Lessons Learned

Experience Speaks of Lessons Learned
ASQ Illiana
February 15, 2011
1
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
INTRODUCTION
 Jack Hamilton
EAGLE Registrations Inc.
2
Top 12 Issues from Auditor Insight
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ISSUE 1
Not knowing if your Quality Management System

is ready to be assessed by a Certification Body.
Corrective Action Strategies:

 Strengthen management’s understanding of ISO
standard and management review
• Analysis of required documents in place
• Processes defined and in place
• Measurables collected
• Effective internal audits
• Corrective and preventive actions occurring
• Effectiveness tracked
4
ISSUE 2
Overcoming the perception that ISO is a

function of the Quality Control Department.

 Top Management spear-heading involvement of all
employees
 Top Management communication of Quality
Policy and Goals to employees and clarify
their understanding
5
ISSUE 3
Lack of management commitment

to the ISO system.

 Management attend ISO training classes (internal or
external)
 Clearly define management team
 Commitment to management review process
 Management and ISO management representative
working towards the same goal
6
ISSUE 4
Not having an auditable documented system.

 Organization chart – responsibilities
 Process maps and charts
 Policies and Procedures
 Create and continually update documents
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PROCESS AUDITING
Turtle Diagram – Key Questions About a Process
With what? With who?

(equipment, (training,
materials) 3 knowledge, skills)
4
Sequence and
linkage to other Input Process Output Sequence and
processes 8 linkage to other
7 1 2 processes 8
How ?
How many ?
(instructions,
(performance
procedures,
indicators) 6
methods) 5
8
EXAMPLE PROCESS MAP
Customer Customers Products

Requirements,
Quotes,
& Feedback
Information,
Decisions, 4.1
5 All
Actions 6 All
7.2
8.2.1
Marketing/ Management/
7.1
8.1
Sales/Quote Improvement
8.4
8.5.1
Customer Customer PO
Requirements
Process
Information &
Improvements
8.2.2
7.3 7.2 Internal Audit & 8.5.2
Product Design Contract Review 8.5.3
7.5.1
7.5.3
CA/PA
7.4
(7.5.2) 7.5.4
7.5.3 7.5.5
8.3
Purchasing 8.3
Requirements Customer
Requirements
Packaging/ Documents
Purchasing Document and 4.2
4.3
Shipping Record Control
Product Design Raw

Materials
Competency
Requirements &
Records
6.3
6.4 Human 6.1
7.5 Manufacturing 6.2
7.6
8.2.4
Resources
8.3
Products
Product Realization Processes
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ISSUE 5
Having excessive, cumbersome documentation.

 Written procedures for processes that impact system
performance
 Say what you do; Do what you say!
 Create simple and concise documents and test them
 Use current documents – reinvention not needed
to become ISO certified
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ISSUE 6
Using a consultant’s system

instead of a client’s personalized system.

 ISO system around your business practices
 Consultant understands your business and works to
enhance/improve your system
 Keep it manageable – eliminate procedures/
records/systems that do not add value
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ISSUE 7
Not knowing your Contract and

Customer Specific Requirements (CSR).

 Contract review for CSR
 Document under your operational guidelines (in-house
product specification)
 Maintain current customer manual – assign ownership
 Include CSR requirements on production
paperwork
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ISSUE 8
Determining what measurables are important to

processes and effectively managing them.

 Define current measurables and their link to processes
 Create measurables for the balance of key processes
 Identify measurables required by the standard
 Document, train, track and look for improvements
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ISSUE 9
Auditing internally by each element of the

standard rather than by process approach.

 Process diagrams
 Train internal auditor on process approach
 Create key process auditing form and reference the ISO
applicable elements
 Knowing hand-offs between processes –
responsibilities and performance measurables
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ISSUE 10
Improper identification of root cause,

ineffective corrective action plan
and ineffective implementation

 Appropriate personnel resource allocation
 Training on root cause analysis
 Corrective action methodology (i.e. use of tools: 5Why, 8D)
 Internal auditing for effectiveness of corrective
action plan
 Top management review of corrective action
effectiveness at management review
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ISSUE 11
Past due calibrations, audits

and management reviews.

 Utilize computer software to manage schedule
 Management review to identify weaknesses in
system
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ISSUE 12
Undocumented preventive action records.

 Take credit for your “Plans/Suggestions”
(i.e. FMEAS, POKA YOKE)
 Companywide understanding documenting
preventive actions
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CLIENTS INSIGHT
Top Six Issues from Client Insight
Quality People With Quality Advice!
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ISSUE 1
How do I Know I am Interpreting the Standard the

Way it was Meant to be Interpreted?

 Utilize Web resources – Accreditation Bodies
(i.e. – IAOB/ANAB)
 Utilize a qualified consultant
 User groups, WebEx events and training
 Association networking (i.e. – American Society
for Quality)
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ISSUE 2
Am I meeting ISO requirements

for customer satisfaction?

 Survey
 Cover all aspects business
 Follow-up one-on-one with issues
 Person in charge of reviewing data and assigning
responsibilities
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ISSUE 3
Realizing perceived audit value verses audit cost.

 Look to internal and external audits to find areas for
improvement and trends
 ISO training
 Resource sharing with other ISO companies
 Research State/Federal Government for
grant money
 Understand how Nonconformance’s (NCRs) and
Opportunities for Improvement strengthen
company processes 21
ISSUE 4
Communication Misunderstandings Between

Client and Certification Body/Auditor.

 Understand the Certification Body audit process – ask for
documentation
 Clarify audit schedule
 Ask questions during audit
 Obtain copies of auditor reports
 Call your Certification Body to resolve issues
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ISSUE 5
Not having strong internal

auditing team performance.

 Shadow Certification Body’s audit team
 External Lead Auditor Training Course
 Communication Skills training
─ Ask open-ended questions
─ Ask questions in a non-threatening approach
 Management support appropriate time needed to
complete an effective audit
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ISSUE 6
Not Understanding Your Certification Body’s

Corrective Action Timeline.

EAGLE’s requirements:
 30 days from close of audit to accept corrective action
 60 days from close of audit to send objective evidence
(corrective action plan implemented)
 90 days from close of audit to close out the audit
 Following audit, auditor will receive objective
evidence of effectiveness of corrective action
plan implemented
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Questions?
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CONTACT INFORMATION
Please call 800.795.3641
visit www.eagleregistrations.com
e-mail jack.hamilton@eagleregistrations.com
Thank you!
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Experience Speaks of Lessons Learned

Not knowing if your Quality Management System

Corrective Action Strategies:

Overcoming the perception that ISO is a

Corrective Action Strategies:

Lack of management commitment

Corrective Action Strategies:

Not having an auditable documented system.

Corrective Action Strategies:

Turtle Diagram – Key Questions About a Process

With what? With who?

Customer Customers Products

Product Design Raw

Product Realization Processes

Having excessive, cumbersome documentation.

Corrective Action Strategies:

Using a consultant’s system

Corrective Action Strategies:

Not knowing your Contract and

Corrective Action Strategies:

Determining what measurables are important to

Corrective Action Strategies:

Auditing internally by each element of the

Corrective Action Strategies:

Improper identification of root cause,

Corrective Action Strategies:

Past due calibrations, audits

Corrective Action Strategies:

Undocumented preventive action records.

Corrective Action Strategies:

Top Six Issues from Client Insight

Quality People With Quality Advice!

How do I Know I am Interpreting the Standard the

Corrective Action Strategies:

Am I meeting ISO requirements

Corrective Action Strategies:

Realizing perceived audit value verses audit cost.

Corrective Action Strategies:

Communication Misunderstandings Between

Corrective Action Strategies:

Not having strong internal

Corrective Action Strategies:

Not Understanding Your Certification Body’s

Corrective Action Strategies:

Please call 800.795.3641

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