MEETING ISO 9000 STANDARDS FOR

QUALITY IN PRODUCT DEVELOPMENT

Michael Prudhomme and Francois Lamy

June 8, 2016

liveworx.com # L I V E W O R X
MEETING ISO 9000 STANDARDS FOR QUALITY IN PRODUCT DEVELOPMENT

• Updates in ISO 9001:2015 emphasize traceability, collaboration, and risk management throughout the
product development process. In this session, attendees will learn about harmonized product
development processes in PTC Windchill that enable companies in highly regulated industries like
medical devices to address ISO 9001:2015 updates ( and it’s derivative standards ) with one PLM
solution. With capabilities to manage changes throughout the product lifecycle, to trace the impact of
those changes in quality feedback systems, and to address quality issues with not just corrective
measures but preventive ones supported throughout the design development and manufacturing
processes. PTC Windchill meets the recommendations of the new standard to close the loop on product
quality and product development.

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 AGENDA
 Last Year Refresh – Case for QMS in PLM – CAPA

 The Journey to Connected Quality

 ISO 9001:2015 – Formal introduction of Risk Processes

 Risk Integrated across the Product Life Cycle

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 AGENDA
 Last Year Refresh – Case for QMS in PLM – CAPA

 The Journey to Connected Quality

 ISO 9001:2015 – Formal introduction of Risk Processes

 Risk Integrated across the Product Life Cycle

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CAPA SYSTEMS
• A True CAPA is not an Issue Log
– Surveillance + Corrective Actions & Preventive Actions = Continuous Improvement
– CAPA systems create self righting products & processes

• CAPA Corrective Action Preventive Action

– Corrective Action: Action taken to prevent re-occurrence of a problem
– Preventive Action: Action taken to prevent the initial occurrence of a problem

• How best to Consolidate CAPA systems

– Focus on key elements
– Consolidate using Key elements

• Key Elements – “The Loop”

– Leverage System Engineering especially Risk and Failure Analysis work
– Integrated Engineering all the way though

• Ford & Firestone – “ A Thought Experiment”

– Use Historic example to illustrate what is important

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FIRESTONE / FORD TIRE CONTROVERSY – OUTCOMES
• Over 240 Deaths [2]

• Over 3,000 serious injuries [3]

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CENTRALIZED QUALITY MANAGEMENT WITH PLM – “THE LOOP”
Audit Issues Nonconformance Customer Experience Management

• Create Audit Project from Template • Enter Nonconformance from Shop Floor or with ERP or • Issue Capture From all sources, Field Service, Call
• Assign and Track Audit Checklist Activities MES Integration Center, Sales
• Lead Auditor Creates Audit Issues Programmatically • Record Immediate Actions, Segregation, Corrections, • Returned Product Investigation, Failure Investigation
upon Final Check-in • Perform MRB, Dispositions & Route to Approvals • Quality Investigations, Product Safety & Regulatory
• Evaluate if Further Dispositions are Necessary • Escalate to CAPA Reports
• Escalate to CAPA • Escalate to CAPA

Windchill Report Builder , Queries, Reports and Data Monitor

 Surveillance Systems use CAPA/SCAR

engineering Risk and Failure
Data • Access Related Quality Inputs  All Inputs use same Codes

• Identify Root Cause  Root Cause Code FMEA

• Create & Approve CAPA/SCAR Action Plan,  Integrate Engineering Change

Implement Engineering Changes & Config Mgmt

• Confirm and Verify Effectiveness  Monitor for re-orccurance

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BY USING RISK CODIFICATIONS IN SURVEILLANCE

What we effectively do is put the Engineer in the Vehicle

An Engineer who designed the vehicle was riding in it the first time the
tread separated

He/She would probably immediately recognize the effect of tire separation

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 AGENDA
 Last Year Refresh – Case for QMS in PLM – CAPA

 The Journey to Connected Quality

 ISO 9001:2015 – Formal introduction of Risk Processes

 Risk Integrated across the Product Life Cycle

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HOW DOES QUALITY INFORM PRODUCT DEVELOPMENT TODAY?

CHANGE Control RISK Prevention EVERY Stakeholder

Typical state for discrete manufacturers

Many sources for quality data .. …separated from engineering, mfg, & service:
PLM:
• CAD Data
• Enterprise Parts
Nonconformances • BoM, Options Manufacturing:
Process Quality • Change Mgmnt
Documents • MBoM
• Project Mgmnt • Manufacturing Planning
• Inspections

Service:
• Service Planning
Training and Audits • Field Performance
Safety, Risk, Customer Complaints CAPAs
Reliability

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WHAT ARE THE RESULTS?

High High IT / Fewer

Warranty Poor
Training Resolved
Costs Visibility
Costs Issues
Typical state for discrete manufacturers
Many sources for quality data .. …separated from engineering, mfg, & service:
PLM:
• CAD Data
• Enterprise Parts
Nonconformances • BoM, Options Manufacturing:
Process Quality • Change Mgmnt
Documents • MBoM
• Project Mgmnt • Manufacturing Plannin
• Inspections

Service:
• Service Planning
Training and Audits • Field Performance
Safety, Risk, Customer Complaints CAPAs
Reliability

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BECAUSE THIS LENGTHENS THE TIME FROM FAILURE TO FIX

Failure Failure is Failure is Identify Trends Root Cause Corrective / Preventive Actio
Occurs Noticed Reported Analysis

Time

Many sources for quality data .. …separated from engineering, mfg, & service:
PLM:
• CAD Data
• Enterprise Parts
Nonconformances • BoM, Options Manufacturing:
Process Quality • Change Mgmnt
Documents • MBoM
• Project Mgmnt • Manufacturing Plannin
• Inspections

Service:
• Service Planning
Training and Audits • Field Performance
Safety, Risk, Customer Complaints CAPAs
Reliability

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CONNECTED QUALITY

Failure Failure is Failure is Identify Trends Root Cause Analysis Corrective /

Occurs Noticed Reported Preventive Action

Connected Products :
• Failure Occurs – Analytics in PTC Quality Solutions, create :
• Sensors Detect metrics, trending,
• Failure Data is reported
directly into quality system One PLM &
Quality
Backbone
Change-managed
Process-driven
Secure access

Reduce the Time from Failure to Fix Prevent the issue in next-generation products

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 AGENDA
 Last Year Refresh – Case for QMS in PLM – CAPA

 The Journey to Connected Quality

 ISO 9001:2015 – Formal introduction of Risk Processes

 Risk Integrated across the Product Life Cycle

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BACKGROUND - ISO 9001 & PLM
• ISO 9000 - The concepts and Language for a family of standards related to quality
management systems.
– designed to help organizations ensure that they meet the needs of customers and other stakeholders.

ISO 9001 Certification produces “Conformity of Product and Service that meets the needs of the customer”

• The ISO 9001 Series describes standards for a Quality Management System (QMS)
addressing the principles and processes surrounding the Design, Development, Delivery
and Service of a general product or service. This is the general PLM standard.

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BACKGROUND ISO 9001 HISTORY OF CHANGES
“All ISO standards are reviewed every five years to establish if a revision is required to keep it
current and relevant for the marketplace.”
• ISO 9001:1987
– Initial - Prescriptive – required documented procedures & records
– Same as UK Standard BS 5750, with three 'models' for quality management systems

• ISO 9001:1994
– Prescriptive – required documented procedures & records
– Emphasized quality assurance via preventive actions and continued to require evidence of
compliance with documented procedures.

• ISO 9001:2000
– Introduction of Process Approach – still required documented procedures & records
– 'a documented system' not a 'system of documents'

• ISO 9001:2008
– Process Focus – Concentrate on managing processes less on documentation

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BACKGROUND ISO 9001 HISTORY OF CHANGES

• ISO 9001:2015
– Extends Process Focus managing using Plan-Do-Check-Act
– Adds focus on Risk as a Backdrop to Process
– Greater integration with other ISO management standard thanks to a common high-
level structure
• “The new version also provides a solid base for sector-quality standards (automotive
TS16949, aerospace AS 9100, medical industries ISO13485, etc.), and takes into
account the needs of regulators.”
• http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2002

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BACKGROUND ISO 9001 - QUALITY IN INDUSTRY

1.1M 2015 ALL

Companies and their Year of the latest Industry verticals &

Who
BU’s are ISO-certified version of ISO 9001 sizes of companies

Uses ISO 9001?

All Industries, Right Now.

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COMMON STANDARD - CORE ELEMENTS & DERIVATIVES
Aerospace & Electronics & Medical Retail &
Automotive High Tech Industrial Device Consumer
Defense

ISO 9001 Base Requirements & ISO ISO 9001 Mandatory Procedures are those that all industries
9001 Mandatory Procedures are those that all industries
require to create the foundation of the derivative Standards
Each industry has evolved a setProcedures require to create the foundation of the derivative Standards
of requirements for Product
Mandatory • Control of Documents (4.2.3)
Development, Management, Service, & support. • Control of Documents (4.2.3)
• Control of Records (4.2.4)
Are used across all industries •• Control of Records (4.2.4)
Internal Audits (8.2.2)
Internal
So building a Quality Management System Is difficult •if you only Audits (8.2.2)
• Control of Nonconforming Product / Service (8.3)
look at industry specific standards. • Control of Nonconforming Product / Service (8.3)
• Internal Nonconformance
• APQP Standards for each Industry are created• by
Derivative Internal Nonconformance
• External Nonconformance –Complaints
• 8D – Automotive • External Nonconformance –Complaints
adding
• …….
industry specific requirements to• the
Corrective Action (8.5.2)
• Corrective Action (8.5.2)
Mandatory Procedures • Preventive Action (8.5.3)
• Preventive Action (8.5.3)
• Risk Management

AS9100 ISO 16949 ISO 9001 ISO 13485

ISO 9001 ISO 9001
ASE APQP IEEE 21 CFR Part 820

Aerospace & Electronics & Medical Retail &

Automotive High Tech Industrial Device Consumer
Defense
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ISO & PLM
PLM is the backbone to evolve the complete definition of a product over its entire life:
Concept Design Manufacture Service
- CAD
- Portfolio Management Based Information -–Mfg
Product-Based
- RiskProduct
& Hazards
Process
Design, Plans
BOM, Parts, Variants - Service Ticketing
- Nonconfor-mances
- Product Requirements - FMEA
Document Based Information -–CAPA - Warranty
SOPs, Policies, Quality Manuals
- Design Inputs - Design Validation - Inventory Mgmt
Change Control – Revision history / change - Mfg BOM of parts, Bills of Material, documents
management
- Quality History - Design Reviews - Complaints
- Instructions
- CAPA - FRACAS
Quality Records Based on Products & Documents- Supplier
– FMEA,Mgmt - CAPA Audits etc..
MTBF, CAPA, NCs, Complaints,
- CAPA

• Products - Provide Control of Product information / CAD Mgmnt, BOM, BOO, history, documentation
• Documents - Manage & Control all key documents, with associativity to related parts
• Change – Manage change process to capture inputs, workflow, approvals and execution of change
• Quality – Quality Activities & Processes interact with the Anchor Points for Products and Processes

Enables: Benefits:
- Control of Documents (4.2.3) - Supports all ISO 9001 Derivative Standards: ISO 13485 & 16949, AS9100
- Control of Records (4.2.4) - Provides a uniform approach
- Internal Audits (8.2.2) - Speeds implementation – reduces costs
- Control of Nonconforming Product (8.3) - Provides immediate value
- Corrective Action (8.5.2)
- Preventive Action (8.5.3)
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THE QUALITY PERSPECTIVE ON INTEGRATION WITH PLM
Integrating PLM with Quality leverages change-managed PLM data and functionality
Directly reference
Enterprise parts from
Quality processes
Q Q such as Complaints,
Document Parts NCs, CAPAs, Audits
Management Management

Q
Change-managed, Change Management
configuration-controlled
Drive change directly from
quality documents (SOPs,
quality investigations in the
work instructions, quality Q same system from their related
manuals, audits) associated
quality artifacts
to quality and engineering
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CENTRALIZED QUALITY MANAGEMENT WITH PLM – “THE LOOP”
Audit Issues Nonconformance Customer Experience Management

• Create Audit Project from Template • Enter Nonconformance from Shop Floor or with ERP or • Issue Capture From all sources, Field Service, Call
• Assign and Track Audit Checklist Activities MES Integration Center, Sales
• Lead Auditor Creates Audit Issues Programmatically • Record Immediate Actions, Segregation, Corrections, • Returned Product Investigation, Failure Investigation
upon Final Check-in • Perform MRB, Dispositions & Route to Approvals • Quality Investigations, Product Safety & Regulatory
• Evaluate if Further Dispositions are Necessary • Escalate to CAPA Reports
• Escalate to CAPA • Escalate to CAPA

Windchill Report Builder , Queries, Reports and Data Monitor

 Surveillance Systems use CAPA/SCAR

engineering Risk and Failure
Data • Access Related Quality Inputs  All Inputs use same Codes

• Identify Root Cause  Root Cause Code FMEA

• Create & Approve CAPA/SCAR Action Plan,  Integrate Engineering Change

Implement Engineering Changes & Config Mgmt

• Confirm and Verify Effectiveness  Monitor for re-orccurance

#LIVEWORX 22
 AGENDA
 Last Year Refresh – Case for QMS in PLM – CAPA

 The Journey to Connected Quality

 ISO 9001:2015 – Formal introduction of Risk Processes

 Risk Integrated across the Product Life Cycle

#LIVEWORX 23
 CASE FOR QUALITY – INTEGRAL MED DEVICE SUITE
2.0
11.0
.0 Preform Risk Analysis to predict Reliability and
Identify areas of concern in Design or
New product is initiated in stage one of the Manufacturing
Corporate Quality Design Control process by evaluating lessons 3.0
learned from prior products. Then creating a new First on Functional then Detailed Design Generate
Product with Customer Requirements and CTQs ( Critical to Quality Characteristics )
establishing a High level end item for it. 3.0
Use CTQ to Create Validation Tests
Start Engineers Design Product and Generate Control Plans for
Manufacturing
1.0
Use Failure Mode and Effect Codes
Initiation New Product to setup Failure Codification for
Surveillance Systems FMEA and
from Requirements CTQ
2.0

Perform Risk Analysis

3.0
Generate CTQ, Control
Plan and DVP
4.0 6.0 5.0
7.0 6.0
Initiate Surveillance 5.0
Compare Predicted versus Actual
5.0
and Corrective Action Failure Modes and Grade Product
Performance 4.0
Utilize Lessons Management Review
5.0 Learned with New Surveillance & Corrective Action All Quality
can Prioritize Corrective inputs Use the outcome of engineering
Compare Predicated Products Action with Closed Loop process to both quantify and codify any
vs Actual Failure Engineerign Change Failure
4.0
Modes CAPAs then are initiated directly from the
6.0 quality inputs
Management Review,
CAPA and Change
7.0

Utilize Lessons
Learned

End
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