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Business Process Flow. C U S T O M E R. C U S T O M E R. PROCESS MANAGEMENT. Requirements. Satisfaction. Input. Output. PROCESS. Important Differences of TS-16949-02. Process Approach to Auditing Performing the Audit and Preparation Customer Specifics, all customers
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Business Process Flow C U S T O M E R C U S T O M E R PROCESS MANAGEMENT Requirements Satisfaction Input Output PROCESS ISO/TS-16949- 02 training rev. 02
Important Differences of TS-16949-02 • Process Approach to Auditing • Performing the Audit and Preparation • Customer Specifics, all customers • *Audits will be performed on processes ISO/TS-16949- 02 training rev. 02
Process Approach to Auditing • The Organization shall describe the processes and their interrelationship.(4.2.2.c) • Primary and support processes in the Quality Manual. (4.2.2.c) • Primary Processes touch the customer directly • These Primary Processes are monitored, validated, & corrected when planned results are not achieved. (8.2.3) (8.2.4) (8.4) (8.5) • Primary Processes have an Owner that is responsible for the performance. ISO/TS-16949- 02 training rev. 02
Process Approach – Basic QMS Management Responsibility R E Q U I R E M E N T S S A T I S F A C T I O N C U S T O M E R C U S T O M E R Resource Management Measurement, Analysis & Improvement C.I. Product Realization Inputs Outputs Product ISO/TS-16949- 02 training rev. 02
Technology & Concept Development Plan Continual Improvement Feedback Assessment & corrective action Plan & Define ACT Product/Process Design & development DO Product & Process Validation Product /Process & Prototype Verification Confirmation of Product & Validation of Process STUDY ISO/TS-16949- 02 training rev. 02
Process – Basics A process has a beginning (input) & an end (output) Output – Satisfied customer Input -Customer Step 1 Step 2 Step 3 The Customer is at the input & the output C.O. P. ISO/TS-16949- 02 training rev. 02
O Organization I Notice how this is a literal application of Process Model Analysis of a Customer Oriented Process ISO/TS-16949- 02 training rev. 02
O Organization 1 D Customer Oriented Process (COP) 2 C Support Processes B A I Organization O Support A d 2 c Support Sub-Support Processes Process b a I Defining an Organization’s “Single/Unified Process Approach” ISO/TS-16949- 02 training rev. 02
Defining an Organization’s “Single/Unified Process Approach” Organization Activity 1 (O)utput Department “A” Support-process A Support-process B Support-process C Support-process (n) Activity 1 (I)nput ISO/TS-16949- 02 training rev. 02
Customer who has found products (O) Customer who wants to pay (I) Customer who wants to find products (I) Customer who has paid (O) 4 5 Customer who has a shopping cart (O) Customer who wants to find his car (I) 3 6 Customer who wants to be able to transport his purchases (I) 2 1 Customer who has found his car (O) Customer who has parked his car (O) The customer does not know of the existence of the supermarket “Incredible Edibles” (I) Customer who has a vehicle to park (I) Customers know the supermarket “Incredible Edibles” (O) Process Approach Chart ISO/TS-16949- 02 training rev. 02
Process Approach Automotive Application • for ISO/TS 16949:2002 • Key Questions of each COP • Are customer requirements understood and • fulfilled? • Is the process value added? • What are the results of Process Performance • and Effectiveness? • What is the evidence of Continual Improvement? ISO/TS-16949- 02 training rev. 02
WITH WHOM? TRAINING, KNOWLEDGE, SKILLS WITH WHAT? EQUIPMENT, INSTALLATION OUTPUT What Should We Deliver? REQU I REMENT S REQU I REMENT S INPUT What Should We Receive? PROCESS HOW MANY? HOW MUCH? KEY MEASURABLES HOW ? INSTRUCTIONS, PROCEDURE, METHODS Four Questions About a Process ISO/TS-16949- 02 training rev. 02
Input output Step 1 Step 2 Step 3 Process Approach • A set of interrelated activities which transforms inputs to outputs is a process. • Responsible process owner. • Defined process with inputs & outputs in a sequence. • Customer inputs are reviewed with the organization, supplier, &/or customer. ISO/TS-16949- 02 training rev. 02
Input output Step 1 Step 2 Step 3 Process Approach Cont. • Create measures of performance linked to customer’s requirements. • Compare/validate measures to requirements. • Analysis of differences/gaps. • Corrective actions to achieve requirements & to close gaps. • Repeat & improve processes ISO/TS-16949- 02 training rev. 02
Input output Step 1 Step 2 Step 3 Plan, Do Check, Action Primary Processes • Plan & Define “P” • Product & Process Design “D” • Product & Process validation “C” • Feedback, Assessment, & Corrective Action. “A” ISO/TS-16949- 02 training rev. 02
Process Approach Plan & Define Phase Inputs • Marketing/Bus. Plan • Feasibility/ Resources • Benchmarking data • Reliability studies • Product requirements • Customer Inputs • CAD, dwgs.,work statement specs. Outputs • Product plan • Who, what, & when • Quality objectives • Reliability goals • Prelim. Flow chart • Prelim. Mat’ Is • Training Plan • Mgt. Awareness & approval support ISO/TS-16949- 02 training rev. 02
Process Approach Product Design Phase Inputs • Product Plan. • Who, what & when • Quality objectives • Reliability goals • Prelim. Flow chart • Prelim. Mat’ spec • Training Plan • Mgt. Awareness Outputs • Design mfg./ ass’y. • Technical training • Eng. & Mat’. Spec. • DFMEA & Des. Revs. • Design verification • Drawings/Specs. • Equipment/Tooling • Test equip./ gages • Mgt. Awareness ISO/TS-16949- 02 training rev. 02
Process Approach Process Design Phase Inputs • Design mfg./ ass’y. • Technical training • Eng. & Mat’1. Spec. • DFMEA & Des. Revs. • Design verification • Drawings/Specs. • Equipment/Tooling • Mgt. Awareness • Test equip./ gages Outputs • Process flow chart • Floor plan layout • PFMEA & revs. • Process & W. I.s • Control Plan • QMS system review • Analysis of gages • Trained personnel • Capability Studies • Mgt. Awareness ISO/TS-16949- 02 training rev. 02
Process Approach Product &Process Validation Phase Inputs • Process flow chart • Floor plan layout • PFMEA & revs. • Process & W. I.s • Control Plan • QMS system review • Analysis of gages • Trained personnel • Capability Studies • Mgt. Awareness Outputs • Production trial run • Packaging eval. • Product testing eval. • Control Plan val.. • Capability results • Drawings/Specs. • Mgt. Sign off & awareness • Approval of part ISO/TS-16949- 02 training rev. 02
Process Approach Assessment of feedback & C. A. Inputs • Production trial run • Packaging eval. • Product testing eval. • Control Plan val.. • Capability results • Drawings/Specs. • Mgt. Sign off & awareness • Approval of part Outputs • Customer Satisfaction • Performance reports • Complaints/concerns • Reduced cost ($) • Delivery/Quality • Continuity of Purpose • Management review & • Internal audit • Improvement & Innovation ISO/TS-16949- 02 training rev. 02
Core Business processes Overview ISO/TS-16949- 02 training rev. 02
Product & Process Realization PROCESS ISO/TS-16949- 02 training rev. 02
Support Processes Requirement Reference Applicable Reference Ref. Doc. # NCN Quote Process 7.1.1-3, 7.2.1, 7.2.1.1, 7.2.2 7.2.2.2 Quotes CQR Agile item Project plans Risk assessment TGW/TGR Feasibility reviews Gate review records Quality Policy manual. MLP manual. MQSP 7.0 Change control 7.1.4 Eng change records Product Design & prototype 6.2.2.1,7.1, 7.1.1,7.1.2, 7.1.3, 7.1.5, 7.3.1,7.3.1.1, 7.3.2.1, 7.3.3.1,7.3.5, 7.3.6, 7.3.6.1, 7.3.6.2, 7.3.6.3, 7.3.7, Project plans Open issues log Designer qualifications Design input records Design outputs drawings, DVP&R Eng Spec. DFMEA Design review records Prototype Verification records Prototype validation records Prototype control plan Prototype Timing chart Gate review records Sample Linkage Matrix ISO/TS-16949- 02 training rev. 02
Manufacturing Operation ISO/TS-16949- 02 training rev. 02
Support Processes Requirement Reference Applicable Reference Ref doc# NCN Training 6.2, 6.2.1, 6.2.2, 6.2.2.2, 6.2.2.3 6.2.2.4, 6.4.1, 6.4.2 Training records Safety records Evidence of employee motivation & empowerment Quality Policy manual Corporate level II Plant level III Process/Product audits 8.2.2.2, 8.2.2.3 Product audit report Process audit report Product/product audit schedule Internal system audit 8.2.2, 8.2.2.1 Internal system audit schedule Internal system audit report List of qualified auditors Corrective actions for NC identified Preventive & Predictive Maintenance 7.5.1.4 Maintenance schedule Maintenance records Maintenance objectives & goals MO Sample Matrix ISO/TS-16949- 02 training rev. 02
Material Management ISO/TS-16949- 02 training rev. 02
Support Processes Requirement Reference Applicable Reference Ref doc# NCN Supplier Quality 7.4.1.2, 7.4.3, 7.4.3.2 Approved supplier list Suppler performance rating Receiving inspection records Supplier FMEA, control plans Supplier assessments Improvement plans Process Sign-off (PSO) Supplier PPAP documentation Quality Policy manual, Supplier quality manual, Corporate level II supplier Development Corrective Action 8.5.2 Purchasing 7.4, 7.4.11, 7.4.1.3, 7.4.2 7.4.3 Purchase order Regulatory requirements Incoming inspection 7.4.3.1 Inspection records Identification & Traceability 7.5.3,7.5.3.1 Identification instructions Product preservation 7.5.5, 7.5.5.1 Preservation methods First-in first-out system Stock assessment record MM Sample Matrix ISO/TS-16949- 02 training rev. 02
Business Process ISO/TS-16949- 02 training rev. 02
Support Processes Requirement Reference Applicable Reference Ref doc# NCN Management Commitment 5.1 MOS, Management Review Quality Policy manual Corporate level II for Management review MQSP 5.6 Customer focus 5.2 Business Forecast Quality policy 5.3 Quality Policy Statement Quality Planning 5.4 Management Review Session Minutes Responsibility, Authority, and Communication 5.5 Organizational Charts Job Descriptions Management Representative 5.5.2 Management Review 5.6 Management Review Session Minutes BP Sample Matrix ISO/TS-16949- 02 training rev. 02
Sales & Marketing ISO/TS-16949- 02 training rev. 02
Support Process TS Requirements Applicable Reference Documents NC Quality policy 5.3 Quality Policy Statement Customer Representative 5.5.2.1 Sales Organization Chart Work Instructions Planning Product Realization 7.1 MLP Customer Related Processes 7.2 MLP Customer Communication 7.2.3 Level 2 Procedures Level 3 Work Instructions Control of Design and Development Changes 7.3.7 MLP Customer Satisfaction 8.2.1 Metaldyne Operating System (MOS) Customer Satisfaction Metrics Level 2 / Level 3 Procedures and Work Instructions S&M Sample Matrix ISO/TS-16949- 02 training rev. 02