Inputs to a process are often outputs from other processes. Any activity or operation that receives inputs and converts them to outputs can be con- sidered a process. Almost all product and service activities and operations are processes. For organizations to function, they have to define and manage numerous linked processes. Often the output from one process will directly form the input into SL3003Ch06Frame Page 109 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC 110 The Manufacturing Handbook of Best Practices the next process. The systematic identification and management of the various processes employed within an organization, particularly the interactions between such processes, may be referred to as the “process approach” to management. The proposed new version of the international standard encourages the adoption of the process approach for the management of an organization and its processes, and as a means of readily identifying and managing opportunities for meeting customer satisfaction needs with continuous improvement. 6.3 QUALITY MANAGEMENT SYSTEM Every business, profession, occupation, and enterprise has an end product, regardless of whether it is a manufacturing, service, consulting, or processing activity. Probably there is no business that does not follow the input–process–output pattern. Even depart- ments or teams within an organization work according to this concept. If we go down to the micro level of an effectively managed company, we find the individual members working with the input–process–output approach. Each one keeps his or her customer in mind and performs to delight him or her. This is the philosophy of Quality Delivery. Any performance or operating process can be characterized as a sequence of input–process–output. Implementing a quality management system has the goal of ensuring that the inputs are according to a specific standard, that the process itself is controlled, and that the output is monitored for conformity with the requirements of the customer (see Figure 6.1). The purposes of the quality delivery process are to 1. Ensure that everyone works on those activities that are most important for the success of the business. This is done by fulfilling work group missions. 2. Improve the quality of deliveries (outputs) to the internal customers (the next person down the line) who receive the work. 3. Eliminate work that is wasted because it has not been done right the first time. 4. Harness the combined skills, ideas, and experience of the work group members to improve the business continuously through teamwork. 5. Ultimately satisfy the external customers. A standard work group in a company consists of a manager and his or her team members. These are the people who can significantly affect the quality of the work they do. The work group manager leads the team. The work group produces outputs that are delivered to either external or internal customers. These outputs must be identified and measured for quality. FIGURE 6.1 Input–process–output sequence. (From Quality Management Systems Require- ments, 3rd ed., ISO 9001:2000, BSI, London, 2000. With permission.) INPUT (Specified) PROCESS (Controlled) OUTPUT (Monitored) SL3003Ch06Frame Page 110 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC ISO 9001:2000 Initiatives 111 There are ten steps in the quality delivery approach. They are as follows: 1. Create a mission statement that defines the work group’s activities. It is focused on the end objective rather than the means of achieving it. 2. Determine the outputs of the work group and ensure that they are accord- ing to the mission. 3. Identify the internal and external customers who receive the outputs. 4. Define the agreed-upon customer requirements for each output that must be met in order to achieve customer satisfaction. 5. Develop the work group’s output specifications for each output. 6. Determine the work group’s processes and identify the inputs that will deliver the outputs to the customers in a cost-effective manner. 7. Identify the measurements of each output that will compare the actual quality level delivered with the output specification. 8. Identify • Any problem caused by a measured shortfall to target. • Any opportunity to exceed target at no additional cost. • Any opportunity to meet customer requirements at a lower internal cost. 9. Establish a project team to solve the identified problem(s) that will improve the actual quality level delivered to the customer or capture the opportunity. 10. Measure customer satisfaction against the agreed-upon customer require- ments. In addition to the cost of quality, there are seven generic ways in which the quality of outputs can be measured. 1. Defects: work that has not been done according to specifications 2. Rework: work that requires correction 3. Scrap: work that has to be thrown away 4. Lost items: work that needs to be done again 5. Backlogs: work that is behind schedule 6. Late deliveries: work done after the agreed time 7. Surplus items or the work not required The above measurements apply equally to office outputs such as paper work, electronic data, telephone calls, etc., as well as to the outputs of manufacturing units, laboratories, warehouses, workshops, hotels, professional service, etc., such as fin- ished products, test results, parts, materials, tools, and so on. There are five measurements for each output. 1. Targets: the budget or target level of performance to be achieved. 2. Forecast: the forecast level of performance that may be better or worse than the target, depending on the current business situation. The forecast also shows when the target will be reached. 3. Actual: the actual level of performance achieved to date. SL3003Ch06Frame Page 111 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC 112 The Manufacturing Handbook of Best Practices 4. Problem: the difference between the actual and target level of performance where “actual” is worse than “target.” 5. Opportunity: the opportunity to improve quality over target at no extra cost. The objective of the quality management system is to ensure that the product offered meets the expectations and needs of the user and that the product is contin- uously maintained to the prescribed standard/specification/contract/order agreement. The Quality Management System ISO 9001:2000 indicates the adoption of a process approach when developing, implementing, and improving to enhance cus- tomer satisfaction by meeting customer requirements. The model of a process-based quality management system as shown in Figure 6.2 illustrates the process linkages presented in clauses 4 to 8. It is evident from the illustration that the role of customer is significant in defining the requirements as inputs. The evaluation of information by the organization plays a key role in determining whether the customer perception is met in the end product. The documented quality management system should be composed of but not limited to the following key documents: • Quality policy and quality objectives • Quality System Manual • Procedures required by this international standard • Documents needed by the organization to ensure the effective planning, operation, and control of its processes • Quality records required by this international standard The documentation is maintained both in hardware and software form as appro- priate. The organization should establish and maintain a quality system manual to FIGURE 6.2 Information flow = → ; value-adding activities — →. Customer Requirements Customer Satisfaction Requirement responsibility Resource management Management analysis & improvement Product Product realization SL3003Ch06Frame Page 112 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC ISO 9001:2000 Initiatives 113 describe the scope of the quality management system, including details of and justification for any exclusions, reference to the procedures established, and a description of the interaction between the processes of the quality management system. Procedures, documents, and quality records required by the quality man- agement system should be reviewed to ensure their adequacy prior to approval and issue, and updated and reapproved as necessary, to ensure that changes and the current revision status of documents are identified. The relevant versions of appli- cable documents should be available at points of use as appropriate and should remain legible and readily identifiable. The documents of external origin should be identified, and their distribution should be controlled to prevent the unintended use of obsolete documents. A suitable identification system should be established to identify the documents if they are withheld for any purpose. Very few publications are available on the market to explain exactly how to transcribe the elements of the existing ISO 9001:2000 standard into practically applicable language. For the easy understanding of readers, the text describes briefly the following elements of ISO 9001:2000 standards starting from clause 4 (Quality Management System) to clause 8 (Measurement, Analysis and Improvement) and provides audit checklists with the hope that they will serve as a valuable tool to ensure that the application of principles and procedures will result in quality, with a particular reference to customer satisfaction. 6.3.1 Q UALITY M ANAGEMENT S YSTEM A UDIT C HECKLIST B ASED ON ISO 9001:2000 C LAUSE 4 The Quality Management System Audit Checklist covers the following clauses: 4, 4.1, 4.2, 4.2.1, 4.2.2, 4.2.3, and 4.2.4. The questions in the checklist in Appendix 6.1 are based on International Stan- dards ISO 9001:2000, clause 4. Because quality management system audits can be performed by more than one person, signature spaces are provided at the end in order to provide a record of each individual auditor’s activities. 6.4 MANAGEMENT RESPONSIBILITY Management responsibility is one of the most critical element of the International Standard ISO 9001:2000, to ensure that quality aims are achieved and the firm’s reputation is promoted in the market through customer satisfaction. The organization should provide objective evidence of its commitment to the development and implementation of the quality management system (QMS). The QMS continually improves its effectiveness through communicating to the organi- zation the importance of meeting customer specifications, as well as statutory and regulatory requirements, establishing a quality policy, and ensuring that quality objectives are established. Adequate resources should be provided and management reviews should be conducted at specified frequencies. A documented quality system should be maintained to ensure that the products conform to the specified require- ments and meet the expectations and needs of the user and that the products are continuously maintained to the prescribed standards, specifications, contracts, and SL3003Ch06Frame Page 113 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC 114 The Manufacturing Handbook of Best Practices order agreements. The quality policy should be appropriate to the purpose of the organization, with a commitment to comply with requirements and continually improve the effectiveness of the quality management system. The policy should be communicated and understood within the organization and be reviewed on a periodic basis for its suitability. To meet customer (satisfaction) and regulatory requirements, the organization should ensure effective planning at all levels. Quan- tifiable quality objectives consistent with the quality policy should be established, including those needed to meet requirements for product-relevant functions at all levels within the company. The integrity of the quality management system should be maintained when changes to the system are planned and implemented. Com- munication should be conducted through identification of job responsibilities, training, and awareness. The responsibilities and authorities including interrela- tions and overlapping responsibilities should be defined and communicated within the organization. The company should hire or identify a management representative who, irrespective of other responsibilities, will have the responsibility and author- ity to • Identify processes and implement and maintain the quality management system needed for quality management • Evaluate and report the performance of the quality management system and any need for further improvement • Promote the awareness of customer requirements throughout the organi- zation Top management should review the organization’s quality management system at specified intervals to ensure its continuing suitability, adequacy, and effectiveness. This review should include assessing opportunities for improvement and the need for changes in the quality management system, including the quality policy and quality objectives. Records of the management reviews should be maintained. The input to management review should include information, which may not be limited to • Recommendations for improvement • Planned changes that could affect the quality management system • Status of preventive and corrective actions • Follow-up actions from previous management reviews • Process performance and product conformity • Customer feedback • Results of audits Output from the management reviews should include decisions and actions related to improvement of the effectiveness of the quality management system and its processes, improvement of product related to customer requirements, and resource needs. The checklist in Appendix 6.2 is prepared to serve as an auditing tool to evaluate the management responsibilities based on International Standard ISO 9001:2000. SL3003Ch06Frame Page 114 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC ISO 9001:2000 Initiatives 115 6.4.1 M ANAGEMENT R ESPONSIBILITY A UDIT C HECKLIST B ASED ON ISO 9001:2000 C LAUSE 5 The Management Responsibility Audit Checklist covers the following clauses: 5, 5.1, 5.2, 5.3, 5.4, 5.4.1, 5.4.2, 5.5, 5.5.1, 5.5.2, 5.5.3, 5.6, 5.6.1, 5.6.2, and 5.6.3. The questions in the checklist shown in Appendix 6.2 are based on International Standard ISO 9001:2000, clause 5. Because management responsibility audits can be performed by more than one person, signature spaces are provided at the end in order to provide a record of each individual auditor’s activities. 6.5 RESOURCE MANAGEMENT The organization should determine, establish, and maintain the infrastructure needed to achieve conformity to product requirements, including human resources, materials and methods, machines, buildings, work environment, workspace, and associated utilities. Process equipment, both hardware and software, and supporting services such as transport or communication should also be reviewed and maintained on a continual basis. Adequate resources should be established to achieve management objectives, customer satisfaction, and product compliance. The organization should determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness and to enhance customer satisfac- tion by meeting customer requirements. Human resources play an important role in the effectiveness of the quality system. Records of human resource development should be documented and maintained. The competency of the employees to fulfill their job functions on the basis of appropriate education, training, skills, and back- ground experience should be ensured. The checklist in Appendix 6.3 is provided to evaluate the resource management requirements based on an International Standard ISO 9001:2000. 6.5.1 R ESOURCES M ANAGEMENT A UDIT C HECKLIST B ASED ON ISO 9001:2000 C LAUSE 6 The Resource Management Audit Checklist covers the following clauses: 6, 6.1, 6.2, 6.2.1, 6.2.2, 6.3, and 6.4. The questions in the checklist shown in Appendix 6.3 are based on International Standards ISO 9001:2000, clause 6. Because resources management system audits can be performed by more than one person, signature spaces are provided at the end section in order to provide a record of each individual auditor’s activities. 6.6 PRODUCT REALIZATION Top management should plan and develop the processes needed for product realiza- tion. Planning of product realization should be consistent with the requirements of the other processes of the quality management system. The following elements should be determined as appropriate: SL3003Ch06Frame Page 115 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC 116 The Manufacturing Handbook of Best Practices • Quality objectives and product requirements • Processes establishment, documents, and provision of resources specific to the product • Verification, validation, monitoring, inspection, and test activities specific to the product to fulfill requirements • Records needed to provide evidence that the realization processes and resulting product fulfill requirements • Documentation of the output of the planning The organization should ensure that it understands current and future customer needs and expectations through the role of leadership, involvement of people, con- tinuous improvement, and mutually beneficial relationships with the suppliers. The organization should determine: • Customer-specified requirements, including delivery and post-delivery activities • Requirements necessary for specified use or known and intended use, even though not stated by the customer • Regulatory and statutory requirements related to the product • Additional requirements determined by the organization, if any Organization reviews should address the requirements related to the product prior to the organization’s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts of orders, acceptance of changes to contracts or orders) to ensure that • Product requirements are defined • Contract or order requirements differing from those previously expressed are resolved • The organization has the ability to meet the defined requirements If product requirements are changed, the organization should ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. The organization should establish and implement effective arrangements for communicating with customers in relation to • Product information • Inquiries, contracts, or order handling, including amendments • Customer feedback, including customer complaints Design and development should be carried out through effective quality plan- ning. Both product and service should be considered with particular reference to customer focus. The design and development of products should include the review, verifications, and validations that are appropriate for each design and development stage, and the responsibilities and authorities for the design and development team. SL3003Ch06Frame Page 116 Tuesday, November 6, 2001 6:09 PM © 2002 by CRC Press LLC [...]... Ⅺ Ⅺ Ⅺ 7.3.4 Ⅺ Ⅺ Ⅺ Ⅺ 7.3.5 Ⅺ Ⅺ Ⅺ Ⅺ 7.3.5 Ⅺ Ⅺ Ⅺ Ⅺ 7.3 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7.3 .6 Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ 7.3 .6 7.3 .6 Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ 7.3.7 7.3.7 7.3.7 Ⅺ Ⅺ Ⅺ Ⅺ 7.3.7 Ⅺ Ⅺ Ⅺ Ⅺ 7.3.7 Ⅺ Ⅺ Ⅺ Ⅺ 7.3.7 Ⅺ Ⅺ Ⅺ Ⅺ 7.3.7 7.3 .6 7.3 .6 SL3003Ch06Frame Page 132 Tuesday, November 6, 2001 6: 09 PM 132 The Manufacturing Handbook of Best Practices 6. 1.1.4 PURCHASING 6. 1.1.4.1 PURCHASING PROCESS • Does the organization... 5.5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5.5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 1 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 1 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 1 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 1 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 2 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 2 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 2 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 2 Ⅺ Ⅺ Ⅺ Ⅺ 5 .6. 2 SL3003Ch06Frame Page 127 Tuesday, November 6, 2001 6: 09 PM ISO 9001:2000 Initiatives 127 4.1.1 .6. 3 REVIEW OUTPUT • Does the output from the management review include decisions and actions related to improvement of the effectiveness of the quality management system... (EX) (AD) (PO) (U.S.) Ref Clause for Int’l Standard ISO 9001:2000 Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ 6. 1 6. 1 Ⅺ Ⅺ Ⅺ Ⅺ 6. 1 SL3003Ch06Frame Page 128 Tuesday, November 6, 2001 6: 09 PM 128 The Manufacturing Handbook of Best Practices 5.1.1.2 HUMAN RESOURCES 5.1.1.2.1 GENERAL • Is there a procedure available to evaluate competence and performance of the employees adequate to perform work affecting product quality? • Does a system... CRC Press LLC SL3003Ch06Frame Page 120 Tuesday, November 6, 2001 6: 09 PM 120 The Manufacturing Handbook of Best Practices Program audits should be conducted that consider the status and importance of the processes and areas to be audited and the results of previous audits The audit criteria, scope, frequency, and methods should be defined The selection of auditors and conduct of audits should ensure... Ⅺ 7.5.4 Ⅺ Ⅺ Ⅺ Ⅺ 7.5.4 Ⅺ Ⅺ Ⅺ Ⅺ 7.5.5 Ⅺ Ⅺ Ⅺ Ⅺ 7.5.5 Ⅺ Ⅺ Ⅺ Ⅺ 7.5.5 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 SL3003Ch06Frame Page 134 Tuesday, November 6, 2001 6: 09 PM 134 The Manufacturing Handbook of Best Practices • Are the calibration standards traceable to NIST standards? • Is there a procedure to assess and record the validity of previous measuring results when the equipment is found not to conform with... irrespective of other responsibilities, to be responsible for the overall quality management system? © 2002 by CRC Press LLC 125 Ⅺ Ⅺ Ⅺ Ⅺ 5.2 Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ Ⅺ 5.3 5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5.3 Ⅺ Ⅺ Ⅺ Ⅺ 5.4 5.4.1 Ⅺ Ⅺ Ⅺ Ⅺ 5.4.1 Ⅺ Ⅺ Ⅺ Ⅺ 5.4.2 Ⅺ Ⅺ Ⅺ Ⅺ 5.4.2 Ⅺ Ⅺ Ⅺ Ⅺ 5.5.2 Ⅺ Ⅺ Ⅺ Ⅺ 5.5.2 SL3003Ch06Frame Page 1 26 Tuesday, November 6, 2001 6: 09 PM 1 26 The Manufacturing Handbook of Best Practices. .. hardwareand software-supporting services such as transport, to achieve conformity with product requirement? 5.1.1.4 WORK ENVIRONMENT • Is there a procedure available to evaluate and determine the work environment needed to achieve conformity with product requirement? Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.1 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.1 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.1 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.1 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.1 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.2 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.2 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.2 Ⅺ Ⅺ Ⅺ Ⅺ 6. 2.2 Ⅺ Ⅺ Ⅺ Ⅺ 6. 3 Ⅺ... records of the results of calibration and verification maintained? • Does the organization utilize computer software for monitoring purposes? • Is the ability of computer software to satisfy the intended application confirmed? • Are the appropriate calibrations being carried out prior to initial use and reconfirmed as necessary? Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ Ⅺ Ⅺ 7 .6 Ⅺ Ⅺ... 8.2.2 Ⅺ Ⅺ Ⅺ Ⅺ 8.2.2 Ⅺ Ⅺ Ⅺ Ⅺ 8.2.2 SL3003Ch06Frame Page 1 36 Tuesday, November 6, 2001 6: 09 PM 1 36 The Manufacturing Handbook of Best Practices • Does the audit program define the audit criteria, scope, frequency, and methods? • Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process? • Does the audit procedure ensure that auditors not audit their own work?... Ⅺ 8.4 Ⅺ Ⅺ Ⅺ Ⅺ 8.4 Ⅺ Ⅺ Ⅺ Ⅺ 8.4 Ⅺ Ⅺ Ⅺ Ⅺ 8.5.1 SL3003Ch06Frame Page 138 Tuesday, November 6, 2001 6: 09 PM 138 The Manufacturing Handbook of Best Practices 7.1.1.5.2 CORRECTIVE ACTION • Does the organization take action to eliminate the cause of nonconformities in order to prevent recurrence? • Are corrective actions taken appropriate to the effects of the nonconformities encountered? • Is there a documented . the actual level of performance achieved to date. SL3003Ch06Frame Page 111 Tuesday, November 6, 2001 6: 09 PM © 2002 by CRC Press LLC 112 The Manufacturing Handbook of Best Practices 4 C LAUSE 6 The Resource Management Audit Checklist covers the following clauses: 6, 6. 1, 6. 2, 6. 2.1, 6. 2.2, 6. 3, and 6. 4. The questions in the checklist shown in Appendix 6. 3 are based. where appropriate SL3003Ch06Frame Page 117 Tuesday, November 6, 2001 6: 09 PM © 2002 by CRC Press LLC 118 The Manufacturing Handbook of Best Practices • Requirements for approval of product, procedures,