The Gwent Group of Companies. Quality Assurance Presentation

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1 The Gwent Group of Companies Quality Assurance Presentation

2 The Gwent Group of Companies Suppliers to Major Multinational Companies in :- The Automotive Industry. The Fuel Cell Industry. The Electro-ceramics Industry. The Pharmaceutical Industry. The Bio Science Industry. The Electronic Display Industry. and General Electronics.

The Electro-ceramics Industry. The Pharmaceutical Industry.

3 The GEM Quality Management System Recognises the need of the market for quality and fitness of purpose of the companies products. The strategic decision was made on the adoption of a Quality Management system. An internationally recognised standard

4 Qualifications

5 QUALITY STANDARDS OVERVIEW ISO 9001:2000 THE INTERNATIONAL QUALITY STANDARD ISO 13485:2003 THE QUALITY STANDARD AS APPLIED TO MEDICAL DEVICES. BASED ON ISO 9001 ISO 16949:2002 REQUIREMENTS FOR APPLICATION OF ISO 9001 TO THE AUTOMOTIVE INDUSTRY

6 QUALITY SYSTEM OVERVIEW ONE QUALITY SYSTEM COVERING ALL THREE STANDARDS IT ADDRESSES EACH SECTION OF THE STANDARDS Documentation and Records Control Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement

Documentation and Records Control Management Responsibility

7 PRODUCT REALISATION OVERVIEW THE PROCEDURES FOR CONTROLLING THIS ARE VERY STRICTLY MAINTAINED. PARTICULARLY FOR ESTABLISHING CUSTOMER REQUIREMENTS, QUALITY PLANNING, DESIGN CONTROL AND PRODUCTION CONTROL THEY DIFFER IN DETAIL AND APPLICATION DEPENDANT ON WHETHER THE CUSTOMER IS SUBSCRIBING TO ISO9001, ISO OR ISO/TS Contract Review 2. Advanced Product Quality Planning 3. Design Projects 4. Production Control

CONTROL THEY DIFFER IN DETAIL AND APPLICATION DEPENDANT ON WHETHER THE CUSTOMER IS SUBSCRIBING TO ISO9001,

8 DESIGN AND PRODUCTION CONTROL DESIGN REVIEWS Does the design satisfy all the requirements? Are the product design and processing capabilities compatible? Have the FMEAs been completed. Does the design meet the functional and operational requirements? Have appropriate materials been selected? Have environmental and Health and Safety requirements been coverd? Can toleranc es be achieved? DESIGN DEVELOPMENT (VALIDATION) Ensure that product confoms to defined user needs and/or requirements. Performed on the final product under defined operating conditions. Design failures shall be documented. Procedures for corrective and preventive action shall be followed in addressing such design failures. INITIAL PRODUCTION VALIDATION Prodution Trial Run, Measurement Systems Evaluation, Preliminary Process Capability Study, Production product approval, Production Validation Testing, Packaging Evaluation, Production Control Plan, Quality Planning Sign-Off DESIGN & DEVELOPMENT PLAN Objectives, Design Inputs/deign Specifications, Time Scales, Feasability Studies, Design Output, Design Reviews, Design Verification & Validation, Costs DESIGN INPUT PRODUCT DEVELOPMENT DESIGN OUTPUT PRODUCTION Functional Requirements, (VERIFICATION) Adequate assessment of the Process Instructions, Performance Requirement Review of FMEAs. Performing conformance to the input Process Flow Chart, Interface requirements, alternative calculations. Comparing requirements and identify the Control Plan, Process Review of Design Spec., the design with similar proven characterisitics of the design that FMEA Analysis. Determining and Agreeing designs. Undertaking tests and are crucial to the safety and the Measurement Systems Customer/Functional/ demonstrations, and reviewing fuctioning of the product, including Analysis Plan, Product Performance and inter- design stage documents before production and material specs. and Quality Systems face Requirements, FMEA releas e. Production specs. include Reveiw, Preliminary analysis, Reliability Manufacturing Instructions, Process Capability Analysis, Labeling and component and material Study Plan, Packaging Packaging Requirements specifications, packaging and labels Specifications.

Can toleranc es be achieved? DESIGN DEVELOPMENT (VALIDATION) Ensure that product confoms to defined user needs and/or requirements. Performed on the final product under defined operating conditions.

9 PRODUCT REALISATION Contract review DESIGN & DEVELOPMENT PLAN Objectives, Design Inputs/design Specifications, Time Scales, Feasibility Studies, Design Out- put, Design Reviews, Design Verification & Validation, Costs

Specifications, Time Scales, Feasibility Studies,

10 PRODUCT REALISATION Design Review DESIGN INPUT Functional Requirements, Performance Requirement Interface requirements, Review of Design Spec., Determining and Agreeing Customer/Functional/ Performance and interface Requirements, FMEA analysis, Reliability Analysis, Labelling and Packaging Requirements

, Determining and Agreeing Customer/Functional/ Performance and inter- face

11 PRODUCT REALISATION DFMEA Advanced daced Product Quality Planning and Control Plan PRODUCT DEVELOPMENT (VERIFICATION) Review of FMEAs. Performing alternative calculations. Comparing the design with similar proven designs. Undertaking tests and demonstrations, and reviewing design stage documents before release.

12 DFMEAs, Lab. Books, Capability Studies PRODUCT REALISATION DESIGN REVIEWS Does the design satisfy all the requirements? Are the product design and processing capabilities compatible? Have the FMEAs been completed. Does the design meet the functional and operational requirements? Have appropriate p materials been selected? Have environmental and Health and Safety requirements been covered? Can tolerances be achieved?

requirements? Are the product design and processing capabilities compatible?

13 PRODUCT REALISATION PFMEAs, Production Control Plan, INITIAL PRODUCTION VALIDATION Production Trial Run, Measurement Systems Evaluation, Preliminary Process Capability Study, Production product approval, Production Validation Testing, Packaging Evaluation, Production Control Plan, Quality Planning Sign-Off

Process Capability Study, Production product approval, Production Validation

14 PRODUCT REALISATION DESIGN OUTPUT Adequate assessment of the conformance to the input requirements and identify the characteristics of the design that are crucial to the safety and the functioning of the product, including production and material specs. Production specs. include Manufacturing Instructions, component and material specifications, packaging and labels

and the functioning of the product, including production and material specs.

15 Prevetative and Corrective Procedures, Design Review PRODUCT REALISATION DESIGN DEVELOPMENT (VALIDATION) Ensure that product conforms to defined user needs and/or requirements. Performed on the final product under defined operating conditions. Design failures shall be documented. Procedures for corrective and preventive action shall be followed in addressing such design failures.

Performed on the final product under defined operating conditions.

16 PRODUCT REALISATION PRODUCTION Process Instructions, Process Flow Chart, Control Plan, Process FMEA Analysis. Measurement Systems Analysis Plan, Product and Quality Systems Review, Preliminary Process Capability Study Plan, Packaging Specifications.

Measurement Systems Analysis Plan, Product and Quality Systems

17 Les. Embury Managing Director The Gwent Group, Monmouth House, Mamhilad Park, Pontypool NP4 0HZ. United Kingdom. Tel: +44 (0) Fax: +44 (0)

GLB QM 02. Supplier Quality Manual 03. 7/11/12 Supplier Quality 1 of 18. Revision Level. Issue Date Issuing Department Page

GLB QM 02. Supplier Quality Manual 03. 7/11/12 Supplier Quality 1 of 18. Revision Level. Issue Date Issuing Department Page 7/11/12 Supplier Quality 1 of 18 7/11/12 Supplier Quality 2 of 18 Table of Contents 1.0 Introduction 3 2.0 Manual 4 2.1 Application 4 2.2 Quality Management System of the Supplier 4 2.3 Quality Management