QUALITY SYSTEMS UNIT 5 1 GE 406 Total Quality Management Syllabus Need for ISO 9000 and other Quality

systems, ISO 9000:2000 Quality systemsElements, Implementation of Quality system, Documentation, Quality Auditing, QS 9000, ISO 14000-concept, requirements and benefits. QUALITY SYSTEMS Introduction The International Organization for Standardization (ISO) was founded in 1946 in Geneva, Switzerland, where it is still based. Its mandate is to promote the development of international standards to facilitate the exchange of goods and services worldwide. ISO is composed of more than 90 member countries. v The United States representative is the American National Standards Institute (ANSI). v The ISO Technical Committee (TC) 176 developed a series of international standards for quality systems, which were first published in 1987. v The standards (ISO 9000, 9001, and 9004) were intended to be advisory and were developed for use in two-party contractual situations and internal auditing. v The standards have become universally accepted. v Most countries have adopted the ISO 9000 series as their national standards. Like- wise, thousands of organizations throughout the world have quality systems registered to the standard. v In the United States, the national standards are published by the American National Institute / American Society for Quality (ANSI/ASQ) as the ANSI/ASQ Q9000 series. v A quality system registration involves the assessment and periodic surveillance audit of the adequacy of a supplier's quality system by a third party, who is a registrar. v When a system conforms to the registrar's interpretation of the standard, the registrar issues a certificate of registration to the supplier. v This registration ensures customers or potential customers that a supplier has a quality system in place and it is being monitored. NEED FOR ISO 9000 AND OTHER QUALITY SYSTEMS • There are various reasons for implementing a quality system that conforms to an ISO standard. • The primary reason is that customers or marketing are suggesting or demanding compliance to a quality system. • Other reasons are needed improvements in processes or systems and a desire for global deployment of products and services. • As more and more organizations become registered, they are requiring their subcontractors or suppliers to be registered, creating a snowball effect. • Consequently, in order to maintain or increase market share, many organizations are finding they must be in conformance with an ISO standard. • Internal benefits that can be received from developing and implementing a welldocumented quality system can far outweigh the external pressures. • ISO 9000 and other Quality Systems are needed to achieve improvements and benefits in the following areas. • To improve internal quality which is measured by the percent of scrap, rework, and nonconformities at final inspection? • To increase production reliability that is measured by the number of breakdowns per month, percent of time dedicated to emergencies, and percent of downtime per shift.




To improve external quality that is measured by product accepted by customers without inspections, claims of nonconforming product, and returned product. • To improve time performance that is measured by time to market, on-time delivery, and throughput time. • To reduce cost of poor quality that is measured by external nonconformities, scrap, and rework. While practicing the above quality systems prevention and appraisal costs are increased. ISO 9000 SERIES OF STANDARDS The ISO 9000 Series of Standards is generic in scope. By design, the series can be tailored to fit any organization's needs, whether it is large or small, a manufacturer or a service organization. v It can be applied to construction, engineering, health care, legal, and other professional services as well as the manufacturing of anything from nuts and bolts to spacecraft. v Its purpose is to unify quality terms and definitions used by industrialized nations and use those terms to demonstrate a supplier's capability of controlling its processes. v .ISO 9001: 2000 - Quality Management Systems (QMS) - Requirements is the standard used for registration by demonstrating conformity of the QMS to customers, regulatory, and the organization's own requirements. v ISO 9004:2000-Quality Management System (QMS) - Guidelines for performance improvement provides guidelines that an organization can use to establish a QMS focused on improving performance. SECTOR SPECIFIC STANDARDS The ISO 9000 system is designed as a simple system that could be used by any industry. Other systems have been developed that are specific to a particular industry such as automotive or aerospace. • These systems use the ISO 9001 as the basic framework and modify it to their needs. There are currently three other quality systems: AS9100, ISO / TS 16949, and TL 9000. • One of the problems with sector-specific standards is the need for suppliers with customers in different industries to set up quality systems to meet each sector's requirements. AS 9100 This aerospace industry quality system was officially released by the Society of Automotive Engineers in May 1997. v Its development and release represents the first attempt to unify the requirements of NASA, DOD, and FAA, while satisfying the aerospace industry's business needs. v In March 2001, the International Aerospace Quality Group (IAQG) aligned AS9100 with ISO 9001:2000.




v These additions are accepted aerospace approaches to quality practices and general requirements. Aerospace organizations in Europe, Japan, and the U.S. will certify registrars and auditors ISO / ITS 16949 This standard is entitled Quality Systems Automotive Suppliers-Particular Requirements for the Application of ISO 9001. • . There are three basic levels: (I) ISO 9001, (2) sector-specific requirements and (3) company-specific requirements, and if appropriate levels for divisionspecific, commodity-specific, and part-specific requirements. Registrars will need to be certified to the standard and their number will be limited. It is assumed that this standard will show the same rate of improvement as QS 9000.

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TL 9000 The Quality Excellence for Suppliers of Telecommunications Forum wrote TL 9000 to consolidate the various quality system requirements within the telecommunications industry. v It is a specific set of requirements based on ISO 9001 that defines the design, development,production,delivery,installation, maintenance of telecommunications products and services. v Figure shows the structure of the TL 9000 standard and its five layers. The first layer is the ISO 9000 requirements

Structures of TL 9000 Requirements v The unique feature of the standard is the use of the metrics specified in the QSM book to communicate and monitor actual results. v Cost and performance-based metrics provides information to enable the industry to measure progress and evaluate results of quality system implementation. ISO 9001 QUALITY SYSTEM REQUIREMENTS The application of a system of processes within an organization, together with their identification and interactions and the managing of these processes, is referred to as the process approach. This approach emphasizes the importance of: • Understanding and fulfilling the requirements. • The need to consider processes in terms of value added.

QUALITY SYSTEMS • • Obtaining results of process

4 performance and effectiveness.


Continual improvement of processes based on objective measure.

For the five required clauses, the system is shown in Figure.

Model of a Process-based Quality Management System 1. Scope The purpose of the standard is for the organization to demonstrate its ability to provide a product that meets customer and regulatory requirements and achieves customer satisfaction. • • • This purpose is accomplished by evaluating and continually improving the system, rather than the product. The requirements of the standard are intended to be applicable to all types and sizes of organizations. Requirements in Clause 7, Product Realization, that are not appropriate to the organization, can be excluded.

2. Normative Reference ISO 9000:2000 Quality Management Systems - Fundamentals and vocabulary are a normative reference that provides applicable concepts and definitions. 3. Terms and Definitions For the purposes of this standard, the terms and definitions given in ISO 9000:2000 apply. In addition the supply chain is defined as: Supplier Organization Customer 4. Quality Management System (QMS) 4.1 General Requirements The organization shall establish, document, implement, and maintain a QMS and continually improve its effectiveness. The organization shall




v Identify needed processes such as management activities, provision of resources; product realization and measurement, v Determine their sequence and interaction, v Determine criteria and methods for effective operation and control of these processes, v Ensure the availability of resources and information necessary to support and monitor these processes, v Monitor, measure, and analyze these processes, v Implement actions to achieve planned results and continual improvement of these processes. v Outsourced processes that affect the quality of the product shall be identified and included in the system. 4.2 DOCUMENTATION 4.2.1 General Documentation shall include • • • • • Statements of a quality policy and quality objectives, A quality manual, required documented procedures, needed documents to ensure effective planning, operation, and control of processes, Required records.

A procedure or work instruction is needed if its absence could adversely affect the product quality. v The extent of the documentation will depend on the organization's size and type of activities. v For example: a small organization may verbally notify a manager of an upcoming meeting, whereas a large organization would need written notification. v The standard should satisfy the contractual, statutory, and regulatory requirements and the needs and expectations of customers and other interested parties. v Documentation may be in any form or type of medium. 4.2.2 Quality Manual A quality manual shall be established and maintained that includes • • • The scope of the QMS with details and justification for any exclusions, The documented procedures or reference to them, and A description of the interaction among the QMS processes.

QUALITY SYSTEMS 4.2.3 Control of Documents.



Documents required by the QMS shall be controlled. A documented procedure shall be in place to define the controls needed to v Approve documents prior to use, v Review, update, and re-approve as necessary, v Identify the current revision status, v Ensure that current versions are available at the point of use, v Ensure that documents are legible and readily identified, v Identify and distribute documents of external origin, and v Provide for the prompt removal of obsolete documents and suitably identify any that may be retained. v Documented procedure means that the procedure is established, documented, implemented, and maintained. 4.2.4 Control of Records. Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS. • A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of records. Records can be used to document traceability and to provide evidence of verification, preventive action, and corrective action.

5. MANAGEMENT RESPONSIBILITY 5.1 Management Commitment Top management shall provide evidence of its commitment to the development, implementation, and continual improvement of the QMS by v Communicating the need to meet customer, legal, and regulatory expectations, v Establishing a quality policy, v Ensuring that quality objectives are established, v Conducting management reviews, and v Ensuring the availability of resources. v Top management is defined as the person or group of people who directs and controls an organization.




Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction. 5.3 QUALITY POLICY Top management shall insure that the quality policy v Is appropriate to the organization's purpose or mission, v Includes a commitment to comply with requirements and continually improve the effectiveness of the QMS, v Provides a framework for establishing and reviewing the quality objectives, (d) is communicated and understood within the organization, and v Is reviewed for continuing stability. v The quality policy gives the overall intention and direction of the organization related to quality. 5.4 PLANNING 5.4.1 Quality Objectives. Top management shall ensure that quality objectives are established at relevant function and levels within the organization and include product requirements. • • They shall be measurable and consistent with the quality policy. In addition, they should ensure that customer expectations are met. Quality objectives are something sought or aimed for related to quality.

5.4.2 Quality Management System Planning. Top management shall ensure that the planning of the QMS is accomplished in order to meet the requirements of the QMS as stated in the General Requirements, Element 4.1, as well as the Quality Objectives, 5.4.1 5.5 RESPONSIBILITY, AUTHORITY, AND COMMUNICATION 5.5.1 Responsibility and Authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. v Responsibilities can be defined in job descriptions, procedures, and work instructions. v Authorities and interrelationships can be defined in an organization chart. 5.5.2 Management Representative Top management shall appoint a member of management, regardless of his/her other duties, that shall have the responsibility and authority that includes • • Ensuring that processes needed for the QMS system are established, implemented, and maintained,




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Reporting to top management on the performance of the QMS and any need for improvement, and Ensuring the promotion of awareness of customer requirements throughout the organization. Appointment of a member of top management as the representative can contribute to the effectiveness of the QMS.

5.5.3 Internal Communication Top management shall ensure that appropriate communication channels are established within the organization and that communication takes place regarding the QMS. v Typical communication techniques are management workplace briefing, recognition of achievement, bulletin boards, e-mail, and in-house news brochures. 5.6 MANAGEMENT REVIEW 5.6.1 General Top management shall review the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the QMS including the quality policy and quality objectives. Records from the reviews shall be maintained. 5.6.2 Review Input The input to the review shall include information on v Results of audits, v Customer feedback, v Process performance and product conformity, v Status of corrective and preventative performance, v Follow-up actions from previous management reviews, v Changes that could affect the QMS, and (g) recommendations for improvement. 5.6.3 Review Output • • The output from the review shall include any decisions and actions related to (a) Improvement of the effectiveness of the QMS and its processes, (b) Improvement of the product related to customer requirements, and

QUALITY SYSTEMS • • (c) Resource needs.



Top management can use the outputs as inputs to improvement opportunities.

6. Resource Management 6.1 PROVISION OF RESOURCES The organization shall determine and provide the-resources needed v To implement and maintain the QMS and continually improve its effectiveness, and v To enhance customer satisfaction by meeting customer requirements. Resources may be people, infra- structure, work environment, information, suppliers, natural resources, and financial resources. v Resources can be aligned with quality objectives. 6.2 HUMAN RESOURCES 6.2.1 General Personnel performing work that affects product quality shall be competent on the basis of appropriate education, training, skills, and experience. 6.2.2 Competence, Awareness and Training The organization shall v Determine the necessary competence for personnel performing work affecting product quality, v Provide training or take other actions to satisfy these needs, v Evaluate the effectiveness of the actions taken, v Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and v Maintain appropriate records of education, training, skills, and experience. Competency is defined as the demonstrated ability to apply knowledge and skills. ISO 10015 Guidelines for Training will help organizations comply with this standard. 6.3 INFRASTRUCTURE The organization shall determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. • • • Buildings, workspace, and associated utilities, Process equipment (both hardware and software), and Supporting services (such as transport or communication).




v The organization shall determine and manage the work environment needed to achieve conformity to product requirements. v Creation of a suitable work environment can have a positive influence on employee motivation, satisfaction, and performance. 7. PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of QMS v Quality objectives and requirements for the product; v The need to establish processes, documents, and provide resources specific to the product; v Required verification, validation, monitoring, inspection, and test activities specific to the product and the criteria for product acceptance; and v Records needed to provide evidence that the realization processes and resulting product or service meet requirements.. 7.2 CUSTOMER-RELATED PROCESSES 7.2.1 Determination of Requirements Related to the Product The organization shall determine v Requirements specified by the customer, including the requirements for delivery and post-delivery activities, v Requirements not stated by the customer but necessary for specified or intended use, where known, v Statutory and regulatory requirements related to the product, and v Any additional requirements determined by the organization. 7.2.2 Review of Requirements Related to the Product The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer and shall ensure that v Product requirements are defined, v Contract or order requirements differing from those previously expressed are resolved, and v The organization has the ability to meet the defined requirements. v Records of the results of the review and actions arising from the review shall be maintained.

QUALITY SYSTEMS 7.2.3 Customer Communication



The organization shall determine and implement effective arrangements for communicating with customers in relation to • • • Product information, Inquiries, contracts, or order handling, including amendments, and Customer feedback, including customer complaints.

7.3 DESIGN AND DEVELOPMENT 7.3.1 Design and Development Planning The organization shall plan and control the design and development of the product. During the design and development planning, the organization shall determine v The design and development stages, v The review, verification and validation that are appropriate to each design and development stage, and v The responsibilities and authorities for design and development. v The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

7.3.2 Design and Development Inputs. Inputs relating to product requirements shall be determined and records maintained. These shall include v Functional and performance requirements, v Applicable statutory and regulatory requirements, v Where applicable, information derived from previous similar designs, and v Other requirements essential for design and development. v These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and Development Outputs. The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall • • Meet the input requirements for design and development,




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Provide appropriate information for purchasing, production, and for service provision, Contain or reference product acceptance criteria, and Specify the characteristics of the product that are essential for its safe and proper use.

7.3.4 Design and Development Review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements v To evaluate the ability of the results of design and development to meet requirements, and v To identify any problems and propose necessary actions. v Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. v Records of the results of the reviews and any necessary actions shall be maintained. v Risk assessment such as FMEA, reliability prediction, and simulation techniques can be undertaken to determine potential failures in products or processes. 7.3.5 Design and Development Verification. Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements v . Records of the results of the verification and any necessary actions shall be maintained. Verification confirms, through objective evidence, that the specified requirements have been fulfilled. 7.3.6 Design and Development Validation. • Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, when known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained. Validation confirms, through objective evidence, that the requirements for a specific intended use have been fulfilled.

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QUALITY SYSTEMS UNIT 5 13 7.3.7 Control of Design and Development Changes Design and development changes shall be identified and records maintained. v The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. v The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. 7.4 PURCHASING 7.4.1 Purchasing Process. The organization shall ensure that purchased product conforms to specified purchase requirements. • The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements . 7.4.2 Purchasing Information Purchasing information shall describe the product to be purchased, including where appropriate v Requirements for approval of product, procedures, processes, and equipment, v Requirements for qualification of personnel, and v QMS requirements. v The organization shall ensure the adequacy of specified requirements prior to their communication to the supplier. 7.4.3 Verification of Purchased Product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 Control of Production and Service Provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable v The availability of information that describes the characteristics of the product, v The availability of work instructions, as necessary, v The use of suitable equipment, v The availability and use of monitoring and measuring devices, v The implementation of monitoring and measurement, and


14 delivery, and

UNIT 5 post-delivery

v The implementation of release, activities.

7.5.2 Validation of Processes for Production and Service Provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement Validation shall demonstrate the ability of these processes to achieve planned results as follows • Defined criteria for review and approval of the processes, • Approval of equipment and qualification of personnel, • (c) Use of specific methods and procedures, (d) requirements for records and (e) revalidation. 7.5.3 Identification and Traceability Where appropriate The organization shall identify the product by suitable means throughout product realization. v The organization shall identify the product status with respect to monitoring and measurement requirements. v Where traceability is a requirement, the organization shall control and record the unique identification of the product.. 7.5.4 Customer Property • • If any customer property is lost, damaged, or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained. Customer property can include intellectual property.

7.5.5 Preservation of Product The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. v This preservation shall include identification. handling, packaging, storage, and protection. v Preservation shall also apply to the constituent parts of a product. 7.6 CONTROL OF MONITORING AND MEASURING DEVICES. The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements • • • Be calibrated or verified at specified intervals or prior to use, against measurement standards. Be adjusted or re- adjusted as necessary, Be identified to enable calibration status to be determined,


15 that would invalidate

UNIT 5 the

Be safeguarded from adjustments measurement result, and

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Be protected from damage and deterioration during handling, maintenance and storage. This shall be undertaken prior to initial use and reconfirmed as necessary

8. MEASUREMENTS, ANALYSIS, AND IMPROVEMENT 8.1 GENERAL The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed v To demonstrate conformity of the product, v To ensure conformity of the QMS, and v To continually improve the effectiveness of the QMS. v This shall include determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 MONITORING AND MEASUREMENT 8.2.1 Customer Satisfaction As one of the measurements of the performance of the QMS, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements • • • 8.2.2 Internal Audit The organization shall conduct internal audits at planned intervals to determine whether the QMS Conforms to the planned arrangements, to the requirements of this standard, and to the requirements established by the organization, and Is effectively implemented and maintained.

8.2.3 Monitoring and Measurement of Processes v The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. v . When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. 8.2.4 Monitoring and Measurement of Product and Service. • • The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements.

QUALITY SYSTEMS • Evidence of conformity with the maintained

16 acceptance criteria

UNIT 5 shall be

8.3 CONTROL OF NONCONFORMING PRODUCT v The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. v By taking action to eliminate the detected nonconformity; v By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; and v By taking action to preclude its original intended use or application. v Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained 8.4 ANALYSIS OF DATA The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. v Customer satisfaction, v Conformity to product requirements, v Characteristics and trends of processes and products, including opportunities for preventive action, and v Suppliers. 8.5 IMPROVEMENT 8.5.1 Continual Improvement The organization shall continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. v 8.5.2 Corrective Action The organization shall take action to eliminate the cause of non- conformities in order to prevent recurrence. v Corrective actions shall be appropriate to the effects of the nonconformities encountered. v A documented procedure shall be established to define requirements for reviewing nonconformities determining the causes of nonconformities action taken. 8.5.3 Preventive Action. v The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. v Preventive actions shall be appropriate to the effects of the potential problems IMPLEMENTATION OF QUALITY SYSTEMS There are a number of steps that are necessary to implement a quality management system. Top Management Commitment




The most important step in implementing a quality system that will meet or exceed an ISO 9000 standard is to acquire the full support of upper management. v The chief executive officer (CEO) must be willing to commit the resources necessary to achieve certification. v This is critical to the success of the project. Without the CEO's support, the process may continuously run into unnecessary roadblocks or even be doomed to failure. 2. Appoint the Management Representative • Once the commitment has been made, the process can proceed by adopting a project team approach and treating it the same as any other business undertaking. The next step is the appointment of a management representative. The representative can be a member of the top management group who is able to ensure that the quality system is effectively implemented, documented, and maintained

3. Awareness This step requires an awareness program. v Because the process is going to affect every member of the organization as well as require their input, it stands to reason that everyone should understand the quality system. v They should know how it would affect day-to- day operations and the potential benefits. v This information can be relayed through short, one-hour awareness training sessions. 4. Appoint an Implementation Team After everyone has been informed of the organization's intentions to develop the quality system, an implementation team should be assembled. • • • This team should be drawn from all levels and areas of the organization so that it is representative. Committees for each of the five clauses may be used. The team should identify the QMS processes and their sequence and interaction

5. Training The implementation team, supervisors, and internal audit team should be trained. This activity can be accomplished by sending team leaders for training and having them train the other team members. 6. Time Schedule This activity develops a time schedule for the implementation and registration of the system. v




v This time frame will vary, depending on the size and type of organization and the extent of its existing quality system

7. Select Element Owners The implementation team selects owners for each of the system elements. • • Many of these owners will be members of the implementation team. Owners may be assigned more than one element..

8. Review the Present System Perform a review of the present quality system. v Copies of all the quality manuals, procedures, work instructions, and forms presently in use are obtained. v These documents are sorted into the system elements to determine what is available and what is needed to complete the system. v This activity is a gap analysis and can be performed by the element owners and their teams or by an external consultant. 9. Write the Documents Prepare written quality policy and procedure manuals-they can be combined into one document. • • Write appropriate work instructions to maintain the quality of specific functions. This process should involve every employee, because the best person to write a work instruction is the one who performs the job on a regular basis

10. Install new system Integrate the policies, procedures, and work instructions into the day-to-day workings of the organization, and document what is being done. v It is not necessary for all elements to be implemented at the same time. v Be sure all people are trained. 11. Internal Audit Conduct an internal audit of the quality system. • This step is necessary to ensure that the system is working effectively and to provide management with information for the comprehensive management review. Minor corrections to the system are made as they occur. A cross-section of trained people should be used for the audit team.

12. Management Review Conduct a management review. The management review is used to determine the effectiveness of the system in achieving the stated quality goals. The system is revised as needed.

QUALITY SYSTEMS 13. Pre assessment



This step is optional. If a good job has been done on the previous steps, preassessment is not necessary. 14. Registration This step has three parts: • • • choosing a registrar, submitting an application, Conducting the registrar's system audit.

A registrar's audit usually lasts one to three days and will consist of an opening meeting to describe the process the auditors will follow, the audit itself, and a closing meeting to discuss the findings of the audit. • Over documentation or documentation that is too complex. • Using external consultants without internal ownership and involvement. Limiting documentation to text rather than other types of media. • Neglecting to obtain top management's involvement. • Developing a system that does not represent what actually occurs. DOCUMENTATION A quality system is the method used to ensure that the quality level of a product or service is maintained. The system documentation can be viewed as a hierarchy containing four tiers, as shown in Figure

Documentation Pyramid Policy The first tier of documentation is the policy manual. This is the document that defines what will be done and why. v A quality policy manual should be written so it is clear, precise, practical, and easy to understand. v The why can be stated just once as a quality policy statement? v This statement should be a short, simple definition of the organization's quality intentions.




The second tier of documentation is the quality procedures. These procedures describe methods that will be used to implement and perform the stated policies. The procedures define who should perform specific tasks, when the task should be done, and here documentation will be made showing that the task was performed. Procedures should be oriented so that they apply to all areas within the organization..

Work Instructions Work instructions are usually department, machine, task, or product oriented and spells out how a job will be done. v These instructions are the most detailed of the documentation hierarchy. v A work instruction may be in the form of a detailed drawing, recipe, routing sheet, specific job function (for example, turn nut four turns clockwise), photograph, video, or simply a sample for comparison of conformity Records Records are a way of documenting that the policies, procedures, and work instructions have been followed. • • Records may be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as a routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products..

Document Development Although documentation is required by the system, its most important purpose is to provide guidelines for internal quality management. v In this respect it can be considered one approach to the road of continuing quality improvement and business success. v This preexisting documentation is the starting point for developing the documents necessary for registration. Writing the Documents The basic thought to keep in mind when writing the documents is to create simplicity out of complexity. • • To accomplish this objective, the documents must be simple and concise. Simplicity can be obtained by having one idea addressed per paragraph, short subject verb-object type sentences, and a simple paragraph-numbering system




Format Example • • When designing the manuals, simplicity and ease of use should determine the structure to be used. A cover page will list the organization name and location as well as the title of the document. to determine that:

They are clearly defined and do not differ from the original proposal or sales offer. • • Any differences are resolved and any changes are appropriately recorded and affected people notified. Wirco Castings Inc. has the ability to meet them.

Quality System Audits After the policies, procedures, and work instructions have been developed and implemented. v This activity is accomplished through the internal audit, which is one of the key elements of the ISO 9000 standard. v All elements should be audited at least once per year and some more frequently, depending on need. Objectives There are five objectives of the internal audit. They are to: • Determine that actual performance conforms to the documented QMS. Initiate corrective action activities in response to deficiencies. . Follow up on noncompliance items from previous audits.




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Provide continued improvement in the system through feedback to management.

Cause the auditee to think about the process, thereby encouraging possible improvements. Auditor Audits should be performed by qualified individuals who have received training in auditing principles and procedures. v Training programs are available from ASQ and RAB. Training should include classroom information as well as practical demonstration by the trainer and a critiqued audit by the trainee. v To be able to audit efficiently, an individual should possess good written and oral communication skills, be a good listener, and be good at taking notes. v Other skills should include the ability to concentrate on the task at hand and not be distracted by other activities that are taking place at the same time, be observant and questioning, and be able to separate relevant facts from other information. v The auditor should be objective, honest, and impartial. Of course, the auditor should be prepared by being knowledgeable about the standards. Techniques During the actual audit, there are a number of techniques that the auditor should employ. • • • • • • • • • • • • The objective is to collect evidence, and there are three methods: examination of documents, observation of activities, and interviews. The easiest method is to examine the documents. The auditor should start with the quality manual to determine that the policies cover the QMS standards, and that they are controlled and assessable. Next, the documents are examined in a systematic manner. . Document control ensures that documents are identified with a title, revision date, and responsible owner; documents are readily available to users; a master list by department or function for procedures, work instructions, and records is appropriately located; there are no obsolete documents at workstations; and Changes follow a prescribed procedure. Observation of activities is also an easy method that requires an aptitude for detail. Use the appropriate type of question. There are open questions, closed questions, clarifying questions, leading questions, and aggressive questions.

Procedure Before the audit takes place, an audit plan and checklist should be prepared by the lead auditor. As much time is spent planning as doing.




The contents of an audit plan should identify the activity or department to be audited; list the procedures, documents, and regulatory requirements involved; name the audit team; and list who is to be notified of the audit and who will receive audit reports v The purpose of the audit is to determine how well the quality system has been implemented and maintained. v In large organizations, an escort should be provided by the area being audited.

Audit Schedule Example

Audit Matrix Example




. Separate reports are prepared for each nonconformance and should include: v The element title and a unique identification number such as NC 7.2.3, where the NC stands for nonconformance and the other numbers give the element number. v . Where the nonconformance was observed. v Objective evidence used as a basis for the nonconformance. v The nonconformance worded as closely as possible to the language of the requirement. At the closing meeting, the lead auditor presents a summary of the audit findings along with the evidence that supports them. • • An estimate is made of when the final report will be issued. Have a cover sheet that includes the audit date, names of the audit team, areas audited, distribution list, a statement that the audit is only a sample, and a unique reference number. 2. List the non-conformances and copies of all nonconformance reports. Outline procedures for corrective action and subsequent follow-up.

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ENVIRONMENTAL MANAGEMENT SYSTEM In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE), which led to the formation of Technical Committee (TC) 207 in 1992. v The mission of TC 207 is to develop standards for an environmental management system (EMS) which was identified as ISO 14000. v Like the ISO 9000 standards, which do not address the performance of the product or service, the committee used the concept that the standards addressed the process rather than the end goal. v Thus, they are process standards rather than performance standards. v TC 207 has established six sub-committees: environmental management systems, environmental auditing, environmental labeling, environmental performance evaluation, life-cycle assessment, and terms and definitions covers terms and definitions that are common to both areas. ORGANIZATIONAL EVALUATION STANDARDS These standards consist of three categories: Environmental Management System (EMS), Environmental Auditing (EA), and Environmental Performance Evaluation (EPE). v ISO 14001, entitled, "Environmental Management Systems-Specifications with Guidance for Use," gives the elements that organizations are required to conform to if they seek registration. v This standard is the heart of the standards and will be discussed in greater detail later in the chapter. v The standards given below support the EMS. v ISO 14004, entitled, Environmental Management Systems-Guidelines on Principles, Systems, and Supporting Techniques, provides supplementary material. v ISO 14010, entitled, "Guidelines for Environmental Auditing-General Principles on Environmental Auditing," provides information for internal or external auditing.

QUALITY SYSTEMS UNIT 5 25 v ISO 14011, entitled, "Guidelines for Environmental Auditing-Audit Procedures- Auditing of Environmental Management Systems," provides information on how to plan and conduct an audit. Some topics are audit team, audit plan, implementation, and report. v ISO 14012, entitled, "Qualification Criteria for Environmental Auditors Performing Environmental Management System Audits," covers information on auditor qualifications, training, and personal attributes and skills. v ISO 14031, entitled, "Guidelines on Environmental Performance Evaluation," presents information on recording information to track performance.

Organizational Evaluation Standards PRODUCT EVALUATION STANDARDS They consist of three categories: v Environmental Aspects in Product Standards (EAPS), v Environmental Labeling (EL), v Life-Cycle Assessment (LCA). "Environmental Aspects in Product Standards," is designed to help writers develop product standards. Writers should carefully consider the environmental consequences when developing criteria, elements, and characteristics that go into the standard.

Product Evaluation Standards v ISO 14020, entitled, "Environmental Labeling-Basic Principles for All Environmental Labeling," provides guidance on the goals and principles that should be used in all labeling programs. v ISO 14021 entitled, "Environmental Labeling-Self-Declaration of Environmental Claims:. v ISO 14022, entitled, "Environmental Labeling-Symbols," provides a standard set of symbols for use by organizations.




v ISO 14023, entitled, "Environmental Labeling-Testing and Verification Methodologies," provides information on the appropriate methods to use to confirm the genuineness of the product as stated by the environmental label. v ISO 14024, entitled, "Environmental Labeling-Practitioner Programs: Guiding Principles, Practices, and Certification Procedures for Multiple Criteria Programs," establishes criteria for third-party labeling or seal programs. v ISO 14040, entitled, "Life-Cycle Assessment-Principles and Framework," provides an overview of the practice, applications, and limitations of LCA. Lifecycle assessment attempts to determine the long-range environmental effect of a product. v ISO 14041, entitled, "Life-Cycle Assessment-Goals and Definition/Scope and Inventory Analysis," is intended to provide guidelines for the preparation, conduct, and critical review of the life-cycle inventory analysis. v ISO 14042, entitled, "Life-Cycle Assessment-Impact Assessment," is intended to use the results of the inventory analysis to evaluate the significance of potential environmental impacts v ISO 14043, entitled, "Life-Cycle Assessment-Improvement Assessment," is intended to provide information to improve the total environmental performance of a product system.. CONCEPTS OF ISO 14001 This standard provides organizations with the elements for an environmental management system (EMS), which can be integrated into other management systems to help achieve environmental and economic goals. • • It describes the requirements for registration and/or self-declaration of the organization's EMS. Demonstration of successful implementation of the system can be used to assure other parties that an appropriate EMS is in place.

. The basic approach to EMS is shown in Figure v It begins with the environmental policy, which is followed by planning, implementation and operation, checking and corrective action, and management review. The approach follows the PDSA cycle. v There is a logical sequence of events to achieve continual improvement. Many of the requirements may be developed concurrently or revisited at any time




Environmental Management System Model The standard is not intended to create non tariff barriers or to change an organization's legal obligations. • • • • • • In addition, it does not include aspects of occupational health and safety management, although an organization may include these aspects in the documentation. . Environment is defined as the global surroundings in which an organization operates and includes air, water, land, natural resources, flora, fauna, humans, and their interaction. Environmental aspect is defined as an element of an organization's activities, products, or services that can interact with the environment Environmental impact is defined as any change, whether adverse or beneficial, wholly or partially resulting from an organization's activities, products, or services. Environmental objective is an overall environmental goal, arising from the policy statement, that an organization sets for itself and which is quantified when practical. There are four sections to the standard-scope, nonnative references, definitions, and EMS requirements and an informative annex.

Requirements of ISO 140012 The standard is divided into six parts or clauses and has a total of 18 requirements. The numbering system used is identical to the standard. 4.1 General Requirements The organization shall establish and maintain an environmental management system that includes policy, planning, implementation and operation, checking and corrective action, and management review. v These requirements are given in the rest of the standard. Because the document is available to the public and other stakeholders, the organization may wish to include in this narrative a brief description of the company v . In addition, this clause is a, good place to include manual control and distribution. In developing the EMS, keep it as simple as possible..

QUALITY SYSTEMS 4.2 Environmental Policy



The organization's policy statement should be based on its mission and values • • • Identification of legislative and regulatory requirements. Identification of environmental aspects of its activities, products, or services that can have significant impact and liabilities. Identification of existing activities with suppliers.

• Identification of existing management policies and procedures. • Feedback from investigation of previous incidents of noncompliance. • Identification of opportunities for competitive advantage. • Identification of benchmarking opportunities. 4.3 Planning This area contains four elements: environmental aspects, legal and other requirements, objectives and targets, and environmental management program(s). 4.3.1 ENVIRONMENTAL ASPECTS .ISO 14004 lists nine issues that can be considered in an organization's procedures for the identification of aspects and their impacts. v What are the environmental aspects of the organizations activities, products, and services? v . Do the organization's activities, products, or services create any significant adverse environmental impacts? v Does the organization have a procedure for evaluating the environmental consideration, for example, sensitive environmental areas? v Does the location of the organization require special environmental consideration, for example, sensitive environmental aspects and their associated impacts? v How will any intended changes or additions to activities, products, or services affect the environmental aspects and their associated impacts? v How significant or severe are the potential environmental impacts if a process failure occurs? v How frequently will the situation arise that could lead to the impact? 8. What are the significant environmental aspects, considering impacts, likelihood, severity, and frequency? v Are the significant environmental impacts local, regional, or global in scope? . 4.3.2 LEGAL AND OTHER REQUIREMENTS The standard requires the organization to have a procedure to identify and have access to all legal and other requirements to which it subscribes. • • In general, legal environmental requirements are those attributed to governmental legislative and regulatory action. Other requirements usually include industry codes of practice, contracts, agreements with public authorities, and no regulatory guidelines.




The organization shall establish and maintain these objectives and targets at each relevant function and level. v They shall be consistent with the policy statement, especially in regard to the prevention of pollution. v In addition to the environmental aspects, and the legal and other requirements which were previously discussed, this clause also requires that the organization consider: . ISO 140041ists different forms of objectives, such as: Reduce waste and the depletion of resources. Reduce or eliminate the release of pollutants in the environment. Design products to minimize their environmental impact in production, use, and disposal. Control the environmental impact of sources of raw material. • Minimize any significant adverse environmental impact of new developments. Promote environmental awareness among employees and the community. 4.3.4 ENVIRONMENTAL MANAGEMENT PROGRAM(S) The organization shall establish and maintain a program(s) for achieving the objectives and targets. This requirement can be achieved with a simple form. It will require completion of the following items: v v v v v v v State the objective/target. State the purpose (How the objective/target will suppol1 the policy). Describe how the objective/target will be achieved. State the program (team) leader. Designate departments and individuals responsible for specific tasks. Establish the schedule for completion of the tasks. Establish the program review, which will include format, content, and review schedule. • • •

4.4 Implementation and Operation This area contains seven elements: structure and responsibility; training, awareness, and competency; communication; EMS documentation; document control; operational control: and emergency preparedness and response. 4.4.1 STRUCTURE AND RESPONSIBILITY Roles, responsibilities, and authorities shall be defined, documented, and communicated for all personnel affecting the EMS. v They must be given the freedom and authority to take the necessary actions. An organization chart is one method to show the flow of authority. v A management representative must be appointed and given the authority to ensure that this standard is being met and to periodically repol1 to senior management the status of EMS with the aim of improvement. v The management representative can only be as effective as their involvement. v Senior management must provide the resources in terms of people, technology, and money to implement and maintain an effective system that achieves its objectives.




4.4.2 TRAINING, AWARENESS, AND COMPETENCY Training needs should be evaluated on a regular basis, usually annually, to ensure their effectiveness. v There are two types of training: general awareness and job competency. General awareness includes the importance of conformance to the EMS, the relationship of significant environmental impacts to the employees' work activities, employee roles and responsibilities, and potential consequences of failing to follow specific operating procedures. v Records must be maintained to document that the training requirements have been met. At a minimum, this training should include: Record of training needs assessments. Task competency requirements. Training procedures. Training plans. Records of training delivered to specific employees. Registrar's audits will require these documented records, and they will be valuable for internal operations and litigation defense if needed. 4.4.3 COMMUNICATION • • • • • • • • A key aspect of any management program is communication with all stakeholders. The standard requires that procedures shall be established and maintained for internal communication among all employees. Effective communication up, down, and laterally should ensure that questions are answered and that understanding is complete and accurate. Internal environmental communication procedures should address reporting on environmental activities to: Demonstrate management's commitment to the environment and EMS. Handle concerns and questions about environmental aspects of the organization's activities, products, and services. Inform appropriate employees of all legal and regulatory changes and all changes to the EMS. Raise awareness of the organization's environmental activities. Ensure that all employees are aware of objectives, targets, programs, and achievements..

In addition, procedures shall be established for receiving, documenting, and responding to relevant external communication from interested parties Further more, the organization shall consider processes for external communication of its environmental aspects and record its decision to implement or to not implement those processes. 4.4.4 ENVIRONMENTAL MANAGEMENT SYSTEM DOCUMENTATION The organization shall establish and maintain information, in paper or electronic form, to describe the core elements of the system and their interaction and provide direction to applicable related documents. v ISO 14000 requires a documentation system very similar to ISO 9000, which makes integration of the two systems very easy.




v The organization must show that it is actually practicing what the documentation states. In other words, "Say what you do and do what you say." 4.4.5 DOCUMENT CONTROL This element requires that procedures be established and maintained to control all EMS documents. • • • Provisions must be made for the review and approval of documents for adequacy before they are issued and after any changes. The purpose of document control is to ensure that appropriate and current issues of documents are in place at all locations. Obsolete documents must be removed and destroyed or stored in a safe place if retention for legal purposes is necessary. Documents shall be legible, dated, readily identifiable and easily located. . The best document control system is the simplest one that meets the needs of the organization and ISO 14000. If the organization has an existing system such as ISO 9000, it can be used as a model.

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Organizational charts and other forms of documentation can be used to clearly define core elements of the system and how they relate to Level 2 procedures. The organization may wish to list environmental aspects; objectives; targets; and legal, regulatory, and other requirements at this level. 1 Level 2, the procedure level, describes what the organization does to meet

Documentation Hierarchy •

Level 1 policy. There are 17 procedures and while only three are explicitly required to be documented, it is best from an effectiveness standpoint to document all 17.




Level 3, the practice level, describes the work instructions by which operating personnel perform their tasks. They are step-by-step instructions dealing with activities required by the standard. Organizations involved with TQM or ISO 9000 will already have these activities documented. Level 4, the proof level, is the location of all forms, records, drawings, and so forth that represent the objective evidence or proof of the performance of the EMS. It is important to note that the system should be an efficient one and not a bureaucratic one-keep it simple.

4.4.6 OPERATIONAL CONTROL This element aligns operations and activities with the identified significant environmental aspects, environmental policy, and environmental objectives and targets v Cover situations where their absence could lead to deviations from the policy and the objectives and targets. v Stipulate operating criteria which are the details and instructions that would normally be included in any process, procedure, or step-by-step work instruction. v They include equipment to be used, materials required, process settings, maintenance program, and so forth. v Cover the identification of environmental aspects of goods and services and communicate relevant procedures and requirements to suppliers and contractors. v Ford Motor Co., which has registered all 140 facilities in 26 countries, requires its suppliers to be certified to ISO 14001. Other major companies such as IBM, General Motors, Xerox, and Honda of America also have made the same stipulation.3 4.4.7 EMERGENCY PREPAREDNESS AND RESPONSE Procedures are required to identify and respond to potential accidents and emergency situations. . Emergency plans should include at a minimum: Emergency organization and responsibilities of key personnel. Details of emergency services such as fire department and spill cleanup services. Internal and external communication plans. • Actions to be taken for the different types of emergencies. • Information on hazardous materials and their impact, including information about • Equipment and protective clothing. • Training plans and testing for effectiveness. • •

These procedures shall be reviewed and revised, if necessary, especially after an emergency. A checklist for lessons learned could include: v Did we follow procedures? v If not, why and how did we deviate?

QUALITY SYSTEMS 33 v What did we do that was right? v What did we do that was wrong? v What procedural changes would result in a more effective response?


These questions can also be asked after any emergency drill or simulation, which would test the procedures for their effectiveness. 4.5 Checking and Corrective Action This area contains four elements: monitoring and 'measuring, nonconformance and corrective and preventative action, records, and EMS audit. 4.5.1 MONITORING AND MEASURING Effective decisions usually require quantifiable data. • The organization is required to monitor and measure the key characteristics of its objectives and activities in order to assess its performance in meeting environmental operations and targets. Measuring equipment is of little value if it is not accurate or functioning properly. Procedures must be in place to control, regularly calibrate, maintain, and record all EMS equipment, whether it belongs to the organization, employee, or an outside agency. In addition, procedures are required to periodically evaluate compliance to relevant regulations.

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4.5.2 NONCONFORMANCE AND CORRECTIVE AND PREVENTATIVE ACTION Procedures are required to define responsibility and authority for v Handling and investigating nonconformance, v Taking action to mitigate any impacts, v Initiating corrective and preventative action. Briefly, the process should include: • • • • Identifying the root cause of the nonconformance. Identifying and implementing the necessary corrective action. Implementing or modifying controls necessary to prevent a recurrence. Recording any changes in the written procedures.

Since operating personnel are usually the most knowledgeable people concerning the process, they should be involved in the corrective and preventative action activity. 4.5.3 RECORDS Procedures are required for the identification, maintenance, and disposition of environmental records such as training, audits, equipment calibration, and reviews. v Records shall be legible, identifiable, and traceable to the activity, product, or service.



UNIT 5 damage,

v They should be readily retrievable; protected against deterioration, and loss; and provided with retention times. 4.5.4 EMS AUDIT

The purpose of this audit is to ensure that the EMS conforms to plans and is being properly implemented and maintained. • • • Internal or self-audit and external audit information should be distributed to senior management to assist in the management review process. Audit procedures should cover the scope, frequency and methodologies, and responsibilities and requirements for conducting audits and reporting results. The audit schedule should be based on the importance of the element and the results of previous audits.

MANAGEMENT REVIEW Management review and revision, if applicable, is required to ensure the continuing suitability, adequacy, and effectiveness of the EMS A fixed schedule of reviews is required to cover all the elements. ISO 14004 recommends that the review include: Review of environmental objectives and targets. Review of environmental performance against legal and other requirements. Evaluation of the effectiveness of the EMS's elements. • Evaluation of the continued suitability of the policy in light of changing legislation; changing expectations; changing requirements of interested parties; changes in activities, products, and services; new technology; lessons learned; market preferences and expectations; and effectiveness of reporting and communication. BENEFITS OF EMSEMS benefits organizational. can be categorized as global and • •

GLOBAL BENEFITS There are three global benefits: v Facilitate trade and remove trade barriers, v Improve environmental performance of planet earth, v Build consensus that there is a need for environmental management and a common terminology for EMS. . ORGANIZATIONAL BENEFITS. According to ISO 14004, an organization benefits from an EMS in a number of ways as given below: • • • • • • Assuring customers of a commitment to environmental management. Meeting customer requirements, the primary reason for organizations to become certified. Maintaining a good public/community relations image. Satisfying investor criteria and improving access to capital. .




Increasing market share that results from a competitive advantage. After certification, Acushnet Rubber obtained more business from European customers. Reducing incidents that result in liability. Improving defense posture in litigation.

GE 406 Total Quality Management Assignment V Part A 1 What is ISO? 2. What is the difference between ISO 9000:1994 version and 2000 version? 3. What are the different types of organization to which ISO 9000 can be applied? 4. What is the importance of ISO? 5. What is non conformity? 6. What is the specialty in ISO 9000:2000 version? 7. What is ISO 14000 and its importance? 8. Define auditor and auditee? 9. Why internal auditing is required? 10. What are all the advantages of ISO 14000 system? Part B 1. Explain the various clauses available in ISO 9000:2000 version. 2. Explain in detail the various activities to be carried out by a manufacturing industry to obtain ISO 9000:2000 versions. 3. Explain the various clauses available in ISO 9000:14000 version. 4. Explain in detail the various activities to be carried out by an educational institution to obtain ISO 9000:2000 versions. 5. Explain the required behavior of internal auditors and Auditees and the process of internal auditing.




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