QUALITY SYSTEM 9000

By: Ajay Agrawal Meeta Murarka

Introduction

Goal:
The goal for Quality System Requirements QS 9000 is the development of fundamental quality systems that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

Purpose:
QS-9000 defines the fundamental quality system expectations of Chrysler, Ford, General Motors, Truck Manufacturers and other subscribing companies for internal and external suppliers of production and service parts and materials. These companies are committed to working with suppliers to ensure customer satisfaction beginning with conformance to quality requirements, and continuing with reduction of variation and waste to benefit the final customer, the supply base, and themselves.

Conti

Approach:
QS-9000 is a harmonization of Chryslers Supplier Quality Assurance Manual, Fords Q-101 Quality System Standard, and General Motors NAO Targets for Excellence, with input from the Truck Manufacturers. ISO 9001:1994 Section 4 has been adopted as the foundation for QS-9000 and is printed in Section I in italic type. Interpretations and supplemental quality system requirements have been harmonized and are printed in normal type. While other companies may adopt this document, Chrysler, Ford, and General Motors retain full control over the content except for ISO 9001:1994, of which copyright remains with the International Organization for Standardization. The word shall indicates mandatory requirements. The word should indicates a mandatory requirement with some flexibility allowed in compliance methodology. Suppliers choosing other approaches to satisfy a should must be able to show that their approach meets the intent of QS-9000. All QS-9000 requirements shall be addressed in the quality system documentation, but not necessarily by individual procedures. Where typical, example, or e.g. are used, any suggestions given are for guidance only.

Applicability
QS-9000 applies to all internal and external supplier sites of: a) production materials, b) production or service parts, or c) heat treating, painting, plating or other finishing services directly to OEM customers subscribing to this document. QS-9000 applies to providers of: 1) semiconductors in conjunction with the Semiconductor Supplement issued by Chrysler, Ford and Delco Electronics; 2) tooling and equipment in conjunction with the Tooling and Equipment (TE) Supplement issued by Chrysler, Ford and General Motors. Availability of third party registration to the TE Supplement will be announced by Chrysler, Ford and/or General Motors as appropriate. Site (see Glossary) is defined as a location at which value-added production processes occur (see Glossary). Remote locations, e.g. engineering, purchasing, internal off-site warehouses, shall be audited as they support a site. Remote locations cannot obtain independent QS-9000 registration. Remote locations shall be included in the initial audit and then be included in the normal surveillance plan and at a regular frequency. Remote locations where design function is performed shall undergo surveillance audits at least once within each consecutive 12-month period. Service parts and materials applicability does not include aftermarket (see Glossary) parts or suppliers. If in doubt regarding QS-9000 applicability, contact your customer. Only those suppliers meeting the Applicability definition are requed to achieve compliance/registration. Any site may elect to pursue third party registration; however, such sites shall have demonstrated capability to comply with all QS-9000 requirements as evidenced by records (see 4.16) except for customer approval of the PPAP Part Submission Warrant. Only 4.19: Servicing (and 4.4: Design Control for ISO 9002) may be determined as not applicable by the certification body/registrar. Commercial/independent laboratory facilities cannot be registered to QS-9000. This document supersedes all editions of Chryslers Supplier Quality Assurance Manual, Fords Q-101 Quality System Standard, General MotorsNAOTargets for Excellence, General Motors Europe General Quality Standard for Purchased Materials and the Truck Manufacturers quality system manuals dated prior to 1995.

QS 9000 Awareness Information

Weve Done This Before...

Why will this be different?

Basic Responsibilities
Know your job duties! Know your documentation! Do you job correctly!

About QS 9000

QS9000 is a quality Standard developed by a joint effort of the Big Three" automakers ;
General Motors Chrysler Ford It was introduced to the industry in 1994. It has been adopted by several heavy truck manufacturers in the U.S. as well. Essentially all suppliers to the automotive industry need to implement a QS9000 system.

Description

The standard is divided into three sections with the first section being ISO 9001 plus some automotive requirements. The second section is titled "Additional Requirements" and contains system requirements that have been adopted by all three automakers - General Motors, Chrysler and Ford. The third section is titled the "Customer Specific Section" which contains system requirements that are unique to each automotive or truck manufacturer.

Enter QS 9000
ISO
A tool for any type of business Non-Specific: Any Industry Any Product

QS
Specific to: 3 Companies Automotive Focus A tool for doing business with: Ford GM Chrysler

The Basics
Say What You Do
This means document your systems so you will consistently do the job the same way every time. We must make sure we have appropriate documentation.

Do What You Say

This is what the auditors want to see. Objective evidence that what you say you are doing in your documentation is what you are doing in practice.

QS 9000 Documentation Origins

Motorola SPS Quality Policy

Quality Quality It

is about passion. is about caring.

is about executing every single detail of our jobs with such total care for the customer that our competitors appear amateur by comparison. is also about winning.

Quality We

must pursue quality in every thing we do, every day.

Quality Systems InterRelationships

Motorola QSR QS-9000 ISO9000

Motorola Six Sigma

ISO14000

Payback

Companies minimize deficiencies in supply and support of products and services. Companies identify problem areas and address them quicker. Companies identify customer needs more accurately. Companies become more consistent in their product and services.

What is Documentation?

There are different types of documents. At Motorola, for example, there are 12Ms. Sector has SOPs and maintains a Quality Systems Manual. There is process documentation in the manufacturing areas. Everyone uses documentation outside of work. If you buy something (like a clock), there are instructions in the box. That is documentation. Think of documentation as instructions. Documentation explains how to do things. The auditors job is to make sure everyone is Following Instructions.

What is Controlled Documentation?

A controlled document is typically one that is Revision sensitive - BUT - Not always!! If a controlled document is changed, a record of the change has to be made. This means we must have a History of All Changes. If a document is changed, people who use it must know about the change. This means there has to be a distribution list or other effective way to let everyone who uses it know the document has changed. Every employee must know how to check to see if documentation they are using is the most current version.

Quality System Requirements

QS 9000 Quality System Manual Level I Document

Level II Documentation - Quality System Procedures

Control Plans FMEAs Review Meetings Quality Records

Level III Documentation - Working Instructions

Level IV

Chrysler-Specific Requirement

Third-Party Registration Requirements

All Production and Service Part suppliers to Chrysler shall be ThirdParty Registered to QS-9000.

Product Creation Process

Reference Figure 1 showing the Chrysler Product Creation Process. Chrysler has a documented method of Product Assurance Planning (PAP). This method combined with the teams dedication and knowledge is the tool used throughout the product creation process to consistently develop and produce products that will satisfy the customer. All team members including suppliers shall participate in producing products using Chryslers PAP method. On occasions when Chryslers PAP method is not required, products shall be developed according to the Advanced Product Quality Planning (APQP) and Control Plan.

Implementation Of QS-9000

Overview: The quality system assessment process is used to determine if a suppliers quality system meets the requirements of this document. The process has been designed to provide this determination with minimal impact on the suppliers operations. The customer shall determine the method for verification of conformance to QS-9000. Alternative Method for verifying Suppliers Conformance: The alternatives are: Second party (customer) assessment - refer to QSA. Third party (quality system certification body/registrar) assessment and registration (see Appendix I). The customer may request from the supplier one or more of the following according to that customers requirements: The suppliers quality manual (level 1 documentation) Supporting procedures (level 2 documentation) A self-assessment using the QSA as requested by the customer Internal audit results Aplan with timing showing the suppliers process to obtain third party registration to QS-9000 (see Appendix B). Acopy of the accredited third party certification body/registrars certificate citing conformance to QS-9000 and the certification body/registrars reports.

List of Main QS Elements

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 Management Responsibility Quality System Contract Review Design Contro l Document and Data Control Purchasing Control of Customer-Supplied Prod uct Prod uct Identification an d Traceability Process Control Inspectio n and Testing Control of Inspection, Measuring and Test Equipment Inspectio n and Test Status Control of Non -Conforming Pro duct Corrective and Preventive Action Handling Storage Packa ging Preservation and Delivery Control of Quality Records Internal Quality Audits Training Servicing Statistical Techniques

Typical Types of Records

Contract Review Purchasing Identification and Traceability Process Control Inspection and Test Control of Measurement and Test Equipment Non-conforming Product Corrective and Preventive Action Internal Quality Audits Training

Records Management Activities

Management of Active records Records creation (forms) Design of records system

Retention schedule Vital records protection

Development of records procedures

Indexing Filing Access Disposition

Preparation

GAP Analysis and Document Mapping To prepare for the audit you should be reviewing your area for problems. Start at one corner of the room and sweep through it. Have a system to identify everything you have looked at. Be ready to identify and explain every piece of paper in your area whether on walls, in drawers or in open files (including 3 ringed binders).

Preparation 2

Find and read your Job Description. Is it relevant? Ask yourself what specifications you are supposed to be using? Review all the questions in this presentation. If there are any questions you cannot answer, FIND the answer - ask someone who knows! If you find what you believe is a problem, notify the appropriate person.

An Example Area Element Responsibility Chart

Management Maintenance

Area responsibilities come from Organization Charts.

ISO 9001 Ele me nt 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 Management Responsib ility Quality System Contract Review Design Control Document & Data Control Purchasing Control of Customer Supplie d Product Product Identification and Traceability Process Control Inspection & Testing Control of I, M&TE Inspection & Test Status Control of Nonconf orming Product Corrective & Preventiv e Actio n Handling, Storage, Preservation & Delivery Quality Records Internal Quality Audits Training Servicing Statistic al Techniques Not Yet Determin ed as of this Report Print Date Know n Def ic iencies - No Know n Resolution Plan Know n Def ic iencies - Resolutio n Behind Schedule Resolution Plan - Unknow n Status Resolution Plan On Schedule Area Appears Compliant (Not V erif ie d thru Audit) Area Complia nt (Verfied Through Audit)

U A A

Assembly - Set-Up

Quality Assurance

New Product Eng.

Tank & Fender

Areas go here.

Each area has certain QS 9000 elements it is responsible for complying with. Each should be listed and the departmental managers should know their responsible elements.

Frame Weld & Paint

Materials

Machine

Chrome

Paint

X A A X A U A U A A A

A A X A X X U A X A U U U A X A U X U A X A X X U A A X X U A A U U U S A X X S A X A X X U S A S A X

A A A A A A

A A A A A

We can track each areas compliance with a matrix like this one. Verification and validation are by the use of internal audits.
One element every area will have to comply with is Element 4.16 Quality Records. Does each area manager know what quality records they have and are responsible for?

A A X

X S B U A X C

It is very important that this responsibility chart be presented during staff meetings weekly to ensure that there is progress!

Internal Document Mapping

To QS 9000 Line Items
Re qui re ment Manage ment Respons ibility Qua li ty Pol i cy (Statemen t) Qua li ty Obj ecti ve s Organ izatio n (Qu al ity) Re spo nsib il ity & Au th ority Re sou rces a nd Trai ned P erson nel Mgmt. Re presentati ve (Qual i ty S ystem Re spo nsib il i ty) Organ izatio nal In te rfaces (per APQP & CP) Man age ment Revi ew Bu si ness Pl an An alysi s a nd Use of Co mpan y-Level Data Cu stomer Satisfacti on & Customer Compl ai nts Qua lity Sys te m Gen eral Qua li ty System Pro ced ures Qua li ty Pl ann in g (p er AP QP & CP) Use Of Cross Fu ncti ona l Te ams (per APQP & CP) QS 90 00 4.1 4.1.1 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 4.1.2.3 4.1.3 4.1.4 4.1.5 4.1.6 4.2 4.2.1 4.2.2 4.2.3 4.2.3 QA Man . Procedu re WI Co mme nt Cross Co lumn Ve ri fi ed (Date)

Minor

Registration
Motorolas registrar is LRQA. Registration lasts for 3 years. Registration is NOT a one-shot deal. Your company will be re-audited at least once a year.

Forever.
And ever.
And ever..... (Not a fairy tale!)

Registration Audit
Registration requires regular audits by your Registrar. These are called Third Party audits. Just as has been done in banks for years, auditing has reached every industry. Whether twice a year or once a year, your company quality system has to audited by the company which registers your company. LRQA is your Registrar.

What Is An Audit?

An Audit is a check to ensure that what a business says it does is actually what it is doing. In ISO 9000 and QS 9000 an audit is meant to validate that a company Says what it does and Does what is says. For the most part this is a verification and validation of written procedures, policies and related documentation.

What is an Auditor?

An auditor is a person. Their job is to validate documentation. This means they look at documentation (instructions) and make sure people are following the documentation.
Auditors go from company to company validating documentation. Auditors are just people who ask questions about how you do your job.

The Reason For Audits

Everyone is familiar with the idea of audits. One place we are all aware of audits is in the banking industry. For years, the government has required banks to submit to periodic audits by government agencies and/or external companies who specialize in auditing. Few people want to put their money in a bank where there are no controls such as periodic audits. If there are no audits, you have no way of knowing if your bank is using your money well. If the bank is not using your money well the bank could easily fail - then you could lose all of your money. Audits in manufacturing industries are not new. Customer audits have been going on for years. But only recently has the idea of third party audits become reality. This is in large part due to the adoption in Europe of ISO 9000 and other international standards.

Reasons for Audits 2

The intent of third party audits is to provide assurance that a company complies with a standard or specification. Many people say that third party audits will eliminate customer audits. This has not been the case up to now in part because customers still see the need to ensure compliance to their specific requirements. Even QS 9000, specific to Ford, GM and Chrysler suppliers, does not eliminate customer audits.

QS 9000 Reminders
Does

NOT define quality Is NOT a one-time process Is NOT easy Requires commitment Requires resources