QUALITY SYSTEMS BASICS

Worldwide Systematic Continual Quality Improvement At General Motors and Their Suppliers Using Basic Quality Tools and Common Principles Common Methods Common Processes

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

QUALITY SYSTEMS BASICS

Quality Systems Basics

This is a quality system of basic quality tools that General Motors has developed over the last 9 years for use internally and by their supply base. Th system is compatible with suppliers thi d party auditing t b The t i tibl ith li third t diti to standards such as ISO and TS. The system is required to do business with General Motors. Some of the tools included in the system are layered audits statistics control plans process failure audits, statistics, plans, mode and effects analysis plus many more. Suppliers systems are audited by General Motors. Quality Systems Basics provides a standardized system of quality management using simple quality tools that is currently used by General Motors and their suppliers and has helped in the success seen at General Motors today .
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

DREW CAMPBELL, BSc, MS, ASQ Certified Quality Auditor

Drew Campbell is a graduate of Brock University, in Ontario, with an Honours Degree in Science. He has also graduated from the University of Buffalo with a Masters of Science Degree Degree. Drew spent the first 31 years of his life working for a Chicago Tribune Newsprint Mill in Thorold Ontario. He worked there as an electrician and as part of the I t t f th International B th h d of El t i l W k ti l Brotherhood f Electrical Workers h spent 15 he t years as a Union Officer and Union President. He then moved into a Management position where he eventually became Acting Director of Quality of this billion dollar site He was part of the team that was able to site. make this paper mill one of the lowest cost, highest quality and cleanest mills in the world with cost savings of 234 million dollars a year. He met Dr. W. W Edwards Deming in 1985, when the company sought his help and with 1985 help, his and Dr. Harold Hallers direction achieved this accomplishment.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

DREW CAMPBELL
Drew has been consulting in New York State for the last 13 years. He has taught a MBA course in Hungary for the University of Buffalo and the State Department, worked in aerospace and the p p p plating industry and for the last g y 13 years has worked in Quality Systems within General Motors, Tonawanda, where he works as a Supplier Quality Engineer and has been able to provide 20 million dollars plus in cost savings and cost avoidance through the use of simple, basic quality tools. Drew has been on the Buffalo ASQ Board since the late 1991 and is a Certified Quality Auditor. Drew is an avid bird watcher and taught this y g subject, for five years in the part time studies program at Brock University. Drew has contributed to a recently published 700 page bird book called Niagara Birds.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

QSB Strategies
1. Fast Response
Fast Response Process Problem Solving Lessons Learned

2. 3. 3 4.

Control of Non-Conforming Product Verification Station Standardized Operations

Work Place Organization The 7 Wastes Standardized Work Instructions SOS Operator Instructions JES Manufacturing Gage Control

5. 6. 7. 8. 9. 10. 11.

Standardized Operator Training JIT Error Proofing Verification Layered Process Audits RPN Risk Reduction Contamination Control Supply Chain Management Managing Change

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

1.0 1 0 FAST RESPONSE

Solving S l i problems f t & earlier bl faster li upstream through visual management Holding task owners accountable g for timely corrective action
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain
FR PS NCP VS WPO SWI (SOS) OI(JES) MGC SOT EPV LPA Risk Contam SCM MC WS

FAST RESPONSE
1.0 - Introduction PURPOSE: SCOPE:

Immediately address quality failures External / Internal Defines the process to be p followed Defines method of displaying p important information as a visual management tool, supporting status at a glance. Applies discipline in responding to issues through a systematic approach.
Quality Systems Basic rev February 2011

Assembly Area Manufacturing Operations Shipping / Receiving All Operations Other Support Functions

RESPONSIBILITY:
Ownership Operations Manager Contingency Plan for All Situations

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

FAST RESPONSE
1.2 - Fast Response Summary

FAST RESPONSE PROCESS KEY STEPS

Quality gathers significant issues from the p yg g past 24 hours. Daily Fast Response Meeting assigns owner to each issue. Outside the meeting the owner utilizes the Problem Solving process to correct and prevent recurrence. Issues are tracked on the Fast Response Tracking Board. Owners are required to give periodic updates at Fast Response meeting. Owner responsible for completion of all exit criteria including Lessons L i l di L Learned. R d Results of P bl lt f Problem S l i Solving process communicated. Fast Response Tracking Board indicates exit criteria is green.
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

FAST RESPONSE
1.3 Problem Solving Step 3 Identify the Root Cause: (Example)
There are several t l Th l tools available to problem solve and get to the root cause. Their use is dependent upon the complexity of the process, the type of failure mode Fit, fail re mode, Fit Function, or Finish, and the system used to measure the specific p characteristic that failed which will be attribute or variable data.
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

Cause

Effect

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

FAST RESPONSE
1.3 Problem Solving Step 3 Identify the Root Cause:
As an initial root cause step, General Motors uses the 7 diamond process as an immediate reaction to internal Quality issues. The first 4 steps are used to quickly determine if an out of standard condition (special cause) exists. This will prevent excessive use of the statistical problem solving techniques.

(Example)

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

10

FAST RESPONSE
1.4 Lessons Learned A Lessons Learned system: Establishes a process for capturing information that will support continual improvement to all operations/processes. Prevents repeated mistakes allowing an organization to p g g capitalize on its successes. Applies to all functions and responsibilities, therefore, everyone in the organization should participate. All documentation that will support continuous improvement should be entered into a Lessons Learned system (e g Master PFMEA Problem system. (e.g. PFMEA, Solving, Read Across)
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

11

FAST RESPONSE
1.4 Lessons Learned Lessons Learned may be identified by anyone.
Examples of activities to Identify Lessons Learned: APQP Process Q Layered Process Audits Error Proofing Verification Failures Problem Solving activity for Internal or external Issues Verification Station Findings Continuous Improvement Teams Risk Reduction-Reverse PFMEA Team Activity Suggestion Programs gg g Company Business/Quality Operating System Management Reviews A disciplined approach to problem prevention using Lessons Learned shall be established. Activities within an organization to prevent future problems or improve performance th t build L i f that b ild Lessons L Learned may i l d d include. GM Drill Wide-Read Across communication and follow up APQP Program reviews of Lessons Learned
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

12

2.0 2 0 - CONTROL OF NONCONFORMING PRODUCT

Containment, Identification,

Segregation, Di S ti Disposition iti

Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

13

CONTROL OF NONCONFORMING PRODUCT Outline

2.0) Introduction; Purpose, Scope, Responsibility 2.1) Benefits 2.2) Nonconforming Identification 2.3) Segregation 2.4) 2 4) Containment 2.4.1 - Containment Worksheet 2.4.2 - Communication - Quality Alert, Internal/External 2.5) Disposition 2.5.1 2.5.2 2522.5.2 Reusable/Rework Reintroduce product Scrap

2.6 ) Summary; Shalls

Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

14

CONTROL OF NONCONFORMING PRODUCT

2.0 - Introduction PURPOSE: SCOPE:

Ensure that product that does not conform to specified requirements is: - Prevented from unintended use - Contained and/or segregated - Dispositioned by Management

Production material or components. Engineering Samples Prototype Samples Incomplete Processed material Other materials not intended to be shipped to the customer. Ownership Q lit Manager Quality M Contingency Plan for All Situations
Global Purchasing and Supply Chain

Ensure proper communication if p p there is an escape. Establish a consistent labeling identification process using Visual g Management such as (Stoplight) RED, YELLOW. GREEN method.
Quality Systems Basic rev February 2011

RESPONSIBILITY:

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

15

3.0 VERIFICATION STATION

IN-PROCESS CONTROL & VERIFICATION Satisfy Your Customer. . . Customer

Do not

Accept Build Ship

a Defect!

Solve Problems Through Teamwork!

Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

16

VERIFICATION STATION Outline

3.0) Introduction: Purpose, Scope, Responsibility 3.1) Benefits 3.2) Description, Roles, and Responsibilities 3.3) Defects Entering the Station Alarm & Escalation Immediate Response Leadership Support 3.4) Defects Leaving the Station Quality Feedback-Feed Forward Performance Metrics 3.5) Problem Solving ) g 3.6) C.A.R.E 3.7) Summary, Shalls
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

17

VERIFICATION STATION
3.0 Introduction PURPOSE: SCOPE:

Improve first time quality (FTQ) and process capability. capability Alert team members of changes in the process and know who and when to call for help help. Obtain the proper support to solve problems as they occur. Prevent escape of defects. Engage team members in Problem Solving to meet improvement goals. Ensure feedback from downstream customers
Quality Systems Basic rev February 2011

Manufacturing Operations Assembly Areas Anywhere 100% Inspection or containment is implemented. p

RESPONSIBILITY: Ownership Manufacturing Leadership Support from all Manufacturing, Engineering, Materials, and Quality leadership and staff

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

18

VERIFICATION STATION
3.2 Description, Roles, 3 2 Description Roles Responsibility

VERIFICATION STATIONS
Definition: The system of building quality in station through prevention, detection, and containment of abnormalities.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

19

VERIFICATION STATION
3.2 Description, Roles, Responsibility

WHAT IS THE PURPOSE OF A VERIFICATION STATION?

Verification Stations check if your process is gi ing you what it was o r giving o hat as designed to give you. Provides the means through an alarm system to address highest priority customer concerns (PR&R type defects).

It will also draw attention to the frequent, low severity nonconformances. (e.g. dirt, burns, b f ( di t b burrs, orange peel) l)

To improve the process by immediately engaging the Team in problem solving as the defects occur occur.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

20

VERIFICATION STATION
3.2 Description, Roles, Responsibility

Where Are Verification Stations Placed?

Points in the process or operation where there exists: high risk Poor FTQ high RPN low capability (Ppk, Cpk) Any operation with a Cpk or Ppk below 1.33 requires 100% inspection Between departments or distinct processes at point of cause.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

21

4.0 - STANDARDIZED OPERATIONS -5S WORKPLACE ORGANIZATION ORGANIZATIONA clean, well-organized work environment.

STANDARDIZED WORK (SOS)

What are the Major Steps, how long should it take? Steps

OPERATOR INSTRUCTIONS (JES)

Detailed Steps for What, How, and Why.

MANUFACTURING GAGE CONTROL

Product is qualified per plan to known standards & specifications
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

22

STANDARDIZED OPERATIONS
4. 1 - Introduction: PURPOSE :
To establish a repeatable, predictable baseline for continuous improvement involving the operator in both the initial and ongoing improvements to achieve the highest levels of safety, quality and productivity.

SCOPE :
Assembly Area Manufacturing Operations Repair/Rework Area All Operations Shipping / Receiving Other support functions (e.g. Inspection)

RESPONSIBILITY:
Single or Dual Ownership - M Manufacturing Engineering f t i E i i - Production Manager

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

23

ELIMINATION OF WASTE
Abstract Thinking Concrete Thinking

WASTE
+ Overburden Unevenness

Waste NOT Defined React To Large Examples Reactive Improvement

Waste Is "Tangible" Identify Many Small Opportunities Leads To Large Overall Change Continuous Improvement y y Note: The memory aid for the 7 Types of Waste is COMMWIP.
Global Purchasing and Supply Chain

Quality Systems Basic rev February 2011

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

24

5 S WORKPLACE ORGANIZATION
STEP ORIGINAL 5S OTHER 5 S TERMINOLOGY QSB DEFINITION
Determine the purpose of the area and remove all unnecessary items from the workplace.

PURPOSE
To prepare the workplace for the next 4 steps and to eliminate items that could cause injury, excessive cost, or any of the forms of wastes. To eliminate many of the forms of waste (such as ( correction & motion) and make items readily available to the user. To eliminate unsafe conditions, improve quality of our products, enhance the workplace i t identify d environment, id tif and correct equipment problems (cleaning is checking), and initiate corrective action to prevent future accumulation of unwanted materials. To allow for quick easy quick, easy, and effective maintenance of the workplace organization process.

Seiri

Organization

Sift

Tidiness

Clear

Sort

Seiton

Neatness

Sort

Orderliness

Organize

Straighten

Identify the best location for all required items in the workplace.

Seiso

Cleaning

Sweep

Cleanliness

Clean

Shine

To become aware of and eliminate all unwanted dirt, dust, grime, paint, labels, tape, etc

Seiketsu

Standardization

Sustain

Standardization Standardize

The standardization required to Standardize maintain the steps of work place organization.

Shitsuke

Discipline

Self-Discipline

Discipline

Continuous Improvement

Sustain

The system designed to sustain and support continuous To assure continuous improvement of workplace p p g growth of this p process. organization.

Workplace Organization is applicable to all types of environments (e.g. offices, conference rooms, tool cribs, operator workstations, team/group rooms, etc.).
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

25

STANDARDIZED OPERATIONS 4.3 WORKPLACE ORGANIZATION-5S ORGANIZATIONVisual Management of Out-of-Standard Conditions

4.4 STANDARDIZED WORK

4.4.1 Standard Operation; Major Steps, how l M j St h long should it t k ? (SOS) h ld take? (SOS) 4.4.2 - OPERATOR INSTRUCTIONS;
Detailed Steps for What, How, and Why. (JES) Why.

4.5 MANUFACTURING GAGE CONTROL

Product is qualified per plan to known standards & specifications

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

26

4.4 - STANDARDIZED WORK

Definition:
The document of work functions performed in a repeatable sequence, which are agreed to, developed, followed, and maintained by the functional organization.

WITHOUT STANDARDIZED WORK

WITH STANDARDIZED WORK

Purpose:
To establish a repeatable, predictable baseline for continuous improvement and to involve the operator in both the initial and ongoing improvements to achieve the highest levels of safety, quality and productivity.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

27

4.4.1 - STANDARDIZED WORK

STANDARDIZED WORK PROVIDES A FOUNDATION FOR FOR: Ensuring operators are consistently performing tasks and p procedures the same across all shifts and p personnel. An efficient production sequence. Identifying value added tasks. Reduced variation within a process. Waste reduction, line balancing and quality built in station Continuous improvement and problem solving A lean organization Auditing operator conformance to work instructions (Layered Process Audit).
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

28

STANDARDIZED OPERATIONS 4.3 WORKPLACE ORGANIZATION-5S ORGANIZATIONVisual Management of Out-of-Standard Conditions

4.4 STANDARDIZED WORK

4.4.1 Standard Operation; Major Steps, how l M j St h long should it t k ? (SOS) h ld take? (SOS) 4.4.2 - OPERATOR INSTRUCTIONS;
Detailed Steps for What, How, and Why. (JES) Why.

4.5 MANUFACTURING GAGE CONTROL

Product is qualified per plan to known standards & specifications

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

29

JOB ELEMENT SHEET

Definition:
A user friendly document that provides detailed information on a specific element of work to ensure the successful execution of that element element.

Purpose: p
To provide detailed training information for new team members. To bridge the gap between engineering information and shop floor knowledge. To provide a written history of that element. To provide a baseline for auditing, problem solving, continuous improvement, rebalancing of work and documentation transfer. g

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

30

OPERATOR INSTRUCTIONS
Where to use operator instructions?
Operator instructions are commonly available for: manufacturing and assembly inspection and data collection pack out laboratory

Often overlooked activities include: offline rework and containment set up set-up and change-over events change over prototype and engineering activities process labeling points material handling shipping and receiving hi i d i i maintenance/repair office
Global Purchasing and Supply Chain

Quality Systems Basic rev February 2011

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

31

STANDARDIZED OPERATIONS 4.3 WORKPLACE ORGANIZATION-5S ORGANIZATIONVisual Management of Out-of-Standard Conditions

4.4 STANDARDIZED WORK

4.4.1 Standard Operation; Major Steps, how l M j St h long should it t k ? (SOS) h ld take? (SOS) 4.4.2 - OPERATOR INSTRUCTIONS;
Detailed Steps for What, How, and Why. (JES) Why.

4.5 MANUFACTURING GAGE CONTROL

Product is qualified per plan to known standards & specifications

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

32

MANUFACTURING GAGE CONTROL

4.5 Introduction PURPOSE:
To establish a common set of definitions and set minimum requirements and guidelines of a system for managing calibration, surveillance of gages, and other measurement devices used within GM Supplier manufacturing sites to evaluate conformance to specifications of parts and products. ifi ti f t d d t

SCOPE: Applies to all devices used to evaluate conformance to part and product specifications

RESPONSIBILITY:
Ownership Quality Leadership Contingency Plan for All Situations
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

33

MANUFACTURING GAGE CONTROL

4.5.1 - Overview This Procedure applies to all GM Supplier Manufacturing sites.
At a minimum, sites should include the following devices within their gage procedures: d Gages included in the sites control plan Devices used to evaluate conformance to part and product specifications p Masters used to evaluate/adjust all devices under gage control Metrology lab and layout room devices Coordinate measuring machines and optical comparators Product torque wrenches and transducers Leak test orifices Balance, flow test weight viscosity and surface texture devices Functional test transducers e.g. torque to turn, final test Hardness testers and chemistry analyzer Personal tools and measuring devices Measuring, tools used to qualify or maintain production tools
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

34

MANUFACTURING GAGE CONTROL

4.5.1 Overview (continued) Organizations shall have written documented procedures for developing, ritten, developing
maintaining and establishing proper use and functions for manufacturing gages within GM supplier locations.

Gage Definitions:
GageAny device used to obtain measurement, or assess the conformance of a part or characteristic relative to specifications. Adjustment A AdjustmentA set of operations to bring a gage into a state of performance suitable for its use. CalibrationA set of operations that compares and evaluates under specified conditions, the relationship between a gage and a traceable g g standard CertificationA set of operations to document the results of a calibration, indicating conformance or non-conformance to specifications. Master a device used to check and/or adjust a gage to a specified value. MasteringA set of operations to verify that the gage results agree with the master.
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

35

MANUFACTURING GAGE CONTROL

4.5.1 Overview (continued)

Additionally:
The Th supplier should indicate in their gage procedure, li h ld i di t i th i d whether other special measuring devices, such as Error Proofing are in or out of scope for gage control activity. Device Mastering is a part of the gage procedure, but the frequency is at the discretion of the supplier. Last Part Checked should be held for confirmation of last known good part at a frequency of at minimum of 1 per shift. Best practice would be to retain hourly samples for each inspection, retained for the entire shift y p p or previous 8 hours.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

36

5.0 STANDARDIZED OPERATOR TRAINING

Was Operator training verified p g and documented?

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

37

STANDARDIZED OPERATOR TRAINING Outline

5.0) Introduction: Purpose, Scope, Responsibility 5.1) Benefits 5.2) The Principles of Learning 5.3) 5 3) How to Train - 4 Step Training Method 5.4) Training Certification - Records 5.5) Summary, Shalls

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

38

STANDARDIZED OPERATOR TRAINING

5.0 - Introduction: PURPOSE: SCOPE:

To ensure all Trainers are trained to and apply the same method of training when teaching others. To ensure all operators including temporary or supplemental t l t l employees work safely, follow standardized work and meet all q quality and p y productivity y requirements To ensure jobs are properly staffed and identify where y additional training or follow up is required to reduce the risk of failures escaping the process.
Quality Systems Basic rev February 2011

Manufacturing Operations Assembly Area Shipping / Receiving All O Operations ti Other Support Functions

RESPONSIBILITY:
Ownership Operations Manager Contingency Plan for All Situations
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

39

6.0 6 0 ERROR PROOFING VERIFICATION

Was e o p oo g verified? as error proofing e ed

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

40

ERROR PROOFING VERIFICATION Outline

6.0) Introduction; Purpose, Scope, Responsibility 6.1) Benefits 6.2) Method of Verification 6.3) Management Review 6.4) Summary; shall

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

41

ERROR PROOFING VERIFICATION

6.0 Introduction 6 0 - I t d ti Purpose: Assures error proof/detection devices are working as intended to prevent nonconforming product f d from being made or b i d transferred . Scope:

- Assembly Area
- Manufacturing Operations - Other support Functions Responsibility: Ownership -Quality Manager C ti Contingency plan f all l for ll situations

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

42

ERROR PROOFING VERIFICATION

6.1 - Benefits Assures error proof/detection devices are working as intended. Prevents nonconforming product from being made or transferred. transferred Establishes a history for each device; indicates when preventative maintenance or repair is needed needed. Instills discipline within the process.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

43

7.0 7 0 LAYERED PROCESS AUDITS

Were Leadership Layered Process Audits Performed?
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

44

LAYERED PROCESS AUDITS Outline

7.0) Introduction page: Purpose, Scope, Responsibility 7.1) Benefits 7.2) Process explanation 7.2.1) Schedule and tracking 7.2.2) Develop hi h risk it 7 2 2) D l high i k items f auditing for diti 7.2.3) Layered Process Audit Check sheet Concept 7.2.4) 7 2 4) Layered Process Audit Check sheet Evaluation 7.2.5) Countermeasure sheet 7.2.6) 7 2 6) Management Review Requirements 7.3) Summary, Shalls
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

45

LAYERED PROCESS AUDITS

7.0 Introduction PURPOSE: SCOPE:

Ensure consistent application pp and execution of standards. Improve built-in-quality and increase operator/leadership awareness facilitated by coaching/teaching interaction between leadership & p operators

Assembly Area y Manufacturing Operations Shipping / Receiving All Operations Other Support Functions

RESPONSIBILITY:
Ownership Plant / Operations Mgr Contingency Plan for All Situations

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

46

LAYERED PROCESS AUDITS

7.1 - Benefits e e ts Layered Process Audits provide a system to: verify compliance to the documented process. instill discipline. improve communication. improve overall quality. Ensures a high level of process control by identifying & controlling high risk / significant process elements. Maintains proper application of standards as defined & achieved through operational readiness process. Identify opportunities for improvement & provide a process for effective follow up.
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

47

8.0 8 0 - RISK REDUCTION PROCESS

PROACTIVE
REDUCING THE RISK OF A POTENTIAL QUALITY FAILURE. REVERSE PFMEA PROCESS

REACTIVE
ERROR PROOFING PAST QUALITY FAILURES
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

48

RISK REDUCTION Outline

8.0) 8 0) Introduction page: Purpose Scope Purpose, Scope, Responsibility 8.1) Benefits 8.2) PFMEA Overview 8.3) PFMEA Review Process ) 8.4) RPN Reduction Process 8.4.1) Proactive RPN Reduction Process 8.4.2) Reverse PFMEA Process 8.4.3) Reactive RPN Reduction Process 8.5) Management Requirements 8.5.1) Tracking Matrix
Quality Systems Basic rev February 2011

8.6) Summary, Shalls

Global Purchasing and Supply Chain
PS NCP VS WPO SWI (SOS) OI(JES) MGC SOT EPV LPA Risk Contam SCM MC WS

FR

49

RISK REDUCTION PROCESS

8.0 - Introduction PURPOSE: SCOPE: Assembly Area M f t i Operations Manufacturing O ti Shipping / Receiving All Operations Other Support Functions

Reduce the risk of a initial quality failures Error proofing past quality failures Ensure that Failure Modes have proper controls (prevention/detection) and work properly.

RESPONSIBILITY: Ownership Engineering Manager Operations Manager O ti M Contingency Plan for All Situations
Global Purchasing and Supply Chain

Quality Systems Basic rev February 2011

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

50

RISK REDUCTION PROCESS

8.1 - Benefits Supports continual improvement as expected by TS16949. Allows leadership to allocate limited resources to critical areas. p Provides a basis for effective error-proofing and problem solving. Core tool for APQP and PPAP requirements. Provides a Lessons Learned archive. Promotes cross-functional teamwork. Meets customer expectations for living documents.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

51

9.0 CONTAMINATION CONTROL

Keeping parts and processes clean and free of debris

Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

52

CONTAMINATION CONTROL Outline

9.0) Introduction: Purpose, Scope, Responsibility 9.1) Benefits 9.2) Contamination Philosophy Identifying contamination issues within individual operations (external / internal) which would potentially contaminate sensitive parts. 9.2.1) Sediment 9.2.1.1) Monitoring and measuring sediment (Sediment Lab) 9.2.1.2) Sediment reduction strategies 9.2.1.3) Clean rooms 9.2.2) Extra Parts reduction strategies 9.2.3) Dirt in i t 9 2 3) Di t i paint 9.2.4) Retained material in castings 9.3) Communication, Report Out Format 9.4) Problem Solving ) g Refer to Section 1.3 - Fast Response Problem Solving 9.5) Summary, Shalls
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

53

CONTAMINATION CONTROL
9.0 Introduction PURPOSE: SCOPE:

Improve part cleanliness over time via measurement, control and process / handling improvements. Utilize Utili a standardized t d di d systematic and a structured approach to monitor and control contamination sources such as sediment, extra parts in assemblies, paint and painted parts contamination. Apply a disciplined approach when responding to issues.
Quality Systems Basic rev February 2011

Manufacturing Operations Assembly Area Shipping / Receiving All I l t operations In-plant ti

RESPONSIBILITY:
Ownership Process / Manufacturing Engineering Evaluation of Performance Operations Manager Quality Manager Contingency reaction plan for all failures.
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

54

CONTAMINATION CONTROL
9.1 BENEFITS: Provides a systematic approach for Contamination Control and communication of Contamination issues. Provides elements of an effective control system. Assigns responsibility for contamination reduction. Supports and establishes defined areas of continual improvement. Prevents repetitive mistakes and reduces waste of resources. Transfers knowledge to all stakeholders in an organization. Improves Quality metrics: reduces PPM and warranty costs.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

55

SUPPLY CHAIN MANAGEMENT

10.0 - Introduction PURPOSE: SCOPE:

To provide a standard process for managing all of the supplier tiers in the supply chain. Ensure all tiers of the supply chain have systems and processes to evaluate, select, communicate expectations and requirements, requirements measure performance, and develop their suppliers. To provide final customer with high stability, high quality parts & service from initial Tier 1 thru entire supplier chain.
Quality Systems Basic rev February 2011

Applies to a suppliers entire supply chain, including all Tiers, sub-suppliers of raw material, outside processes, and purchased component suppliers.

RESPONSIBILITY:
Ownership Senior Purchasing Senior Leader Champion: Supplier Quality Leader
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

56

SUPPLY CHAIN MANAGEMENT

10.1 - BENEFITS Supports continuous improvement efforts and achievement of goals th l through applying common principles, methods, and h l i i i l th d d processes. Improves Quality metrics, reduces PPM and warranty costs. metrics costs Creates the ability to identify where problems exist and actions required to prevent additional problems entering the supply chain that negatively impact customer enthusiasm.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

57

11.0 11 0 Managing Change g

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

58

MANAGING CHANGE Outline

11.0) Introduction page: Purpose, Scope, Responsibility 11.1) Benefits 11.2) Change Process 11.3) PTR Process 11.4) Banking Process 11 4) B ki P 11.5) By-Pass Process 11.6) Summary, Shalls
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

59

MANAGING CHANGE
11.0 - Introduction PURPOSE: SCOPE:

Have a system to manage all p plant p process changes. g Planned Changes Unplanned Changes (Emergency) Establish a common Trial Run process with standardized communication, readiness reviews and quality reviews. Define minimum requirements for bypassing existing production processes. Implement a controlled banking process
Quality Systems Basic rev February 2011

Changes that may affect the final p product. Machines and systems that have been approved by the Customer. Manual and automated stations within the plant. Controlled through a Document Control Process. Process Ownership Operations Manager Manufacturing/Engineering Manager Quality Manager
Global Purchasing and Supply Chain

RESPONSIBILITY:

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

60

MANAGING CHANGE
11.1 - Benefits Improves notification and awareness throughout the organization regarding actions taken which may create out-of-control conditions. Assigns responsibility and process for communicating and conducting production trial runs. Improves quality of banked parts. Proactively defines and approves process methods / controls for bypassing and returning to an existing production process. Assures a systematic approach for all changes to customer approved processes.

Quality Systems Basic rev February 2011

Global Purchasing and Supply Chain

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

61

KEY STRATEGIES
1. Fast Response p Fast Response Process Problem Solving Lessons Learned 2. Control f Non-Conforming Product 2 C t l of N C f i P d t 3. Verification Station 4. Standardized Operations g Work Place Organization The 7 Wastes Standardized Work Instructions SOS Operator Instructions JES Gaging Standards 5. Standardized O 5 St d di d Operator Training t T i i 6. Error Proofing Verification 7. Layered Process Audits 8. Risk Reduction 9. Contamination Control 10. Supply Chain Management 11. Managing Change
Quality Systems Basic rev February 2011
Global Purchasing and Supply Chain

No Major Disruptions No N PRRS + 0 PPMS = World Class Quality

FR

PS

NCP

VS

WPO

SWI (SOS)

OI(JES)

MGC

SOT

EPV

LPA

Risk

Contam

SCM

MC

WS

62