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5.1
Need for measurement
It is a known fact that unless we measure, we cannot improve. It is suggested to convert all subjective statements to objective statements by developing some means for measurement. In the quality management systems, measuring the results is given maximum importance. All objectives must be measurable. The standards also insist on continuous improvement at all places. Continuous improvement can be demonstrated only when we have objective evidences, and the means for measuring. The QMS implementation is not an exemption for this. We need to improve the effectivity of implementation of quality management systems on a continuous basis. Therefore, we need to learn the method of measuring the maturity of QMS implementation. ISO 9000 quality management systems have emerged out as one of the most popular quality management systems. The standards which were adopted from BS 5750 in 1987 underwent amendments in 1994 and 2000, and now again in 2008. Why these amendments? There is a mechanism for reviewing the suitability of the systems to the changing business environment. Similarly, it is essential to see the suitability of the systems adopted in a company to the changing requirements. Only adhering to basic requirements to get a certificate is not sufficient. By considering the advantages of getting consistency in the supplies and smooth working, the organizations who were familiar with BS 5750 / ISO 9000 started insisting their suppliers for getting accredited to ISO 9000. The government agencies also started insisting on ISO 9000 certificate from their suppliers before submitting tenders for various supplies of products and services. This insistence compelled number of organizations to align their activities inline with the requirements of QMS, and the number of companies with ISO 9001 certification is increasing alarmingly. People started using different means to (some how) get the certificate. As the numbers of certifying bodies are increased there is a competition between them. Their survival depends on the number of clients they have. Therefore, they are forced to grant more and more certificates. The certifying agencies started becoming lenient in giving certificates. In
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a number of cases, it is found that auditors are closing their eyes even when a major non-conformance is noticed. ISO 9001 guidelines give basic requirements for a good quality management system, which are practical and simple. In the initial stages, people were considering the certification of ISO 9000 as a great achievement, but now due to innumerable number of certificate holders, it is no more considered as an achievement. It has become the basic or fundamental requirement for any organization to survive. If one is not following a QMS, he is likely to collapse shortly. With over one million ISO 9000 certified companies world over, the significance of the certificate is getting lost. Almost everyone is ISO certified. The customers, who were recognising their suppliers because of their accreditation to QMS, are now in confusion. They are finding difficulty in identifying good suppliers those are matured in understanding the requirements, could proactively respond and have quality management systems implemented effectively company wide and following religiously. There is no method of assessing the effectiveness of implementation, although some companies have developed their own systems to measure their performance. There is a need for scientific/logical measurement of the maturity of implementation of quality management in an organization.
5.2
Measuring maturity by linking to the principles
The British Standard Institute (BSI) (17) has recently started benchmarking system in QMS. The companies are assessed considering the eight quality management principles adopted in ISO 9001:2000. For each principle five criteria are verified, and the companies are fitted in one of the five levels, viz No level, Bronze, Silver, Gold and Platinum. In BSI method, there are 5 × 8 = 40 questions, and each question has maximum of 50 marks. Total marks are 2000. The companies scoring 20% and below shall not get any rank. The Bronze status is given for companies getting 21–40% marks, Silver for 41–60% marks, Gold for 61–80% marks and Platinum for 81–100%. The members can have an access to find out the highest ranking in each category. BSI gives reports for each principle separately and also indicates threat, risk, business impact and area for improvement. Any company, whether ISO 9000 certified or not, can participate in this benchmarking assessment. Once a company is assessed and graded, a certificate is issued, which is valid for 2 years. There shall be one assessment every year. This certificate helps the companies in impressing their customers. The customers are likely to prefer the companies with platinum ranking compared to bronze or silver ranking, although they are ISO 9001 certified.
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5.3
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Measuring maturity by considering the clauses
Any one if wants to improve, should first know the level in which he is. It is true for the companies also. It might not be feasible for all to go for a benchmarking survey, as one need to wait for one year after getting assessment to understand the changes in status if any. Also the external auditors might not get complete exposure to the depth the systems have gone. As the purpose is to assess self and plan for improvement, we need to device a method, which is simple and can be handled by internal quality auditors. The assessment should be done after each internal quality audit so that the effects of efforts made can be understood. One needs to carefully understand the requirements of the quality management system and the extent to which it can be implemented. The various levels between a starting level company and the best company may be identified and marks may be allotted. By this it shall be possible to understand the level at which we are working and the area needed to be improved and track the performance of quality management systems in numerical terms. The internal auditors, who are matured enough and trained in assessment for maturity, can allot the marks independently followed by a consensus method. By this the company can assess the level of implementation of QMS and work out the plans to make it more effective. The guidelines are explained in section 5.4. The companies, who are still not matured enough to have self-assessment, can understand the expectations of a good QMS system by reading the guidelines for assessment. The concepts which have been given higher marks are the ones to be benchmarked. In the guidelines prepared, the maturity is assessed by 100 different angles, referred as elements of implementation of QMS. In each element, 5 possible levels are identified and marks are allotted for them. One need to verify in which level the company is there against each element of QMS. The maximum marks are 5 for each element and minimum is 1. Zero mark is not considered as we have taken a company for assessment which already has implemented QMS and is certified. A company can therefore have maximum of 500 marks and minimum of 100. If the company scores 100 marks, it is considered as base level or Level 1. Company scoring between 101 and 200 is Level 2, 201 and 300 is Level 3, 301 and 400 is Level 4 and 401 and 500 shall be Level 5. The chances of a company falling in Level 1 is very remote, as they cannot score just 1 in all the 100 elements, but could score more than 1 in number of elements. As the concepts in QMS change depending on the developments of new concepts, the guidelines prepared also will change. However, by the
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logics adopted here, we can measure the effectiveness of implementation of any quality management system.
5.4
Guidelines for assessing maturity in QMS implementation
The following are the general guidelines. They are developed considering the clauses of ISO 9001:2008. The auditee should give frank answers. There is nothing called as wrong. Frankness helps in understanding the level, and suitable action plan might be prepared to move further. As systems undergo changes, we can rework the guidance. Level and marks 1 2
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Description
1. Scope of application Covers production, maintenance and quality control sections. Covers production, purchases, production planning, quality control, research and development, maintenance and delivery operations. Covers production, purchases, production planning, quality control, research and development, marketing, maintenance and delivery operations. Covers production, purchases, production planning, quality control, research and development, designing, marketing, outhouse trading, maintenance and delivery operations. Covers all sections of the organization including accounts, finance and corporate functions. 2. Purpose of implementing QMS
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The customers are demanding. To get entry in export market, and also in some public bidding with out ISO certificate. Implementation of QMS improves the image of company and helps entering into new markets with ease. Implementing QMS gives confidence to customers that product and services shall meet their requirement. We can analyse self, identify the loop holes and work towards continual improvement. This can build confidence in our customers and we can have long-lasting relations. Apart from self-analysis and correcting the loops, we can identify potential problems and take suitable strategic decisions to prevent the problems.
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3. Awareness and use of quality policy 1
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Quality policy is released and displayed at prominent places. However, people working are not in a position to explain what it is. Quality policy is explained to all employees by conducting programme apart from display at prominent places. However, no evaluation is done to understand whether the people have understood it. Understanding of quality policy is verified during internal quality audits, and the people are able to recite the quality policy any time. However, they are unable to explain how it is connected to the day-to-day activities. People are clear about the linking of their activities to the quality policy and are able device procedures accordingly. All procedures are reviewed periodically and verified for its suitability to meet the changed quality policy considering the changing situation. The procedures are modified to work inline with the changed policy. 4. Deriving of quality policy
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Quality policy is decided by referring to a number of good companies, and the combination is made to get the best Policy. Quality policy was decided by the chairman after discussing with eminent consultants in QMS. Quality policy was decided based on the purpose of the company by the chairman. Quality Policy was decided basing on the purpose of the company by the chairman after a number of rounds with chief executive and the functional heads. Quality policy is reviewed periodically by the team consisting of chairman, chief executive and the functional heads considering the changing economic and social scenario. 5. Deployment of quality objectives
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Quality objective is defined for the company and displayed at prominent places. However, there is no clarity as to how the objectives were arrived. Departmental objectives and goals are prepared and displayed at prominent places in the work spot. However, there is no clarity as to how the departmental objectives are arrived.
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Integration of quality policy, company quality objectives and department objectives are made by involvement of top management and the functional heads. The procedures and action plans are prepared to achieve them and concerned officers are educated. The employees on work spot are clear about the departmental objectives and company objectives, but are not in a position to link their day-to-day works for achieving the objectives. Individuals are clear about their roles, responsibilities and goals, which are aligned with department objectives and goals, and in turn are aligned with company objectives and goals. People review the achievements periodically and modify the action plans wherever required. 6. Determination of quality objectives
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Quality objectives are specified considering the benchmark companies. The objectives are defined for the area where the company has strength, so that the auditors could be impressed. Objectives are determined by considering the quality policy requirements. Objectives are decided considering the requirements of the customers and the effectiveness of processes. Objectives are reviewed periodically to suit the changing requirements of the customers, the company and the society. 7. Preparation of quality manual
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Quality manual is prepared by referring the manual of a benchmarking company that has been certified long back. Quality manual is prepared referring to the clauses of quality management system, and care is taken to ensure that all clauses are addressed. Quality manual is prepared to guide the people to work as per the requirement of quality management system. Quality manual is prepared to explain how we are implementing the QMS at our company by taking the guidance of international standards. Special training classes are conducted for the staff to read and understand quality manual, and to link their procedures and other documents to the quality manual.
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8. Distribution of quality manual 1 2 3 4
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The quality manual is kept with management representative. It is issued to senior managers and a copy is kept in the library. The copies are given to each departmental head and the section head for reference. All employees are made aware of the quality manual and its use, and interested employees were given permission to read the manual and return to the head of the department. The HOD ensures that every one has read the manual and understood the contents and refers them regularly as a routine work. They either correct or advise the management if any deviations are observed in the system. 9. Process evolution
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Processes being followed in the company are listed down. Processes mandatory for the implementation of QMS are identified and listed. Processes required for achieving the company objectives while moving in the path defined by quality policy are identified. Processes required to enhance QMS to achieve continual improvements are identified. Processes required to achieve the results at par with benchmarks are identified and implemented. 10. Process implementation
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Processes required for the implementation of QMS are identified and listed. The sequence and interaction of the processes are identified and charts prepared. Control points and check points for each process are determined, and the users are educated to use them on regular basis. The processes are evaluated periodically to ensure their effectiveness, and modifications made to make it more effective. The users do the analysis of process performance and compare with the best achieved results. Root cause analysis is made for the deviations and actions taken to correct them. 11. Terms and definitions
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People are supposed to understand the terms used as they are working here from a long time.
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List of abbreviations used are given in the end of each document and the meaning is defined. The abbreviations used in different documents are listed and a chart is made giving the meaning. A separate document is prepared indicating all the technical terms and abbreviations used company wide and in the industry, and are defined. Periodic audits are done to ensure that the terms used give the same meaning as defined, and the users are repeatedly trained to use the words with same meaning all the time. 12. Work procedures documentation and control
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Mandatory procedures as per the guidelines for the implementation of QMS are documented and controlled. All the processes required for fulfilling the company objectives are identified and procedures documented. The procedures are controlled and referred in the quality manual. All the managers and staff are trained for using the documented procedures and its usage is ascertained by periodic audits. A separate committee of experts reviews the procedures for their suitability. The procedures are reviewed at a periodic interval by the concerned heads of the department and the senior staff to ensure their suitability considering the changing need. The trials are conducted with changed systems before deciding on the amendments. Employees are encouraged to read the procedures and give their feedback from time to time for the suitability and effective implementation. The procedures are amended as and when required. All employees refer the procedures on regular basis even for the routine works. 13. Procedure deployment
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The copies of the procedures are given to concerned heads of the department. The copies of the procedures are made available to all users by displaying them prominently at strategic points. The HOD conduct monthly meeting for the staff and ensure that everyone has read the procedure and understood. The internal quality auditors verify the understanding level of procedures by asking number of questions during audits.
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The head of the department conducts monthly review of the performance, and verifies the achievement of objectives against specified in the procedure. Corrective actions are taken for the deviation. 14. Review of procedures
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While writing a new procedure, or while amending a procedure, review is done by the management representative. While writing a new procedure, or while amending a procedure, review is done by the person preparing the procedure. Procedures are reviewed for suitability by the concerned HOD before approving. Procedures are reviewed at least once in 2 years by the HOD to ensure that they are suitable for working condition. Procedures are reviewed periodically to ensure them as the best possible for the activity in question. Amendments are made as and when better method is established or defined. 15. Work instructions
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The work instructions are written for important activities in production area. Work instructions are documented for all the activities done by workers, and displayed at prominent places. The work instructions are written in local language and the workers are encouraged to read them while working. Senior workers are involved in writing work instructions so as to ensure that all practical aspects are covered. Senior workers train the junior workers on a regular basis for the use of work instructions in their routine works and they contribute for amending the instructions when needed. 16. Organization structure
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The company has a documented organization structure giving broad outline of the authorities and responsibilities. The organization structure is defined up to shop floor supervisor level. Their authorities and responsibilities are documented. The staff is involved in preparing the organization structure as and when a change is made. The HOD specifies the authorities and responsibilities of each designation. The top management reviews periodically the changes taking
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place, and changes needed in the organization structure. They define the authorities and responsibilities of all key positions, and empower them to perform. The top management ensures that the organization structure defined is effective in achieving the company objectives, the communications are smooth and there is no confusion or friction at any place. People are suitably empowered so that there is no need for them to wait for instructions in routine matters. 17. Roles and responsibilities
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Roles and responsibilities of heads of the departments are documented in quality manual. Roles and responsibilities of all the staff are documented as separate job descriptions and controlled. Roles and responsibilities of all the designations in the company are established and documented and made known to all concerned. Roles and responsibilities are reviewed as and when there is a change in organization structure, and documented. All concerned are educated on the changes. Roles and responsibilities of all employees are reviewed periodically and aligned with the company and departmental objectives. People are completely aware of their roles and responsibilities in achieving the goals. 18. Document control
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The documents required as per the QMS requirements are identified, listed and controlled. All documents generated are identified with specific codes, listed in the master list and their distribution controlled. Document distribution is reviewed periodically by an expert committee and their distribution controlled. In addition to the in-house documents, the external documents are also listed and maintained at a centralized library for the benefit of users. All documents including those of external origin are reviewed periodically by users for their continued suitability, and revised suitably. 19. Document changes
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Documents prepared for the implementation of QMS are not
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changed unless there is a non-conformity identified by an auditor. Documents are verified before each audit and amendments are made as needed to avoid non-conformities during audit. Documents are reviewed periodically by an expert committee along with management representative and changes are made as required. Documents are reviewed periodically by internal auditors with in the sections and amendments are made as per the suitability. The management representative reviews the changes suggested by users in the documents, verify the alignment with the QMS requirements and releases the changed document. 20. Control of obsolete documents
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The management representative sends note to all users to return the old documents while issuing new documents. He keeps one set for his reference, and destroys others. The internal auditors verify the documents during the audits and raise nonconformity if obsolete documents are found. Such documents are removed and NC is closed. The team representatives periodically verify the documents they have and compare with the master list of documents with the management representative. All users have an access to the master list of documents with the amendment status, and are empowered to do self-auditing to identify redundant documents. The HOD verifies periodically the master list of documents and the documents he has. He ensures the return of old documents to management representative. 21. Record control
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Records as specified in QMS are identified, maintained in files or registers. All the files and registers maintained in the company are listed, coded and brought under control. All the records including those maintained in soft copies are listed and controlled. Records are scrutinized by the concerned HOD on periodic basis for its effective maintenance. All records are reviewed periodically and aligned with the changing needs and controlled.
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22. Maintenance of records 1
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All records are having title, starting date, responsibility, life and storage place mentioned on it as per the list of files and records. The records are kept in their identified places, and office boys are trained to maintain the records in their places. The record keeping place is clean and tidy. Periodically, the record maintenance is audited by internal quality auditors, and corrective actions are taken as per their findings. Each user ensures that the records used by him/her are kept back in the specified place after the work is completed. The HOD personally conducts a file recall exercise and ensures that all records are available as required. 23. Information availability
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The users are responsible for ensuring that they get the required information from the right source. The concerned HOD by his experience and knowledge identifies the key information requirement, and arranges for data collection and information generation on a regular basis. The information required for the effective implementation of QMS is identified by an expert committee, and programme is developed to collect those data and information on a regular basis. The users review periodically the effectiveness of the information available for the implementation and control of the required activities, and design means to acquire the data from the reliable sources. The HODs review the information availability for taking decisions and for carrying out the activities, and discuss with the concerned persons and make arrangements for their procurement. 24. Understanding customer requirements
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Whatever customer sends in writing is regarded as requirements. Customer is asked to send a sample and complete specifications to avoid confusions. Agent visits the customer and collects all information. Senior marketing personnel visit the customer and understand the requirements.
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Senior production personnel visit the customer along with marketing personnel and understand the customer needs by discussing with the actual users. 25. Communicating the customer requirements
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Marketing sends the customer needs to PPC and production managers. Marketing persons discuss with production, PPC and quality heads regarding the orders booked and enquiries received. Marketing persons discuss with all HODs regarding the market trends, feedbacks, requirements and specific customer requirements in a meeting. Customers are invited to the company to discuss with the concerned production, quality, PPC, maintenance and sourcing personnel regarding the specific requirements of customers. Production, quality and maintenance personnel are sent to customer’s place to discuss with the actual users to understand their specific requirements. 26. Communicating customer concerns
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All market complaints are recorded and discussed in the management review meeting. All market complaints received are displayed prominently in the work area so that concerned persons can take suitable remedial actions. Marketing person visits the customer and brings the feedback and complaint samples and discusses with concerned production and quality personnel. Senior managers visit the customer’s place to understand the concerns, and explain the same in an open house to all the staff. Production and quality executives visit the customer place, study the working, discuss the concerns with the actual users, and explain the same to the people involved in manufacturing and quality control. 27. Communicating legal and regulatory requirements
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The circulars relating to legal and regulatory requirements are kept in a file at the library, and HODs has an access to them. The CEO conducts a meeting of all HODs and explains the legal and regulatory requirements. HRD collects the latest
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gazette notices and sends circular to concerned officers as and when required. The persons responsible for monitoring the compliance to legal and regulatory requirements are given periodic refresher training, and sent to seminars and conferences as needed. Periodical audits are conducted by internal auditors for compliance to legal and regulatory requirements, and corrective actions are taken. The procedures, work instructions, job descriptions etc., are reviewed periodically to ensure their alignment with legal and regulatory requirements. The quality auditors verify the compliance, and the HODs take action. 28. Verification of compliance to legal and regulatory requirement
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The government authorities verify the compliance by their surprise rounds. If any deviation is found, suitable action is taken. The buyer nominated auditors verifies the compliance during audits. The HRD officers are responsible for adhering to compliance, and hence they verify adherence on a regular basis. A special committee headed by HRD verifies the adherence to legal and regulatory requirements. The CEO takes personal interest in ensuring that the legal and regulatory requirements are met, and nominates internal auditors to audit the systems on a regular basis. 29. Compliance to safety requirements
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A separate safety officer is appointed to take care of all safety requirements. Safety audit is conducted once in every 3 months and deviations found are reported to management. A safety committee is formulated, which meet every month and discuss on the requirements, and give report to management. The safety officer along with the maintenance in charge takes rounds especially for safety and ensures the compliance. The users are educated on safety requirements, and they check the safety gadgets before starting the work, and the shop floor supervisor monitors the activities.
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30. Management representative 1 2
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A fresh, highly qualified person is recruited specially for implementing QMS as a management representative. A young officer from quality control section is freed from all responsibilities and made independent to work as management representative. The head of the quality control section is given the responsibility of management representative. A senior manager is relieved from his regular responsibilities and made management representative, and is assisted by a trained internal auditor in documentation works. A senior manager has taken the additional responsibility of becoming management representative, who is a certified lead auditor and has undergone training in management representative skills. 31. Management representative reports to
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Quality control in-charge Head of production operations Factory manager / Head of HRD General manager / Unit head CEO / MD of the company 32. Management review is conducted by
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Quality control in-charge Head of production operations Management representative General manager / Unit head CEO / MD of the company 33. Consistency of management review
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Conducted Conducted Conducted Conducted Conducted
when the CEO and HODs are free. before external audits. before the next internal audit. with in one month from the scheduled date. periodically on the specified date and time.
34. Records of management review 1
The management representative maintains the record.
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Management representative prepares the minutes and sends hard copies to the members who attended the meeting. Minutes are sent to all the HODs irrespective of their attending the meeting. The minutes of meeting are sent by e-mail to all, and the users keep the record at their place for reference and taking actions. The internal quality auditors verify the records for the actions taken on the decisions made at management review. 35. Points discussed in management review
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The non-conformities rose in the audits and whether they are closed. The performance against the targets fixed for production, quality, cost and the non-conformities. The corrective actions taken for the non-conformities and market complaints, along with the performance review. The performance, resource utilization, the cost cutting, future plans, non-conformities and market feedback. The performance, proactive preventive actions, customer feedback, future plans, resource utilization, recommendations for improvements and changes that could affect QMS implementation. 36. Members attending management review
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The internal auditors and the auditee who faced the audits All staff members One representative from each department The heads of the departments or their next person in hierarchy All HODs and senior executives 37. Minimum competency fixed
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People best suitable for the job are selected from the available candidates. No minimum criteria are fixed. Minimum competency is documented for all posts by actually referring to the competency the people have. The minimum competency is fixed in consultation with a qualified HR consultant. Jobs of similar nature are identified and grouped. The company requirement is judged by a team of experts along with an expert in HRD.
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Each element of the job needed to be performed is analysed and the competency required is identified. The highest level got is decided as minimum requirement. 38. Competency evaluation
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Competency is checked while recruiting, and promotions are given as per seniority. Efficiency and performance levels are judged by the concerned heads of the department. Records are maintained of individuals for their efficiency and quality and the one with higher productivity and quality is considered as competent. Periodic assessments are made for performance, behaviour, attendance and records are maintained, which is used for evaluating the competency. Periodically, the employees are interviewed and enquired about the additional skill or competency acquired by them. They are encouraged to participate in trial order production or take extra assignments. Performance is measured by experts. 39. Training need identification
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Good performers are encouraged to attend trainings conducted by eminents. About 4 to 6 people are sent for training in a year. We ensure that everyone undergoes training. Hence, people are sent on rotation to seminars and conferences. The HOD identifies the training needs at the time of annual appraisal. He recommends the trainings from the selected subjects given by the HRD. The performance of individuals is tracked, and the low performers are sent for training to training department. The competency requirements for the jobs to be done and the changes likely to take place are considered, and the competency of the persons likely to do those are analysed. The training is provided in case a gap is found. 40. Maintaining the record of competency
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The HRD maintains personal files of all employees with details of their qualification and experience which was collected during recruitment. Training manager maintains the records of persons attending
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different training programme. HOD can get the data as to who all have completed the training. Training manager maintains the person wise record of trainings attended in our company. The industrial engineer maintains the records of skill and speed. The industrial engineering department maintains the records of skill and speed of each operator. The training department maintains the person wise records of training attended. The medical officer maintains the record of physical fitness. The HOD maintains the records of people working under him with the details of trainings undergone, not only in this company but also prior to joining this company, the types of works done, the responsibilities shouldered along with the present physical condition. 41. Training evaluation
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Immediately after a training programme, a feedback form is given to all participants and their opinions taken. Members participating in training are encouraged to make a presentation to colleagues and explain what they learnt. Feedback is taken from the HOD regarding the performance of the candidate after 3 months of the training. The performance of individuals are tracked for quality, productivity, discipline, safety precautions etc., depending on the programme undergone and analysed for trends. The extent to which the departmental objectives were met as a result of trainings given are analysed, which not only evaluates the participants for their learning, but also the competency of the HOD in identifying the training needs and utilising the trained persons effectively. 42. Infrastructure decided by
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Project engineer or an expert consultant Heads of the department General manager discusses with CEO Board of Directors and MD Users discuss their requirements with CEO and give justification that the infrastructure is for improving customer satisfaction, achieving the company goals and for meeting legal and regulatory requirements.
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43. Physical work environment 1 2 3 4 5
Minimum requirements given as per Act. We are better than the neighbouring company. We have provided better than the best benchmark. Work environment provided considering the suggestions given by employees. Studies are conducted as to which level of light, noise, dust level, passage etc., give the best results considering the quality and productivity. 44. Human related work environment
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We honour the agreements made. We give incentives to the best performers. We sit and negotiate before taking any decision. We take suggestions from employees and act in time to solve their grievance. Transparency is there in all the activities and decisions relating to Human relations. 45. Quality objectives of the product
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We go by our standard specifications. We honour the specifications agreed with in the limits of legal requirements. We study our competitor’s quality and try to give slightly better than that, but with in the legal limits. We analyse the market feedback and complaints and arrive at unspecified needs of the customer. We understand the real requirements and concerns by personally discussing with the customers. 46. Quality planning
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The shift supervisors plan the activity for their shift considering the production completed and to be completed. Production plans for next day is written on a white board, so that the activities can be done smoothly. Weekly planner board with the details of machines to be used, the critical points to be observed is displayed prominently. Monthly operation plans are maintained with the HOD. Order-wise plans are made and the shop-floor operators are made clear about the production plan by their superiors so that
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they can keep all the required materials ready to achieve maximum production. Market complaints and feedback received for a similar product and from the same customer are displayed on the machines to facilitate inspection and testing by quality control personnel and the machine operators. 47. Contract review
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The orders booked and are served on first-come first-served basis. Marketing personal refers the monthly plan and target proposed by PPC, and books order accordingly. PPC indicates the orders blocked and capacity available on daily basis to the marketing personnel, who in turn books the order. Detailed review is done by production, quality, maintenance and planning personnel of the proposal given by marketing. The limitations if any in providing quality of products and services are discussed with customer representative, and consensus is made if they can have an in-between solution when we do not have confidence. 48. Complaint handling
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Customer contact person is responsible for convincing the customer. The complaints are received at marketing. The marketing chief and the manufacturing chief shall study together and make a reply to customer. Customer complaint is recorded, and sent for analysis to laboratory. After getting the reply, the customer is suitably informed by marketing. Customer’s complaint is acknowledged and a senior person from marketing visits the customer to assess the losses. If needed, a technical person from factory shall visit to suggest the actions to be taken at customer’s end to overcome the problem. Customer is provided with an alternate supply to prevent production loss while the complaint is being analysed. The customer is apprised of the situation, and the help offered to consume the materials in stock made for them. 49. Design inputs considered
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Functional and performance requirements of the products and applicable statutory and regulatory requirements. Details of previous similar product development and the problems faced during the development of previous sample. Apart from the product requirements, the present process capability, human capability, availability of raw materials, etc. Apart from the product requirement and company capabilities, the critical concerns of the customer, the seasonal effects on quantity and quality. 50. Design output
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Blue print and standard operating procedures developed. Apart from blue print and SOP the raw material requirement, availability, cost etc., are worked out. Product characters are described for its safe use in the blue print and SOP. Estimation of wastes, seconds and reworks are made along with the blue print, SOP, production parameters and specification. Problems likely to be faced while manufacturing, the skill level of workmen required, the modifications to be done on the machines, etc., are provided along with SOP, blue print and other details. 51. Design review
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The design head knows the problems and shall specify if there is any thing likely to affect. The design head discusses with the design team members and quality control team. The design team discuss with production team for the likely problems. A team consisting of members from design, quality and production work together to identify the likely problems. A team consisting of members from design, manufacturing, quality, maintenance, purchase study the design in detail and identify the likely problems. 52. Design verification
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Verification is done by the designer himself. The design head verifies the designs made by all subordinates. The design is verified by quality control personnel.
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Design is verified by senior production personnel. Design is verified in a team meeting, consisting members from production, design, quality, maintenance and purchase. 53. Design validation
1 2 3 4 5
Design validation is done by the design team. Validation is done by quality control team. Validation is done jointly by quality and production team. Validation is done by market team. Validation is done by the customer. 54. Control of design and development changes
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Final parameters of the approved samples are entered in a register, and the samples are kept in cup board. Records with the parameters of the product, process and raw materials are maintained along with a sample for all the successful designs, after getting approval from marketing/ quality head. Records with all the parameters of the product, process, raw materials etc., are maintained along with a sample for all the successful designs, after getting approval from customer. While records are maintained for all the trails conducted along with the samples, the approved samples and their records are maintained in a separate file. All trials are coded, and the parameters used are documented. The reason for not approving the sample is discussed and documented. A cause and effect analysis is made for the approved samples and the rejected samples. 55. Vendor selection
1 2 3 4 5
Vendors are selected by closed tender system, and lowest price bidder gets the order. Vendors are selected after verifying the samples, and negotiating the price. Vendors are selected by referring to other companies who are buying materials from them. Vendors are selected after getting their profile and getting approval from the CEO. Vendors are selected after visiting the actual manufacturing area and assessing their quality and performance level, capacity,
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logistic problems, technical capability for giving after sales service. 56. Vendor evaluation 1 2 3
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5
We purchase from the lowest bidder. Vendors are evaluated for quality along with price on yearly basis. Vendor evaluation is done for major suppliers on the basis of quality and price on yearly basis. Vendors are updated by a separate letter. Vendors are evaluated on the basis of quality, price, delivery and service on yearly basis. Vendors are updated by a separate letter. Vendors are evaluated on the basis of quality, price, deliver, after sales service, with different weightage depending on the product on a quarterly basis. Vendors are updated on-line and invited to discuss their problems and plans. 57. Vendor development
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Purchasing shall be done from standard vendors and original manufacturers. Chance shall be given to new vendors to develop by giving free trial orders. Our technical team shall explain the critical requirements, and the suppliers are encouraged to see our machines and type of working so that they can decide on developing. Our technical team shall be involved in the designing, developing and validation of products at suppliers end before bulk supply. Our technical and commercial teams keep regular vigil on the happenings and provide necessary assistance where the supplier finds it difficult to manage. 58. Purchasing information
1 2
3
Purchase order consists of product name, purchase conditions, transport requirements, quantity and value. Apart from the product name, the catalogue number, the standard reference (for e.g., ISI Number) is given in purchase order. Apart from the normal purchase order details, the criteria for
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approval of the product and the procedure reference of testing are incorporated. Purchase orders are verified for adequacy by an expert team before the orders are sent to suppliers. Samples are provided where ever it is required. Supplier is invited for discussions to understand the critical requirements of the product and also to collect dimensions and other details in case required to avoid duplication or rejection. 59. Verification of purchased product
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5
Stores verify the quantity and issue the materials to users. Users verify the quality and approve the products received. Only approved product shall be issued. The representative of supplier is invited while inspecting critical materials. The quality checkers visit the supplier place and check the materials ready for despatch to ensure that they meet our requirement. The quality checkers visit the supplier place and check the critical components being used for the product being manufactured for us. 60. Validation of processes
1 2 3 4 5
Special processes are not identified. Special processes are identified and the work procedures are documented. Procedure for establishing process parameters is established. Periodic validation is done for the process parameter fixed to ensure its continued suitability. The workers are retrained whenever there is a change in process parameter and audited periodically to ensure adherence to the systems. 61. Identification and traceability
1 2 3
All materials in process are identified by their physical appearance. Materials in process and material in stock are identified by suitable colour coding / bar-coding systems. The codes used for identification and traceability are displayed prominently in the production area.
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A record is maintained of the identifications used on different days for the products being manufactured. Employees are repeatedly educated on the colour codes being used, and periodically audited to ensure that every one is following the same coding system. 62. Customer property
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Customer supplied materials are used along with other materials. At the end of the production, account is given considering the materials supplied back to customer. Account is maintained at stores for the customer supplied products, entries are made while issuing it to production and information is sent to customer regarding rejections. Senior managers are nominated for different customers to follow up with the materials being supplied by customer for incorporation in the product. Quality issues or any discrepancy in quantity are handled by that nominated manager. Periodic audits are done by the nominated manager for the materials in stock, the wastes generated and materials consumed. Periodic reconciliation is made and submitted to customer. Nominated managers keep in touch with customer on day to day basis and update them on quality and productivity aspects, and take instructions for correcting the situation in case of problem. 63. Preservation of product
1 2 3 4 5
Final product is packed as required by customer by taking all care, and are preserved in a dry and clean area. Apart from the final product, the raw materials are ensured of proper packing and kept in clean warehouses to avoid losses. The in-process materials are kept in suitable containers to prevent them from getting damaged due to handling. Suitable material handling equipments are used to ensure no damage due to handling. Materials in stock are periodically checked for their continued acceptability. 64. Control of monitoring and measuring devices
1 2
A list of all monitoring and measuring equipments is made. Master samples of each equipment or device is identified and got calibrated by an authorised laboratory.
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Calibration is done for all monitoring and measuring devices. Operators are trained for handling the monitoring and measuring devices. Periodically, the equipments are validated by conducting round tests apart from the calibration. The deviations if found are analysed statistically. Periodic checks are done for the validity of calibration and the accuracy of results. 65. Decision of out sourcing
1 2 3 4 5
Out sourcing is done to reduce the cost of manufacturing. Out sourcing is done not only to reduce costs but also to avoid labour problems. Out sourcing is done as we are not capable of meeting the despatch schedules. Out sourcing is done from a good party when we are not getting quality. Out sourcing is done for the process which we do not have. 66. Control of out-sourced goods
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5
Payment shall be made only for good quality materials supplied in time. Out sourcing contractor is educated on our requirements by the sourcing manager. Our quality control person visits the out sourcing unit regularly and inspects the materials before packing. The staff and other employees of the out sourcing unit are educated on the quality requirements, and trained on job by experts at our cost to produce required quality. The internal quality auditors audit the out sourcing units also on a regular basis to ensure compliance to the system requirements. 67. Measurement of customer satisfaction
1 2 3
Reputed consultants are appointed for conducting customer satisfaction survey. The customer satisfaction is measured by the number of complaints received and the orders booked. Customer satisfaction is measured by continuity of a customer for a long time with repeated orders.
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5
121
Customer satisfaction is measured by discussing with the customer regarding the critical concerns and our ability to meet his requirement in a scale of 1 to 5. The customer’s customers are contacted with the knowledge of our customers to find out the performance of our products at the customer’s end. 68. Customer satisfaction assessment
1 2 3 4 5
The customer is assumed as satisfied when we do not get any complaint. Customer is assumed as satisfied when he is coming back with repeated orders. Customer is assumed as satisfied when he comes and discusses the performance and gives suggestions for improvement. Customer is assumed to be satisfied when he increases our share in his purchases. Periodic reviews are made to validate the customer satisfaction data by linking it to company performance. New devices are developed to get fairly reliable information for taking action in time. 69. Internal quality audits – schedule
1 2 3 4 5
Audits are not done as per plan and in some cases audits are not done. Audits are not done as per plan in 50% of the cases and are replanned where it is not done. Audits are not done as per plan in some area, where as 75% area, it is as per plan. Audits are not done as per plan on the same day but at different timing. All audits are done as per plan. 70. IQA – Quality of audit
1
2
The audit reports are written but auditors have not written date, time, etc. at number of places. The auditee has signed and accepted the non-conformity, but has not written the root cause, the proposed date of taking action. The clause numbers are not correct. The clause numbers written by auditor are not correct and no one has taken objection for that. The auditee has written the
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Effective implementation of quality management systems
proposed date of action, but has not identified the root cause. The clause number is correct, but the non-conformity is in a suggestion mode or dictation mode. The root cause analysis is not made by the auditee. The MR has written the root cause. The root cause analysis is made by the auditee for all the nonconformities and actions taken. Trend analysis is made for identifying the repeated type of nonconformities and taking preventive actions. The MR is tracking the progress. 71. IQA – Closing of the NC
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4 5
Number of NC is not closed and kept pending for months. They are closed after the follow up of MR just before the external audits. Non-conformities are closed but later than the committed date. The MR follows up on weekly basis for closing the NCs. Non-conformities are closed on the committed day in majority of the cases, where as in few cases it was late. The auditee takes initiative. Majority non-conformities are closed before the committed date. Average days for closing NC is monitored and trends are drawn which show a continuous improvement. 72. IQA – Auditor competency
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Quality control checkers are taken as quality auditors as they have experience of auditing on a regular basis. Smart intelligent officers from different sections are taken and given the responsibility of auditing. Auditors are selected from all sections, with an aptitude for learning and are smart in identifying the deviations. They were trained internally by a consultant as auditor. Auditors are sent for training by a competent authority, which train and conduct a test and give certificate to those who have completed successfully. Auditors are trained under eminent lead auditors, and refresher trainings are given to improve their auditing skills. 73. IQA – Auditor punctuality
1
A number of auditors have not reported for the audit and MR could not make any alternative arrangement.
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123
Some of the auditors could not attend in time, but have informed the MR in advance. No alternative arrangement is made. Auditors are conducting the audits on specified date or on mutually agreed date in consultation with the management representative. Some reports are delayed. Analysis of auditor’s punctuality shows a positive trend and continuous improvement. Some audit reports are submitted late. All auditors are attending the audit as per schedule, and submitting the report in time. 74. IQA – Auditee response
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3 4 5
Auditee is afraid of the audits and wishes to avoid. Some of the HODs have not faced the internal audits. Some of the auditee team members are confident of facing an audit, and are covering other colleagues. The HOD always presents such persons to face the audit. All members are ready to face an audit, but prefer not to get audited. All members are willing to get audited and invite the auditor to conduct audit in his/her area. Members are disappointed if the auditor does not visit their area. 75. IQA – Auditor–Auditee interaction
1 2 3 4 5
Auditee simply accepts the report given by the auditor. Auditee seeks the help of management representative for understanding the comments made by auditor. Auditee demands clarification where the wordings are not clear. Refuses to accept a non-conformity if clarity is not there. Auditee accepts the non conformities willingly and works to close at the earliest. Auditee closes the NC at the earliest and goes to auditor to close the NC. 76. Top management commitment in audits
1 2 3
Heads of the department are not following for getting their area audited. Heads of the department are not getting their area audited, but are directing the auditors towards subordinates. Head of the department sits for audit for some time, and then
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goes out because of emergency works/meeting/follow up for production. Head of the department attends the audit fully, but leaves the responsibility of closing the NC on the subordinates. Head of the department takes active part in audits and follows up with his subordinates and gets the non-conformities attended at the earliest. 77. Measurement of processes
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5
Processes are assessed on a subjective basis, as no measurables are identified. Majority of the processes have measurable parameters. All processes have measurable parameters that can be controlled and used as a tool to measure. Critical processes are periodically reviewed by top management for performance, where as others are left to supervisors and shop floor workers. Critical processes are reviewed by top management on a regular basis, and the HODs review all the processes in their work area on a periodic basis. 78. Monitoring of process
1 2 3 4
5
Processes are set as per the suggested parameters before the start of the works. Quality control investigators study the process efficiency and give their report to the management. Control points identified for the process are monitored by shop floor supervisors and reported to HOD on daily basis. The HOD is reviewing the monitoring activities at random along with the supervisors and ensures the compliance and performance. The system of process monitoring is reviewed periodically by the top management for its effectiveness. 79. In-process product inspection
1 2 3
Concerned departmental head sends samples to laboratory and get the quality tested before starting any new lot. Laboratory assistant collects samples as per the sampling plan given to him, and get the materials tested in lab. The shift supervisors test themselves some of the lots in addition
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5
125
to laboratory testing in case of critical quality requirements. The operators ensure the quality by checking the materials produced with reference to a standard material at the start of each day/shift. The operators ensure the quality by checking the materials produced with reference to a standard material at regular intervals. 80. Final product inspection
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5
SQC inspectors draw the samples from packed materials at random and check for the conformance. SQC inspectors draw samples ready for packing and check for the parameters and then allow the packing to be done. SQC inspectors draw samples from ready stock as well as from warehouses and check for their conformance. SQC draws sample on daily basis before packing and test them. The results are compiled for the lot, and the variations with in lot are studied before despatching. Apart for checking the materials before packing, after packing before despatch, SQC draws samples from the passed lots and preserve at the laboratory, and check them for change in properties after lapse of certain months and season. 81. Acceptance criteria
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The specifications and tolerance developed by statistical approach by our R&D shall be the base. Any material out of tolerance shall be rejected. The specifications and tolerance given by the customer shall be the base. If any material is found out of tolerance shall be rejected. Basing on the customer specifications control charts are developed and run theory is applied for accepting and correcting the product. A process capability index of 1.33 is targeted (3ó level). Control limits are made stringent to accept only if the process capability is 1.7 and above with the specifications and tolerance given by the customer as the base. Control limits are set to accept materials if the process capability index is around 2 with the specifications and tolerance given by the customer as the base (6ó level).
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82. Identification of non-conforming product 1 2 3
4
5
The packers identify the non-conforming products and remove them before packing. Non-conforming products are identified by specially trained QC checkers on line apart from the final inspection by packers. Apart from the QC checker, whenever the HOD and general manager come on round, they identify some non-conforming products and remove them. Supervisor checks the quality of material in process and in stock and removes the non-conforming material. This is in addition to checking by QC and the final packers. The operators ensure the quality by carefully observing the materials produced and identifying the non-conforming products on-line, in addition to inspection by QC, supervisors and the packers. 83. Segregation of non-conforming products
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3
4
5
Rejected materials are kept at a specified place as decided by the supervisor and the details are written in log book. Rejected materials are tagged with Red tag and kept at the place decided by the supervisor, and the details are written in log book. Specific bins are identified and earmarked for keeping the rejected material. The supervisor enters the details in the log book. Specific bins are identified and earmarked for keeping the rejected material. The supervisor ensures that all rejected materials are kept in that bin, and entered in the log book. Non-conforming materials are put a tag or given a different colour code and kept at the bin reserved for rejected materials. A separate register is maintained for tracking the generation and use of rejected material. 84. Authority to dispose non-conforming products
1 2 3
Worker on the spot is empowered to take a decision for scrapping or using the nonconforming materials. The supervisor on floor is authorised to decide on spot the disposing of the nonconforming material. The chief of production operation is authorised to decide on the mode of disposal of rejected goods including its reuse as per the situation.
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127
The chief of quality shall discuss with the chief of production, and jointly decide the disposal action. The chief of marketing, chief of production and chief of quality jointly take a decision for the disposal of non-conforming materials. 85. Recording of non-conformities and actions
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3
4
5
The supervisor daily enters the quantity of wastes produced in the log book. The supervisor daily enters the quantity of wastes produced and the wastes reused, the rejections made and sent as saleable wastes in the log book. The supervisor records the reason-wise non-conformities found and the quantity rejected and reused/altered in log book, which is reviewed by the HOD on daily basis. A separate register is maintained for tracking the generation and use of rejected material. The supervisor ensures the entry of required information reason-wise. The physical verification of non-conforming materials in stock is made once in month to reconcile the data entered in the register. 86. Verification after correction
1 2 3 4 5
The one who is correcting is responsible for ensuring the quality, and delivers to packing. The packing in-charge gets the verification done of the repaired/ corrected items. A separate quality control team verifies the corrections made and approves the corrected material. Verification after correction is done by the same person who had rejected it. Verification after correction is done by a team consisting of quality control and marketing personal along with the person who had rejected it earlier. 87. Analysis of data
1 2
The concerned supervisor or in-charge analyses the data on dayto-day basis to ensure it as correct, and takes decision accordingly. The HOD analyses the data submitted to him for its correctness and takes actions for the deviations.
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The HOD gets the trend charts prepared of the data and analyses on a monthly basis. The cause-wise trends are prepared and analysis is made on monthly basis, season wise, product wise and submitted to top management. The trends of improvement or deterioration are compared with similar industry, and also with the best in the class. The reasons for deviations are identified. 88. Measuring the objectives
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5
The company objectives are the targets to be achieved on a long-term ideal situation and cannot be measured. Measurable for each objective is identified, and the unit of measure is defined. The extent to which the objectives are achieved are verified on an annual basis while preparing for surveillance audits. The measurable are identified for each of the key result area identified for the objectives, and performance is measured and reviewed on a monthly basis. The measurable identified are reviewed on a yearly basis to find their suitability to represent the achievement of the objective in a true sense. 89. Continual improvement
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5
Areas where improvements are seen are highlighted on monthly basis to encourage others to improve. Targets are revised considering the performance of previous month on a practical approach. Targets are given in selected area, and teams are formed to achieve it. The results are monitored and presented in management review. Key result areas are identified for meeting the company objectives and targets are fixed for them. Action plans are made to achieve them. Targets are stretched where the results are achieved to move towards the benchmarks or to remain as benchmarks. 90. QMS effectiveness
1
The quality policy and objectives are known to senior officials. The procedures are written as per mandatory requirements. Quality manual is written.
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3
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129
Procedures and instructions are written for all activities. Processes are audited as per schedule. Records are maintained as per the requirement The policy, objectives, procedures, organization structure are reviewed periodically and communicated to all. The people are adequately trained to perform their jobs. All the processes are realigned considering the market needs, the resources are provided to achieve the results, and process is corrected when deviations are found. Proactive actions are taken to prevent deviations in the process performance and in delivering the goods and services. Continual improvement is achieved in customer satisfaction, company performance, and in the employee morale. 91. Corrective action
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4
5
Reply made in time for the complaint and non-conformities received. Complaints and non-conformities are discussed with senior members and suitable reply is drafted in a convincing way. The persons responsible for the non-conformity are apprised of the situation and the corrective actions to be taken are decided depending on the situation. Analysis of the complaint and non-conformity are done by a team of experts and the root cause is found. Actions are taken to correct the root cause. People working are involved in analyzing the problem, and identifying the root cause. The corrective actions are jointly arrived at by considering the pros and cons. Actions are taken and the procedures are modified to ensure that the problem does not repeat. 92. Preventive action
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3
The Board of Directors by taking views of eminent consultants works out the strategy to face the potential problems. The CEO discusses the potential problems with the HODs in a meeting during his visit to the company. Serious issues are discussed by taking the union into confidence. The HR, purchase and marketing personnel, who have daily contacts with outside world, collect information through various sources regarding the changes that are taking place and advise the management regarding the potential problem.
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All employees are encouraged to identify potential problems according to their level of thinking and submit to the HRD. These are reviewed by a committee where preventive actions are proposed for the potential problem. The person identifying a potential problem is encouraged by making him a committee member for identifying a suitable preventive action and for training the fellow employees in preventing the problem. The top management gives full support to prevent that problem. 93. Involvement of top management
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5
Preparation of quality policy and objectives. Involved in defining of organization structure, authorities and responsibilities, and preparing the quality manual. Involved in the regular internal audits, reviews of all activities and training programme. Actively involved in getting the nonconformities closed in time of all sections, physically verifying the resource utilization and company wide implementation of QMS. Reviewing periodically the effectiveness of implementation of QMS and providing necessary guidance and resources for making it effective company wide. 94. Employee well-being
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Minimum wages are assured for employees as per the statutory requirements. Workers are paid bonus, gratuity, provident fund, ESI facilities etc., as per the regulations. Workers are encouraged to do overtime so that they can earn something extra. Salary advances are given for festivals. Employees are allowed to accumulate their leaves and encash when needed. Incentives are given based on regularity in attendance and achievement of production. Workers intending to study are encouraged by adjusting their shifts and providing leaves for examinations. Scholarships are paid to meritorious children of employees in tenth standard. Soft loans are given to needy employees considering their performance. Employee’s children are given preference for jobs. Interactions are made with families of employees to understand their needs, and help rendered where ever practical.
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95. Employee satisfaction measurement 1 2 3 4
5
Employee satisfaction is measured by conducting survey from external agencies. Employee satisfaction is measured by the absence of strikes Employee satisfaction is measured by the reduction in absenteeism, employee turn over. Employee satisfaction is measured by improved performance per employee, i.e. production along with quality at lower expenses. Employee satisfaction is assessed by close interaction with employees and understanding their views and problems. 96. Strategy for continual improvement
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Latest technology shall be adopted by keeping continuous vigil on the technological developments. Training and retraining the employees shall be given preference to improve productivity and reduce wastes. Benchmarking the best in category shall be adopted to improve the systems continually and reduce costs. Unexplored area by our competitors shall be explored to develop niche products and markets. Market surveys are done along with customers for their market to understand the change in requirements and processes are aligned as per the future needs. 97. Involvement of people
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People never refuse instructions. People willingly come forward and take instructions. People discuss the points before accepting. People do the work as required and there is no need for follow up. People report the activities from time to time and get ensured that they are as per target. 98. Supplier relationship
1 2
Suppliers have to agree to our terms as we are giving them business. We ensure proper payment in time as agreed provided the quality of materials are good and supplied in time.
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Supplier takes back the materials and settles claims whenever we complain. Supplier discusses his problems and costs and the same are studied carefully to enhance price if needed. Supplier is involved in product development and the costs are worked out jointly and processes are adjusted to suit the required. 99. Leadership
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People respect the CEO. Whenever he visits, complete premises shall be kept clean and senior officers shall be present during his rounds. Whatever the CEO says is the ultimate and everyone follows it with out any grumbling. CEO discusses the plans and problems with senior managers, and reviews during his next visit. CEO demonstrates his commitment to the system by personally following it all the time. CEO discusses his plans even with senior workmen and union leaders while planning for future, and implements the plan as discussed. 100. Fact-based decision
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Records are maintained at all important places, and decisions are based on the data available. The decisions are taken basing on the facts provided by the concerned heads of the department who scrutinize the data before submitting further. ERP system is implemented and hence all data are captured by the system and decisions taken accordingly. Computer software is periodically calibrated to ensure its suitability and reliability for the purpose. Linking exercises are done to cross check the validity of data before taking any decision.
By assessing our present level of maturity, targets can be given to achieve the next level in certain time frame. Once the targets are given, it is not only the employees, but also the top management must work to achieve the target. Once we achieve the score at highest level, the questions may be changed considering the latest developments in the concepts and the systems.