experience speaks of lessons learned

© EAGLE Registrations Inc. 2011 CONFIDENTIAL 1

Experience Speaks of Lessons Learned

ASQ IllianaFebruary 15, 2011


INTRODUCTION

Jack Hamilton EAGLE Registrations Inc.


Top 12 Issues from Auditor Insight


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


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


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


ISSUE 4

Not having an auditable documented system.


Organization chart – responsibilities

Process maps and charts

Policies and Procedures

Create and continually update documents


PROCESS AUDITING

Turtle Diagram – Key Questions About a Process

Input

7

Process

1

Output

2

Sequence and linkage to other processes 8

With what? (equipment, materials) 3

With who? (training,

knowledge, skills) 4

Sequence and linkage to other

processes 8

How many ? (performance indicators) 6

How ? (instructions, procedures, methods) 5


EXAMPLE PROCESS MAP

Product Realization Processes

Customers

Marketing/ Sales/Quote

Human Resources

CustomerRequirements,

Quotes,& Feedback

7.4(7.5.2)7.5.38.3

7.28.2.1

6.16.2

Management/ Improvement

Document and Record Control

Internal Audit & CA/PA

4.15 All6 All7.18.18.4

8.5.1

4.24.3

8.2.28.5.28.5.3Product Design Contract Review7.3 7.2

6.36.47.57.6

8.2.48.3

7.5.17.5.37.5.47.5.58.3

Packaging/ Shipping

Manufacturing

Products

RawMaterials

Purchasing

Customer POCustomer Requirements

Customer Requirements

Product Design

Purchasing Requirements

Products

Information, Decisions,

Actions

Process Information & Improvements

Documents

Competency Requirements &

Records


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


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


ISSUE 7

Not knowing your Contract andCustomer 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


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


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


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


ISSUE 11

Past due calibrations, audits and management reviews.


Utilize computer software to manage schedule

Management review to identify weaknesses in system


ISSUE 12

Undocumented preventive action records.


Take credit for your “Plans/Suggestions” (i.e. FMEAS, POKA YOKE)

Companywide understanding documenting preventive actions


CLIENTS INSIGHT

Top Six Issues from Client Insight

Quality People With Quality Advice!


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)


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


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


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


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


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


Questions?


CONTACT INFORMATION

Please call 800.795.3641

visit www.eagleregistrations.com

e-mail [email protected]

Thank you!