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Quality Management Consultants, (An ISO 9001:2000 Certified Organization) Kolkata on ISO 9001 : 2008
E-mail ID: qmccal41@yahoo.co.in
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ISO 9001 - 2008 HAS ADOPTED PROCESS APPROACH FOCUS ON CUSTOMER SATISFACTION MEASUREMENTS AND MEASUREMENT ANALYSIS - RESOURCE MANAGEMENT CONTINUAL IMROVEMENT
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ISO 9001 - 2008 QMS : REQUIREMENTS COMPATIBLE WITH ISO 9004 - 2000 QMS : GUIDANCE FOR PERFORMANCE IMPROVEMENT
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CORE STANDARDS
ISO 9000 - Q.M. SYSTEMS - FUNDAMENTALS & VOCABULARY ISO 9001 - Q.M. SYSTEMS - REQUIREMENTS ISO 9004 -Q.M. SYSTEMS - PERFORMANCE IMPROVEMENT ISO 19011 - GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS ISO 10012 - REQUIREMENTS FOR MEASURING EQUIPMENT
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REWORKS
RETURNS RECALLS
5.
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REGRETS
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REJECTS : NOT CONFINED TO PRODUCTS ALONE; A WRONGLY WRITTEN INFORMATION SENT FROM ONE DEPT TO ANOTHER ENDS UP AT SOME STAGE IN A WASTE PAPER BASKET AS A REJECT. REWORKS : NOT CONFINED TO PRODUCTS ALONE; A LETTER TYPED WRONGLY ENDS UP AS A REWORK. RETURNS : NOT CONFINED TO A NON-CONFORMING PRODUCT RETURNED FROM A CUSTOMER; A CONSIGNMENT ADDRESSED WRONGLY ENDS UP AS A RETURN. RECALLS : NOT CONFINED TO A WRONG PRODUCT SENT TO A CUSTOMER
AND RECALLED ON REALIZATION OF THE ERROR; A PERSON POSTED WRONGLY IN THE ORGANISATION SETUP ENDS UP AS A RECALL.
REGRETS : NOT CONFINED TO A REGRET LETTER SENT TO A CUSTOMER FOR A DELAY IN DELIVERY OF THE PRODUCT; IT INCLUDES MANY REGRETS EXCHANGED BETWEEN PEOPLE WITHIN THE ORGN WHO END UP DOING THINGS WONG EVERY MINUTE, EACH TIME.
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PLAN
DO
STANDARDISE
DO
ACT
CHECK
ACT
CHECK
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THE STANDARD IS STRUCTURED INTO 5 SECTIONS 4. QUALITY MANAGEMENT SYSTEM 5. MANAGEMENT RESPONSIBILITY
6. RESOURCE MANAGEMENT
7. PRODUCT REALIZATION 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
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Customer focus : Organizations depend on their customers ( Internal & External ) and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
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Leadership :
Leaders establish unity of purpose, direction, and the internal environment of the organization. They create the environment in which people can become fully involved in achieving the organizations objectives.
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Involvement of people :
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit,
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Process approach: A desired result is achieved more efficiently when related resources and activities are managed as a process. Power Control, Distribution Control, Fuel Coordination
Input
Activities
Output
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System approach: A desired result is achieved more efficiently when related resources and activities are managed as a process.
Day to day MTD / YTD Record / Log book Keeping Keeping Latest position of distribution network Etc.
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Communication. Education and training. Corrective action task force, corrective actions groups. Preventive Attitude Error cause removal schemes. Team. Problem solving. SPC. Recognition of performance. Suggestion programmes. Self inspection programmes. So on
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Factual approach to decision making : Effective decisions are based on the logical or intuitive analysis of data and information.
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Mutually beneficial supplier relationships: The ability of the organization and its suppliers to create value is enhanced by mutually beneficial relationships
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DESIGN OUTPUT
DESIGN VERIFICATION
S.P.C. CHARTS; REGRESSION ANALYSIS; D.O.E.; PROCESS CAPABILITY ANALYSIS SAMPLING; RELIABILITY ANALYSIS
CALIBRATION
CORRECTIVE AND PREVENTIVE ACTIONS
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1.2 APPLICATION
SOME REQUIREMENTS WITHIN CLAUSE 7 PRODUCT REALIZATION MAY BE EXCLUDED, BECAUSE OF
NATURE OF ORGANISATION AND PRODUCT BUT MUST FULFILL CUSTOMER REQUIREMENTS AND APPLICABLE REGULATORY REQUIREMENTS EXCLUSIONS TO BE DETAILED IN QUALITY MANUAL WITH JUSTIFICATION. E.g. DESIGN, INSTALLATION, CUSTOMER PROPERTY, PRESERVATION OF PRODUCT CONTROL OF
TERM ORGANISATION REPLACES TERM SUPPLIER SUPPLIER NOW USED TO DENOTE SUB CONTRACTOR PRODUCT ALSO MEANS SERVICE
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DOCUMENTATION IS
DOCUMENTED STATEMENTS OF QUALITY POLICY AND QUALITY OBJECTIVES QUALITY MANUAL DOCUMENTED PROCEDURES REQUIRED BY THE STANDARD. DOCUMENTS NEEDED BY THE ORGANISATION TO ENSURE THE EFFECTIVE PLANNING, OPERATION AND CONTROL OF ITS PROCESSES. RECORDS SPECIFIED BY THE STANDARD.
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4.2
DOCUMENTATION REQUIREMENTS
THE ORGANISATION IS EXPECTED TO ESTABLISH AND MAINTAIN A QUALITY MANUAL WHICH COVERS : - THE SCOPE OF THE Q.M. SYSTEM INCLUDING EXCLUSIONS (SECTION 7) IF ANY AND THE JUSTIFICATION FOR THE EXCLUSIONS. - DOCUMENTED PROCEDURES ESTABLISHED FOR THE QUALITY MANAGEMENT SYSTEM OR REFERENCE TO THEM. - DESCRIPTION OF THE INTERACTION BETWEEN THE PROCESSES OF THE QUALITY MANAGEMENT SYSTEM.
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CONTROL OF DOCUMENTS
Requirement on maintenance of master list or equivalent document control procedure identifying the current revision status of documents shall be established and made readily available to be deleted. But this is covered through ensuring that relevant versions of applicable documents are available at points of use. - It should be ensured that documents remain legible, are readily identifiable, readily retrievable. - Documents of external origin are to be given an identification and their distribution needs to be controlled.
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CONTROL OF RECORDS
Contractual requirements on making available the records to the customer or his representative as given in the older version seem to be missing. But these are expected to be taken care of under Determination of the requirements related to the product (7.2.1)
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5. MANAGEMENT
RESPONSIBILITY
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5.1.
MANAGEMENT COMMITMENT
Top management has to demonstrate its commitment to the Development and Implementation of the quality management system and continual improvement of its effectiveness by.
A. Communicating to the Organisation the importance of meeting customer and legal regulatory requirements
B. Establishing the quality policy and quality objective
Top Management to ensure that customers requirements are determined and fulfilled with the aim of enhancing customer satisfaction.
QUALITY POLICY
Centom Constructions is a fast growing Company in the field of extra high voltage electrical contracting is committed to : Ensuring effective & efficient structure to satisfy its customers needs & expectations with respect to quality & safety. Continually improve the processes, productivity & reducing negative impact on environment. Maintaining high level of employee moral through training & involvement. Establishing measurable objectives & performance indicator at relevant functions and levels. Ensuring that various processes are monitored and reviewed for continuing suitability.
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5.4
PLANNING
5.4.1 QUALITY OBJECTIVES Quality Objectives are needed to be established at relevant functions shall include those needed to meet product requirements Quality objectives are expected to be measurable, be consistent with the Quality Policy and commitment to continual improvement.
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Quality Objectives
Business volume. Securing order for projects
Department
Target
Project
Marketing
6 Nos.
3 (New)
Quarterly
3. 4. 5. 6.
Response to queries / complaints. Compliance to Customers Schedule. Logging of Customer Complaints. Accident
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5.6.2 REVIEW INPUT REVIEW INPUTS TO INCLUDE : Audit Findings Customer feedback Process performance, product conformance. Status of corrective preventive actions. Follow up actions from earlier management reviews. Planned changes affecting the Q.M.S Recommendations for improvement.
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5.6.3 REVIEW OUTPUT REVIEW OUTPUTS ARE EXPECTED TO BE ACTION ORIENTED AND INCLUDE
Improvement of effectiveness of the Q.M.S and its processes Improvement of Product Resource needs Other requirements are as per the older version of the Standard.
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6 RESOURCE MANAGEMENT
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The organization is expected to identify and provide resources needed to implement, maintain and continually improve effectiveness of the Q.M.S and to enhance customer satisfaction by meeting customer requirements.
6.2. HUMAN RESOURCES
6.2.1 General Personnel performing work affecting conformity to product requirement are competent on the basis of appropriate education, skill, training and experience. Centom Construction provide continual O.J.T for development of employees.
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6.3 INFRASTRUCTURE The Organization is expected to identify, provide, maintain facilities needed to achieve the conformity of product requirement. => Buildings,workspace and associated utilities. => Process equipment, both hardware and software. => Supporting services (such as transportation & communication / or information system). 6.4 WORK ENVIRONMENT The organization is expected to define and manage the work environment needed to achieve conformity to product requirements.
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7 PRODUCT REALISATION
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7.1 PLANNING OF PRODUCT REALIZATION The organization to plan and develop product realization processes, consistent with other processes of QMS. Following to be defined: Q-objectives and Product requirements Need to establish Processes,documents; provide resource specific to product Verification, validation,monitoring, inspection test and test activities, acceptance criteria for the product. Quality records needed Out put of planning to be in suitable form
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7.2.3
Customer Communication
The Organization is expected to define and implement arrangements for customer communication w.r.t. a. Product information. b. Enquiry, order handling including amendments. c. Customer feedback, complaints.
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7.3.2 Design and Development Inputs. The inputs are expected to include a. Functional , performance requirements b. Regulatory legal requirements. c. Information from previous similar design. 7.3.3 Design and Development Outputs Apart from all the requirements laid down in the older version of the Standard. Additional requirement reads as :=> The Design development output is expected to provide information for purchasing, production and service Quality Management 49 ver 1.0 Consultants provision.
7.3.4 Design and Development Review Ability of design results to fulfill the requirements added as an objective of the review. Review is also aimed at identifying any problems and propose suitable actions against the problems. 7.3.5 Design and Development Verification
Design and development work in progress and final stage have to be verified by alternative method / second person / procedure.
7.3.6 Design and Development validation Where practicable validation to be completed prior to the delivery or implementation of the product. Records of validation to be maintained.
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The organization is expected to evaluate the effect of the changes on components, parts and already delivered products. These changes are expected to be verified, validated and approved before implementation. Records of the review of changes and any necessary actions are to be maintained.
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7.4 PURCHASING
Criteria for selection, evaluation and re-evaluation
of suppliers need to be established. Records of the results of evaluation and any necessary actions arising from the evaluation need to be maintained. Verification arrangements and method of product release to be made a part of purchasing data extended to verification of the product by customer of the organisation at the suppliers premises.
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7.5.1 Control of production and service provision (contd..) => Implementation of suitable monitoring measurement => Implementation of release, delivery and post delivery activities
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7.5.2 Validation of Processes for production and service provision Where results of processes cannot be verified by subsequent monitoring or measurement, processes to be validated to demonstrate ability to achieve planned results. Establishing of arrangements include: Define criteria for review and approval Approval of equipment and personnel qualification Use of specific methods and procedures Requirements for records Revalidation
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7.5.3 Identification and Traceability 1. Product identification from receiving end upto the use including process. 2. Traceability
7.5.4 Customer Property => Customer supplied product is termed as customer property => Scope to include intellectual property information provided in confidence.
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7.5.5
Preservation of Product
=> The organization is expected to preserve the product and or service during internal processing and final delivery to intended destination. => This control is expected to include identification,handling, packaging, storage and protection. => All these controls are to be applied to parts, components of a product and elements of a service.
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7.6 Control of Monitoring and Measuring Equipment => Calibration of instruments, traceability of measurement and confidence on measured data. => The scope has been made explicit by including monitoring devices also.
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8. MEASUREMENT,
ANALYSIS AND IMPROVEMENT
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8.1 PLANNING The organization is expected to plan and implement a system for monitoring, measuring and analysing of various activities to assure conformance of products /QMS. It is also expected of define and implement a system to achieve continual improvement of effectiveness of QMS. To do this the organization is expected to define and use applicable methods including statistical techniques.
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8.2.2.
INTERNAL AUDIT
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES The organization is expected to evolve and implement a system for measuring and monitoring the processes. The system should be such that through the system the organization should be able to confirm the continuing ability of each process to satisfy its intended purpose. Correction and corrective action to be taken.
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8.2.4 MEASUREMENT AND MONITORING OF PRODUCT => The large clause 4.10 of the earlier version of the standard is replaced by this short compact clause. => The organization is expected to measure and monitor the characteristics of the product to verify that requirements of the product are met. This should be carried out at appropriate stages of the product realization process. => Evidence of conformance with the acceptance criteria used should be recorded. => Records to indicate the authority responsible for release of product. => Product release and service delivery are not to be executed until all planned activities have been satisfactorily completed. Unless otherwise approved by relevant authority and where applicable by the customer.
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=> When non conforming product and or service is detected after delivery, or use has started, the organisation is expected to take actions appropriate to the consequences of the N.C.
=> No non-conforming product should go to the process or customer. => Identification of non-conforming product /
service.
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8.5 IMPROVEMENT 8.5.1 Planning for Continual Improvement The organization is expected to have a formal system for continual improvement of the Q.M.S, through the use of Quality policy, Quality Objectives, Audit results, Data Analysis, Management Reviews, Corrective and preventive actions.
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8.5.2
Corrective Actions
Centom Constructions takes action to eliminate the causes of non-conformities in order to prevent recurrence. Corrective actions are appropriate to the effects of non-conformities encountered. A documented procedure (QSP/8.5.2) is established to define requirements for : Reviewing non-conformities including customer complaints. Determining the cause of non-conformities. Evaluating the need for action to ensure that nonconformities do not recur. Determining and implementing actions needed. Records of results of actions taken. Reviewing corrective action taken.
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8.5.3
Preventive Actions
Centom Constructions determine actions to eliminate cause of potential non-conformities in order to prevent occurrence. Preventive action shall be appropriate to the effect of potential problems. A documented procedure (QSP/8.5.3) is established to determine requirements for,
Determining potential non-conformities and their causes. Evaluating the need for action to prevent occurrence of non-conformities. Determining and implementing actions needed. Records of results of actions taken. Reviewing preventive action taken.
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Thank You
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