iso 9001-2000 training (engl).ppt
TRANSCRIPT
1 Corporate Quality Rev 1.0 07/29/02
ISO 9001:2000ISO 9001:2000TL 9000 Telecom TL 9000 Telecom
Quality Management Systems Quality Management Systems (QMS) Requirements (QMS) Requirements
2 Corporate Quality Rev 1.0 07/29/02
ISO 9000:2000 Core Standards9000:2000 •Provides (QMS) principles and fundamentals
•Describes the ISO series •Lists basic definitions of terms
9001:2000 •States requirements for quality management
9004:2000 •Provides guidance for establishing a (QMS) •States requirements to meet and exceed customer expectations
TL 9000 •Quality Management System Requirements Handbook•Provides quality management system requirements
TL 9000 •Quality Management System Measurements Handbook•Provides metrics collection information
3 Corporate Quality Rev 1.0 07/29/02
This class was developed to meet the following instructional needs:
Provide a basic understanding of ISO 9001: 2000, quality management systems(QMS) requirement Provide an overview of TL 9000 registration requirements
Purpose of Course
4 Corporate Quality Rev 1.0 07/29/02
Audience:
Management Quality and Process Engineering Process Owners in all functions (I.e. Finance, HR,
IT, Materials, etc.)
Audience
5 Corporate Quality Rev 1.0 07/29/02
Participants will be able to:
Discuss how ISO 9001 and TL 9000 fits into Solectron’s strategies and policies
Describe the philosophy of the new standards Define implementation strategies associated with
the standard
Course Objectives
6 Corporate Quality Rev 1.0 07/29/02
I Quality Management Systems(QMS) OverviewII Philosophy of New StandardIII Implementation Strategies
Course Outline
7 Corporate Quality Rev 1.0 07/29/02
The philosophy of QMS Standards is based on defining tools, and criteria necessary to meet customer’s expectations.
Criteria: Satisfy customer requirements Provide consistency and repeatability Support company's needs for internal efficiencies
QMS Philosophy
8 Corporate Quality Rev 1.0 07/29/02
I Quality Management Systems(QMS) OverviewII Philosophy of New StandardIII Implementation Strategies
Course Outline
9 Corporate Quality Rev 1.0 07/29/02
Customer satisfaction is required, not implied Quality processes required in all sectors, not just
manufacturing Efficient processes, with known inputs and outputs Data and nonconformance data used for continuous
improvement
Evolution of Quality Systems
10 Corporate Quality Rev 1.0 07/29/02
The new ISO 9001 Standard is built on 8 principles of Quality Management Systems:
1. Customer Focused Organization
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual process Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
Quality Management
11 Corporate Quality Rev 1.0 07/29/02
ISO 9001-2000 and MBNQA
ISO 9001-20001. Customer Focused Organization2. Leadership3. Involvement of People4. Process Approach5. System Approach to Management6. Continual Process Improvement7. Factual Approach to Decision
Making8. Mutually Beneficial Supplier
Relationships
MBNQA3. Customer and Market Focus1. Leadership5. Human Resource Development &
Management6. Process Management6. Process Management, 2. Strategic Planning6. Process Management4. Information and Analysis, 7. Business
Results6.3 Supplier and Partnering Processes
ISO 9001-2000 and MBNQA have similar concepts and organization9000
12 Corporate Quality Rev 1.0 07/29/02
Principle 1
Organizations depend on their customers and therefore should;
•understand current and future customer needs
•meet customer requirements
•strive to exceed customer expectations
Tools that Solectron uses are the CFT’s and weekly CSI process.
Customer Focused Organization
13 Corporate Quality Rev 1.0 07/29/02
Principle 2
Leaders should;
•establish unity of purpose and direction of the organization
•create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives
LEADERSHIP
Tools Solectron uses are Hoshin planning, AOP and LRP processes.
14 Corporate Quality Rev 1.0 07/29/02
Principle 3
Involvement of People•People at all levels are the essence of an organization
•Employee’s full involvement enables their abilities to be used for the organization’s progress
15 Corporate Quality Rev 1.0 07/29/02
Principle 4
A desired result is achieved more efficiently when related resources and activities are managed as a process
Process Approach
Tools Solectron uses are SIPOC, process mapping and clearly documented process.
16 Corporate Quality Rev 1.0 07/29/02
Principle 5System Approach to Management
Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency
17 Corporate Quality Rev 1.0 07/29/02
Principle 6Continual Improvement
Continual improvement should be a permanent objective of the organization
Focus is on the Seven Step improvement process at Solectron Corporation.
18 Corporate Quality Rev 1.0 07/29/02
Principle 7Factual Approach to Decision Making
Effective decisions are based on the analysis of data and information
19 Corporate Quality Rev 1.0 07/29/02
Principle 8Mutually Beneficial Supplier
RelationshipsAn organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
20 Corporate Quality Rev 1.0 07/29/02
I Quality Management Systems(QMS) OverviewII Philosophy of New StandardIII Implementation Strategies
Course Outline
21 Corporate Quality Rev 1.0 07/29/02
4 Quality Management System
4.1 General requirements 4.2 Documentation requirements
22 Corporate Quality Rev 1.0 07/29/02
GeneralThe organization will document, implement and maintain a QMS and and continually improve its effectiveness.
The organization shall Identify processes needed for the QMS Determine sequence and interaction of
processes Monitor, measure and analyze these processes Implement actions necessary to achieve
planned results
23 Corporate Quality Rev 1.0 07/29/02
DocumentationRequirements:
• Documented statements of a quality policy and quality objectives
• A quality manual
• Documents needed by the organization to ensure the effective planning, operation and control of its processes
• Control of Customer-Supplied Documents and Data
• Maintain records
24 Corporate Quality Rev 1.0 07/29/02
DocumentationControl of Documents, including
Customer documents and data:
• Approve documents for adequacy prior to issue
• Review and update as necessary and re-approve
• Ensure that changes and the current revision status of documents is identified
• Ensure that relevant versions of applicable documents are available
• Ensure that documents of external origin are identified and their distribution controlled
25 Corporate Quality Rev 1.0 07/29/02
Documentation
Control of Records:
• Records should remain legible
• Readily identifiable
• Retrievable
A documented procedure should be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
26 Corporate Quality Rev 1.0 07/29/02
5. Management Responsibility
5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility and Communication
27 Corporate Quality Rev 1.0 07/29/02
Management CommitmentTop Management will provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness.
The organization shall Communicate the importance of meeting
customer and regulatory requirements Establish a quality policy Conduct management reviews Ensure the availability of resources
28 Corporate Quality Rev 1.0 07/29/02
Customer FocusTop management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.Top management establishes and maintains customer relationshipsProcedures are established for customer communication and joint reviews
29 Corporate Quality Rev 1.0 07/29/02
Quality Policy
• Is appropriate to the purpose of the organization
• Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system
• Provides a framework for establishing and reviewing quality objectives
• Is communicated and understood within the organization
• Reviewed for continuing suitability
30 Corporate Quality Rev 1.0 07/29/02
31 Corporate Quality Rev 1.0 07/29/02
Quality PolicySolectron is committed to total quality management and
the requirements of its quality management system to provide product and product-related services that conform to all established requirements. We are committed to defining measures that are effective and drive decisions from factual and current data. Through the continual improvement of our management systems, we are committed to achieving total customer satisfaction, exceed the expectations of our customers, and provide error-free, competitive products/solutions on time with customer satisfaction second to none.
32 Corporate Quality Rev 1.0 07/29/02
PlanningQuality Objectives
The organization shall
Top management ensures that quality objectives, including those needed to meet requirements for product, are established at relevant functions. This includes TL 9000 metrics.
Quality Management System Planning Management ensures that that short and
long term planning is implemented and the integrity of the QMS is maintained
Customer and supplier input is used for planning
33 Corporate Quality Rev 1.0 07/29/02
Management Representative Top management will appoint a member of
management, who will have the responsibility and authority that includes:
Establishing QMS processes Report the performance of QMS and any need for
improvement Reports results of audits, customer feedback,
process performance, product conformity, preventive and corrective actions, and changes that could affect the QMS
This individual is the Quality Manager for California Site
34 Corporate Quality Rev 1.0 07/29/02
6. Resource Management
6.1 Provision of Resources 6.2 Human Resources
35 Corporate Quality Rev 1.0 07/29/02
6 Provision of ResourcesThe organization shall Implement and maintain the QMS and continually
improve its effectiveness Enhance customer satisfaction by meeting
customer requirements
36 Corporate Quality Rev 1.0 07/29/02
Human ResourcesCompetence Awareness and Training
The organization shall Determine the necessary competence for
personnel performing work affecting product quality and define requirements for all positions affecting quality
Provide training, including quality improvement techniques
Evaluate the effectiveness of the training, including internal course development
Maintain appropriate records of education, training, skills and experience
37 Corporate Quality Rev 1.0 07/29/02
Training• ESD training is required for all
employees handling sensitive devices
• Advanced quality training is available for all employees that need it
• Hazardous material handling training is required for all employees that handle hazardous material
• Operators are qualified, not just trained, to do their jobs
38 Corporate Quality Rev 1.0 07/29/02
7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and
Measuring Devices
39 Corporate Quality Rev 1.0 07/29/02
The organization shall plan and develop the processes needed for product realization, and will be consistent with the requirements for other processes.
The organization shall Determine quality objectives and
requirements for the product Establish processes, documents, and
provide resources specific to the product Verify, validate, monitor, and test activities
specific to the product
Planning of Product Realization
40 Corporate Quality Rev 1.0 07/29/02
More Planning Requirements• Life cycle model – a set of integrated
guidelines covering the life cycle of the product
• New Product introduction procedure• Disaster recovery plans• End of life planning• Configuration management
41 Corporate Quality Rev 1.0 07/29/02
Customer-related ProcessesDetermination and Review of Requirements Related to the Product
The organization shall Determine requirements specified by the
customer Determine Statutory and regulatory
requirements related to the product Ensure that product requirements are defined Implement arrangements for effective
customer communication, including: product information, contracts, and feedback
42 Corporate Quality Rev 1.0 07/29/02
Customer-related Processes
• Notification about problems• Problem severity• Problem escalation• Customer feedback• Recall process
43 Corporate Quality Rev 1.0 07/29/02
Design and DevelopmentProcedures to control, verify, and validate product design and supporting software. A design control process in operation that has adequate resources and assigned responsibilities.
The organization shall Determine the design and development
stages Determine functional and performance
requirements Meet input requirements, regulations and
statutory law
44 Corporate Quality Rev 1.0 07/29/02
Design and DevelopmentThe organization shall
Provide output verifications through Alternative calculations Qualification tests
Validate the design by Ensuring that design verification is successful Confirm that the final product meets user needs Assess the need for multiple validations
45 Corporate Quality Rev 1.0 07/29/02
Design and Development• Project Plan• Requirements traceability• Test Planning• Customer and Supplier Input• Design and development requirements• Content of requirements• Change management process• Informing customers • Problem resolution• Component Changes
46 Corporate Quality Rev 1.0 07/29/02
PurchasingThe organization will ensure that purchased product conforms to specified purchase requirements. Also, evaluate and select suppliers based on their ability to supply product.
The organization will Prepare, review, and approve purchasing
documents Establish criteria for determining supplier
acceptability Develop a supplier classification system Establish a record system
47 Corporate Quality Rev 1.0 07/29/02
Production and Service ProvisionThe organization will plan and carry out production
and service provision under controlled conditions.
Controlled conditions include: Availability of information that describes the
characteristics of the product Use of work instructions The use of suitable equipment The availability and use of monitoring and
measuring devices
48 Corporate Quality Rev 1.0 07/29/02
Production and Service ProvisionValidation of processes for production and service
provision
The organization shall Define criteria for review of processes Use specific methods and procedures Revalidate Approve of equipment and qualification
personnel
49 Corporate Quality Rev 1.0 07/29/02
Production and Service Provision
• The organization shall identify product by suitable means throughout product realization
• Product status shall be identified with respect to monitoring and measurement requirements
• Recall traceability shall be maintained• Design traceability to identifiable dates,
lots or serial numbers
50 Corporate Quality Rev 1.0 07/29/02
Production and Service ProvisionCustomer Property
The organization shall Exercise care with customer property while it
is under the organization’s control or being used by the organization
Identify and verify, protect and safeguard customer property provided for use or incorporation into the product
51 Corporate Quality Rev 1.0 07/29/02
Control of Monitoring and Measuring Devices
A process to ensure that equipment is properly calibrated and will remain so. The organization shall: Verify and calibrate at specific intervals the measuring equipment, prior to use, based on standard traceable to national measurement standards Adjust or re-adjust equipment as necessary Identify as to calibration status
52 Corporate Quality Rev 1.0 07/29/02
Control of Monitoring and Measuring Devices
Safeguard from adjustments that would invalidate the measurement results
Protect equipment from damage and deterioration during handling, maintenance and storage
Label equipment that is either inactive or unsuitable for measurement and remove from use.
All monitoring and measurement devices that do not requirement calibration shall be identified
53 Corporate Quality Rev 1.0 07/29/02
8 Measurement, Analysis and Improvement
8.1 General 8.2 Monitoring and Measure 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement
54 Corporate Quality Rev 1.0 07/29/02
General
The organization shall Demonstrate conformity of the product Ensure conformity of the QMS Continually improve the effectiveness of the
QMS
55 Corporate Quality Rev 1.0 07/29/02
Monitoring and MeasurementAn active plan to search out and put to use information
that reflects the degree of satisfaction being experienced by customers.
The organization shall Monitor information relating to customer Conduct internal audits at planned intervals Demonstrate the ability of the processes to
achieve planned results Verify that product requirements have been
met
56 Corporate Quality Rev 1.0 07/29/02
57 Corporate Quality Rev 1.0 07/29/02
Monitoring and MeasurementThe organization shall
• Document with detail inspection and test requirements
• Keep test and inspection records• Perform periodic retesting• Ensure initial and periodic retest is more
extensive than initial testing• Document frequency of testing• Test return and repair appropriately• Establish test documentation
58 Corporate Quality Rev 1.0 07/29/02
Control of Nonconformingproduct
The organization will Identify nonconforming product Evaluate degree and extend of the
nonconformance Dispose of nonconforming product according
to quality plan or procedures Notify concerned parties
59 Corporate Quality Rev 1.0 07/29/02
Analysis of DataA process for identifying the need for collecting the data required for establishing, controlling, and verifying process capability and product quality. The organization shall perform trend analysis of the nonconforming data.
The organization shall analyze data relating to Customer satisfaction Conformity to product requirements Characteristics and trends of processes and
products
60 Corporate Quality Rev 1.0 07/29/02
ImprovementA constant search for ways to improve the QMS, and an investigation and elimination of causes of nonconforming product, at any point in the process, distribution, and installation.
The organization shall Review nonconformities (including customer
complaints) Determine the causes of nonconformities Determine and implement action needed Review corrective actions taken Implement Quality Improvement Programs
61 Corporate Quality Rev 1.0 07/29/02
The End
A good Quality Management System makes life easier for everyone by providing an efficient way to run a
business.