Professional Documents
Culture Documents
This standard is applicable to sites where products are manufactured to meet the customer requirements. All functions of the organization including remote locations are to be covered. Exclusions are permitted based on the operations of the Organisation
BASIC FEATURES :
Process oriented approach
MAJOR REQUIREMENTS :
Emphasis on Management Commitment Data analysis with a view to achieve continual improvement in all the processes Customer perception monitoring
1. Customer Focus
The organisation should understand the specified and implied requirements of the customer Plan and implement requirements methods to meet these
Organisation must exceed customer expectations Measure the customer satisfaction and dissatisfaction levels Take actions to enhance the customer satisfaction on continual basis.
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2. Leadership
Create effective communication channels with in the organisation for information sharing Provide adequate resources both hardware and software for effective functioning of the organisation
Provide conducive atmosphere to the employees for getting the best out-of -them
Educate the employees on customer requirements/needs
Motivate the employees to achieve the objectives set for the organisation
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3. Involvement of Employees
Accept that the employees are the strength of the organisation Make employees accountable for their performance Identify the constraints of the employees performance and help them to improve their performance Understand their importance in achieving the corporate goals
Evaluate their performance against the goals and objectives set for them
Encourage employees to take more responsibilities
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4. Process Approach
Captures who, what, when, where and how for each process
All the inter related activities are captured and defined Facilitates to identify the weakness in the activities related to each process
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Helps to improve the system and processes through constant review & evaluation mechanism.
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6. Continual Improvement
Performance monitoring for improving the organisational capabilities
Providing training improvements to employees on continual
Every employee participation in continual improvement activity in the organisation Quick reaction for the opportunities identified Recognising and acknowledging improvements
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Process:
An inter-relationship between different activities to convert input into output.
WITH WHAT Equipment Support processes INPUT Customer requirements HOW MUCH Performance Indicators OUTPUT PROCESS Customer whose needs are met WITH WHO Competent Personnel
HOW
Instructions Procedures Methods
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Planning
Policy establishment Defining the objectives/ targets
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Deploy the policy with-in the organisation Define and document measurable objectives
Delegate authorities
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Act
Based on the out-come of the review make changes in the planning Provide additional resources, if required Provide training required. to the personnel wherever
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STANDARD REQUIREMENTS
4.1 GENERAL REQUIREMENTS
Quality Management System to be established, documented, implemented and maintained with a view to continually improve the effectiveness
Out-sourced processes and the controls exercised on them should be documented in the system Control over out-sourced processes does not absolve the organisations responsibility to ensure quality product to the customer
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STANDARD REQUIREMENTS
4.2 DOCUMENTATION REQUIREMENTS
The Quality Management System documentation should address all the requirements of the standard.
Scope and exclusions justification to be documented.
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STANDARD REQUIREMENTS
5.1 MANAGEMENT COMMITMENT : Establishing the quality policy and objectives/ targets Communicating the statutory regulatory requirements related to the product to all the concerned. Ensuring availability of resources Conducting the reviews
STANDARD REQUIREMENTS
5.2 CUSTOMER FOCUS Determine the customer requirements and meet them with a view to enhance the customer satisfaction. 5.3 QUALITY POLICY Enunciate Quality Policy relevant to the organisational goals and customer requirements. 5.4.1 QUALITY OBJECTIVES
Document quality objectives in relation to the policy in measurable terms and should be in-line with business goals
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STANDARD REQUIREMENTS
5.5 RESPONSIBILITY AND AUTHORITY : Responsibility and Authority of each function should be documented and communicated
Authority for initiating the corrective action on process and product deviations should be specified.
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STANDARD REQUIREMENTS
5.5.2 MANAGEMENT REPRESENTATIVE Establish system. and maintain the quality management
Report the management on the performance of quality management system. Promote awareness of customer requirements in the organisation.
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STANDARD REQUIREMENTS
5.5.3 INTERNAL COMMUNICATION
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STANDARD REQUIREMENTS
6.0 RESOURCE MANAGEMENT Competency requirements for each function to be documented and the personnel working in the functions to be evaluated to identify the gaps Training to be provided to bridge the gaps Evaluate the effectiveness of the training provided
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STANDARD REQUIREMENTS
6.2.2 COMTETENCY, AWARENESS AND TRAINING
Competency of each function to be defined and persons in these functions are to be evaluated. Operating personnel should be aware of their contribution in achieving quality objectives.
6.3 INFRASTRUCTURE
The organisation should provide infrastructure for effective working necessary
All the statutory and regulatory requirements to be met with respect to the equipments and buildings used during manufacture.
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STANDARD REQUIREMENTS
6.3.1 PLANT, FACILITIES AND EQUIPMENT PLANNING
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STANDARD REQUIREMENTS
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STANDARD REQUIREMENTS
7.1 PLANNING OF PRODUCT REALIZATION
Process changes made during the product realization process to be controlled and validated.
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STANDARD REQUIREMENTS
7.2 CUSTOMER-RELATED PROCESSES Customer requirements should be understood including the statutory and regulatory requirements related to the product.
STANDARD REQUIREMENTS
7.3 DESIGN & DEVELOPMENT Design & development should include product and process design process.
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STANDARD REQUIREMENTS
7.4 PURCHASING
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STANDARD REQUIREMENTS
7.4 PURCHASING
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STANDARD REQUIREMENTS
7.5 PRODUCTION AND SERVICE PROVISION Suitable equipment to be provided.
Process approval and monitoring records to be maintained. Preventive and Breakdown to be evidenced. Maintenance activities
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STANDARD REQUIREMENTS
7.5 PRODUCTION AND SERVICE PROVISION Production Scheduling should be in line with the Customer requirement. Wherever after sales is a requirement effectiveness of the service provided to the end user to be evaluated.
All process whose output can not be measured immediately need to be validated at defined intervals
Identification system should be in place during manufacturing and storage as necessary.
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STANDARD REQUIREMENTS
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENTS
out
against
When the equipment is out of calibration validity of previous results to be verified. Calibration results need to be analysed
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STANDARD REQUIREMENTS
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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
Methods for obtaining the customer satisfaction to be defined and documented Actions to be initiated on the areas where customer dissatisfaction is evidenced to enhance the customer satisfaction.
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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Internal Audits to be conducted at defined intervals to verify the system compliance in the organisation Evidence of compliance and non-compliance to be collected Audit evidence should be verifiable Corrective actions to be initiated on the conformities observed with-out undue delay non-
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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT All new manufacturing processes are to be validated Product inspection to be carried out to ensure that all the customer requirements are met. A Procedure is required on control of non -conforming product
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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Customer to be informed in case non- conforming product is shipped Data with respect to customer satisfaction, product conformity, process trends and suppliers performance need to be analysed and improvements made wherever required. Continual improvement philosophy should be evidenced through-out the organisation and cover product & process characteristics with a view to enhance the customer satisfaction
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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Corrective Actions need to be initiated on the process and product non-conformances to eliminate/reduce the incidence. Effectiveness of the Corrective Actions implemented to be monitored. Based on the analysis of data potential nonconformance to be identified and actions initiated to avoid non-conformances Effectiveness of these actions to be monitored.
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THANK YOU
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