Quality Management Systems How ISO Processes Can Power Your Business Management System

Transcription

1 Quality Management Systems How ISO Processes Can Power Your Business Management System June 12, 2013 Helping Manufacturing Enterprises Grow Profitably

2 Session Objectives What s the benefit of a QMS? What are my options? How do I do it? What does it cost? How long does it take? What happens next year? 2

3 Benefits Industry Week Magazine Survey of Manufacturing Companies Find differences between otherwise equal companies that have unequal performance Key difference: Companies that have a system are measurably better than companies that fix problems as they occur. 3

4 Benefits Harvard Business Review Study: First large-scale study to examine ISO 9000 effects on employment and earnings Nearly 1,000 companies in California. 1. Sales are almost 9% higher 2. Employment is about 10% higher 3. ISO 9001 Companies are more likely to stay in business by a factor of 99.5% to 93% over 4 years 4

5 Benefits Personal Experience Growth Profitability Control Sustainability 5

6 QMS Options Informal System Inspection ISO Compliant Formal System Supplier Qualification Survey Six Sigma Certified UL, USDA ISO 9001 Derivatives: AS9100, ISO 13485, TS

7 QMS Options 1. Supplier Qualification Survey 2. ISO 9001 Quality Management System 3. AS9100 QMS: Aviation, Space & Defense 4. ISO QMS: Medical Device 5. TS 16949: Automotive 6. ISO 14001: Environmental Management System 7. DLA QSLM: Defense Logistics Agency 7

8 Supplier Qualification Survey Developed, Maintained and Delivered by. Public Document (Open Source) Intention was that large MN OEMs would use a consistent approach to evaluating suppliers Can be used with customers and with suppliers. 8

9 Supplier Qualification Survey 10 Sections, 57 questions 1000 points max The question weight can be customized Very strong scoring guidelines Each question is linked to ISO, cgmp and MBNQA clauses 9

10 Supplier Qualification Survey Document can be easily ed to a customer Used as an assessment tool before starting the ISO project EM delivery includes recommendations for techniques to implement each topic (best practices) 10

11 ISO 9001 The most common quality standard Most important parts (according to Kent) Quality Manual Procedures Internal Audit Management Review Corrective and Preventive Action 11

12 ISO 9001 Full system requires third party audit 2 to 4 day audit Surveillance audit, usually once per year 3 year cycle, then repeat Many companies claim ISO Compliant Allegedly have all the pieces, but don t pay for the third party audit Allegedly.. 12

13 ISO 9001 Hours to build a system Hours to maintain a system Keys to a successful project Quality Manager 13

14 ISO 9001 Forced to get certified Cummins Power Generation Want to get certified Can t get in the door Customer has more work, but only for certified suppliers Unexpected benefit The company runs better 14

15 ISO 9001 Other Project Costs Internal Audit training About $5,000 for a full class Registration Audit costs About $10,000 for a 25 person company Calibration costs Many companies have let this slide 15

16 AS 9100 Aviation, Space & Defense Additive to ISO 9001 Company gets 2 Certificates About 3 months longer than an ISO project Can be done as a separate project after the ISO project New AS 9100 revision is a big deal 16

17 AS 9100 It s harder to build and to maintain Need a good quality manager Very fussy about traceability Purchasing is a big challenge Revision C is hard for everyone But has important payback 17

18 AS 9100 Revision C PEAR Process Effectiveness Assessment Report Inputs, Outputs, Measures, Objectives, Results Old auditors can t cut it Both Internal and 3 rd party 18

19 AS 9100 Revision C Adds Required Processes (not procedures) Work Transfer Configuration Mgmt Risk Management Project Management 19

20 AS 9100 Registration Additional Costs (beyond ISO 9001) Registration Audit costs Pre-Assessment, Usually 1 day audit Stage 2 Registration Audit, start with 1 extra day 20

21 ISO Medical Device Quality Management System Many modifications to ISO 9001 Deals with Regulatory and Device Approval requirements Removes Continual Improvement requirements of ISO 9001 and AS 9100 Many additional procedures 21

22 ISO Requires a Device File for each model Complete manufacturing process Also for installation and servicing Risk Management Manufacturing Lot Record Keeping Cleanliness and Sterilization 22

23 ISO Environmental Management System (EMS) Sub set of ISO 9001 requirements Quality Manual Procedures Internal Audit Management Review Corrective and Preventive Action 23

24 ISO Aspects Impacts Legal Rqmts Emission of Gases from Boiler NOx Discharge to Atmosphere (Significant Aspect) NOx Regulations Limit Emissions Programs Targets Objectives Install Low NOx Burners (Sets Method) October 2001 (Sets Time Frame) 24 Decrease NOx Discharge by 15% (Goal)

25 ISO Want to get certified Company sees the reduction in materials and energy as a key improvement initiative. Company wants to reduce the MPCA burden Forced to get certified Hearing some requests from Rockwell Collins, but not being forced If selling into Europe Unexpected benefit The company runs better 25

26 ISO Easier if the company is already ISO 9001, but this is not a requirement. If ISO, or other QMS, we investigate: Separate system Blended system Integrated system 26

27 ISO Costs for Registration (beyond ISO 9001) Registration Audit costs Recommend Pre-assessment Instrumentation and assessment costs Such as power, gas or water to a workcenter 27

28 TS Automotive Quality Management System Full set of ISO 9001 requirements with additions Continual improvement, Emphasizing defect prevention Reduction of variation and waste in the supply chain. 28

29 TS Forced to get certified Donaldson Want to get certified Existing good control of processes, and see the automotive market as an opportunity Unexpected benefit The company runs better. Requires solid process development 29

30 TS Costs for QMS Registration Audit costs increase New gauging and statistics software (MiniTab) Probably needed to perform PPAP 30

31 DLA QSLM: Defense Logistics Agency There are multiple Department of Defense purchasing and warehousing operations that have their own quality system requirements These quality requirements are similar to AS

32 Other Quality Programs 8. ISO Six Sigma DMAIC 10. FMEA (Failure Mode Effects Analysis) 11. Pre-Production Approval Process (PPAP) 12. Pre-Assessment Audit 13. QMS Management Course 32

33 ISO Energy Management System (EMS) Sub set of ISO 9001 requirements Quality Manual Procedures Internal Audit Management Review Corrective and Preventive Action 33

34 ISO Similar in format and requirements to ISO Environmental Management System Requirements could be included as additions to an ISO

35 Six Sigma Originally developed by Motorola, made popular by GE Organizational approach to continuous improvement and problem solving Not a recognized QMS 35

36 Six Sigma Most common approach is to use DMAIC Define Measure Analyze Implement Control Effective, very formal addition to other improvement programs 36

37 FMEA Failure Mode Effects Analysis Gold standard for preventive action Reviews high risk work, formally assigning scores for: Likelihood Detectability Severity Results in a Risk Priority Number 37

38 PPAP Pre-Production Approval Process This is a robust, statistical analysis of the production of a part Request comes from your customer, through the Part Acceptance Warrant 38

39 PPAP Pre-Production Approval Process Design of the Process Process Capability Study Gage R&R Statistical Evaluation MiniTab Writing the report 39

40 Pre-Assessment Audit When you re not feeling confident Lets you fix problems without the trouble of formal corrective action Usually performed by your auditor 3 rd Party help is an option Expect tips to improve your system 40

41 QMS Management Course What do you do when your ISO Management Representative leaves? Need to develop a new QMS owner Provide ISO training from a QMS owner viewpoint Develop confidence to represent the company during the next audit 41