1. Quality Audits 102 Objectives
“Quality (environmental, safety, food safety, financial, IT, …) audits are required.”
Audits can enable quality control and quality assurance.
Product or service conformance
Meet customer requirements
System conformance
Process conformance
Process capability
Continual improvement
Share personal experience and
Explore recent information from others
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

2. Review about Audits Audit Requirements: Goals:
A systematic, independent and documented process for obtaining records, facts or other information and evaluating it objectively to determine the extent to which policies, procedures or requirements are fulfilled. ISO 19011
Audit Requirements:
Planned: audit criteria, scope frequency and methods
Select auditors who are objective and impartial; shall not audit own work.
Procedure for conducting, recording and reporting
Management must take action
Goals:
Analyze processes
Review conformance
Confirm information
Evaluate risks
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

3. Quality Control and Quality Assurance
Fulfilling quality requirements (ISO 9000:2005)
Providing confidence that quality requirements will be fulfilled (ISO 9000:2005)
Concepts/ requirements:
Quality objectives (ISO 9001, clause 5.4.1)
Standardized processes (7.5.1, 7.5.2)
Process monitoring and control (7.5, 8.2.3)
Statistical process control, SPC (ISO/TS 16949, clauses and 8.1.2)
Measurement system analyses, MSA (TS 7.6.1)
Inspection, measurement and testing (8.2.3, 8.2.4)
Calibration (7.6)
Measurement traceability (7.6.a)
Process capability (TS )
Product or service conformance (8.1.a, 8.2.4)
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

4. Quality Control and Quality Assurance
A process is a sequence of activities or steps which transforms inputs into outputs (ISO 9000:2005).
Processes should be standardized, monitored, controlled, measured and continually improved.
Every individual participates in at least one process that impacts the product, service or customer.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

5. Quality Control and Quality Assurance
Annual internal audits of the system, every process and products/ services.
Document, record, process and information control systems
Manufacturing processes (including order management, R&D, scheduling, purchasing, inspecting, testing, shipping, transportation)
Support processes (personnel services, training, maintenance, testing, safety, utilities) and
Other processes (control of nonconforming product or service, billing and invoicing, internal audits, CA, PA) that impact customers.
Top management processes (resource management, management review)
Product coming to and leaving from each processing unit and in storage
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

6. Supplier  Inputs  Process  Outputs  Customer
A process is a set of interrelated or interacting activities which transform inputs into outputs.
Supplier  Inputs  Process  Outputs  Customer
Materials
Information
Inquiries, Orders
VOC, voice of the customer
People
Requirements, Specifications
Procedure
Energy
Money
Activities/ Steps
Product (Material, report, plan, schedule)
Service (Inspection, testing, maintenance)
Report
Plan (business, production, maintenance)
Results
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

7. The SIPOC model may be used to understand processes
Supplier
Inputs
Process
Output
Customer
Inquiry
Review inquiry
Contract
Order
Enter order
Accepted order
Order management
Accepted order Manufacturing limits
Prepare manufacturing order
Manufacturing order
Scheduling
Materials producer
Order for material
Procurement
Material
Production unit #1
Prepare line-ups
Line-ups
Production units
Line-up
Production process #1
Product #1
Production unit #2
Production process #2
Product #2
Production unit #3
Product # 2
Product #3
Final production unit
Audit team
Audit schedule Audit procedure
Internal audit
Audit report
Auditee
Product #n
Inspect, test
Results
Packaging unit
Packaging specs
Package
Packaged coil
Shipping
Packaged product
Deliver packaged product
Delivery of product
Processor or customer
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

8. Lessons Learned
Train auditors about the standard(s) and process approach to auditing; use ISO
Train all auditors annually.
Revised standard requirements
New interpretations/ understanding about requirements
Discuss focus areas (e.g., performance training, calibration) for the current audit cycle.
Review feedback from previous audits.
Provide aids to auditors:
Checklists (e.g., manufacturing, non-manufacturing, maintenance processes
Checklists for layered process audits
Practice
Review findings from previous audits
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

9. Lessons Learned Include process/ technology experts on audit teams.
Be efficient and effective:
Time management – audits are an intrusion in the audited area.
It may not be necessary to audit what has been audited by Internal Affairs and SOx auditors and financial consultants. Verify that action was taken to correct any findings.
Interview small groups of individuals performing the same activity.
Observe the evidence for effective implementation of actions taken to correct nonconformances from previous audits
Representative/ random sampling – enough to reach comfortable conclusions
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

10. Lessons Learned Observe measures of performance for each process
Not just output provided, also consider,
Was process effective and efficient?
Allow correction and corrective action
Allow RCA and correction of minor nonconformances.
Expect formal corrective action for systemic problems.
Expect continual improvement for some, not all measures of performance.
Remember the organization
Exists for its customers
Must run the business
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

11. Lessons Learned Recognize good performance Share information
Processes capable
Processes improving
Share information
About successful implementation in another area
From benchmarking
Offer opportunities for improvement
How to audit mature systems
Consider the audit team – rotate the members, include different persons.
Consider the audited areas – have the systems, processes or people changed since the previous audit?
Are measure of performance being met? Is performance improving?
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

12. Lessons Learned
Inform/ train all employees about the benefits of auditing:
Understanding about the audit process
Employees’ role in the audit
Reduce the fear about an audit
Enables participation in continual improvement activities.
See “Improving the Internal Audit Experience”, Theresa Wasche and Nancy Sciortino, QP, November 2007
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

13. Lessons Learned Explore/ benchmark Consult consultants
Don’t allow them to dictate
What does the standard require?
How can we most efficiently and effectively meet requirements?
How can the management system enable meeting customer requirements and continual improvement?
Read and evaluate
Network
Stay current with rapidly advancing technology and use it to improve audit efficiency
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

14. “Word Power, 12-point style guide for the quality professional”, Burjor Mehta, QP (Quality Progress), October 2010
Use words and phrases with positive connotations.
Be brief and concise.
Use consistent terms.
Use consistent formats.
Use white space.
Be specific.
Don’t use jargon or clichés.
Use complete words and sentences.
Use “I” to ask and “you “ to give.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

15. “Brace for Impact, Modified approach improves outcome of internal audits”, James Wells, QP, October 2010
Observe measures of performance (metrics) and determine which are not meeting target performance.
Audit processes that support these metrics.
Analyze finding for impact on the business (reputation, scrap, rework, wasted time and effort).
For many findings a direct or indirect connection may be found to a potential financial risk associated with a poor practice found during the audit:
Past due calibration/ daily verification
Closure time of a customer complaint
Also see “All Ears, Use financial terms to get management to take notice of your quality message”, Peter J. Sherman and James G. Vono, QP, July 2009
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

16. “Dealing with DISCONNECT”, Joseph D. Conklin with Michael J
“Dealing with DISCONNECT”, Joseph D. Conklin with Michael J. Mazu, QP, October 2010
Raise the awareness about significant nonconformances.
Same recommendation made each year:
Trained person to back-up lone knowledgeable person
Funding needed to improve system
Question upper management and external auditors
Clearly understood expectations
Poorly written findings
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

17. “Trust, but Verify”, J.P. Russell, QP, November 2009
There are systems audits.
There are more product, service and process audits.
Combined product, service and process audits = verification audit.
Verification should be performed when there are routine changes (suppliers, equipment, process settings, methods, requirements, personnel).
This audit helps minimize risk and ensure sustainability.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

18. “Think Again, Change your view of audits to improve their effectiveness”, Sonny Sahi, QP, October 2009
Auditors and management must accept nonconformances and present them and receive them as opportunities to investigate how the process or system failed not how the person(s) failed.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

19. “Gauge Audit Program Value”, J.P. Russell, QP, June 2009
Effectiveness of a system or process:
Achieves desired result consistent with objectives for the product
Is capable, efficient and consistent with objectives for the process
Effectiveness of audit process and follow-up actions:
Counting audits performed, nonconformances cited, closed corrective actions are typical performance measures.
Consider:
Objectives
How?
Performance measures
Meet customer requirements
Obtain feedback
Internal satisfaction
Meet management system requirements
Identify and report CAs that improved performance
Upgrade competence of auditors
No serious findings from external audits
Root cause(s) identified
CA effective, no reoccurrences
Maintain supplier and outsourcing requirements
Verify claimed improvements
Quality and delivery met
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

20. “Gauge Audit Program Value”, J.P. Russell, QP, June 2009
Effectiveness of audit process and follow-up actions:
Counting audits performed, nonconformances cited, closed corrective actions are typical.
Consider:
Objectives
How?
Performance measures
Improve effectiveness and efficiency of management system
Prompt audit reporting
Findings linked to objectives or customer requirements
Report terminology understood
Repeat nonconformances
Address OFIs = PAs
Determine management objectives for lowering expenses
Mini audits
Reduced cost of audits
Implement processes to ensure sustainability
Schedule audits based on process changes
Train QS resources in areas
Validate management system design to meet future needs ?
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

21. “Can Do, Effective Overseas Food Safety Audits”, Steve Wilson, QP, May 2009
These audits must/ can be successful when considering and planning for
Language and social barriers
Varying requirements in other countries.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

22. “Putting Your Internal Audit System on Steroids”, Mike Micklewright, presented at NIQC, May 2008
Audit for conformance
Audit for effectiveness
Teach auditors about wastes
Overproduction → PA
Excess inventory → PA
Transportation → PA
Delays → PA (If there was objective/ target, then CA)
Excess processing → PA
Wasted motion → PA
Defective product → CA
Underutilized employees → PA
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

23. “Putting Your Internal Audit System on Steroids”, Mike Micklewright, presented at NIQC, May 2008
Teach auditors about
Value stream mapping and process mapping
RCA
Mistake proofing
Evaluate auditors:
Preparation
Auditing
Report
Relevance of nonconformances
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

24. “Drill Deep for Strategic Alignment”, Joe Kausek, QP, October 2008
Provide auditors the organization’s:
Vision, mission and values
Overall business plan
Balanced scorecard
Process for establishing metrics and reporting performance.
Audit for strategic alignment
How does process contribute to strategic objectives?
How have process owners aligned processes with strategic objectives?
Were resources provided for successful accomplishment of the objectives?
Were process metrics aligned with metrics for strategic objectives?
Is the process contributing to the success of the strategic objective?
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

25. “10 Auditing Rules”, Joe Kausek, QP, July 2008
Make auditees feel like members of the audit team.
Start by asking general, open-ended questions, then use clarifying questions to fill the gaps.
Be an active listener.
Never let the auditee pick the samples.
Always try to identify the financial effects of findings, when possible.
Always confirm your findings with the auditee.
Don’t look for findings that could never have an impact on the performance of the management system.
Provide sufficient information about the requirement, nonconformance, and evidence found.
When citing areas of strength, be specific.
Feed the auditor.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

26. “The Great Debate, Can one process approach apply to QMS and EMS audits?”, Terry A. Mors, QP, April 2008
(And Safety management system and Food Safety management and other management system audits?
OHSAS does require determining effectiveness of the OHSAS management system.)
ISO 9001 and ISO/TS support the process approach.
Although an EMS (and SMS) is a system of processes, some adjustments are required due to language, system and standard differences.
ISO (and OHSAS 18001) was not written based on the process approach.
ISO does not require measuring effectiveness of each process.
Using inputs and outputs (interaction) terminology can steer organizations toward a process approach.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

27. “Sharpen Your Auditing Skills”, Joe Kausek, QP, February 2008
Use checklists to guide planning, auditing and reporting.
Identify the process, inputs, procedures, instructions, outputs, recent performance.
Prepare an audit planning checklist.
Review procedures, diagrams and other information.
Select items to verify.
Mark up the documents to serve as a checklist.
After initial interviews were completed, enter the objective evidence.
Identify additional questions or items to be audited.
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

28. Other resources
“The Right Approach, An effective QMS audit requires a process-based strategy”, Sandford Leibsman, QP, September 2009
ISO 9004, Managing for the sustained success of an organization
Other periodicals:
“Quality”
“Quality Digest”
The Process Auditing and Techniques Guide, J.P. Russell, second edition, 2010
Websites:
ASQ,
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011

29. Your Comments and Questions are desired.
Thank you!
Quality: The Basic Tool Kit Quality Audits 102, Alex Klein
ASQ Illiana section and Calumet College of St. Joseph, January 21, 2011 29