Internal Auditing Pitfalls - and Some Preventive Actions - - PowerPoint PPT Presentation

1 / 21
About This Presentation
Title:

Internal Auditing Pitfalls - and Some Preventive Actions -

Description:

Former RAB-QSA QMS Lead Auditor ... Conduct formal Root Cause Analysis and Effective Corrective Action training for all managers/supervisors CAR responders must ... – PowerPoint PPT presentation

Number of Views:355
Avg rating:3.0/5.0
Slides: 22
Provided by: RobertAA152
Category:

less

Transcript and Presenter's Notes

Title: Internal Auditing Pitfalls - and Some Preventive Actions -


1
Internal Auditing Pitfalls- and Some
Preventive Actions -
  • Common / Frequent Stumbling Blocks
  • Some Preventive Actions
  • and Some Helpful Auditing Tools
  • Presented to ASQ Louisville Section, October 11,
    2012
  • by Robert A. Abbott, CQE, Fellow, ASQ
  • Former ANAB Accreditation Assessor
  • Former RAB-QSA QMS Lead Auditor
  • Internal Auditing Pitfalls Rev. 1, 9/17/12

2
Four Phases to Internal Audits
  • Planning and Preparing for the Audit
  • Conducting the Audit
  • Reporting Results and Writing NCRs
  • Performing Root Cause Analyses and Implementing
    and Verifying Corrective Actions
  • All four phases must be addressed for internal
    audits to be effective !

3
Planning and Preparing
  • We always scramble to get our audits done
    sometimes we dont finish them
  • P.A. Suggestion Schedule defined processes
    within your QMS to be done each month dont
    overload auditors
  • Alternate Schedule an annual blitz of whole
    system (Ref.The Auditor, Nov-Dec 2007 issue,
    Ready, Set, Blitz)

4
Planning and Preparing
  • Some of our processes always seem to have more
    problems or take longer to audit because they are
    more complex
  • P.A. Suggestion Schedule additional audits of
    certain processes based on status or
    importance. This is a requirement of ISO
    90012008, 8.2.2 Internal Audits

5
Planning and Preparing
  • Our auditors say they are not sure what to look
    for when they audit
  • P.A. Suggestion Auditors should study applicable
    sections of the standard, quality manual and
    procedures, customer and legal requirements.
    Make a Turtle diagram and a flow diagram
    (Process Map) of the process, make a checklist.
    Have a professional auditor coach your auditors
  • Alternate Outsource Hire professional
    external auditors (Ref. The Auditor, Nov-Dec
    2007 issue, Outside Looking In)

6
The Turtle Diagram
7
Planning and Preparing
  • Can we use trained employees as auditors (aside
    from regular job)?
  • Pro Absolutely. What a great way for employees
    to get to know the company and to conduct a
    Learning Audit by explaining the WHY of
    requirements. Training is key!!
  • Con Internal auditors can develop blind spots
    to actual nonconformities. They can lose their
    keen inquisitiveness if their regular job
    requirements are nagging or their boss resents
    their absence to audit.

8
Conducting the Audit
  • Our auditors rarely report any problems. What
    they do report is inconsequential
  • P.A. Suggestion Audit for effectiveness by
    asking four challenging questions
  • How are you (or your job) doing?
  • How do you know that?
  • Are you improving?
  • How do you know that?
  • How connected are employees with the companys
    Quality Objectives?

9
Conducting the Audit
  • Our registrars auditor often finds that our
    procedures dont match the work
  • P.A. Suggestion Audit for three contrasts
  • Policy Is it clearly stated in our manual?
  • Procedure Is it up to date, support the policy?
    Do our people understand it?
  • Practice Do we do what we say? Are innovative
    ways of doing things better being considered,
    evaluated, approved?
  • When did you last review procedures ?

10
Conducting the Audit
  • Our auditors dont know how to follow audit
    trails or ask the probing questions
  • P.A. Suggestion Conduct a Learning Audit.
    Evaluate auditors regularly using a more
    experienced auditor. Use Turtle Diagrams and
    process maps as sources of questions. Ask Why?
    five times when something doesnt jive with the
    QAM or procedures. Get copies of evidence for
    better reporting.
  • Practice, evaluate, practice, evaluate !

11
Reporting the Audit
  • Our supervisors resent internal audits as
    useless fault finding
  • P.A. Suggestion Start audit reports by
    summarizing the good areas, especially best
    practices. Include ideas/suggestions for
    resolving nonconformities (Yes, internal auditors
    CAN consult!!). Constantly preach that
    nonconformities are not the end of the world or
    cause for personnel punishment, but Opportunities
    for Improvement !

12
Reporting the audit
  • Is it appropriate for internal auditors to
    provide consulting on their own findings?
  • Pro Absolutely yes! How better to get open
    discussions on problems and potential solutions.
    Auditees and auditors often have ideas that they
    can jointly explore.
  • Con Not if incompetent!! They must know
  • Customer and stat/reg requirements
  • The audit criteria (e.g. Mgt. system standard)
  • Process details, technology, and interactions
  • Business goals, objectives, status
  • Organization culture and resistance barriers

13
Reporting the Audit
  • Our nonconformity write-ups are often difficult
    to understand (What do I do?)
  • P.A. Suggestion ALWAYS state three items in
    Corrective Action Requests (CARs)
  • The requirement violated (doc/para/text)
  • Take time to explain the what why
  • The nonconformity (text related to reqt)
  • The objective evidence (what, where, when)
  • If you cant cite the requirement, you shouldnt
    write a CAR ! (An OFI ???)

14
Closing the Audit
  • Our corrective actions dont work. The problems
    keep coming back
  • P.A. Suggestion Conduct formal Root Cause
    Analysis and Effective Corrective Action training
    for all managers/supervisors
  • CAR responders must fully comprehend the
    difference between containment, correction, and
    corrective action and understand that there is a
    system cause to the nonconformity, not just
    operator error

15
Containment ( aka Quarantine )
  • In some cases, swift action needs to be taken to
    contain the problem and prevent any consequences
    of the problem (escapes) from affecting
    customers
  • This containment action must lead to the
    immediate fixing of the problem at hand, which is
    referenced in ISO 9000 as correction it should
    not be confused with containment or corrective
    action

16
Correction vs. Corrective Action
  • ISO 90002005 defines these as
  • Correction Action to eliminate a detected
    nonconformity (3.6.6)
  • Corrective action Action to eliminate the cause
    of a detected nonconformity or other undesirable
    situation(3.6.5)
  • Note 1 There can be more than one cause for a
    nonconformity
  • Note 2 Corrective action is taken to prevent
    recurrence
  • Bold Abbott emphasis

17
Some More Advice ( from Ford )
  • Recognize that there are at least two causes for
    each quality problem
  • A technical cause (and there may be more than one
    !!!) such as a bearing failure or an operator
    error and
  • A system cause such as an ineffective preventive
    maintenance program or incomplete employee
    training program or incorrect procedure or work
    instruction
  • You Must Fix Both (ALL)

18
Even More Advice ( from Abbott )
  • Utilize all appropriate quality tools to get at
    the root cause, such as
  • Ishikawa fishbone cause/effect diagram with the
    seven Ms as the branches, Man, Machine, Method,
    Materials, Measure- ments, Mother Nature,
    Management
  • Five Whys fault tree analysis diagram, looking
    for common grandfathers as high priority items
    to fix
  • Kepner-Tregoe Cause Analysis

19
Assuring Effectiveness
  • Dont forget to prevent recurrence by changing
    the system as appropriate
  • Revise procedures, policies, QA Manual
  • Train/retrain employees, adjust training needs
    matrix
  • Inform all who touch the process
  • Look at other processes/products. Can or should
    the fix(es) be used on them?

20
Closing the Audit
  • Our CARs seem to hang open forever
  • P.A. Suggestion Set agreed completion dates.
    Monitor CAR action timing, remind owners, only
    accept corrective action plans that address true
    root causes. Escalate non-responses!
  • Audit the process to verify that ALL actions have
    been effectively implemented, other processes
    have been considered, there has been NO
    RECURRENCE since the corrective action has been
    implemented
  • Only then can you close the CAR

21
Some Helpful References
  • The Auditor, a bi-monthly newsletter from Paton
    Professional, 99/year, has informative articles
    from auditing gurus, available at
    www.theauditoronline.com
  • Booklets by Denise Robitaille from Paton
    Professional on Root Cause Analysis, Corrective
    Action, others, typically 25, available from
    www.patonprofessional.com
  • Root Cause Analysis, book by Duke Okes ASQ
    H1363, 28 (member price)
Write a Comment
User Comments (0)
About PowerShow.com