ISO 9000 Standard Awareness Course

What is ISO?
Acronym for International Organization for Standardization Greek word, isos meaning "equal".

Network of national standards institute of 156 countries, with a Central Secretariat in Geneva, Switzerland Practical , Tested , Quality Management Standards

The ISO 9000 Family of Standards

Current Structure:
ISO 9000 --- Fundamentals and Vocabulary ISO 9001 --- QMS Requirements ISO 9004 --- Guidelines for Performance Improvement

Philosophy behind ISO 9000 Standards

Everything is done through processes. Bad Processes result into bad Quality. What is a good Process? What is a bad Process? Are your processes under control? Are the results satisfying? If not improve the process. Is the Process documented? Write down process steps clearly. The Goal is preventing defects. This is the ISO 9000 Philosophy : to attain QUALITY

The Process Approach

PROCESS APPROACH The systematic identification and management of the processes and the interactions between processes, affecting the quality of products. PROCESS Any activity or set of activities that uses resources to transform inputs to outputs.
QMS LINK OUTPUT TO INPUT TO OTHER PROCESS MEASUREMENTS OBJECTIVES/KPIs VALUE ADDING TRANSITION

Goal
the

development of a quality management system that provides :

Continual improvement Emphasizing defect prevention The reduction of variation and waste in the supply chain

Benefits of QMS/Process Approach

1. Policies and objectives set by 'top management' 2. Understanding customer's requirements with a view to achieving customer satisfaction

3. Improved internal and external communications

4. Greater understanding of the organization's processes 5. Understanding how statutory and regulatory requirements impact on the organization and your customers

6. Clear responsibilities and authorities agreed for all staff 7. Improved use of time and resources 8. Reduced wastage 9. Greater consistency and traceability of products and services

10.Improved morale and motivation

The BUILDING BLOCKS of a PROCESS

1. Management Responsibility >>> who owns the process 2. Resource Management >>> personnel, skills, equipment, infrastructure, materials 3. Product Realization >>>the steps to make- realize- the product 4. Measurement, Analysis and Improvement >>>know what you need and what you have

Main Clauses of ISO 9001

4. Quality Management System 4.1 General Requirements 4.2 Documentation 4.3 Use of Quality Management Principles 5. Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Administration 5.6 Management Review

6. Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.3 Facilities 6.4 Work Environment

Main Clauses of ISO 9001

7. Product Realisation 7.1 Planning of realisation processes 7.2 Customer related processes 7.3 Design and / or development 7.4 Purchasing 7.5 Production & service Operation 7.6 Control of measurement device

8.

Measurement, Analysis & Improvement 8.1 Planning 8.2 Measurement & Monitoring of Product 8.3 Control of Non-conformity 8.4 Analysis of Data 8.5 Improvement

Mandatory Procedures
The standard specifies that the organization shall issue and maintain the following six documented procedures:
1. Control of Documents (4.2.3) 2. Control of Records (4.2.4) 3. Internal Audits (8.2.2) 4. Control of Nonconforming Product / Service (8.3) 5. Corrective Action (8.5.2) 6. Preventive Action (8.5.3)

Turtle Diagram
With What? *Equipment / Installations *Environmental requirement
INPUT OUTPUT Requirements Requirements

With Who?

What should we receive?

PROCESS

How Many? Performance Indicator

How?
Instructions, Procedures, Method

Continual Improvement Cycle

C U S T O M E R R E Q U I R E M E N T S

Management Responsibility
C U S T O M E R

Resource Management

C.I.

Measurement, Analysis & Improvement

S A T I S F A C T I O N

Inputs

Product Realization

Product

Outputs

BUSINESS PROCESS MAP

Outsourced Process: none Sales

Customer Requirements

Customer Satisfaction

Product Design

Production Planning/ Advance Product Quality Planning

Purchase of Materials

MAIN PROCESS / PRODUCTION XXXXXXXX

Product Inspection (Quality Assurance)

Warehouse and Delivery

Equipment Maintenance and Calibration (Engineering/Facilities/QA)

Support Processes Top Management Training Human Resources Accounting/Finance Quality, Environment, Health & Safety Production Control/Material Control Management Information System

QMS Processes Internal Audit Document Control Control of Records Corrective and Preventive Action Quality, Environment, Health & Safety

QUALITY POLICY
The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.

It is the commitment of AAA to provide customer with high quality products at a competitive cost, delivered on time. Through our Quality Management System, we commit to implement continual improvement activities at all levels of our organization to meet customer standard and other applicable requirements.

LEVELS OF DOCUMENTS
Definition
States the quality policy and describes the quality system Standards to implement the Quality Manual

Note
Level 1 Quality Manual

Vision / Mission

Level 2 Procedures

Procedures / Manuals

Detailed instruction on how to perform a specific task

Level 3 Work Instructions

Instructions

Evidence of activities performed

Level 4 Support Documents

Records Forms Files

Steps to obtain ISO 9000 Certification

1. Commitment of Top Management 2. Appointing Management Representative and Core Groups

3. Evaluation of existing quality system against the requirements of ISO 9001 Standards
4. Documents preparations / revisions 5. Training for the documented procedures and processes

6. Implementation of procedures. 7. Internal audits including root cause analysis, corrective and preventive actions. 8. Select Certification Body

9. Pre-assessment meetings / audit

10. Actual assessment and certification.

Process Name / Level:

Document No./ Release No.

Prototype Process - Farmington Hills (Level 2)

P ro c e s s O bje c t iv e :
Build and deliver on-t ime, prot ot ype part s t hat meet cust omer design & perf ormance requirement s.

345643/ERD 2345
P ro c e s s M e a s ura ble s :
1. On-t ime delivery. 2. Prot ot ype reject ions by t he cust omer.

P ro c e s s R is k s :
1. M issed delivery dat e t o t he cust omer. 2. Part s do not meet cust omer requirement s in qualit y or perf ormance.

S uppo rt P ro c e s s e s :
Conf igurat ion M anagement M anuf act uring Program M anagement Purchasing

Input s

P ro c e s s

O ut put s

R ule s / R e s po ns ibilit ie s
( 1) Sales Depart ment .

Cust omer Order

( 1) Receive Cust omer P.O., EDI, Phone, Fax, M ail

Funct ionally Test Prot ot ypes

( 2 ) Sales Depart ment . ( 3 ) Team usually can consist s of Engineering, Qualit y, Sales, Program M gt ., M anuf act uring.

( 2 ) Ent er order int o SAP Syst em

Test Issues ?

( 4 ) Sales Depart ment . Yes ( 5) If part s are required, part s may be ordered by Engineering, Sales or supplied int ernally f rom a TRW manuf act uring f acilit y. ( 6 ) Prot ot ypes built in accordance t o build checklist , drawings & specif icat ions. ( 7) Engineering t o coordinat e deviat ion or cust omer concurrence.

No

( 7) Resolve wit h t he Cust omer

( 3 ) Review Order Requirement s wit h Prot ot ype Team

( 8 ) Qualit y Inspect ion

( 8 ) Qualit y Assurance perf orms & document s inspect ions using inspect ion st andards or prot ot ype cont rol plans, depending upon t he specif ic cust omer requirement s. ( 9 ) Qualit y Assurance coordinat es any required deviat ions using t he specif ic cust omer f orms.

Order Issues ? Yes

No

Qualit y Issues ?

Yes

( 4 ) Resolve wit h Cust omer

No

( 9 ) Resolve wit h t he Cust omer

( 10 ) Qualit y Assurance document s result s using t he specif ic cust omer paperwork and maint ains copies f or f ut ure ref erence. Paperwork may be sent wit h t he prot ot ype part s or f orwarded t o t he cust omer via mail or f ax depending upon specif ic cust omer requirement s. ( 11) Shipping Depart ment packas part s and coordinat es develivery. Sales isrwponsbile f or alert ing shipping in advace if expidat ed develiry will be require3d. Prot ot ype Paperwork ( 12 ) Finance Depart ment coordinat es billing and collect ion. Sales Depart ment may assist in overdue collect ion t hrough direct cust omer cont act .

Yes

Revised P.O. Req'd?

No

( 5) Component s Invent ory Check

( 10 ) Complet e Prot ot ype Paperwork

( 11) Packing & Shipping Component s

Prot ot ype Part s

Drawings

( 6 ) Build Prot ot ypes

( 12 ) Issue Billing t o Cust omer

Cust omer Invoice

Specif icat ions

Process Nam:

Back to Marshall Key Processes

P ro c e s s R is k s : P ro c e s s M e a s ura ble s : 1 . On-time delivery perfo rmance repo rt (internal). 2. On-time delevery perfo rmance repo rt (external) 3. P remium Freight. 4. Custo mer Quality 5. Finished Go o ds Invento ry 6. Finished Go o ds A ccuracy

Document No.

Revision

Marshall Shipping Process

P ro c e s s O bje c t iv e : Ship quality pro duct per 1 . On-line system go es do wn and custo mer o rders are missed. custo mer requirements. 2. The wro ng quantities are shipped. 3. The shipment is no t o n time to the custo mer schedule. 4. Custo mer no t no tified (no A SN) 5. No invo ice o r no t co rrect. 6. Custo mer requirements no t met.

MPM0078

A
S uppo rt P ro c e s s e s : M aterial M anagement Do cument Co ntro l No n-Co nfo rming M aterial

Input s

P ro c e s s

O ut put s

R ule s / R e s po ns ibilit ie s / C o m m e nt s 1. S hipping A s s o c ia t e

Report and M ove to Finished Goods

Warehouse Storage

Invoice Customer

Assemble/Verify Shipment Pull Signal to M anufacturing

G o v e rning D o c um e nt s
Ship Product

1. S hipping ins t ruc t io ns . 2 . G o v e rnm e nt R e gula t io ns 3 . C us t o m e r R e quire m e nt s

Process Nam:

Back to Marshall Key Processes

P ro c e s s R is k s : P ro c e s s M e a s ura ble s : 1 . On-time delivery perfo rmance repo rt (internal). 2. On-time delevery perfo rmance repo rt (external) 3. P remium Freight. 4. Custo mer Quality 5. Finished Go o ds Invento ry 6. Finished Go o ds A ccuracy

Document No.

Revision

Assemble / Verify Shipment

P ro c e s s O bje c t iv e : Ship quality pro duct per 1 . On-line system go es do wn and custo mer o rders are missed. custo mer requirements. 2. The wro ng quantities are shipped. 3. The shipment is no t o n time to the custo mer schedule. 4. Custo mer no t no tified (no A SN) 5. Dro pped parts.

MPM0079

A
S uppo rt P ro c e s s e s : M aterials M anagement Do cument Co ntro l No n-Co nfo rming M aterial

Input s
Delivery Note from Customer Service Review Pick List

P ro c e s s

O ut put s

R ule s / R e s po ns ibilit ie s / C o m m e nt s 1. S hipping A s s o c ia t e 2 . S hipping C le rk

Stored Finished Goods

Consult SAP inventory screen.

Reference on-hand inventory screen when picking shipment

Is container within the two week window of stock

No

Identify out of rotation or missing box and forward to inventory analyst. (2) Warehouse Nonconformance

Yes Yes Yes

G o v e rning D o c um e nt s
Is all stock available? No

1. C us t o m e r P a c k a ging S pe c if ic a t io ns 2 . D e liv e ry N o t e
Contact M anufacturing or Customer Service

Yes No Is the box damaged or dropped?

3 . H o nda D e lt a S ys t e m 4 . D C X S M A R T S ys t e m 5 . F o rd D D L 6. M M OG

Is stock in the correct quantity?

No

No

Yes

Is another box required?

Pull Order

Shipment Configuration

Assemble order per customer directives

Place on truck