Quality Management System Requirements for the Suppliers Of Arçelik A.Ş. Rev : 0.1 Date of issue : September 2005-1/23-
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0. INTRODUCTION... 5 0.1. GENERAL... 5 1. SCOPE... 5 1.1. GENERAL... 5 1.2. IMPLEMENTATION... 5 2. REFERRED STANDARDS AND/OR DOCUMENTS... 6 3. TERMS AND DEFINITIONS... 6 4. QUALITY MANAGEMENT SYSTEM... 7 4.1. GENERAL REQUIREMENTS... 7 4.2. DOCUMENTATION REQUIREMENTS... 7 4.2.1. General... 7 4.2.2. Quality manual... 8 4.2.3. Control of documents... 8 4.2.4. Control of records... 9 5. RESPONSIBILITY OF MANAGEMENT... 9 5.1. MANAGEMENT COMMITMENT... 9 5.2. CUSTOMER FOCUS... 9 5.3. QUALITY POLICY... 9 5.4. PLANNING... 9 5.4.1. Quality objectives... 9 5.4.2. Planning of the quality management system... 10 5.5. RESPONSIBILITY, AUTHORITY AND COMMUNICATION... 10 5.5.1. Responsibility and authority... 10 5.5.2. Management respresentative... 10 5.5.3. Customer respresentative... 10 5.5.4. Internal communication... 10 5.6. MANGEMENT REVIEW... 10 5.6.1. General... 10 5.6.2. Input of the review... 11 5.6.3. Output of the review... 11 6. RESOURCE MANAGEMENT... 11 6.1. PROVISION OF RESOURCES... 11 6.2. HUMAN RESOURCES... 11 6.2.1. General... 11 6.2.2. Competence, awareness and training... 11 6.3. INFRASTRUCTURE... 12 6.4. WORK ENVIRONMENT... 12 7. PRODUCT REALIZATION... 12 7.1. PLANNING OF PRODUCT REALIZATION... 12 7.1.1. Confidentiality... 13 7.1.2. Control of change... 13 7.2. CUSTOMER-RELATED PROCESSES... 13 7.2.1. Determinng the product-related requirements... 13 7.2.2. Review of requirements related to the product... 13 7.2.3. Communication with the customer... 14 7.3. DESIGN AND DEVELOPEMENT... 14 7.3.1. Design and develpoment planning... 14 7.3.2. Design and develpoment inputs... 14 7.3.3. Design and develpoment outputs... 15 7.3.4. Design and develpoment review... 15 7.3.5. Design and develpoment verification... 16 7.3.6. Design and develpoment validation... 16 7.3.7. Control of Design and develpoment changes... 16 7.4. PURCHASING... 16 7.4.1. Purchasing process... 16 7.4.2. Purchasing information... 17-3/23-
7.4.3. Verification of purchased product... 17 7.4.4. Suuplier performance monitoring... 17 7.5. PRODUCTION AND SERVICE MONITORING... 17 7.5.1. Control of production and service provision... 17 7.5.2. Validation of production and service provision... 19 7.5.3. Identification and traceability... 19 7.5.4. Customer property... 19 7.5.5. Preservetion of product... 20 7.6. CONTROL OF MONITORING AND MEASURING DEVICES... 20 8. MEASURING, ANALYSIS AND IMPROVEMENT... 20 8.1. GENERAL... 21 8.2. MONITORING AND MEASURING... 21 8.2.1. Customer satisfaction... 21 8.2.2. Internal audit... 21 8.2.3. Monitoring and measuring of processes... 21 8.2.4. Monitoring and measuring of the product... 22 8.3. CONTROL OF NONCONFORMING PRODUCT... 22 8.4. DATA ANALYSIS... 22 8.5. IMPROVEMENT... 23 8.5.1. Continual improvement... 23 8.5.2. Corrective action... 23 8.5.3. Preventive action... 23-4/23-
0. Introduction 0.1. General This standard is a technical specification for Arçelik A.Ş. suppliers in order to enhance the performance. The intent of this technical specification is to achieve development of a basic quality system management system which will ensure continual improvement by emphasizing fault prevention and reduction of nonconformities and waste in the supply chain. It contains the implementations, examples, illustrations, descriptions and conditions specific to Arçelik A.Ş. This standard can be used by Arçelik A.Ş. in assessing the Quality Management System of the supplier for its ability to meet customer, regulatory and the organization s own requirements. However it is not intended to use for certification purposes. Uniformity with the other management systems is intended. In order to enhance the uniformity ISO 9001:2000 article numbers are used. Within this standard which has the character of a technical specification, the words "should or should be" indicates a requirement. The paragraphs under the phrase "Note" are for guidance in understanding or clarifying the associated requirements. 1. Scope 1.1. General This standard specifies the requirements for the suppliers of Arçelik A.Ş. in the following cases: a) The supplier needs to demonstrate its ability to consistenly supply the product that meets customer and current regulatory requirements. b) The supplier aims to the objectives of customer satisfaction enhancement through effective implementation of the system including the processes for continual improvement of the system and the assurance of conformity to customer and current regulatory requirements. This standard does not include the requirements related to environmental management, job health and safety management and finance management. However, this standard allows the supplier to align or integrate its own quality management system with related management system requirements. It is possible for the supplier to adapt its existing system(s) to establish a quality management system that complies with the requirements of this standard. Note - In this standard the term product applies only to the product intended for, or required by, customer. This standard can be applied as a whole in all Arçelik A.Ş. supply chain and in work places of the companies where the products specified by customers for production and/or service are produced. The complementary functions which take place in the work place or in remote places (such as design centers, organization headquarters and distribution centers) become the part of the work place inspection since they support the work place. 1.2. Implementation All the requirements of this standard are generic and it has been intended that it could be implemented by all Arçelik A.Ş. suppliers whatever their types, sizes and products are. In case some of the requirements of this standard are not applicable due to the nature of the product then it can be regarded as "exclusion". Where exclusions are made, the claims of conformity to this standard are not acceptable, unless these exclusions are limited by the conditions in Article 7 and unless such exclusions do -5/23-
not affect the ability and responsibility of the organization for providing the products meeting customer and the current regulatory requirements. The only exclusion that could be relevant with this standard is regarding the Article 7.3 where the organization is not responsible for the product design and development. The exclusions do not include the design of the production process. 2. The referred standards and/or documents In this standard, references are made to other standards and/or documents with or without mentioning any date. These references are made in appropriate places in the text and listed below. For dated references, the subsequent amendments or revisions will not be taken into consideration. For undated references, the latest edition of the document will be applied. ISO 9000:2000 Quality Management Systems-Basic Concepts, Terms and Definitions ISO 9001:2000 Quality Management Systems-Requirements ISO / TS 16949:2002 Quality in Automotive Production and Organizations of Relevant Service Parts The Requirements of the Management System ISO 10012-1 Guideline for Auditing Quality Systems - Part 1: Auditing ISO 10012-2 Guideline for Auditing Quality Systems - Part 2, July 1992 ISO 10012-3 Guideline for Auditing Quality Systems - Part 3-Management of Audit Programmes ISO 10012-1 Requirement for Measuring Equipment Metrological confirmation System for measuring equipment ISO 10012-2 3. Terms and definitions Quality Assurance for Measuring Equipment Section 2: Guidelines for Control of the Measurment Processes The terms and definitions given in ISO 9000 standards are applied regarding the intention of this standard. The terms used this edition of ISO 9001 standard for describing the supply chain have been changed to reflect the current vocabulary as given below. Supplier Organization Customer The term organization replaces the term supplier in ISO 9000:1994 edition and indicates the way this standard is implemented. In the same manner, the term supplier replaces the term subcontractor. Throughout the text of this standard, wherever the term product takes place, it can also mean service. -6/23-
4. Quality Management System 4.1. General Requirements The organization should establish, document, implement and maintain a quality management system meeting the requirements stipulated in this standard and it should continually improve its effectiveness. The organization should; a) identify the processes needed for the quality management system and their application in the organization (Article 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of the resources and the information needed for supporting the operation and monitoring of these processes, e) monitor, measure and analyze these processes and, f) implement the necessary actions in order to achieve the planned objectives and continual improvement these processes, These processes should be managed by the organization in compliance with the requirements of this standard, The organization should ensure control over a process that is preferred to be outsourced and is effective on the product conformity with the requirements. The control of such outsourced processes should be identified within the quality management system. Having ensured a control over the outsourced processes does not relieve the organization of the responsibility of complying with all customer requirements. Note : The processes needed for the aforementioned quality management system should include the processes for the management activities, provision of the resources, product realization and measurement. 4.2. Documentation requirements 4.2.1. General The documentation of the quality management system should include the following items: a ) The documented statements of the quality policy and quality objectives, b ) The quality manual, c ) The documented procedures stipulated in this standard, d ) The documents needed by the organization for the effective planning, implementation and control of the processes, e ) The records required by this standard (Article 4.2.4) Note 1: In this standard where the term documented procedure is met, it means that the procedure has been esatablished, documented, implemented and maintained. -7/23-
Note 2: The content of the quality management system documentation may differ from one organization to another depending on the followings: a ) The size of the organization and the nature of its activities, b ) The complexity of the processes and their interactions, c ) The competence of its personnel. Note 3: The documentation can be in any form or medium. 4.2.2 Quality manual The organization should establish and maintain a quality manual including the following. a ) The scope of the quality management system including the details and justifications of any exclusions (Article 1.2) b ) The procedures established and documented for the quality management system or the reference to them, c ) The description of the interaction between the quality system processes. 4.2.2. The control of the documents The documents deemed necessary by the quality management system should be controlled. The records are a special type of document and should be controlled according to the requirements stated in Article 4.2.4. A documented procedure should be established for describing the following necessary controls: a ) Approval of the documents in terms of conformity and adequacy before they are issued, b ) Reviewing of the documents, updating if necessary and re-approval. c ) Ensuring that changes and the current revision tatus of documents are identified d ) Ensuring the availability of the relevant versions of the applicable documents at points of use e ) Ensuring that the documents remain legible and readily identifiable, f ) Ensuring that the documents of external origin are identified and their distribution controlled, g ) Preventing the unintended use of obsolete documents and applying a suitable identification to them if they are retained for any purpose 3.1.1.1. Engineering specifications The organization should have processes for providing the timely reviewing, distribution and implementation of any engineering standards / specifications and modifications of customer depending on the delivery schedule specified by customer. The timely reviewing operation should be realized promptly and should not exceed two weeks. The records showing the starting dates of implementation of modifications should be maintained. -8/23-
4.2.3. Control of the records The records should be established and maintained to demonstrate that the quality management system conforms to the requirements and is implemented effectively. The records should remain legible, readily identifiable and retrievable. A documented procedure should be established to describe the controls needed to for the identification, storage, protection, retention time and disposal. The control of the records should be at such a level that will fulfill the requirements relevant to the laws and customers. Note 1 The records also include the records specified by customer. 5. Management Responsibilty 5.1. Management commitment The top management should demonstrate its commitment for developing, implementing and improving its effectiveness of the quality management system by the following ways: a ) By communicating to the organization the importance of fulfilling customer requirements as well as the statutory and regulatory requirements, b ) By establishing a quality policy, c ) By ensuring that the quality objectives are established, d ) By conducting management reviews, e ) By ensuring the availability of the resources. 5.2. Customer focus In line with the aim of enchancing customer satisfaction, the top management should ensure that customer requirements are determined and fulfilled as required (Article 7.2.1 and 8.2.1) 5.3. Quality policy The top management should ensure the followings for the quality policy: a ) It is appropriate to the mission of the organization, b ) It has the commitment of compliance to the requirements of the quality management system and continual improvement of its effectiveness, c ) It provides a framework for establishing and reviewing the quality objectives, d ) It is communicated and understood within the organization, e ) It is reviewed for continual suitability. 5.4. Planning 5.4.1. The quality objectives The top management should ensure the establishment of quality objectives at relevant functions and levels of the organization including those needed to meet the product requirements (Article 7.1.a). The quality objectives should be measurable and consistent with the quality policy. -9/23-
Note: The quality objectives should meet customer expectations and be achievable within a certain time limit. 5.4.2. Planning of the of the quality management system The top management should ensure; a ) The planning of the quality management system to fulfill the requirements given in Article 4.1 including the quality objectives, b ) The sustainability of the integration of the quality management system when changes are planned and implemented in the quality management system. 5.5. The responsibility, authority and communication 5.5.1. The responsibility and authority The top management should ensure that the responsibilities and authorities are defined and communicated within the organization. 5.5.2. The management representative The top management should appoint a member of the management team as a representative, irrespective of his/her other responsibilities with the authorities and responsibilities including the followings: a ) To ensure the establishment, implementation and persistence of the processes needed for the quality management system, b ) To report to the top management in case any need arises for the performance and improvement of the quality management system, c ) To ensure the promotion of awareness of customer requirements throughout the organization. 3.1.1.2. Quality responsibility The person in charge of the product quality should have the authority to stop the operations for correction of the quality problems. There will be a person present in each shift, in charge of quality or delegated with the product quality assurance responsibility. 5.5.3. Customer representative The top management should assign a person having the responsibility and authority to address customer requirements. Note - The responsibility of the management representative may also iclude liaison with external parties on matters relating to the quality management system. 5.5.4. Internal communication The top management should ensure the establishment and communication of appropriate communication processes within the organization regarding the effectiveness of the quality management system. 5.6. The management review 5.6.1. General The top management should carry out reviews of the quality management system at planned intervals to ensure its continual conformity, adequacy and effectiveness. This reviewing should include assessing opportunities for improvement and the need for changes in the quality management system including the quality policy and quality objectives. -10/23-
A part of the management review will follow the regular reporting and assessment of the quality objectives, customer satisfaction of the supplied products and the cost of inferiority. The records obtained by the reviews should be stored and maintained (Article 4.2.4) 5.6.2. Input for the review The inputs to the management reviews should include the information on the following subjects: a ) The results of the audits b ) Customer feedback c ) Process performance and product conformity d ) The status of the preventive and corrective actions e ) The follow up actions from the previous management reviews f ) Changes that could affect the quality management system g ) Recommendations for improvement 5.6.3. Output of the review The outputs from management reviews should include the decisions and activities regarding the followings: a ) The improvement of the effectiveness of the quality management system and its processes b ) The improvement of the product related to customer requirements c ) The needs for resource 6. Resource management 6.1. The provision of the resources The organization should determine and provide the resources needed: a ) To implement and maintain the quality management system and continually improve its effectiveness b ) To enhance customer satisfaction through fulfilling customer requirements 6.2. Human resources 6.2.1. General The personnel carrying out the jobs affecting the product quality should be competent in terms of proper education, training, skill and experience. 6.2.2. Competence, awareness (consciousness) and training The organization; a ) Should determine the required competence for the personnel carrying out the jobs affecting the product quality, b ) Should provide training or take other measures to meet such needs, -11/23-
c ) Should assess the effectiveness of the measures taken, d ) Should ensure that its personnel are aware of the importance of their activities and how easily they could contribute to the achievement of the quality objectives, e ) Should maintain and store the appropriate records of education, training, skill and experience (Article 4.2.4). The organization, in all its levels, should determine and provide the competence for all the employees who have effects on product quality. The personnel who could affect the quality should be informed of the results of customer perception created by conforming to the the quality requirements. 6.3. Infra-structure The organization should determine, provide and maintain the needed infra-structure in order to conform to the product requirements. The infra-structure will include the following, where applicable: a ) Buildings, workspaces and associated facilities, b ) The equipment for the processes (software and hardware), c ) Supporting services (such as transportaion and communication) 6.4. Work environment The organization should determine and manage the work environment needed to ensure conformity to the product requirements. The safety of the personnel should be ensured to achieve product quality and the actions for reducing the potential risks should be performed. The organization should keep the workspaces organized, neat and well maintained according to the product and production procedure requirements. 7. Product realization 7.1. The planning of product realization The organization should plan and develop the necessary processes for the realization of the product. The product realization planning should be consistent with the requirements of the other processes of the quality management system (Article 4.1). In product realization planning, where applicable, the organization should determine the followings: a ) Quality objectives and requirements for the product, b ) The needs for the establishment of processes and documents and for the provision of the resources specific to the product. c ) The necessary criteria for verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance d ) The required records to demonstrate that the realization processes and the resulting product meet the requirements (Article 4.2.4) The outputs of this planning should be in a form conforming to the working methods of the organization. -12/23-
Note 1 - A document that includes the processes of the quality management system (including the product realization processes) and decribing the resources applied to a specific product or a contract may be called as a quality plan. Note 2 - The organization can implement the requirements given in Article 7.3 to the development of the product realization processes. 7.1.1. Confidentiality The organization should ensure the confidentiality of the customer contracted products and projects being developed and the related product data. 7.1.2. Control of the changes All kinds of product realization changes which affect the product requirements should be informed to customer and its approval obtained. The effects of all kinds of changes including the changes caused by any supplier should be evaluated and verification and validation actions should be defined to ensure conformity with customer requirements. The changes should be verified prior to application. Related to the proprietary designs, their forms, dimensions and functions (including their performances and/or reliablilities) should be reviewd together with customer. When it is aproved by the customer too, the additional verification/validation requirements for the new product should be carried out. Note: The aforementioned term changes is applicable for the changes in product, material, supplier and production process. 7.2. Customer-related processes 7.2.1. Determining the product related requirements The organization should determine; a ) The requirements stated by the customer including the requirements for delivery and postdelivery activities; b ) The requirements not stated by the customer but necessary for specifed or intended use, where known. c ) The statutory (legal) and regulatory requirements related to the product, d ) Any additional requirements determined by the organization. The organization should demonstrate the conformity to the customer requirements related to the determination, documentation and control of the specific characteristics. 7.2.2. Review of requirements related to the product The organization should review the requirements related to the product. This review should be conducted prior to the organizations commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and should ensure that; a ) Product requirements are defined, b ) Contract or order requirements differing from those previously expressed are resolved. -13/23-
The records of the results of the review and actions arising from the review should be maintained and stored (Article 4.2.4) Where the customer provides no documented statement of requirement, the customer requirements should be confirmed by the organization before acceptance. Where the ptoduct requirements are changed, the organization should ensure that relevant documents are amended and that relenavt personnel are made aware of the changed requirements. Note 1 - In some cases, such as internet sales, a formal review is impractical for each order. Instead the review can cover relavant product information (such as catalogues or advertising material). Note 2 - Declination from the requirements in Article 7.2.2 related to a formal review requires the permission of the customer. 7.2.3. The communication with the customer The organization should determine and implement effective arrangement for communicating with customers related to the followings; a ) Product information b ) Enquiries, contracts or order handling, including amendments, c ) Customer feedback, including customer complaints. The organization should have the ability to communicate the required information including the data in language and format specific to the customer. Note: Computer aided design data and electronic data transactions can be considered as the information that require data communication ability. 7.3. Design and development 7.3.1. Design and development planning The organization should plan and control the design and development of product. During the design and development planning, the organization should determine the followings; a ) The design and development stages, b ) The review, verification and validation that are appropriate to each design and development stage, c ) The responsibilities and authorities for design and development. The organization should manage the interfaces between different groups involved in design and development to ensure effective communication and assignment of responsibility. Planning output should be updated, as appropriate, as the design development progresses. 7.3.2. Design and development inputs Inputs relating to product requirements should be determined and records maintained (Article 4.2.4). These inputs should include the followings: a ) Functional and performance requirements, -14/23-
b ) Applicable statutory (legal) and regulatory requirements, c ) Where applicable, infırmation derived from previous similar designs, d ) Other requirements essential for design and development. These inputs should be reviewed for adequacy. Requirements should be complete, unambiguous and not not in conflict with each other. Note 1- The customer requirements such as descriptions of a particular product specifications, traceability and packaging are considered as design inputs. Note 2 - The objectives for product quality, process adequacy, serviceability, timing, efficiency and cost are considered as design inputs of production process. Note 3 - The process control documents include the technical drawings, FMEA s, control plans and operational instructions. 7.3.3. Design and development outputs Design and development outputs should be provided in a form that enables verification against the design and development inputs and should be approved prior to relase. Design and development outputs should; a ) Meet the input requirements for design and development, b ) Provide appropriate information for purchasing, production and for service provision. c ) Contain or refer to product acceptance criteria, d ) Specify the characteristics of the product that are essential for its safe and proper use. Note 1- Product descriptions including the FMEA of design, reliability results, particular product specifications, technical drawings or mathematical based data, and where applicable, the methods relating with the results of product design reviews and quick determination and feedback of the faults (non-conformities), are considered as product design outputs. Note 2- The document/data related with the technical specifications and drawings, operational flowcharts, control plans, operation instructions, process approval criteria, quality and reliability, and measurability, and where applicable, the methods relating with the quick determination and feedback of the product and production process faults (non-conformities) are considered as design outputs of production process. 7.3.4. Design and development review At suitable stages, systematic reviews of design and development should be performed in accordance with the planned arrangements (Article 7.3.1) for the following purposes: a ) To evaluate the ability of the results of design and development to meet the requirements, b ) To identify any problems and propose necessary actions. The participants in such reviews should include representatives of functions concerned with the design and development stages being reviewed. The records of the results of the reviews and any necessary actions should be stored and maintained (article 4.2.4). -15/23-
7.3.5. Design and development verification Verification should be performed in accordance with planned arrangements (Article 7.3.1) to ensure that the design and development outputs have met the the design and development inputs. Records of the results of the verification and any necessary actions should be stored and maintained (Article 4.2.4). 7.3.6. Design and development validation Design and development validation should be performed in accordance with the planned arrangements (Article 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practical, validation should be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions should be stored and maintained (Article 4.2.4). When required by the customer, the organization should have a proptotype programme and control plan. All performance test activities should be completed on time and should be monitored for conformity to the requirements. The organization, where applicable, should use the same suppliers, tools and production processes as used in production for the performance test activities. The organization should comply with the product or production procedure recognized by the customer. The product approval should be considered as a process following the production process procedure. 7.3.7. Control of design and development changes The design and development changes should be identified and records stored and maintained. The changes should be reviewed, verified and validated, as appropriate, and approved before implementations. The review of design and development changes should include evaluation of the effect of the changes on constituent parts and product already delivered. The records of the results of the review of changes and any necessary actions should be stored and maintained (Article 4.2.4). Note - The changes of design and development include all the changes occurring during the lifetime of the product programme. 7.4. Purchasing 7.4.1. Purchasing process The organization should ensure that purchased product conforms to the specified purchase requirements. The type and extent of control applied to the supplier and the purchased product should be dependent upon the effect of the purchased product on sunsequent product realization or the final product. The organization should evaluate and select suppliers based on their ability to supply product in accordance with the organizations s requirements. The criteria for selection, evaluation and reevaluation should be established. Records of the results of evaluations and any necessary actions arising from the evaluations should be stored and maintained (Article 4.2.4). Note - The aforementioned term purchased product should include all the products and services that might affect the customer requirements such as second tier assembly, classification, reprocessing and calibration. -16/23-
3.1.1.3. The sources approved by customer Where indentified by customer, the organization should purchase products, materials, services, equipment and measuring equipment from approved sources. Using sources approved by customer does not relieve the organization from the responsibility of ensuring the quality of the purchased products. 7.4.2. Purchasing information Purchasing information should describe the product to be purchased, including the following, where appropriate: a ) Requirements for approval of product, procedures, processes and equipment, b ) Requirements for qualification of personnel, c ) Quality management system requirements. The organization should ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3. Verification of purchased product The organization should establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier s premises, the organization should state the intended verification arrangements and method of product release in the purchasing information. The process to be applied for ensuring that the product to be purchased meets the required quality should include one or more of the following methods: a ) Statistical data and analyses, b ) Reception inspections and/or tests such as sampling based on performance, c ) Assessment of the part performed by an assigned laboratory d ) Any other method in agreement with customer. 7.4.4. Supplier performance monitoring The performance of the supplier should be monitored by using the following indicators: a ) the quality of the delivered product, b ) The complaints from customers, including the claim returns within warranty period, c ) The performance on delivery schedule (including the overcharged shipping costs), d ) Special status customer information related to the quality and delivery matters. 7.5. Production and service provision 7.5.1. Control of production and service provision The organization should plan and carry out production and service provision under controlled conditions. Controlled conditions should include, where applicable; -17/23-
a ) The availability of information that describes the characteristics of the product, b ) The availability of work instructions, as necessary, c ) The use of suitable equipment, d ) The availability and use of monitoring and measuring devices, e ) The implementationof monitoring and measurement, f ) The implementation of release, delivery and post-delivery activities. 3.1.1.4. Control plans The organization should develop and implement control plans at product, semi-product, component ans/or material levels. The control plan should include the followings: a ) The list of the controls used for production process controlling, b ) The methods for monitoring the controls on the special characteristics of the product defined by both customer and organization. c ) The information required by the customer, as applicable, d ) The reaction plan determined, to be applied when the process becomes unstable and incapable in terms of stastistics. The records of the implementation of the control plans and any necessary actions should be stored and maintained. 3.1.1.5. Operation instructions The organization should establish operation instructions for the use of the personnel who have the responsibilities to operate the processes that affect the product quality. These instructions should be available for use in the workspaces. These operation instructions should be derived from sources such as quality plans, control plans and product realization processes. 3.1.1.6. Verification of work adjustments At the start of production, when the material or production process is changed, the work adjustments should be verified. The operation instructions should be readily available for the personnel performing the adjustments. The stastistical techniques (SPC-statistical process control) should be used for verification, when possible. Note It is recommended that the comparions of the last produced parts are performed. 3.1.1.7. Management of production equipment and protective maintenance The organization should provide resources for the design, manufacturing and verification of the production equipment and measuring equipment. Production equipment management system should be established and implemented including the descriptions for the facilities and personnel of maintenance and repair, storing and recovering and adjustment and equipment. -18/23-
The organization should define the equipment for the main process, provide resources for the maintenance of the machinery / equipment and establish a planned protective maintenance system. This system should provide minimum the following; a ) the planned maintenance activities, b ) the availability of the replacement parts for the main production equipment, c ) the documentation, evaluation and enhancement of the maintenance objectives. The records of maintenance applications and any necessary actions should be stored and maintained. 7.5.2. Validation of processes for production and service The organization should validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where defiviencies become apparent only after the product is in use or the service has been delivered. Validation should demonstrate the ability of these processes to achieve the planned results. The organization should establish arrangements for these including, as applicable; a ) Defined criteria for review and approval of these processes, b ) Approval of equipment and qualification of personnel, c ) Use of specific methods and procedures, d ) Requirements for records (Article 4.2.4) e ) Revalidation 7.5.3. Identification and traceability Where appropriate, the organization should identify the product by suitable means throughout product realization. The organization should identify product status with respect to monitoring and measuring requirements. Where traceability is a requirement, the organization should control and record the unique identification of the product (Article 4.2.4). Note 1 - In some industry sectors, configuration management is a means by which identification and traceability are maintained. Note 2 - Where it is obviously identified, it will be sufficient to define the location of the product in the automated production transfer process. Where it is not clearly identified, it will not be sufficient to define the location of the product. 7.5.4. Customer property The organization should exerecise care with customer property while it is under the organization s control or being used by the organization. The organization should identify, verify, prorect and -19/23-
safeguard customer property provided for use or incorporation into the product. If any customer property is lodt, damaged or otherwise found to be unsuitable for use, this should be reported to the customer and records maintained (Article 4.2.4). Note Customer property can include intellectual property. Note The returnable packaging under customer property is included in this clause. 3.1.1.8. Production equipment under customer property The production equipment, tools for production, testing and inspection of customer property should be identified by indelible marking. By this means, the owner of the good is readily apparent and identifiable. 7.5.5. Preservation of product The organization should preserve the conformity of product during internal processing and delivery to the intended destination. This preservation should include identification, handling, packaging, storage and protection. Preservation should also apply to the constituent parts of a product. 7.6. Control of monitoring and measuring devices The organization should 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 (Article 7.2.1) The organization should establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the mpnitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment should; a ) be calibrated or verified at sprficied intervals, or prior to use, against measurement standarts traceable to international or national measurement standards; where no such stsndards exist, the basis used for calibration or verification should be recorded; b ) be adjusted or re-adjusted as necessary; c ) be identified to to enable the calibration ststus to be determined; d ) be safeguarded from adjustments that would invalidate the measurement result; e ) be protected from damage and deterioration during handling, maintenance and storage. In addition, the organization should assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization should take appropriate actions on the equipment and any product affected. Records of the results of calibration and verification should be maintained (Article 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of omputer software to satisfy the intended application should be confirmed. This should be undertaken prior to initial use and reconfirmed as necessary. Not For guidance, see ISO 10012-1 and ISO 10012-2 standards. 8. Measurement, analysis and improvement -20/23-
8.1. Genaral The organization should plan and implement the monitoring, measurement, analysis and improvement processes needed; a ) To demonstrate conformity of the product, b ) To ensure conformity of the quality management system, c ) To continually improve the effectiveness of the quality management system. This should include dtermination of applicable methods, including statiscal techniques, and the extent of their use. 8.2. Monitoring ans measurement 8.2.1. Customer satisfaction As one of the measurements of the performances of the quality management system, the organization should monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information should be determined. Note Customer satisfaction should mean both the internal and external customer satisfaction. 8.2.2. Inernal audit The organization should conduct internal audits at planned intervals to determine whether the quality management system; a ) Conforms to the planned arrangements (Article 7.1), to the requirements of this standard and to the quality management system requirements established by the organization, b ) Is effectively implemented and maintained. An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods should be defined. Selection of auditors and conduct of audits should ensure objectivity and impartiality of the audit process. Auditors should not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (Article 4.2.4) should be defined in a documented procedure. The management responsible for the area being audited should ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities should include the verification of the actions taken and the reporting of verification results (Article 8.5.2). Note For guidance, see ISO 10011-1, ISO 10011-2 and ISO 10011-3 standards. 8.2.3. Monitoring and measurement of processes The organization should apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods should demonstrate the ability of the process to achieve planned results. When planned results are not achieved, corrective actions should be taken, as appropriate, to ensure conformity of the product. The organization should commence the reaction plans including all types of retaining and 100% inspection of the products against unstable and inadequate characteristics. -21/23-
8.2.4. Monitoring and measurement of product The organization should monitor and measure the characteristics of the product to verify that product requirements have been met. This should be carried out at appropriate satges of the product realization process in accordance with the planned arrangements (Article 7.1). Evidence of conformity with the acceptance criteria should be maintained. Records should indicate the person(s) authorizing realse of product (Article 4.2.4). Product release and service delivery should not proceed until the planned arrangements (Article 7.1) have been satisfactorily completed, unless otherwise approved by a relavant authority and, where applicable, by the customer. 8.3. Control of nonconforming product The organization should ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product should be defined in a documented procedure. The organization should deal with nonconforming product by one or more of the following ways: a ) By taking action to eliminate the detected nonconformity; b ) By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c ) By taking action to preclude its original intended use or application. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, should be maintained (Article 4.2.4). When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization should take action appropriate to the effects, or potential effects, of the nonconformity. Note Any product that is unidentified or with unclear status will be considered as nonconforming product. When nonconforming product has been delivered, the customer should be promptly informed. The organization should seek and obtain a concession or a privilege by the customer when product or production processes are different than those approved. 8.4. Data Analyssis The organization should determine, collect and analyse appropriate dta to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This should include data generated as a result of monitoring and measurement and from other relevant sources. The analsis of data should provide information relating to the following; a ) Customer satisfaction (Article 8.2.1), b ) Conformity to product requirements (Article 7.2.1), c ) Characteristics and trends of processes and products including opportunities for preventive action, -22/23-
d ) Suppliers. 8.5. Improvement 8.5.1. Continual improvement The organization should continually improve the effectiveness of the quality mnagment system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews, and define a process related to this. 8.5.2. Corrective action The organization should take action to eliminate the cause od npnconformities in order to prevent recurrences. Corrective actions shall be appropriate to the effects of nonconformities encountered. A documented procedure should be established to the define the requirements for; a ) Reviewing nonconformities (including customer complaints), b ) Determining the the causes of nonconformities, c ) Evaluating the need for action to ensure that nonconformities do not recur, d ) Determining and implementing actions needed, e ) Records of the results of action taken (Article 4.2.4), f ) Reviewing corrective action taken. The organization should define a process aimed to problem resolution which will provide detection and elimination of the original causes of nonconformities. The effects of the corrective actions taken should be monitored and should be applied to similar peocesses and products. 8.5.3. Preventive actions The organization should determine action to eliminate the casuses of potential nonconformities in order to prevent their occurrence. Preventive actions should be appropriate to the effects of the potential problems. A documented procedure should be established to define requirements for; a ) Determining potential nonconformities and their causes, b ) Evaluating the need for action to prevent occurrences of nonconformities, c ) Determining and implementing action needed, d ) Records of results of action taken (Article 4.2.4), e ) Reviewing preventive action taken. -23/23-