flow charts for 2000
TRANSCRIPT
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 1Example Flow Charts
Flow Chart Examples
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Elsmar.comSlide 2Example Flow Charts
A diagram that uses graphicsymbols to depict the nature and
flow of the steps in a process
Flowchart
Benefits of Using Flowcharts
• Promotes understanding of a process
• Identifies problem areas and opportunities for processimprovement
• Provides a way of training employees
• Depicts customer-supplier relationships
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Elsmar.comSlide 3Example Flow Charts
Start / End
Process Step
Decision
Connector
No
Yes
A
Symbols Used In Flowcharts
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Elsmar.comSlide 4Example Flow Charts
Required Level II Flow Charts (Procedures)
° 4.2.3 Control of Documents
° 4.2.4 Control of QualityRecords
° 8.2.2 Internal Audit
° 8.3 Control of Nonconformity
° 8.5.2 Corrective Action
° 8.5.3 Preventive Action
• 4.3 Contract Review
• 4.4 Design Control
• 4.5 Document and Data Control
• 4.6 Purchasing
• 4.7 Control of Customer SupplierProduct
• 4.8 Product Identification andTraceability
• 4.9 Process Control
• 4.10 Inspection and Testing
• 4.11 Control of IM&TE
• 4.12 Inspection and Test Status
Procedures ‘Required’ By the 2000 RevisionPartial Listing of Procedures
‘Required’ By the 1994 Revision
If you read through ISO 9001:2000, you will find 6 places where Documented Proceduresare specifically stated to be a requirement. Some folks have been saying how nice it is thatthe documentation requirements have been reduced. While this is technically the case, it isreally a non-issue. For the most part companies are not going to be reducing theirdocumentation significantly if at all.
What about new implementations? Will this be a big help to you? No - not really. You willhave to have the ‘appropriate’ documents in place regardless. Take for example 7.4Purchasing. There is very likely that your company will need a purchasing procedure. Oftenthere are a number of purchasing ‘procedures’ (systems) which will require some type ofdocumentation. The absence of the requirement does not exempt your company fromhaving documentation ‘where appropriate’. Where appropriate will be determined by acommon sense look at the process in context.
One must remember that to comply with the 1994 version, most companies adopted theLevel II approach - make 20 top level procedures or flow charts to address each element ofthe standard.
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Elsmar.comSlide 5Example Flow Charts
Some Other Expected Process Maps° Planning (5.4, 7.1, 8.1, 8.5.1)
° Management Review (5.6)
° Resource Management (6)
° Training (6.2.2)
° Customer Processes (7.2)
° Customer Communication (7.2.3)
° Design and Development (7.3)
° Purchasing (7.4)
° Operations Control (7.5.1)
° Product ID / Traceability ( 7.5.2)
° Customer Property (7.5.4)
° Preservation of Product (7.5.5)
° Validation of Processes (7.5.2)
° Process Measurement /Monitoring (8.2.3)
° Product Measurement /Monitoring (8.2.4)
° Analysis / Improvement (8.4, 8.5)
Note: Some of these may not be relevant to your company. An example is ProductIdentification and Traceability. If you are a service company, Product Preservationwill probably not apply to your situation. Remember, however, that exclusions are
limited to requirements within Element 7 - Product Realization.THIS LIST IS NOT INCLUSIVE!
As you can see, most of the documents in the above listing are parallels to the 20 ‘old’ ISOelements. It may be that the new standard does not specifically require a document tocover each of these, however it will most often be the case that your company will have todocument these systems at least minimally.
As I have stated before, the level of documentation your company will need cannot bedetermined by a book or reference. Your company may have relatively simple systems andon-the-job training may be utilized more than at another company. You may be a facilitywhich is part of a corporation where there are flow-downs you will have to comply with(some of which will probably be documentation requirements). Or, your company may onlyconsist of 8 souls who provide a service - your documentation will probably be minimal.
You have to review, within your company, what you are doing now and making somecommon sense determinations of where documentation is relevant and ‘necessary’.
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Elsmar.comSlide 6Example Flow Charts
Management ReviewPeriodic (Minimum of 4 per
calendar year) Review Scheduled by
Vice-President of Operations
Notification of Review to President, VP - Production
and Plant Manager
VP - Operations presents the following (as a minimum):Old Business
A review of minutes from prior meeting.Action Items from prior meeting.
New BusinessInternal Audit Status
Corrective ActionsMeasurement Assurance, Calibration and Metrological Actiuvities
Supplier Quality Activities
Items to be reviewed at a minimum of once per calendar year:Relevancy of Quality Policy
Customer Satisfaction
Trends Identified?Action items initiated and
taskedYes Minutes RecordedNo
Management Review Minutes Distributed & Filed
Minutes (including action items)
Recorded
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Elsmar.comSlide 7Example Flow Charts
Planning For QualityProcure, examine and derive requirements from the accepted quotation or contract relating to the product being
planned;Review Standards of Acceptability for all features and requirements including those containing a subjective
element that must be clarified;Consideration of any quality standards,, legal requirements, regulations or codes that apply or may be affected;
Ensure the compatability of the design, the production process, inspection and test procedures and other applicable documentation
Confirm or determine the necessary documented procedures, instructions,, drawings, or other documentation required
Confirm or determine the resources needed including raw material, machinery, number of employees, etc.Identify and acquire any controls,, processes, inspection equipment, total production resources ands skills
required to achieve the required quality.Update, as necessary, quality control, inspection and testing techniques and development of new
instrumentation, if required.
VP - Operations retains records file
Examine the production operatrions, sequences and tests and inspection test points required;
Identify and define responsibility for the preparation of quality records
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Elsmar.comSlide 8Example Flow Charts
Order FlowCustomer Order
Order Source May Be: FAX
Telephone Conversation Mail (or courrier ie: FedEx)
Order Desk
Plant Office Determines availability
In Stock?
Pull From Stock
Yes
Take to Shipping
Dock
Produce Batch per Process
DocumentationNo
Complete Shipping Paperwork
Excess To StockPull Ordered
Amount
Ship
Notes:We need a little more detail here. Examples are my 'suggestions' alongside the boxes. My questions are in BOLD type.
We also need to look at paperwork trails involved in doing these things.
You are on the right track! You might want to feed these to Bill in Columbus to show him how I am marking up your flow charts.
Enters order in ? Log.
How does this happen?Verbal? Paperwork involved?
Is there an inventory record?
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Elsmar.comSlide 9Example Flow Charts
Account Management
Sales / Marketing
Order Receipt
Order toMFG.
Procure Material
Build Product
Ship Product
BillCustomer
CollectMoney
Mrkting ProcessSales ProcessQuote ProcessCredit Approval
Order ReviewGen. Doc.Acknowl. OrderNotify Mfg.
Verify InputsPlan the JobRelease for Purch 7Mfg.
Review ReqmtsMake vs. BuySelect SupplierIssue RFQPlace OrdersEval. Incoming MatlsMaterial Dispo.Autorize Supp. pay
Review Doc. Pack.Kit MaterialsSet up Equip.Mfg. per Route CardPackageSend to Finish goods
Confirm Date Create Pack. Docs.Create / Dist InvoiceSched. CarrierGenerate Ship. Docs.Pass to shipperFile Paperwork
Mail Invoice Receive PaymentsResolve Disputes
ManagementProcesses
Results / ForecastsBusiness PlanMgmnt Mtgs.
DesignEngineering
QualitySystems
Internal AuditsProcedures &
Standards
SupplierApproval
DocumentControl
Control of TestEquipment
Data Security
Training
PersonnelProcesses
Customer Complaints
FacilitiesProcesses
CorrectiveAction
CustomerServices
MaterialStocking
FinancialProcesses
PreventativeMaintenance
Support Processes
Typical Top Level Operations Flowchart
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Elsmar.comSlide 10Example Flow Charts
Business As A System (Process)
Fabrication
Component Test
Assembly Ship
Device Test
Process Validations
Sub-Processes(Sub-Systems)
Design Product
PurchaseMaterials
ReceiveMaterials
Receive Order Sales / Marketing
An example of a manufacturing company defining and mapping its processes.
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Elsmar.comSlide 11Example Flow Charts
Define Product and Base Processes
Sub-ProcessA
Sub-ProcessB
InformationServices
Process 3
Sub-Process A
Sub-Process B
Process 4
Sub-Process C
High level ProcessDescription
High level ProcessDescription
WholesaleProcess 2
Retail ClientsProcess 1
1. Product 12. Product 2
External Customers
1. Product 1
Products
Sub-Process
Sub-ProcessThis is not meant to represent YOUR process
structure. It is only meant to serve to give you foodfor thought on looking at your processes.
An example of a service company defining and mapping its processes.
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Elsmar.comSlide 12Example Flow Charts
Sales Proposal
OutsideRetailerSelling
CoveredProducts
Contract Implement
Proposal toRetailer
For RetailerRelationship
Add NewContracts
Tele-MarketRetailer ProvidesSales Information
ContactProspectiveCustomers
SuccessfulSale
Process 1
Process 2
Process 3
IndividualCalls forService
ContactServicer &
IssueAuthorization
ServiceSupplierProvidesService
ServiceSupplierInvoices
Company
Process 4
CompanyPays
Invoice
Main Processes / Systems
An example of a service company defining and mapping its processes.
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Elsmar.comSlide 13Example Flow Charts
Miscellaneous Sub-Processes
• Contract Negotiation• Compliance to State
Regulations• Maintenance of
Fulfillment Process
• Load client dataelectronically
• Dealer Set Up• Table maintenance• New client
installations(implementations)
DirectMarketing
WarrantyAdministrationClient Services
Contracting &Compliance
• Claims• Review & Approve Payments• OTL authorizations for retail
contracts
• Customer Service• Entitle & issue all initial
authorizations• Inbound Sales Calls
• Calculations for cash out
• Service Recruitment• Maintain Servicer Database• Satellite Customer Service
• Compliance &Training
• New Employee Training• Quality audits of staff• QA Card review & reporting
• PC Help Desk• Entitle & issue all initial
authorizations
• Campaign Planning• Execute Direct Mail
& Telemarketingcampaigns
• Reporting for Clientand management
• Develop proposals• Control collateral
materials
Sales & MarketingSupport
• Load client datamanually
• ProcessCancellations
Data Entry
An example of sub-processes in a service company.
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Elsmar.comSlide 14Example Flow Charts
Document Types / Classification & Controls
SystemsManual and
Level IIs
DepartmentSpecificTrainingMaterials
DepartmentalMaster Systems
DepartmentalWork Instructions
Control by:Department Manager
Control by:Quality Systems
Manager
QualityRecords
TrainingRecords
Control by:DepartmentManager
Master Systems
OrientationTrainingMaterials
Control by:HR
Control by:DepartmentManager
Specific requirements are detailed in Clause_Interp_and_Upgrading.doc
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Elsmar.comSlide 15Example Flow Charts
4.2.3 Control of Documents (4.5)
Base SystemProposedDocument
Identify Document / DataAffecting Quality and
Location(s) RequiringAccess
ProposedRevision
Identify Need for aChange to an ExistingDocument / DataAffecting Quality
Produce DocumentIn Personal SpaceUsing Appropriate
TemplateFrom the Q Drive
Review
Approve
Revise Document
Upload Document to AppropriateQ (Secure) Drive Directory
Communicate and Implement
Document ‘Owner’
Copy Old Document from the Q Drive toAppropriate S Drive Directory or File Hard
Copy to Maintain History.
If Electronic, Copy toPersonal Space From Q
Drive
Any employee mayrecommend a new
procedure or arevision to an
existing procedure.
Yearly review in accordancewith local procedure.
This is your COMPLIANCECONTROL feature.
The above is an example of where a company had a simple control system.Masters are kept on a protected drive. Each person responsible for a document‘owns’ a directory which only s/he can write to. Control is, obviously, verydecentralized.
Companies control documents in many was. Some use canned software. Somesmaller companies have everything on paper. The position of the computertoday makes paper systems very rare, but there are some that still exist.This isonly to say that your system has to meet some basics but the variability makesit impossible to predict.
Important elements of your system should include:
Approval
Review - during initial construction, when changed and “…on a regularbasis…” (which may be yearly).
Change control
Availability
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Elsmar.comSlide 16Example Flow Charts
A Document Control System
Request to Create (Add), Changeor Obsolete a Controlled
Document
DoesDocument
Exist?
Create DocumentAccording to Defined
Rules
Obtain AppropriateReview(s)/Approvals
Change/ReleaseDocument
Record Change,Release or
Obsolescence(History)
Notify AppropriatePersonnel, Train andDistribute Document
Is DocumentBeing Obsoleted?
Document is Implemented
Document to Trashor History File
As Defined
Yes
No
Requestor(Review and
Approval Loop)
Yes
No
Update Master ListingDocument Control Clerk
Document Control Clerk
Document Control Clerk
Appropriate Personnel
Document Control Clerkor
Appropriate Personnel
DocumentControl Clerk
Requestor
R-05001BRequestor
This is your COMPLIANCECONTROL feature.
This is an example of a more complex document control system.
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Elsmar.comSlide 17Example Flow Charts
4.2.3 Control of Documents (4.5)
Base SystemProposedDocument
Identify Document / DataAffecting Quality andLocation(s) Requiring
Access
ProposedRevision
Identify Need for aChange to an ExistingDocument / DataAffecting Quality
Produce DocumentIn Personal SpaceUsing Appropriate
TemplateFrom the Q Drive
Review
Approve
Revise Document
Upload Document to AppropriateQ (Secure) Drive Directory
Communicate and Implement
Document ‘Owner’
Copy Old Document from the Q Drive toAppropriate S Drive Directory or File Hard
Copy to Maintain History.
If Electronic, Copy toPersonal Space From Q
Drive
Any employee mayrecommend a new
procedure or arevision to an
existing procedure.
Yearly review in accordancewith local procedure.
The above is an example of where a company had a simple control system. Masters arekept on a protected drive. Each person responsible for a document ‘owns’ a directory whichonly s/he can write to. Control is, obviously, very decentralized.
Companies control documents in many was. Some use canned software. Some smallercompanies have everything on paper. The position of the computer today makes papersystems very rare, but there are some that still exist.This is only to say that your systemhas to meet some basics but the variability makes it impossible to predict.
Important elements of your system should include:
Approval
Review - during initial construction, when changed and “…on a regular basis…”(which may be yearly).
Change control
Availability
See Clause_Interp_and_Upgrading.doc for details.
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Elsmar.comSlide 18Example Flow Charts
A Document Control System
Request to Create (Add), Changeor Obsolete a Controlled
Document
DoesDocument
Exist?
Create DocumentAccording to Defined
Rules
Obtain AppropriateReview(s)/Approvals
Change/ReleaseDocument
Record Change,Release or
Obsolescence(History)
Notify AppropriatePersonnel, Train andDistribute Document
Is DocumentBeing Obsoleted?
Document is Implemented
Document to Trashor History File
As Defined
Yes
No
Requestor(Review and
Approval Loop)
Yes
No
Update Master ListingDocument Control Clerk
Document Control Clerk
Document Control Clerk
Appropriate Personnel
Document Control Clerkor
Appropriate Personnel
DocumentControl Clerk
Requestor
R-05001BRequestor
This is an example of a more complex document control system.
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Elsmar.comSlide 19Example Flow Charts
ExampleDocumentStructure
Paper copies printed & compiled into manuals controlled by the Document Control Clerk.
Quality(Systems)
Manual
Pre-Fix = Cf Pre-Fix = M Pre-Fix = CcPre-Fix = Cp
Machine specificdocuments.
Printed manualsare found at
machines. Thesecontain Check
Sheets,InspectionSheets and
Machine Logs.
Administrative:Area or
functional arespecific
document listing.Printed manuals
are found inoffices.
Process /Machine
specific. Facepages describingcontents. Printed
manuals arefound in QA.
SystemsProceduresper R-05001
WorkInstructionsper R-05001
Level IGallipolisPolicies
Level IIHow PoliciesAre CarriedOut (Details)
Level IIISub-Details of
Level II Documents
Part SpecificDocuments
per W-05002
Impact, PerformControl Plan
PFMEAFlow DiagramCheck Sheets
MS WordTravelers
Check Sheets
Computer 'MasterDocument' Files
MasterManual
-Process
ProcessSpecificManuals
OperatingSystemsManuals
FormsManuals
Process specificdocument listing
and trainingrecord. Printedmanuals are
found atmachines.
Computer 'Master Manual' Index Files
Index:Masterdoclist.doc
Index:Partmast.xls
Developed duringProgram Planning.
May be altered duringPPAP change.
Driver=
W-60100A
Pre-Fix = R Pre-Fix = W
OperatingSystemsManuals
FormsManuals
MasterProcessManuals
ProcessSpecificManuals
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Elsmar.comSlide 20Example Flow Charts
Computer File Prefix = Cp.The computer file is a detailed index of contents, which, when
printed out form the manual.Process Manuals
Contents: 1. Index Page 2. Operator Inspection Codes 3. Changeover Instructions 4. Expeditor Check Sheet 5. Set-Up, Run and Production Instructions 6. Gage Instructions 7. Team Activity Report (PDCA) 8. Control Plans 9. Target Parameters
Contents: 1. Index Page 2. Set-Up Verification Instructions 3. Control Plans / Part Specific Instructions 4. Process Instructions 5. Visual Standard Reference 6. Gage Instructions 7. General Instructions
Manufacturing All Other ProcessesBased upon a computer fileindex, Process manuals are
manuals which contain a basicset of information for specific
processes. Some are machinespecific as well as process
specific.
Computer File Prefix = Cf .The computer file is a detailed index of contents,
which, when printed out form the manual.
Operating Systems Manuals
Situation Specific Index.
Based upon a computer indexfile, Operating Systems
manuals are manuals which arespecific to functional groups or
individuals. They are 'asneeded' documents. They are a
sub-set of relevant masterdocuments. Their intent is to
provide specific documents forgroups or individuals. They are
maintained by DocumentControl Clerk.
Computer File Prefix = M .The computer file is a detailed
index of contents, which, when printed outform the manual.
Master Systems Manuals
Process Specific Index.
Based upon a computer indexfile, Master Systems manuals
are manuals which are specificto a process.
Example of a manufacturing document structure.
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Elsmar.comSlide 21Example Flow Charts
Example Print ControlSub-System
External Originator
Review ProposedPrint Change(s)
R-02002 'Quality Planning'Request for Quotation Process
EngineeringManager
RFQRequired?
R-05001BDocument Change Request Process
Log in PrintLog Notebook
W-05001BCustomer Print Log
Stamp, Initial& Date Print
Review PrintAgainst CurrentPrint - Mark Up
New Print,If Necessary
Designer
Designer
Designer
Designer
R-05001BDocument Change Request
+W-05055 L.E.C.D. Form
No
Yes
SalesCustomer
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Elsmar.comSlide 22Example Flow Charts
Example External Documents Control Sub-System
External Document Received(Any Area)
EXCEPT Prints
Review andApproval by
DepartmentalManager
Approval ForAcceptance
Yes
No
Rules:Controlled Documents of External Origin aremaintained by the Document Control Clerk.
Controlled Documents of External Origin areidentified by a "Controlled Document" stamp insidethe front cover and an ID Number hand written besideit. The ID number is derived from the listing in thePartMast.xls file. ID numbers are not reused once adocument is removed from control.
Approval?Review ReasonWith Requestor
DoesDocument
Exist?
Create DocumentID in Cross ListingIn PartMast.xls file.
Update DocumentCross Listing
IdentifyDocument
Is DocumentBeing Obsoleted?
Document isAvailable In Book Shelf
Document to Trashor History File
As Defined
Yes
No
Document Control Clerk
Document ControlClerk
Document ControlClerk
Document ControlClerk
Document ControlClerk
Forward to DocumentControl Clerk
DepartmentalManager
Yes
No
Check for Latest Revision
DocumentRevised?
NoNo Action
Yes
Order/ReceiveDocument
Update DocumentCross Listing
Document Control Clerk
Document Control Clerk
DocumentControlClerk
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Elsmar.comSlide 23Example Flow Charts
Example DesignProcess Records
System(ConfigurationManagement)
InitiateEvidence
Book
Base Rules:1. Evidence Book Base Contents Defined By W-02002H 'Evidence Book Contents Page'.2. New Evidence Book Initiated Only For New Part Number.3. Changes to Process and/or Product Initiates New W-02002H 'Evidence Book ContentsPage'. Actual additional contents determined by change details and CustomerRequirement(s).4. Removal of any document from the evidence book requires an 'Inquiry Sign Out Sheet'R-02002C.
BeginProduction
NewW-02002H
Productand/or
ProcessChange
Productand/or
ProcessChange
NewW-02002H
EndProduction
PPAP AsNecessary
Post-Production -Retention Time,
Storage Location,Destruction
Methodper R-16001
NOTE:Other than the actual
warrant, PPAP documentsare derived from W-02002G
outputs.
Evidence Book Contents
Pre-Production Production
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Elsmar.comSlide 24Example Flow Charts
Example PlanningProcess System
From Purchase OrderReview Process
New PartNumber?
R-05001E'PPAP Change
Request'
No
Yes
Initiate NewEvidence Book
W-02002G 'Four Phase APQPEvidence Book Statement of
Work
W-02002W'Evidence Book Contents Page'
Assign'Responsible'
Resource
AssignProgramManager
Engineering Manager
Engineering Manager
Program Manager
Track Program toBeginning of Production
Hand-Off to ManufacturingEngineering Manager at start of
production.
Determine ProgramTeam Members
W-02002F'Cost Tracking Log'
(Issued from, and kept in,accounting when an A.R
is required)
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Elsmar.comSlide 25Example Flow Charts
Example POReview System
To Controller
PO Source
PurchaseOrder
To POSource
Review
Controller:Reviews for DiscrepancyAgainst RFQ Packageor existing Purchase Order
No Discrepancy
Discrepancy
EngineeringManager
SF NumberAssigned
Enter In R-02002BPrototype Part
Production Summary
Engineering Manager
To Planning ProcessFlow Chart
ControllerIf Current Production,
XXXX Review
OK?
Controller:Sign Off On Purchase Order
Yes
No
PurchaseOrder
Prototype
Other
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Elsmar.comSlide 26Example Flow Charts
ExampleQuotation
Review System
EngineeringManager
Log Inquiry& Assign Number
To EngineeringManager
RFQ Source
EngineeringManager
RFQPrint
DFMEA
W-02001BInquiry Register
AppropriateInfo?
Need Additional Information(Print(s), Specification(s),
Etc.
Process DefinitionW-02001A
R-03001ARFQ - Cost Summary
Controller
Quote ReviewFile
EngineeringManager
No
Yes
NOTE:DFMEA Requested,
but seldomreceived.
NOTE: Quote No Quote Need MoreInformationMay occur at variouspoints.
Form 005'Quote Review Sign-Off'
PUR290Sa'Manufacturing
Feasibility Sign-Off'
Controller
Quote:E-Mail or Letter
Controller
Eng. Mgr. DelegatesA Responsible Engineer
ResponsibleEngineer
Contents:1. Process Definition
2. Cost Analysis3. Quote Review Sign-Off
4. ManufacturingFeasibility Sign-Off5. Copy of Quote
ResponsibleEngineer
W-05002Print Changes
NOTE:For print changes,only the 'applicable'sequence elements(as determined bythe nature of thechange) will be
addressed.
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Elsmar.comSlide 27Example Flow Charts
Examples of Document Change Triggers
Control PlanChange
FMEAChange
Process FlowDiagram Change
Update OperatingSystems Manuals
1. Chief Met.2. Product Dev.
3. QA lab
UpdateProduct Dev.
OperatingSystems Manual
Update PPAPFile
UpdateProduct Dev.
OperatingSystems Manual
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Elsmar.comSlide 28Example Flow Charts
Example Dock Audit System
ChooseSampling
Plan
PerformAudit
Include:1. Labeling Correct Label Correct Number of labels Correct label positioning Other or 'Special' Identification2. General Product Condition3. Package Quantity4. Packaging Material / Container5. Attachments (e.g. Certs, etc.)
Reseal Box andReturn to Pallet
ResponsibilityTBD
XXXX Review(Trigger)
ChooseMeasurable
R-13001Control of Non-conforming
Product
ResponsibilityTBD
ResponsibilityTBD
ResponsibilityTBD Make Plan
Accept
Reject
Assign Champion
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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4.2.4 Control of (Quality) Records (4.16)
Identify QualityRecord
Record Assigned:1. Identification2. Person Responsible3. Retention Location4. Retention Time5. Post-Retention Disposition
Quality SystemsManager
Determine Methods of:1. Collection2. Indexing3. Access4. Storage5. Maintenance to preventdamage, deterioration or loss
ResponsibleAuthority for Record
Annotate Record:1. Identification
2. Person Responsible3. Retention Location
4. Retention Time5. Disposition
Maintain:1. Master List of Records2. Revision Status3. Location4. Responsibility5. Disposition
Quality SystemsManager
Department Managers
Enter RecordInto Master List
Quality Records are defined in: XXXXXX.xls
It is important that you can show that you determine what is and is not during planningstages. If you are going through implementation, you probably already have quality recordsdefined - you don’t go back. The point is planning now is very important. Any planning youdo - product, process or other system - should include an evaluation for quality recordsrequirements. These may be (only a few examples) taking of data, traceability or statusrelated. In addition, feedback from a process or system may drive the need for ‘new’ qualityrecords.
Remember that records typically start out as forms. Those forms must be controlled just asprocedures / flow charts are.
White-out on a quality record is a very questionable practice. I advise you to establish acompany policy, and implement / communicate it, which states where and when white-outmay be used (if anywhere).
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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6.2.2 Training (4.18)
On The Job Individual NeedsAssessments
Determine JobAffecting Quality
Determine Qualifications and/or Training Necessary
To Perform JobTraining NeedsDocumented
DocumentRequirements
In Job Description& Job Posting
OJT - New Hire Schedule
EmployeeTrained?
Assign New orExisting Employee
To Job
Trains Employee
No
Employee PerformsAssigned Job
Determine IndividualTraining Needs
Departmental Manager Updates
Training Record
Yes
EmployeeScheduled ForAnd Attends
Training
EmployeeTrained?
No
Yes
YearlyReview
DepartmentManager
Supervisor
Supervisor
Supervisor OrSpecialist
Note that there are different types of training. You must address all types. The ‘typical’ BigFive are:
• Orientation - Basics given when someone starts their employment.
• On-The-Job - An example would be training on how to run a machine.
• Systems / Procedure Changes - Whenever a procedure or system is trained, thishas to be ‘communicated’.
• Individual Needs - Generally training which will help in the future. An example wouldbe managers training for someone
• Elective
Records: No records, it never happened. Training records and their control is absolutely atop priority and will, not maybe, WIL be assessed during the registration and subsequentaudits.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Preventive Maintenance Schedule Developed on aYearly Basis for Key Equipment
Preventive Maintenance Procedures AndChecklists Developed Per Vendor Recomendations
and Knowledge / Experience On Machine /Equipment..
P.M. Performed Per Schedule andEstablished Procedures.
Evidence of P.M. Recorded on ChecklistAnd Signed off .
PM Database Updated, Equipment / Machine Delivered ToProduction/Eng Once Activity Completed
Production / Eng OpensWorkorder for Repairment.
Maintenance RepairsMachine /
Equipment.
Normal Production
Correct Performance?
No
Yes
Example Preventive Maintenance System
Reactive Maintenance
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 32Example Flow Charts
ProcessCapability
Preliminary ProcessRequiremntsNew Process
Ppk >= 1.67Yes
Ongoing ProcessControls
Re - Evaluation
No
Stable / NormalCPK >= 1.67
Yes
Continuous Improvement.
Action Plan to Improve CPK.
SPCCP and CPK
Stability IndexTrend Analysis
Chronic Unstable PPK >= 1.67
Yes
Action Plan
No
Continuous Improvement.
No
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 33Example Flow Charts
7.6 IM&TE
Collect FromManufacturing
Area
Calibration DueMaster List
Gives Location
CalibrationSource
Internal
External
Inspect andCalibrate per
Work Instruction
Arrange ForCalibration
per W-11025Outside Calibration
Pull AppropriateWork Instruction
Seal Adjustment(Where Appropriate)
After Adjustment
QualityTechnician
QualityTechnician
QualityTechnician
QualityTechnician
SuspectIM&TE
CalibrationLaboratory
Any Personnel-TransportTo Lab
CompleteAppropriateWork Sheet
Enter Results IntoGagetrol Software
Place CalibrationSticker on Device
QualityTechnician
WithinCalibrationTolerance?
Can BeAdjusted?
No
No
Yes
Yes
R-11001COut of Calibration Review
QualityTechnician
Tag Device"Out Of Calibration"
R-11001AScrap Measuring Device
Return DeviceTo Service
Can BeRepaired?
No
Yes Internal/External?
R-23001AToolroom
Work Order
Internal
External
R-06001Purchasing
-Complete PO
Form
UpdateGagetrolSoftware
An example Inspection, Measurement and Test Equipment calibration control system.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 34Example Flow Charts
8.1 Statistical Techniques
Management Determines Method and Acceptabilityof Sampling Technique
Management Determines a Need for StatisticalTechnique(s) to Control or Verify Process Capability or
Characteristic
Management Prepares / Revises InstructionsDefining Requirements
Data Collected at Specified Interval
Data Reviewed and Analyzed
Record Filed and Retained for Period Specified inInstructions
ResponsibilitiesDefined in
Instruction
Process Improvement Mgr. reviews statisticaltechnique to include as a Quality Record, if applicable
‘Management’ isDefined asDepartmentalManagers andOtherManagement
The standard assumes a high reliance upon management by data analysis (acting ondata). This was a problematic area for some companies - especially small companies. Thekey to their compliance was ISO 9001:1994 specifically required a company to “... identifythe need for…” statistical techniques. As long as you could show you evaluated the needfor statistical techniques and found none (typically during a management review meeting)you didn’t have to do any. This has not really changed. But - try to convince some auditors.
The point of 8.1 is to make sure you evaluate where data analysis would benefit yourcompany. An example might be an analysis of nonconformances over time. I have to agreethat every company does have such a need, even small companies.
Most companies are already doing some type of data analysis. Remember, this readsstatistical techniques, not statistical process control (for some reason this used to bemisunderstood regularly by auditors but isn’t much of a problem these days). One clientwas a small trucking company. They insisted they had no need. I pointed out that theytracked delivery time. And they reacted to ‘bad’ trends. Statistical techniques can be simplestuff. A bar graph. A trend line. Don’t over complicate the issue.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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2002 Cayman Business SystemsRev: ReleasePrint: Wednesday, November 17, 2004
Elsmar.comSlide 35Example Flow Charts
8.2.2 Internal Audit (4.17)
FormulateYearly Audit
Schedule
PlanIndividual
Audit
Schedule AuditAnd Assign Auditor
AuditPlan
Exists?
Contact Auditee -Agree on Date,Time, Scope of
Audit
Perform Audit
Nonconformance /Corrective Action
Report
Nonconformance?
Yes
Close Audit& File
Results
UpdateAudit
Schedule
ManagementReview Input
Track FollowUp
On Time? Escalate
Yes
ScheduleFollow Up
Contact Auditee -Agree on FollowUp Audit Date
DetermineAppropriate Follow
Up Audit Date
Perform Audit EnsuringImplementation Of and
Effectiveness OfReaction
OK?
Yes
Yes
No
No
No
No
AuditManager
AssignedAuditor
Key: Box colour /line weightindicates
responsibility
Your internal audit system should include:
• Schedule - at least 1 year, preferably 2 years.
• Trained auditors
• Much of the response to a nonconformance should go through a system like yourcorrective action system. Many companies use one database to track nonconformancesfrom all areas. That is nonconformances found in audits (internal and external),production, customer complaints, etc. all are tracked in 1 database. The key to thismethodology is well thought out ‘defect’ categories. I recommend using Access or otherdatabase software and that you make your own database. Canned software seldom hasthe flexibility which you will find you need.
• A method of escalation when findings are not acted on. This is really part of yourcorrective action response system.
Take a read through http://Elsmar.com/Audit/ for more details on Internal Audits.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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2002 Cayman Business SystemsRev: ReleasePrint: Wednesday, November 17, 2004
Elsmar.comSlide 36Example Flow Charts
8.5.2 Corrective Action (4.14)
Identify Need forCorrective Action
InitiateNonconformance /Corrective Action
Report
EstablishResponse Team (If
Necessary)
Describe theProblem
Implement andVerify Interim
Actions(Containment)
Identify PotentialCauses
Select LikelyCause(s)
RootCause?No
Select PermanentCorrective Action(s)
ImplementPermanent
Corrective Action(s)
Verify Effectivenessof Permanent
Corrective Action(s)
Close OutNonconformance /Corrective Action
Report
This flow diagramillustrates the coreelements of the correctiveaction investigativeprocess from the pointwhere the need for acorrective action isidentified.
Responsibility will dependupon the specifics of theidentified need, but theProcess ImprovementManager is theresponsible authority foroverseeing andadministrating theCorrective Action system.
See section 8.5.2 in theCompany Systems Manualfor overall systemspecifics.
Important parts of a corrective action system include:
• You MUST have ‘triggers’ and ‘escalation’ paths.
• That you understand that you have multiple sources for nonconformances. Not justproduct, but also audits (internal and external), customer complaints, etc.
• That you have a method of ensuring evaluation of nonconformances for a determinationof whether a partial or complete corrective action should / must be started. If you don’tyou will find you are requiring corrective actions for every nonconformance which willquickly overload your system and have everyone up in arms.
• You MUST ensure every corrective action is evaluated for effectiveness.
• You should follow the 8-D system. One reason is it touches on every requirement andfulfills it.
Take a read through http://Elsmar.com/8D/ for more details on corrective actions.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 37Example Flow Charts
8.5.2 Corrective Action (4.14)
QualityManager
Decision toRequest CA
Initiate CA Form
Log inCALog
Assign CA
System Requirements
Quality Manager isresponsible for trackingcorrective actions.The person assigned the CAhas 7 days to give an initialresponse to the CA.If (1) a response is notobtained, or if (2) the CAbecomes ‘bogged down’ or(3) is insufficient in theopinion of the QM, the CAwill be escalated to theresponsible person’simmediate superior.
Anyone?
Requestor
QualityManager?
Follow 7Step
CorrectiveAction
Process
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 38Example Flow Charts
The ‘8-D’ Corrective Action System
Awarenessof Problem
Use TeamApproach
Describethe Problem
Implement andVerify Interim(Containment)
Action(s)
1.
2.
3.
ImplementPermanent
Corrective Actions
PreventRecurrence
CongratulateYour Team
5.
6.
7.
Choose/VerifyCorrective Actions
8.
4. IdentifyPotentialCause(s)
Select LikelyCauses
Identify PossibleSolutions
Yes
Is thePotentialCause a
RootCause?
No
The ‘D’ in 8-D stands for Disciplines
Teams are important. Why do you think this is so?
Normally people in a company have skills, experience and abilities which complement each other. A companyas a whole is complex - a set of systems with different functional experts in different areas. The areascomplement each other and many have interactions. Quality affects manufacturing. Design affects quality.Quality affects design.
The 8-Disciplines methodology requires a team effort to ensure that there is communication between‘interested parties’ and that interactions are identified and effects assessed.
You might want to take a read through http://Elsmar.com/8D/ for details on the 8-D Corrective Action / PreventRecurrence process.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Elsmar.comSlide 39Example Flow Charts
Thoughts About
DatabasesDatabases
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Items To Track
NOTE: Parts of some of these may be included in the current MRP software system.
• Receiving Inspection
• Suppliers - including Supplier Rating and Approved Supplier List(Excel Spreadsheet)
• Customer Concerns/Complaints (Excel Spreadsheet)
• Nonconformances (Database)
Internal
External
• Corrective / Preventive Action (Database)
• Internal AuditsTracking (Calendar) (Excel Spreadsheet)
Audit Forms (Excel Spreadsheet)
• Management ReviewsTracking (Calendar) (Excel Spreadsheet)
Meeting Form (Excel Spreadsheet)
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CA DatabaseMaster Inputs
1. Receiving Verification (‘Inspection’)•Wrong Part•Nonconforming Parts•Count Wrong•Delivery
2. In-House Nonconformances•‘Expectations’ Issues•Nonconforming Parts
3. Installation ‘Report’•‘Expectations’ Issues•Installation Problems
4. Customer Complaints•‘Expectations’ Issues•Personnel Issues
5. Customer Returns•‘Expectations’ Issues•Repair Analysis
6. Service Findings•‘Expectations’ Issues•Conditions of Use Issues
7. Internal Audits•Process / Systems Related Issues•Business Standards Compliance Issues
‘Expectations’ IssuesDesign
PerformanceMaintainability
ReliabilityDurability
Supplier ProblemsPart Specific Problems
Seven BaseInput Screens
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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CA Database
Outputs (General)
•‘Standard’ Reports (Scheduled)
Must Define Measurables, thenWeekly ReportsMonthly Reports
•Ad Hoc Reports
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CA Database Files
SupplierData
NonconformanceData
PartData
CorrectiveActionData
InternalAuditData
ConsiderationsHow you handle your corrective action system will, obviously, be dependentupon your current systems. You may or may not have a MRP or other ‘control’software. If you do it may or may not be accessible by outside programs.
Flat-file vs. RelationalThere are canned stand-alone databases you can purchase. If you have someone who is OKprogramming Access, I recommend that over canned software. However, again, I want to saythat your solution will be specific to your company. Some companies do not want to bebeholden to canned software vendors. Some companies have no one proficient in Access (orother database software). In addition, there are hardware issues.This said, if you would like to discuss your situation I’d be happy to talk with you. But thesolution will not come from a phone call alone.
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Common Database Fields
• Customer Name / Number• Product ID• Serial Number
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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Example Customer Recall System
Return for AnalysisRECALL
IS ACCEPTED?
- RE-INSPECT- UNIT PROBE VERIFICATION (RE-TEST)- ELECTRIC GATE- RE-PACK
YES
NO
Review with the customer (criteria, odj.)
CUSTOMERRECALL
FIELDQ.A. Eng.Customer
Service
- V/M or Electric Reject Revision- Contact with Mfg. Eng.- R.M.R.- Autorization to return material- Gave a credit to the Customer
WHAT TO DO?
To Include or
to Replace with a Current
Device Order
GOOD MATERIAL
Warehousedwaiting tobe sold
OLD MATERIAL
IS REJECTED(SCRAP) because
of Design Changes
CorrectiveAction
System Input
Cayman Business SystemsElsmar.com - The Cove! ISO 9001:2000 Level II Flow Charts
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2002 Cayman Business SystemsRev: ReleasePrint: Wednesday, November 17, 2004
Elsmar.comSlide 46Example Flow Charts
8.5.3 Preventive Action (4.14)Management Review Process
Nonconformance-Corrective Action SystemCustomer Complaints System
HelpDesk SystemCorporate Suggestion Program
Process Control System
The Quality Systems Manager is the responsible authority for PreventiveAction. As directed by Management, Continuous Improvement andPreventive Action philosophies will be relayed to the entire organizationthrough one or a combination of the following (non-inclusive) techniques:
° Paycheck Stuffers° Banners° Meetings° Memos° Formal Training° Published Metrics
Analysis DataOutputs
Analyze forTrends
Considerations:1. Risks to Consumer2. Risks to Company
3. Probability of Occurrence4. Probability of Detection
5. Existing Controls6. Costs
‘Bad’ TrendIdentified(PotentialPreventive
Action)
Evaluate Potential ofIdentified Preventive Action
Project?
No
DevelopPotential
PreventativeActions
The person responsible for the project is assigned by the Quality Systems Manager and is responsible for theinitiation of preventive action and application of controls to ensure it is effective. The Quality Systems Managerfeeds back project outputs to Management Review.
ImplementPreventative
Actions
WasPreventative
ActionEffective?
No
Yes
PresentPreventative
ActionProjects for
ManagementReview
Inputs To:
8.2 SystemsData Outputs
All
This is an example of a way to address the Preventive Action documentation (system)requirement. As with the other maps, this map shows the ‘main’ points of the system. Whodoes what in your company (responsibilities) is company dependant.
If you do FMEAs, these are Preventive Actions and should be identified as such.
I have addressed Preventive Action within Clause_Interp_and_Upgrading.doc which is apart of this package. I suggest you take a read through it as you consider your systemdesign.