Quality Management Systems and ISO 9001 Series - Coursework Example

ISO 9001 Section Quality Management Systems 1) Define four stages of quality management. Quality (ISO 9000:2005) refers to the degree to which a set of inherent characteristics fulfils requirements. The four stages of Quality Management (Dale et al 1994) are Inspection, Quality Control, Quality Assurance and Total Quality Management. Inspection includes all those activities such as acceptance, testing, verification etc. involved in ascertaining if the product meets the required specifications. Quality Control (Juran 1988) is the process of measurement of actual quality performance, comparison of the actual performance with the standards established and initiating necessary corrective action. Quality Assurance (Oakland 1995) is a planned and systematic approach to ensure the quality of the product through prevention of quality problems. Total Quality Management is an organisation wide philosophy aimed at identifying and achieving the needs and expectations of all the stakeholders, with an underlying principle of continual improvement. Quality Management System (BS EN ISO 9001:2008) is a complex web of the tangible and intangible assets of an organisation. An organisation is greatly influenced by its business environment (Kotler & Keller 2006) which is made up of the micro and macro environments. The micro environment is a set of factors which are unique to the individual organisation. It consists of the organisation’s internal values, super ordinate goals, employees, customers, distribution and other intermediaries and the public, at large. Macro environment factors are uncontrollable and affect all organisations, irrespective of nature, size and industry. The various elements such as the political, economic, socio-cultural, technological, demographic, international, physical etc. comprise this phenomenon. 1.2) List the reasons for implementing a Quality Management System (at least 5).  Quality Management Systems (QMS) has become a requisite in today’s hyper-competitive world. By means of a transparent and clear authority-responsibility hierarchy, the quality of leadership and management is improved resulting in a more effective organisation. This also lays the foundation for enhanced employee commitment and satisfaction and a sense of organisational ownership is fostered. There is a remarkable improvement in the quality of products which leads to greater customer satisfaction. All these benefits add up to a better corporate image with the stakeholders of the organisation such as shareholders, internal and external customers, distributors and supply chain intermediaries, government and society, at large. It is a source of sustainable competitive advantage. 1.3) What are the requirements for the successful implementation of a QMS within a company?  QMS to be successful must have the blessings of the top management. Quality is not a one shot activity and is resource driven. Strategic leadership, co-operation and involvement of all the employees, barring none, are the keys to effective implementation. Patience is a virtue and any undue haste or short cuts would prove detrimental to the QMS cause. Clear and elaborate documentation eases the entire quality effort. Regular monitoring and review paves the way for success of the QMS initiative. 1.4) Discuss organisational versus process approaches to the implementation of a QMS.  Two major approaches to implementation of QMS are the Organisational and the Process approaches. The organisational approach to QMS represents an organisation wide effort to produce and deliver quality products and services to its customers. All the four factors of production namely men, material, money and management contribute to the overall effort of achieving its goals and objectives. Based on the Agree-Say-Do-Improve (ISO 9001: 2008) cycle, it enables an organisation to obtain a clear perspective on what needs to be done and provides an understanding of the structure and requirements of the ISO standard. The first stage involves a clear understanding of what exactly needs to be done. This is then explicitly communicated to all the stakeholders so that effective implementation takes place. Continual efforts are undertaken to improve upon the processes laid down which translates to better quality and a sustainable competitive advantage (Porter1985). Though the benefits are limited, it provides for easy understanding. The process approach which entails identification, application and interplay of the various organisational processes is highly effective in terms of customer needs identification so that customer satisfaction can be achieved. The following visual highlights this approach. Value adding activities Information flow Source:BS EN ISO 9001:2008 By focusing on the customer requirements which make up the input base for the organisation, it ensures that customer, who is the major stakeholder in any business organisation, is given primary and due importance. All the efforts are then centered towards fulfilling these requirements so that a high level of satisfaction and customer retention is guaranteed. The continual improvement efforts lead to a greater value addition and a higher effectiveness of the overall operations. The information flow systems positively influences and enriches the communication and corporate culture within the organisation. The PDCA cycle (Deming 1950) can be gainfully employed to all the relevant processes. Source: www.iso.org A QMS based on ISO 9000 standards is certifiable, live and up to date. Continuous improvement and preventive action, the hallmarks of such a system, go a long way in achieving its desired short term and long term strategic plans. Section 2: ISO 9000 series 2.1) Provide a brief history of ISO 9001 and the changes it has experienced in terms  of content and requirements since the first version was published.  International Organisation for Standardization (ISO) founded in February 1947, is today the world’s largest organisation for standards development. Till date, it has published over 18,500 standards covering every nature of industry, from agriculture to engineering to information technology. In 1987, BS 5750 the British standard for manufacturing process was adopted by ISO as ISO 9000. Developed as a solution to quality problems in British high tech industries during World War II, this was considered a management standard which dwelt not on what but on how to manufacture a product. It also drew upon the US and Defence Standards. Emphasis was laid on conformance to procedures rather than management of the various processes. This 1987 version has been replaced by the 1994 and 2000 versions of ISO standards. The 1994 standard brought in the concept of quality assurance through preventive actions. The documentation requirements of these standards were so great that organisations were overwhelmed by procedural manuals and bureaucratic framework. ISO 9001: 2000, a combination of three standards 9001, 9002 and 9003, came to be known as ISO 9001. It heralded process management and integration of quality into the business system, as a whole. Customer focus and continual improvement requirements made for a more robust standard. The ISO 9001: 2008 standard was released in February 2008. 2.2) Discuss the general and Documentation requirements for a QMS as defined by ISO 9000:2008.  This standard explicitly lays down the general and documentation requirements in an organisation. It demands a quality management system based on continual improvement. The process-based approach envisions determination and sequence of the various processes. Management commitment and resource availability aims at achieving effective operation and control of the identified processes. Periodical monitoring and review of operations is called for with a bias towards preventive action and continual improvement. Outsourcing of products is subject to conformance to customer requirements and the overall responsibility of the organisation. Documentation requirements are elaborate and necessitate establishment of a Quality Policy, Objectives and the Quality manual. Each and every process must have a procedure document with relevant records supporting it. An elaborate system must be put in place for design, issue, amendment and re-issue of documents. All documents should be appropriately controlled and a clear responsibility-authority structure must be outlined. Proper identification and easy retrieval must be built into the system. 2.3) How should an organisation control non-conforming product? What procedure should be followed to eliminate causes of nonconformities (corrective actions)? A product which does not conform to the requirements, termed as a non-conforming product, must be clearly identified and corrected. The objective is to ensure that no unintended use or delivery takes place. Control measures include: Establishing a well documented procedure including causes, evaluation, corrective action and its effectiveness. A responsibility-authority structure. Necessary action to eliminate the non-conformity. Accept the non-conformity under concession, where appropriate. Corrective action, in case of detection after delivery/ use of the non-conforming product. Re-verification procedure. Maintenance of records on non-conforming products. A more pro-active approach would be to initiate preventive action to avoid and eliminate non-conformities. The first step is to determine potential non-conformities of products. Once this is done, the likely causes for these non-conformities and appropriate corrective actions, must be identified. Root cause analysis is an effective technique. It is a process of looking beyond the immediate reason and exploring deeper into the causes for the occurrence of non-conformance. The last stage represents the implementation of the actions necessary to prevent the cause of the identified problems. A good record maintenance will facilitate easy measurement and review of the effectiveness of the preventive action framework. Section 3 – ISO 9001:2008 series case study Scenario 1 One non-conformity exists in this scenario. The Manager indicated that the drawings/ sketches were prepared by the engineers. According to him, the engineers got the draughtsmen to prepare the specifications. The specifications were then checked by the engineers and approved by them by signing in the ‘Approved by’ box on the specification. Contrary to this, the Section Leader explained that the standards were listed by the engineers and then discussed with the draughtsmen. Specification BX12C4 carried the initials of the senior draughtsman under both the ‘Prepared by’ and ‘Approved by’ boxes. This means that approval of the specifications was done, in practice, by the draughtsmen and not by engineers, as explained by the Manager. The preparation and checking of the specifications can be done by either the engineers or the draughtsmen. However, the procedure must have been clearly laid down or the existing procedure must have been modified. This also demonstrates a lack of proper internal communication with regard to document/ record preparation and approval under Clause 5.5.3. There is also the issue of document retrieval time. Sections 4.2.3 (d) and 4.2.4 on document/ record control clearly specify that records must be retrievable. The Quality Manager indicating to the Team Leader that it will take some time for retrieval of the drawings and specifications is not acceptable. The typical time available for retrieval of documents, in audit settings, is a maximum of two minutes. Though the Team Leader suggested and walked into the relevant section to save time, the time lag requested by the Manager, is unacceptable. Concessions can be made in retrieval time, where essential and appropriate, but not for all documents/ records. Scenario 2 There is one non-conformity. Competency, Training and Awareness requirements find a mention against Clause 6.2.2. This establishes the need for assessment and identification of training needs and maintenance of appropriate records. The Manager had nominated himself as the department’s training instructor. This should have been ratified and documented. An undated entry was found in the training assessment log on the need for training of all draughtsmen on recent voltage safety guidelines in the industry. However, in the six years that Stackpole had worked, he had not been on any induction course/ training that was recorded. Also, the most recent entry in the Training Assessment logs was three years old. Hence, it is clear that no training is imparted to the employees. The Manager claims that he had advised the Training department. No follow-up or review was carried out subsequently. All this points to the fact that Training activity at Temple was not being carried out properly. Scenario 3 No non-conformity is present here. Scenario 4 One non-conformity exists in this situation. The responsibility and authority framework requirements find a mention in Clause 5.5.1. The Software Systems Manager indicated that no formal organisation charts existed and that it was not possible to keep the Quality Manual in the department up to date since the lines of responsibility and authority, varied from project to project. The project folder which the manager showed to the auditors contained a list of eighteen persons against the indication of only six to eight people in the Quality Manual. The difference was explained away as programmers and system designers being subcontracted and released at the end of the project. This line of argument is not tenable. A formal organisational chart must have been made available in the Software Office, outlining the lines of reporting and responsibilities, for all fulltime employees at Temple. In the case of subcontracted staff and others involved in specific projects, their lines of reporting should have been defined in the Project Quality Plans. Scenario 5 Two non-conformities exist. Amendments made by the Manager to the Product Inventory List were handwritten and not signed or dated. This is not at all acceptable. All amendments, major or minor, must be dated, signed and approved by the relevant authorities. Changes to product quality or specifications must have the acceptance of the customer. The more up to date printer with a larger paper carrier may not find customer acceptance, in some cases, in view of design and specifications constraints. The customer cannot be taken for granted, even in the context of better quality provision. In all cases, information must be passed on to the customer regarding the amendments and delivery of the product/ service, must be carried out only upon the customer’s acceptance, oral or written. Clauses 7.2.2 and 7.2.3 (b) deal with these customer related processes. Scenario 6 Two non-conformities exist under this section. First, the PQP did not contain the Lead Programmer duties. Therefore, the situation was that the Lead Programmer duties and responsibilities were not be found anywhere in the Software department – neither in the PQP nor in any departmental organisation chart. Second, there was no proper communication to the programmer on the amendments required by the customer against program UIP 013. All changes required by the customer must be first assessed by the Lead Programmer and necessary corrections made. A revised specification must be created with all the requisite changes. Mere hand written notes on the original specification are not acceptable. Also, the revised document must indicate clearly all the affected programs which need modifying, without the Programmer having to look out on her own. Clauses 5.5.1 and 7.3.7 respectively deal with the above issues. Scenario 7 There is no non-conformity. Scenario 8 There is a single non-conformity. The tool used was ‘SL YFILE’. However, ‘SL YFILE’ was not listed in the Engineering Standards Manual Section 300 manual which only contained the listing of ‘Cutecall’. Usage of alternative tools was permitted subject to appropriate checks prior to usage. Since no checks were carried out, usage of ‘SL YFILE’ in place of ‘Cutecall’ was not permissible. This activity finds a reference in Clause 7.5.1 (c) of the ISO standards. Scenario 9 Two non-conformities exist. In the case of subcontracting of products, purchased product inspection and systems integration procedures must be established and implemented. This is a mandate as per Clause 7.4.3. Two issues are involved here. One is the inspection activity and the second, integration and systems acceptance. The products were inspected by the Chief Engineer and test reports were available. However, the Manager was not aware of any procedural document on acceptance tests and inspection. There is no evidence of the existence of such a document. This is unacceptable. Also, there appears to be no procedure available for systems integration and acceptance. This is a serious issue and can have adverse effects on the quality of product realization and customer satisfaction. This is the second non-conformity. Scenario 10 Two non-conformities are to be found here. The University of Milan was appointed as a subcontracting agency without any proper assessment of their capability to deliver the product as per required specifications. Mere personal acquaintance of the Chief Engineer with the University Professor does not justify their appointment and capability. A detailed procedure is necessary and appropriate documentation prepared. This is the first non-conformity. The second non-conformity deals with not getting customer acceptance for subcontracting. Even if the customer had not insisted on this and had left it to the discretion of Temple, this must have been recorded, which is not the case. Clauses 7.4.1, 7.4.2 and 7.4.3 deal with purchased product requirements and control. References ISO Concept base, ISO 9000:2005, Available from https://cdb.iso.org/cdb/termentry!display.action?entry=550180&language=1 [20 May 2011] Dale, B G, Boaden, R J & Lascelles, D M, 1994, Levels of Total Quality Management Adoption’ Managing Quality, edited by Dale, B.G., New York, Prentice Hall Juran, J. M., and Gryna, F. M., (1988), ‘Juran’s Quality Control Handbook’, McGraw-Hill Book Company New York, NY Kotler P, Keller P L, 2006, Marketing Management, 12th edition, Prentice Hall. Oakland, J., (1995), ‘Total Quality Management’, 2edn. Oxford, Butterworth Heinemann Ltd Porter, ME 1985, Competitive Advantage: Creating and Sustaining Superior Performance, Available from www.quickmba.com/strategy/competitive-advantage/ [20 May 2011] Introduction and support package: Guidance on the concept and use of the process approach for management systems, Available from http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/quality_management/iso_9001_2008/concept_and_use_of_the_process_approach_for_management_systems.htm [20 May 2011] Quality Management Systems requirements, BSI Standards publication 2008, BS EN ISO 9001:2008, European Committee for Standardization, Brussels. Simulation and Quality Control ISO 9001:2008, Lecture Notes, Perea E, Available from pereae@hsbu.ac.uk [20 May 2011] Corrective and Preventive Action Management, Available from http://www.quality-assurance-solutions.com/corrective-and-preventive-action-management.html#ixzz1O59otYGS [21 May 2011] Read More