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© 2008 JP Russell 1
By: J.P. RussellE-learning at www.QualityWBT.org
Verification Auditing
Inputs OutputsProcessesVERIF
IED
© 2008 JP Russell 2
Verification Audits
“little q”
Process audit
Product audit
Service audit
“Big Q”
System audit
Integrated audit
Tactical
Strategic
© 2008 JP Russell 3
System Audit
Process Audit
ProductAudit
© 2008 JP Russell 4
Verification Audit
Process Audit
ProductAudit
© 2008 JP Russell 5
Verification Methods
Audit?
Other methods?
© 2008 JP Russell 6
Verification AuditVerification AuditThe act or process of verifying product and service characteristics by means of observation and examination
Means to confirm and authenticate actions
Isolated activities or part of project execution
Yes-No outcomes
© 2008 JP Russell 7
Why Verify?Standards require it
Lower risk of failureproduct/ serviceprocess
Prudent due to qualitative natureamount transacted, not reversible, nature of product or service (i.e. medical, nuclear).
Business/ relationship environment
Or increase?
© 2008 JP Russell 8
Outsourcing
Reliance on critical products and services
Organizations with different goals, skills, values, cultures, management styles
Tomorrow
More options but advantages must be verified
© 2008 JP Russell 9
Field Failure
Broken spring to 9 month old saltwater- ready trolling motor. Spring engages locking mechanism during operation and storage. Used less than 12 times.
© 2008 JP Russell 10
Project Design/ Construction
Outsource elements of design
Verify materials and services used in implementation/ construction of project design/plan
© 2008 JP Russell 11
In-house verification/ validation
Verify process inputs, outputs and performance
complexitynot able to verify by inspection or testcritical due to negative consequences
FMEA
© 2008 JP Russell 12
Verification Audit PreparationCriteria
procedures, methods, standardsproduct/service specificationsproduct/service performance
Approved Equipment? How approved?
Qualifications of personnel/operatorsmethod?
Ongoing process verification
© 2008 JP Russell 13
Internal Audit ObjectivesVerify process
special test or procedure
Verify product characteristics/ performance
Verify project implementationnew productconstruction
Verify defects/ nonconformities addressed
Verify training, equipment capabilities, process setting(s)
© 2008 JP Russell 14
2nd Party Audit ObjectivesVerify supplier processes
calibration processheat treatmentmaintenance
Verify supplier product/service characteristics or performance measures
Verify conformance to contract requirements
Verify nonconformities have been addressed
Verify material sources and traceability
Others?
© 2008 JP Russell 15
3rd-Party Audit ObjectivesApprove/Disapprove process for license or certification
Approve/Disapprove product or service for license or certification
© 2008 JP Russell 16
ScopeProduct, service, process
Internal or supplier
One time, many times, depends
© 2008 JP Russell 17
Auditing Strategies
Construction Project
Implementation of a new method
Oper.
Project and Department Activities
Shipping
Sawing
Treating
Finishing
Checking
Packing
Projects
© 2008 JP Russell 18
Forming Drilling FinishingLine 1
Process Auditing Scope
Forming Drilling FinishingLine 3
Forming Drilling FinishingLine 2
© 2008 JP Russell 19
Verification Audit PreparationAuditor
product (equipment) knowledgeprocess/service knowledge (good practices)
How many auditors?how many processes?
© 2008 JP Russell 20
Verification Audit PreparationContact the auditee
request documents related to product/service or process
Verifycoordinate time of visit
Surprise?
© 2008 JP Russell 21
Understand the processPrior experience
Use tools to evaluate
© 2008 JP Russell 22
ToolsFishbone Diagram/Cause and Effect Diagram
Turtle Diagram
Spider Diagram
© 2008 JP Russell 23
Turtle Diagram for Realization
Realization ActivitiesRealization Activities
People (who):• competence(skills, knowledgeand training)
Inputs:• product• material• information (drawings,specifications)
Methods (how):• step-by-step• procedures• standards
Measures (results):• rate or units completed• rate or units defined• rate or units monitored
Outputs:• completed
service• finished product
Materials/Equipment/Service (what):• defined and approved• maintained(in-sourced and outsourced)
© 2008 JP Russell 24
CE Diagram
© 2008 JP Russell 25
Tree Diagrams - for Processes
Grouping
StaffingTrainingQualification
People
StandardsProceduresUpdated
Methods
DefinedProcuredCertified/Approved
Materials
DefinedProductProcessMonitored
Measures
ApprovedMaintainedCalibrated
Equipment
Work Process
© 2008 JP Russell 26
Check-Diagram for Production
Staffing, 6.1Training 6.2.2Qualification6.2.2
People
StandardsISO 9001ProceduresMFG7511Updated4.2.3Sufficent, 4.2.1Process Changes7.3.3, 7.3.7Identification &Traceability7.5.3Storage, 7.5.5Nonconfomring, 8.3Corrective Action, 8.5.2
Methods
Defined, 7.1Procured, 7.4Certified/Approved7.4.1, 7.4.3Customer7.5.4
Materials
DefinedMFG-SP05Product7.5.1Process, RunMonitored8.2.3, 8.2.4Record, 4.2.4
Measures
ApprovedMaintained9.3, 7.5.2Calibrated7.5.1, 7.6
Equipment
Safety. 6.4Ergonomics, 6.4Health FacilitiesAppropriate
Environment
Mfg. Run Control
© 2008 JP Russell 27
Spider Diagram
Equipment
Environment
Measures
Operations
Process 1
Materials
Methods
People
Change control, documents,process, product
Confidential informationprotected
FMEA , Error Proof
Plans
Operating Methods
Standards
Setup/ Startup
Competency
Staffing
Re- qualification /Certification
Qualification/Certification
ExperienceSkills
EducationTraining
Validated
Verified, Approved
Products
Revalidation
Changes Controlled
Process Approved
Records
Monitored andrecorded
Product/ Process
Defined andunderstood
Criteria and actions
Capacity
Output rates
EnvironmentalAspects and
Impacts
ManagementSupport
Safety
Calibrated, accurate
How
Documentation,operating
instructions
Approved
Maintained
Preventive andPredictive
MaintenanceProgram
Nonconforming productactions
© 2008 JP Russell 28
Checklist
Checklist
Diagrams
Flowchart
© 2008 JP Russell 29
Receive/ View Schedule
Set-up Machine per work orderand procedure. Shift Mechanic
Verify mold, conditions andmaterials, approve on WO. Line Sup. and operator [MFG7511:2.2]
Start up machine and sample for first article. Adjust controls as necessary. Operator MFG7511:2.4
NotOkay
Approved
Inspect sample and report results to Operator. MFG7511:2.5
Lab
Approved
Operate per schedule. Follow WO. Take samples and test as directed. Sort rejects. Operator [MFG7511:2.6]
Set up area for run. Check WO for totes, markers, materialsinstruments, reject box, etc..Operator [MFG7511:2.3]
Identify and prepare scrapSalvage Operator. MFG7511:2.7
ReclaimRejects
Accepted5
MachineRun
© 2008 JP Russell 30
DocumentationPlans
Methods
Output criteriaspecification, list drawing, picture, diagramdesired result or avoidance of undesired result
Non conforming product/service controls
Other criteria?
© 2008 JP Russell 31
HistoryHistory
defects and corrections madeinternal and field failuresprocess and product changesoperator/technician changescorrective actionssafety environmental aspectscustomer complaints
© 2008 JP Russell 32
Performing
Meet with area supervisor/ manager
Observe process
Sample product, records and people
Interview (if process)
Collect evidence
Verify characteristics
Verify outputs
Validate?
© 2008 JP Russell 33
Make Observations
© 2008 JP Russell 34
Performing plusMistake proofing
Lean/ performance indicators
Opportunities for improvement
Good practices
© 2008 JP Russell 35
Process Performance Indicators
StartStart
FinishFinish
WaitingWaiting
RedoingRedoing
ByBy--passpassRejectingRejecting
MovementMovement
> < =
parts and people
Tracing?
© 2008 JP Russell 36
Report
Keep it short and to the point
Address objectives/purpose
© 2008 JP Russell 37
Process Audit Report and Corrective Action Record
To:Audit Date(s): Report Date:
From: Audit No.:
Copy: Auditor(s):
Process Audited:
Purpose:
Standard – Procedure – Instruction:
Overall Findings/ Conclusion:
Report Details Status
No. Finding/ Nonconformance
Ref #Para.
Follow-up ActionRemedial and/or Corrective Action
PlannedComple-
tion Date
PlanApprove
d
ActualComple-
tion Date
Verified
© 2008 JP Russell 38
What should you audit?Based on Risk
direct dollars (cost) indirect dollars (customer goodwill)
Areas of weakness
Legal, regulatory requirements
Consistent with organization’s risk policy
Consider alternate less expensive verification methods
© 2008 JP Russell 39
RiskEvent—likelihood—consequences (in dollars)
Prevention—acceptable--consequences
Use collaborative approach involving a wide cross-section of interested parties and participants
Rebar not installed correctly, mix-up of organ donor records, spring not heat-treated, contamination, metal fatigue, discoloration..
© 2008 JP Russell 40
Contact information:Web-based training at: www.QualtiyWBT.comJP Russell at: www.JP-Russell.comE-mail: [email protected]: 888.737.4488
J.P. RussellJ.P. Russell
© 2008 JP Russell 41
Equipment
Environment
Measures/criteria
Operations/Adm.
Process/Product
_________
_________
IncomingMaterials
Predetermined Methods
People
Audits conducted? Corrective actionscompleted?
Change control, documents,process/product
Confidential information protected
FMEA, Error Proofing
Quality/Control Plans,Routing Cards
Operating Methods
Standards
Setup/ Startup
Competency
Staffing
Validated-process-changes-records
Verified, Approved-tested
-Specifications
Incoming Products/services
Monitored and recorded
Product/ Process-rates-capacity- -non-conforming
Defined, understood, current
Environmental Aspects and Impacts
Management Support
Safety, health
Calibrated, accurate
Documentation and operating instructions
Approved
Maintained
Verification Audit Elements (simplified)Product and process verification
Copyright 2009 JP Russell