+ All Categories
Home > Business > Harmonize your qms model to meet iso 13485 regulations april 2013

Harmonize your qms model to meet iso 13485 regulations april 2013

Date post: 20-Jan-2015
Category:
Upload: john-cachat
View: 1,060 times
Download: 0 times
Share this document with a friend
Description:
 
Popular Tags:
47
Copyright 2010-2013 John Cachat Harmonize Your QMS Model to Meet ISO 13485 Regulations John M. Cachat [email protected]
Transcript
Page 1: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Harmonize Your QMS

Model to Meet ISO

13485 Regulations

John M. [email protected]

Page 2: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Housekeeping

Phones are muted

Use the question

block for questions Copy of presentation

available upon request

Page 3: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

About John M. Cachat

• Driving Business Performance

– Helping companies align their business and technology

– Focus on people, process, and then the technology

– Subject matter expert on business process management

– On-going research into next generation of technology for enterprise

systems

• 28 years experience in enterprise systems

– USAF Research Project (1985)

– Founder of enterprise quality software company (1988)

– Chair of ASQ technical committee on computerizing quality (1992)

• Trusted advisor to global organizations, government agencies,

and professional groups

http://www.linkedin.com/in/johncachat

Page 4: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Agenda

• The requirements of ISO 13485

• Why you should become registered to this

standard

• The best quality management software

strategy to help you achieve compliance

4

Page 5: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

• The medical device market will present greater opportunity and greater challenges for device companies, as it grows by 19.9 percent from 2009-2013

• The medical market is one of the most demanding sectors to serve, as rigorous oversight from regulators and customers requires "robust operational management"

• United States remains the largest consumer and producer of medical devices, others are growing rapidly

• United States’ medical device market was valued at more than $100 billion in 2008, accounting for roughly 42% of the world’s total

Medical Device Opportunity

5

Page 6: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

ISO13485 Concepts Apply to ALL Markets

6

Page 7: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

ISO13485 = ISO9000 plus

• The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.

• Controls in the work environment to ensure product safety

• Focus on risk management activities and design transfer activities during product development

7

Page 8: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

ISO13485 = ISO9000 plus

• Specific requirements for inspection and

traceability for implantable devices

• Specific requirements for documentation and

validation of processes for sterile medical

devices

• Specific requirements for verification of the

effectiveness of corrective and preventive

actions

8

Page 9: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Comparison of ISO900 and ISO13485(source 13485store.com)

9

Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001

Page 10: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Comparison of ISO900 and ISO13485(source 13485store.com)

10

Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001

Page 11: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Comparison of ISO900 and ISO13485(source 13485store.com)

11

Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001

Page 12: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Comparison of ISO900 and ISO13485(source 13485store.com)

12

Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001

Page 13: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Comparison of ISO900 and ISO13485(source 13485store.com)

13

Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001

Page 14: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

“Quality” in Your Organization

Is it just a cost of doing business?

OR

Is it a competitive advantage?

14

Page 15: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Quality as a Competitive Advantage

• Quality professionals need a better

understanding of financial terms

and methods

• Executives need a better

understanding of Quality terms and

methods

• Everyone need to focus on

profitable business growth

15

Page 16: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Are We That Different?

Finance – SOX, GAAP Quality

Documentation Documentation

Training Training

Audits Audits

Risk Management Controls

16

Page 17: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Are We That Different?

Finance Quality

Likes Numbers Likes Numbers

Likes Processes and Audits Likes Processes and Audits

Discusses Cash, Profit, etc. Discusses PPM, CAR, Cpk, etc.

Reports what happened Can explain why it happened

17

Page 18: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

The Disconnect between

Accounting and Manufacturing

• Finance has been consumed with GAAP and audited financial statements for external

reporting

• These traditional GAAP reports do not help manufacturing

• What information can Quality provide the organization to help make better decisions?

• How can this “quality” stuff help profitable growth?

18

Page 19: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Quality Costs Model

• Prevention—cost to

prevent mistakes

• Inspection—cost to

find mistakes

• Failure—cost of

mistakes (internal &

external)

19

Page 20: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Management Accounting

• Information for internal business support

• Great gains can be made by Quality and

Accounting working together

• The main focus should be cause and effect

analysis

• What makes this number go up or down?

20

Page 21: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cause and Effect ExampleIncrease Profit on New Products

21

PEOPLE

MFG PROCESS

EQUIPMENTPRODUCT

DESIGN PROCESS PURC PROCESS

INCREASE

PROFIT ON

NEW PRODUCTS

Page 22: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Increase Profit on New Products

22

INCREASE

PROFIT ON

NEW PRODUCTS

0

20

40

60

80

100

120

Design Proto Pre-Prod Production

Program A

Program B

Number of Engineering Changes by Product Stage

Page 23: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Increase Profit on New Products

23

Supplier Changes by Program

0

2

4

6

8

10

12

New Suppliers Suppliers Dropped Same Suppliers

Program A

Program B

INCREASE

PROFIT ON

NEW PRODUCTS

Page 24: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cause and Effect Example

24

PEOPLE

MFG PROCESS

EQUIPMENTPRODUCT

DESIGN PROCESS PURC PROCESS

INCREASE

MARKET SHARE

INCREASE CUSTOMER

SATISFACTION

REDUCE COST OF

NONCONFORMACE

REDUCE

INVENTORY LEVELS

INCREASE

PRODUCTIVITY

Page 25: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Why ISO13485?

• The goal of ISO

13485 compliance

and the FDA's 21

CFR Part 820

requirements is to

ensure medical

device quality,

safety, and

effectiveness

25

Page 26: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

The Business Goal for ISO13485

• Reduce costs

• Reduce risk

• Fast product launch

• Increase market

share

26

Page 27: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Strategy & Culture of a Quality

Management System

• Adoption must be a strategic decision

• Design and implementation is influenced by:

– Needs

– Objectives

– Products provided

– Processes employed

– Size and structure of the organization

• It is not the intent to imply uniformity in the structure or uniformity of documentation

27

Page 28: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

QMS Model

28

Page 29: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Quality Management System (Next Level of Detail)

29

PROJECT MANAGEMENT

New Business Product/Process Validation Risk Management

PEOPLE

Customers Employees Suppliers

DOCUMENTATION

Process Flows/Procedures Product Information Records

EQUIPMENT

Capital Tooling Inspection

MANUFACTURING

Receiving Work Orders, Routers, Inspection Shipping

CONTINUOUS IMPROVEMENT

NCM and CAPA Project Teams Audits

Page 30: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Should We Use a Business Model?

30

Page 31: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Business Model(Next Level of Detail)

31

Page 32: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

My Quality Projects

Never Get Funded!

• You are choosing

between several projects

• You have limited money

to invest

• How do you decide

which project to fund?

32

Page 33: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Too Expensive? Compared to What?

33

Page 34: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Finance Terms

34

• Return on Investment (ROI)

• Net Present Value (NPV)

• Internal Rate of Return (IRR )

• Payback Period

Page 35: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cost Justification

35

MaterialTimeLabor Increase Revenue

Page 36: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cost Justification

36

LaborPrevention

• People that design parts/processes• People that work with suppliers• People that define customer expectations

Inspection• People that check parts• People that check paperwork

Failure• People that scrap, rework, repair parts• People that scrap, rework, repair

paperwork• People that put out fires

Page 37: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cost Justification

37

Time Prevention

• Time to design new parts/processes

• Time to process ECRs

• Time to generate reports

Inspection

• Delays in receiving inspection

• Manufacturing waiting on inspection

• Cannot ship until paperwork is done

Failure

• Time to get MRB disposition

• Time to solve problems

Page 38: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cost Justification

38

Material Failure (Scrap, Rework, Repair)

• Buying incorrect material

• Making to incorrect revision

• ECR makes inventory obsolete

• Downgrades

• MRB inventory sitting around

Page 39: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Cost Justification

39

Increase Revenue

I want to give you this $10M order,

but you are only a $5M company.

I am concerned about the risk of

rapid growth at your company.

Page 40: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

How Do I Get Started?

• Where Am I?

• Costs/Risks

• People/Process IssuesPoint A

• Where Do I Want to Go?

• Savings/Benefits

• Technology RequiredPoint B

40

Page 41: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

ISO13485 Implementation Program

41

• ISO13485 Overview

• Gap Analysis

• Registrar Liaison

• Management Representative Selection

• Process/Procedures Implementation

• Internal Audit Assistance

• Corrective Action Assistance

• Pre-assessment of prior to registration audit

• Consulting during the registration audit

Page 42: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

ISO13485 Maintenance Program

42

• Internal Audits, which are a crucial

component in QMS checks and balances

• Corrective Actions, which are performed

after surveillance audits to close out

nonconformities

• Software technology support

Page 43: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Software Technology Support

43

Page 44: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Software Technology Support

44

WORKFLOW

BUILT IN REPORTING

SUPPORT

MOBILE

DEVICES

Page 45: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

About Us

John Cachat

[email protected]

Contact

Proven expertise in business

information systems

Rapid Solution

Development™ process

ServicesAssess Current Status

Develop Short and Long

Term Plans

Develop Specific Solutions

to Your Problems

Assist in ROI Analysis

45

Page 46: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

FREE Proof of Concept

46

WeWe

Page 47: Harmonize your qms model to meet iso 13485 regulations april 2013

Copyright 2010-2013 John Cachat

Harmonize Your QMS Model to Meet ISO 13485 Regulations

&

Contact:

John Cachat

[email protected]

Copy of Presentation

&

Request a Demo

Visit:

http://peproso.com/webinars

Future Webinars

47


Recommended