- 1. Getting theMost Out of Your Internal QMS and EMS Audits -
BuildingInnovative, Value-Added Practices Ann W.
PhillipsPresidentQuality Techniques,
[email protected]
2. Experience From Participants! What has been particularly
effective inyour audit program? What have you implemented that has
beenespecially successful for you? What experience have you had
with processauditing or integrated auditing that has beenpositive?
Have you had successes that you can sharewith others? 3. Experience
From Participants! What challenges have you faced in your
auditprocesses? Buy-in from management? Buy-in from employees?
Timely, thorough corrective action? No time for preparation?
Struggling to understand process auditing? Lack of expertise in
integrated auditing? Evaluating effectiveness of processes? Others?
4. Buy-In From Management! Speak in terms of facts, data, and
return oninvestment! Where has your audit process generated
savingsto the bottom line? Capture the dollars Report potential
savings/losses in the audit report Has this caused a problem for
you? Can you point me in the right direction to get the data so
that I can write this up for you? 5. Buy-In From Employees! What is
the purpose of the internal audit?! Who is the customer of the
internal audit?! Communicate these points!! Basis of process
audits: Have competencies for this position been defined?Has
appropriate training been provided? Are you getting the information
that you need toachieve the desired results? Are there any
repetitive problems with your rawmaterials, equipment, tools, spare
parts, etc.?! Who benefits from this audit? 6. Timely, Thorough
CorrectiveAction! Has this caused a problem for you?! Document the
impact on the organization! Use a Corrective Action Log and
trackconformance to estimated completion dates(for items that are
verified as effective thefirst time)! Reward effective corrective
actions 7. Effective Audit Nonconformances Of the five customer
specificationsreviewed in the QC Lab, three were at least one
revision out of date and none were approved by the Customer
ServiceManager as required in BP-01. (Ref: 4.2.3.a/d) Auditors
Note: Two of the lastthree returned shipments were due to obsolete
specifications. 8. Effective Audit NonconformancesThere is no
defined process to review customer satisfaction data and initiate
CARs where indicated. Responsibilities relative to this reviewhave
not been defined. (Ref:8.2.1/8.4/8.5.1/5.5.1) Auditors Note: There
are two specific areas that have been rated very low in the last
two surveys: on-time delivery and customer service. We havelost two
customers in the last six months due tothese two issues. 9.
Effective Audit NonconformancesDuring the audit, three reject
products were noted on the D line that were not identified or
segregated. (Ref: 8.3 and BP-13, Section 5.4) Auditors Note: Three
customer complaints were noted in the past six months due toour
shipping products that had already been found to be reject. 10.
Effective AuditNonconformancesThe training program in the press
operation needs further evaluation. Accident rates show a
significant increase after each round of new hires.Auditors note:
Incident rates increased 76% in the first three months after the
last hiring and 103% after the previous hiring. 11. Effective Audit
NonconformancesThere was no documented action takenfollowing the
last emergency response drill. Auditors note: Several items were
discovered that could have resulted in anundetected environmental
release. 12. No Time For Preparation! Step 1: Understand the scope
and purpose of the audit! Step 2: Read, study, and understand the
requirements ofthe standard(s) against which the audit will take
place! Step 3: Read, study, and understand any
applicabledocumentation! Step 4: Prepare/review a process model!
Step 5: Review previous audit results! Step 6: Create an effective
audit checklist/plan! Step 7: Conduct a pre-audit meeting with
auditees 13. No Time For Preparation! Pre-audit meetings
Participation of process owners and other auditees Participation
from all active auditors! Preparation lunches! Off-Site Planning
14. Struggling to UnderstandProcess Auditing! See handout 15. Lack
of Expertise in IntegratedAudits! Knowledge of the applicable
standard(s)! Knowledge of the organizations documentedprocedures!
Ability to collect information throughinterviewing, listening,
observing, or reviewingappropriate documents! Ability to record
appropriate evidence ofconformance and nonconformance! Ability to
communicate effectively 16. Lack of Expertise in IntegratedAudits!
Open-minded! Diplomatic! Ethical! Curious! Energetic! Ability to
treat others with dignity andrespect (*) 17. Evaluating Process
Effectiveness! What is the desired output of the process?! What
metrics are maintained to determinethe effectiveness?! Are goals
and objectives being achieved?! If not, are action items initiated?
18. Evaluating Process EffectivenessProduction! Desired output:
Acceptable products producedon-time at a competitive! Potential
metrics: On-time delivery performance First-pass rate Productivity!
Other verification Interview Shipping personnel and review customer
feedback 19. Evaluating Process EffectivenessPurchasing! Desired
output: Acceptable products arriving on-time at a competitive
price! Potential metrics: On-time delivery performance of incoming
products Pass rate at incoming inspection Performance in
Operations! Other verification Interview customers Receiving and
Operations personnel 20. Evaluating Process Effectiveness
Maintenance! Desired output: Process equipment reliability!
Potential metrics: Unscheduled downtime Number of breakdowns
Conformance with planned preventive and predictive maintenance
activities! Other verification Interview customers Operations
personnel 21. The Checklist: Advantages andDisadvantages!
Advantages: Saves time in preparation Improves consistency among
auditors Ensures thorough coverage of your quality system Requires
the recording of facts and data! Disadvantages Audits become stale
Discourages adequate preparation Discourages auditor follow
through! Resolution Developing an effective checklist Using the
checklist effectively 22. Audit Matrices! Facilitates the audit
process! Facilitates the collection and recording ofdata! Speeds up
conformance verification toallow more time to explore
processinterfaces 23. Conducting the Audit! Key secret: Treating
the auditee withdignity and respect! I cant do anything with
generalities. Canyou give me specifics? ! Help me find the evidence
so that I canwrite this up for you.! Has this caused a problem in
the past? 24. Questions and Comments Ann W.
[email protected]: ISO
9001:2000 Internal Audits Made Easy (August2002)Co-Author:
Integrating Quality, Environmental, and SafetySystems (October
2001)