R I F I E D Processes Outputs - QualityWBT · Inputs Processes Outputs V E R I F ... ycalibration process yheat treatment ... Turtle Diagram for Realization Realization Activities

© 2008 JP Russell 1

By: J.P. RussellE-learning at www.QualityWBT.org

Verification Auditing

Inputs OutputsProcessesVERIF

IED


Verification Audits

“little q”

Process audit

Product audit

Service audit

“Big Q”

System audit

Integrated audit

Tactical

Strategic


System Audit

Process Audit

ProductAudit


Verification Audit

Process Audit

ProductAudit


Verification Methods

Audit?

Other methods?


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


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?


Outsourcing

Reliance on critical products and services

Organizations with different goals, skills, values, cultures, management styles

Tomorrow

More options but advantages must be verified


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.


Project Design/ Construction

Outsource elements of design

Verify materials and services used in implementation/ construction of project design/plan


In-house verification/ validation

Verify process inputs, outputs and performance

complexitynot able to verify by inspection or testcritical due to negative consequences

FMEA


Verification Audit PreparationCriteria

procedures, methods, standardsproduct/service specificationsproduct/service performance

Approved Equipment? How approved?

Qualifications of personnel/operatorsmethod?

Ongoing process verification


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)


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?


3rd-Party Audit ObjectivesApprove/Disapprove process for license or certification

Approve/Disapprove product or service for license or certification


ScopeProduct, service, process

Internal or supplier

One time, many times, depends


Auditing Strategies

Construction Project

Implementation of a new method

Oper.

Project and Department Activities

Shipping

Sawing

Treating

Finishing

Checking

Packing

Projects


Forming Drilling FinishingLine 1

Process Auditing Scope




Verification Audit PreparationAuditor

product (equipment) knowledgeprocess/service knowledge (good practices)

How many auditors?how many processes?


Verification Audit PreparationContact the auditee

request documents related to product/service or process

Verifycoordinate time of visit

Surprise?


Understand the processPrior experience

Use tools to evaluate


ToolsFishbone Diagram/Cause and Effect Diagram

Turtle Diagram

Spider Diagram


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)


CE Diagram


Tree Diagrams - for Processes

Grouping

StaffingTrainingQualification

People

StandardsProceduresUpdated

Methods

DefinedProcuredCertified/Approved

Materials

DefinedProductProcessMonitored

Measures

ApprovedMaintainedCalibrated

Equipment

Work Process


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


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


Checklist

Checklist

Diagrams

Flowchart


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


DocumentationPlans

Methods

Output criteriaspecification, list drawing, picture, diagramdesired result or avoidance of undesired result

Non conforming product/service controls

Other criteria?


HistoryHistory

defects and corrections madeinternal and field failuresprocess and product changesoperator/technician changescorrective actionssafety environmental aspectscustomer complaints


Performing

Meet with area supervisor/ manager

Observe process

Sample product, records and people

Interview (if process)

Collect evidence

Verify characteristics

Verify outputs

Validate?


Make Observations


Performing plusMistake proofing

Lean/ performance indicators

Opportunities for improvement

Good practices


Process Performance Indicators

StartStart

FinishFinish

WaitingWaiting

RedoingRedoing

ByBy--passpassRejectingRejecting

MovementMovement

> < =

parts and people

Tracing?


Report

Keep it short and to the point

Address objectives/purpose


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


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


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..


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


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

Documents

R I F I E D Processes Outputs - QualityWBT · Inputs Processes Outputs V E R I F ... ycalibration process yheat treatment ... Turtle Diagram for Realization Realization Activities