Experience Speaks of Lessons Learned
ASQ Illiana
February 15, 2011
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© EAGLE Registrations Inc. 2011 CONFIDENTIAL
INTRODUCTION
 Jack Hamilton
EAGLE Registrations Inc.
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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Top 12 Issues from Auditor Insight
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© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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ISSUE 2
Overcoming the perception that ISO is a
function of the Quality Control Department.
Corrective Action Strategies:
 Top Management spear-heading involvement of all
employees
 Top Management communication of Quality
Policy and Goals to employees and clarify
their understanding
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ISSUE 3
Lack of management commitment
to the ISO system.
Corrective Action Strategies:
 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
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ISSUE 4
Not having an auditable documented system.
Corrective Action Strategies:
 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 who?
(training,
knowledge, skills)
4
With what?
(equipment,
materials) 3
Sequence and
linkage to other
processes 8
Input
Process
Output
7
1
2
How many ?
(performance
indicators) 6
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
Sequence and
linkage to other
processes 8
How ?
(instructions,
procedures,
methods) 5
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EXAMPLE PROCESS MAP
Customers
Customer
Requirements,
Quotes,
& Feedback
Products
Information,
Decisions,
Actions
7.2
8.2.1
Marketing/
Sales/Quote
Management/
Improvement
4.1
5 All
6 All
7.1
8.1
8.4
8.5.1
Customer PO
Customer
Requirements
Process
Information &
Improvements
7.3
Product Design
Contract Review
7.4
(7.5.2)
7.5.3
8.3
Purchasing
Requirements
Internal Audit &
CA/PA
7.2
7.5.1
7.5.3
7.5.4
7.5.5
8.3
8.2.2
8.5.2
8.5.3
Customer
Requirements
Packaging/
Shipping
Purchasing
Product Design
Documents
Document and
Record Control
4.2
4.3
Human
Resources
6.1
6.2
Raw
Materials
Competency
Requirements &
Records
6.3
6.4
7.5
7.6
8.2.4
8.3
Manufacturing
Products
Product Realization Processes
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ISSUE 5
Having excessive, cumbersome documentation.
Corrective Action Strategies:
 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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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ISSUE 6
Using a consultant’s system
instead of a client’s personalized system.
Corrective Action Strategies:
 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).
Corrective Action Strategies:
 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.
Corrective Action Strategies:




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.
Corrective Action Strategies:
 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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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ISSUE 10
Improper identification of root cause,
ineffective corrective action plan
and ineffective implementation
Corrective Action Strategies:




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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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ISSUE 11
Past due calibrations, audits
and management reviews.
Corrective Action Strategies:
 Utilize computer software to manage schedule
 Management review to identify weaknesses in
system
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ISSUE 12
Undocumented preventive action records.
Corrective Action Strategies:
 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?
Corrective Action Strategies:
 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?
Corrective Action Strategies:
 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.
Corrective Action Strategies:
 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
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ISSUE 4
Communication Misunderstandings Between
Client and Certification Body/Auditor.
Corrective Action Strategies:
 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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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ISSUE 5
Not having strong internal
auditing team performance.
Corrective Action Strategies:
 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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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ISSUE 6
Not Understanding Your Certification Body’s
Corrective Action Timeline.
Corrective Action Strategies:
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
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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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!
© EAGLE Registrations Inc. 2011 CONFIDENTIAL
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