Flow Chart Examples

2002 Cayman Business Systems Rev: Release Print: Wednesday, November 17, 2004

Example Flow Charts

Elsmar.com Slide 1

Cayman Business Systems Elsmar.com - The Cove!

ISO 9001:2000 Level II Flow Charts

Printed 11/17/04 9:10 PM Page 1

Flowchart
A diagram that uses graphic symbols to depict the nature and flow of the steps in a process Benefits of Using Flowcharts
• Promotes understanding of a process • Identifies problem areas and opportunities for process improvement • Provides a way of training employees • Depicts customer-supplier relationships

2002 Cayman Business Systems Rev: Release Print: Wednesday, November 17, 2004

Example Flow Charts

Elsmar.com Slide 2

Cayman Business Systems Elsmar.com - The Cove!

ISO 9001:2000 Level II Flow Charts

Printed 11/17/04 9:10 PM Page 2

Symbols Used In Flowcharts
Start / End Process Step Decision
Yes No

Connector
2002 Cayman Business Systems Rev: Release Print: Wednesday, November 17, 2004

A
Elsmar.com Slide 3

Example Flow Charts

Cayman Business Systems Elsmar.com - The Cove!

ISO 9001:2000 Level II Flow Charts

Printed 11/17/04 9:10 PM Page 3

Required Level II Flow Charts (Procedures)
Procedures ‘Required’ By the 2000 Revision Partial Listing of Procedures ‘Required’ By the 1994 Revision

° ° ° ° ° °

4.2.3

Control of Documents

• • • • • • • • • •

4.3 4.4 4.5 4.6

Contract Review Design Control Document and Data Control Purchasing

4.2.4 Control of Quality Records 8.2.2 8.3 8.5.2 8.5.3 Internal Audit Control of Nonconformity Corrective Action Preventive Action

4.7 Control of Customer Supplier Product 4.8 Product Identification and Traceability 4.9 Process Control 4.10 Inspection and Testing 4.11 Control of IM&TE 4.12 Inspection and Test Status

2002 Cayman Business Systems Rev: Release Print: Wednesday, November 17, 2004

Example Flow Charts

Elsmar.com Slide 4

If you read through ISO 9001:2000, you will find 6 places where Documented Procedures are specifically stated to be a requirement. Some folks have been saying how nice it is that the documentation requirements have been reduced. While this is technically the case, it is really a non-issue. For the most part companies are not going to be reducing their documentation significantly if at all. What about new implementations? Will this be a big help to you? No - not really. You will have to have the ‘appropriate’ documents in place regardless. Take for example 7.4 Purchasing. There is very likely that your company will need a purchasing procedure. Often there are a number of purchasing ‘procedures’ (systems) which will require some type of documentation. The absence of the requirement does not exempt your company from having documentation ‘where appropriate’. Where appropriate will be determined by a common sense look at the process in context. One must remember that to comply with the 1994 version, most companies adopted the Level II approach - make 20 top level procedures or flow charts to address each element of the standard.
Cayman Business Systems Elsmar.com - The Cove!

ISO 9001:2000 Level II Flow Charts

Printed 11/17/04 9:10 PM Page 4

5.4.1. 2004 Example Flow Charts Elsmar. THIS LIST IS NOT INCLUSIVE! 2002 Cayman Business Systems Rev: Release Print: Wednesday.com .The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 5 .1.Some Other Expected Process Maps ° ° ° ° ° ° ° ° ° Planning (5.2. You have to review.6) Resource Management (6) Training (6.2.1) Management Review (5. Or. As I have stated before.your documentation will probably be minimal.2. that exclusions are limited to requirements within Element 7 . You may be a facility which is part of a corporation where there are flow-downs you will have to comply with (some of which will probably be documentation requirements).5.5. within your company. however it will most often be the case that your company will have to document these systems at least minimally.4) Analysis / Improvement (8.2. If you are a service company.4) Preservation of Product (7. An example is Product Identification and Traceability.3) Design and Development (7. most of the documents in the above listing are parallels to the 20 ‘old’ ISO elements.2) Customer Communication (7.3) Purchasing (7.4. 8.5.5) Validation of Processes (7.4) Operations Control (7. your company may only consist of 8 souls who provide a service .1) ° ° ° ° ° ° ° Product ID / Traceability ( 7.2) Process Measurement / Monitoring (8.5. 7.com Slide 5 As you can see.3) Product Measurement / Monitoring (8. November 17.5) Note: Some of these may not be relevant to your company.Product Realization. 8. the level of documentation your company will need cannot be determined by a book or reference.2) Customer Processes (7. It may be that the new standard does not specifically require a document to cover each of these. Your company may have relatively simple systems and on-the-job training may be utilized more than at another company. Product Preservation will probably not apply to your situation. Cayman Business Systems Elsmar. Remember.2) Customer Property (7. however.5. 8. what you are doing now and making some common sense determinations of where documentation is relevant and ‘necessary’.

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 Action items initiated and tasked Yes Trends Identified? No Minutes Recorded Minutes (including action items) Recorded Management Review Minutes Distributed & Filed 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 Example Flow Charts Elsmar.Management Review Periodic (Minimum of 4 per calendar year) Review Scheduled by Vice-President of Operations Notification of Review to President. November 17. New Business Internal Audit Status Corrective Actions Measurement Assurance. Action Items from prior meeting.com .com Slide 6 Cayman Business Systems Elsmar.Operations presents the following (as a minimum): Old Business A review of minutes from prior meeting.Production and Plant Manager VP . VP .The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 6 .

Consideration of any quality standards.. processes. quality control. legal requirements..com .com Slide 7 Cayman Business Systems Elsmar. instructions. Examine the production operatrions. Identify and define responsibility for the preparation of quality records VP . or other documentation required Confirm or determine the resources needed including raw material.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 7 . Identify and acquire any controls. examine and derive requirements from the accepted quotation or contract relating to the product being planned. if required. number of employees.Planning For Quality Procure.Operations retains records file 2002 Cayman Business Systems Rev: Release Print: Wednesday. the production process. November 17. regulations or codes that apply or may be affected. inspection and testing techniques and development of new instrumentation. total production resources ands skills required to achieve the required quality. inspection equipment. inspection and test procedures and other applicable documentation Confirm or determine the necessary documented procedures. machinery. 2004 Example Flow Charts Elsmar. Review Standards of Acceptability for all features and requirements including those containing a subjective element that must be clarified. etc. Ensure the compatability of the design. sequences and tests and inspection test points required. Update. drawings. as necessary..

Elsmar.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 8 .Order Flow Customer Order Order Source May Be: FAX Telephone Conversation Mail (or courrier ie: FedEx) Order Desk Enters order in ? Log. Ship 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 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. We also need to look at paperwork trails involved in doing these things.com Slide 8 Example Flow Charts Cayman Business Systems Elsmar. Examples are my 'suggestions' alongside the boxes. How does this happen? Verbal? Paperwork involved? Plant Office Determines availability In Stock? No Produce Batch per Process Documentation Is there an inventory record? Yes Pull Ordered Amount Excess To Stock Pull From Stock Complete Shipping Paperwork Take to Shipping Dock Notes: We need a little more detail here.com . My questions are in BOLD type. November 17.

Procure Material Review Reqmts Make vs. Pass to shipper File Paperwork Bill Customer Mail Invoice Collect Money Receive Payments Resolve Disputes Support Processes Quality Systems Internal Audits Procedures & Standards Management Processes Results / Forecasts Business Plan Mgmnt Mtgs. Acknowl. Verify Inputs Plan the Job Release for Purch 7 Mfg. November 17. Autorize Supp. Pack. Docs.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 9 . Buy Select Supplier Issue RFQ Place Orders Eval. Docs. Kit Materials Set up Equip.Typical Top Level Operations Flowchart Account Management Sales / Marketing Mrkting Process Sales Process Quote Process Credit Approval Order Receipt Order Review Gen. per Route Card Package Send to Finish goods Ship Product Confirm Date Create Pack. Incoming Matls Material Dispo.com .com Slide 9 Cayman Business Systems Elsmar. Document Control Control of Test Equipment Training Facilities Processes Corrective Action Customer Services Material Stocking Financial Processes Preventative Maintenance Personnel Processes Customer Complaints Design Engineering Supplier Approval Data Security 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 Example Flow Charts Elsmar. pay Build Product Review Doc. Order to MFG. Doc. Carrier Generate Ship. Mfg. Create / Dist Invoice Sched. Order Notify Mfg.

com .Business As A System (Process) Design Product Receive Order Sales / Marketing Purchase Materials Sub-Processes (Sub-Systems) Receive Materials Fabrication Assembly Ship Component Test Device Test Process Validations 2002 Cayman Business Systems Rev: Release Print: Wednesday.com Slide 10 An example of a manufacturing company defining and mapping its processes.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 10 . November 17. Cayman Business Systems Elsmar. 2004 Example Flow Charts Elsmar.

Define Product and Base Processes External Customers Retail Clients Process 1 High level Process Description 1.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 11 .com Slide 11 An example of a service company defining and mapping its processes. Product 1 Products Process 4 This is not meant to represent YOUR process structure. Sub-Process Sub-Process A Sub-Process B Sub-Process C 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 Example Flow Charts Elsmar. Product 1 2. November 17.com . It is only meant to serve to give you food for thought on looking at your processes. Product 2 Process 3 Sub-Process Sub-Process A Sub-Process B Information Services Wholesale Process 2 High level Process Description 1. Cayman Business Systems Elsmar.

2004 Example Flow Charts Elsmar. Cayman Business Systems Elsmar.com Slide 12 An example of a service company defining and mapping its processes.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 12 .com . November 17.Main Processes / Systems Process 1 Process 3 Sales Outside Retailer Selling Covered Products Proposal Proposal to Retailer Contract For Retailer Relationship Implement Add New Contracts Process 2 Tele-Market Retailer Provides Sales Information Contact Prospective Customers Successful Sale Process 4 Individual Calls for Service Contact Servicer & Issue Authorization Service Supplier Provides Service Service Supplier Invoices Company Company Pays Invoice 2002 Cayman Business Systems Rev: Release Print: Wednesday.

2004 Example Flow Charts Elsmar.com . Cayman Business Systems Elsmar.com Slide 13 An example of sub-processes in a service company.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 13 .Miscellaneous Sub-Processes Contracting & Compliance • Contract Negotiation • Compliance to State Regulations • Maintenance of Fulfillment Process Client Services • Load client data electronically • Dealer Set Up • Table maintenance • New client installations (implementations) Warranty Administration • Claims • Review & Approve Payments • OTL authorizations for retail contracts Direct Marketing • Campaign Planning • Execute Direct Mail & Telemarketing campaigns • Reporting for Client and management • Customer Service • Entitle & issue all initial authorizations • Inbound Sales Calls • Calculations for cash out Data Entry • Load client data manually • Process Cancellations Sales & Marketing Support • Develop proposals • Control collateral materials • 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 2002 Cayman Business Systems Rev: Release Print: Wednesday. November 17.

com .doc Cayman Business Systems Elsmar. November 17.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 14 . 2004 Example Flow Charts Elsmar.Document Types / Classification & Controls Master Systems Control by: Quality Systems Manager Systems Manual and Level IIs Department Specific Training Materials Control by: Department Manager Departmental Master Systems Control by: Department Manager Quality Records Training Records Control by: Department Manager Departmental Work Instructions Orientation Training Materials Control by: HR 2002 Cayman Business Systems Rev: Release Print: Wednesday.com Slide 14 Specific requirements are detailed in Clause_Interp_and_Upgrading.

The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 15 . very decentralized.3 Control of Documents (4. Upload Document to Appropriate Q (Secure) Drive Directory Communicate and Implement Yearly review in accordance with local procedure.during initial construction. Copy to Personal Space From Q Drive Revise Document This is your COMPLIANCE CONTROL feature.This is only to say that your system has to meet some basics but the variability makes it impossible to predict. Change control Availability Cayman Business Systems Elsmar.2. Important elements of your system should include: Approval Review .com . Document ‘Owner’ Copy Old Document from the Q Drive to Appropriate S Drive Directory or File Hard Copy to Maintain History.com Slide 15 2002 Cayman Business Systems Rev: Release Print: Wednesday. Some use canned software. Each person responsible for a document ‘owns’ a directory which only s/he can write to. 2004 Example Flow Charts The above is an example of where a company had a simple control system. Some smaller companies have everything on paper.4. The position of the computer today makes paper systems very rare. November 17. Companies control documents in many was. when changed and “…on a regular basis…” (which may be yearly). Masters are kept on a protected drive. but there are some that still exist. Control is. Elsmar. If Electronic. obviously.5) Base System Identify Document / Data Affecting Quality and Location(s) Requiring Access Proposed Document Produce Document In Personal Space Using Appropriate Template From the Q Drive Review Approve Proposed Revision Identify Need for a Change to an Existing Document / Data Affecting Quality Any employee may recommend a new procedure or a revision to an existing procedure.

2004 Example Flow Charts Elsmar. Change or Obsolete a Controlled Document Requestor Does Document Exist? Yes R-05001B Requestor Notify Appropriate Personnel.com .A Document Control System Request to Create (Add). Release or Obsolescence (History) Document Control Clerk Is Document Being Obsoleted? No Yes Document Control Clerk Document to Trash or History File As Defined Document Control Clerk or Appropriate Personnel Document Control Clerk Document is Implemented 2002 Cayman Business Systems Rev: Release Print: Wednesday. Cayman Business Systems Elsmar. Requestor (Review and Approval Loop) Document Control Clerk Obtain Appropriate Review(s)/Approvals Appropriate Personnel Update Master Listing Change/Release Document Record Change.com Slide 16 This is an example of a more complex document control system. November 17. Train and Distribute Document No Create Document According to Defined Rules This is your COMPLIANCE CONTROL feature.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 16 .

November 17. If Electronic. Cayman Business Systems Elsmar. Some smaller companies have everything on paper.com Slide 17 2002 Cayman Business Systems Rev: Release Print: Wednesday. The position of the computer today makes paper systems very rare. Copy to Personal Space From Q Drive Revise Document Document ‘Owner’ Copy Old Document from the Q Drive to Appropriate S Drive Directory or File Hard Copy to Maintain History. but there are some that still exist. Important elements of your system should include: Approval Review .2. Control is.doc for details.3 Control of Documents (4.4.during initial construction.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 17 . Elsmar. Upload Document to Appropriate Q (Secure) Drive Directory Communicate and Implement Yearly review in accordance with local procedure.com . 2004 Example Flow Charts The above is an example of where a company had a simple control system. obviously. very decentralized. Masters are kept on a protected drive. Change control Availability See Clause_Interp_and_Upgrading. Each person responsible for a document ‘owns’ a directory which only s/he can write to.5) Base System Identify Document / Data Affecting Quality and Location(s) Requiring Access Proposed Document Produce Document In Personal Space Using Appropriate Template From the Q Drive Review Approve Proposed Revision Identify Need for a Change to an Existing Document / Data Affecting Quality Any employee may recommend a new procedure or a revision to an existing procedure. Companies control documents in many was. Some use canned software. when changed and “…on a regular basis…” (which may be yearly).This is only to say that your system has to meet some basics but the variability makes it impossible to predict.

Release or Obsolescence (History) Document Control Clerk Is Document Being Obsoleted? No Yes Document Control Clerk Document to Trash or History File As Defined Document Control Clerk or Appropriate Personnel Document Control Clerk Document is Implemented 2002 Cayman Business Systems Rev: Release Print: Wednesday.com . Train and Distribute Document No Create Document According to Defined Rules Requestor (Review and Approval Loop) Document Control Clerk Obtain Appropriate Review(s)/Approvals Appropriate Personnel Update Master Listing Change/Release Document Record Change. 2004 Example Flow Charts Elsmar.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 18 .A Document Control System Request to Create (Add). November 17. Cayman Business Systems Elsmar. Change or Obsolete a Controlled Document Requestor Does Document Exist? Yes R-05001B Requestor Notify Appropriate Personnel.com Slide 18 This is an example of a more complex document control system.

Perform Level III Sub-Details of Level II Documents Control Plan PFMEA Flow Diagram Check Sheets MS Word Travelers Check Sheets Index: Masterdoclist. 2004 Master Process Manuals Process Specific Manuals Forms Manuals Paper copies printed & compiled into manuals controlled by the Document Control Clerk.com . May be altered during PPAP change. Developed during Program Planning.xls Impact. Printed manuals are found in offices. Operating Systems Manuals 2002 Cayman Business Systems Rev: Release Print: Wednesday.com Slide 19 Cayman Business Systems Elsmar. Inspection Sheets and Machine Logs.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 19 . Printed manuals are found at machines. Pre-Fix = M Master Manual Process Process / Machine specific. Example Flow Charts Elsmar.doc Level II How Policies Are Carried Out (Details) Systems Procedures per R-05001 Pre-Fix = R Work Instructions per R-05001 Pre-Fix = W Part Specific Documents per W-05002 Example Document Structure Computer 'Master Manual' Index Files Pre-Fix = Cf Operating Systems Manuals Administrative: Area or functional are specific document listing. Driver = W-60100A Pre-Fix = Cc Forms Manuals Machine specific documents.Level I Gallipolis Policies Quality (Systems) Manual Index: Computer 'Master Document' Files Partmast. Printed manuals are found in QA. Pre-Fix = Cp Process Specific Manuals Process specific document listing and training record. Face pages describing contents. November 17. These contain Check Sheets. Printed manuals are found at machines.

Control Plans / Part Specific Instructions 4. Index Page 2. 2002 Cayman Business Systems Rev: Release Print: Wednesday. Computer File Prefix = Cf . when printed out form the manual. Gage Instructions 7. The computer file is a detailed index of contents. Master Systems manuals are manuals which are specific to a process. The computer file is a detailed index of contents. The computer file is a detailed index of contents. Based upon a computer index file.Master Systems Manuals Process Specific Index. Computer File Prefix = M . Team Activity Report (PDCA) 8. General Instructions Based upon a computer file index. Operating Systems Manuals Situation Specific Index. Their intent is to provide specific documents for groups or individuals. Set-Up. Set-Up Verification Instructions 3. Visual Standard Reference 6. Control Plans 9. Some are machine specific as well as process specific.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 20 . They are a sub-set of relevant master documents. November 17. They are 'as needed' documents. Cayman Business Systems Elsmar. Process Manuals Manufacturing Contents: 1. Run and Production Instructions 6. Operating Systems manuals are manuals which are specific to functional groups or individuals. Changeover Instructions 4. 2004 Example Flow Charts Elsmar. Based upon a computer index file. They are maintained by Document Control Clerk.com Slide 20 Example of a manufacturing document structure. which. which. Gage Instructions 7. Process manuals are manuals which contain a basic set of information for specific processes. Operator Inspection Codes 3. Index Page 2. when printed out form the manual. when printed out form the manual. Expeditor Check Sheet 5. Target Parameters Computer File Prefix = Cp. All Other Processes Contents: 1.com . which. Process Instructions 5.

D.E.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 21 . Initial & Date Print Designer Review Print Against Current Print .Mark Up New Print. November 17. 2004 R-05001B Document Change Request Process Example Flow Charts Elsmar. Form Engineering Manager Review Proposed Print Change(s) RFQ Required? No Yes R-02002 'Quality Planning' Request for Quotation Process 2002 Cayman Business Systems Rev: Release Print: Wednesday.com .External Originator Sales Customer Example Print Control Sub-System Designer Log in Print Log Notebook W-05001B Customer Print Log Designer Stamp. If Necessary Designer R-05001B Document Change Request + W-05055 L.com Slide 21 Cayman Business Systems Elsmar.C.

com Slide 22 Cayman Business Systems Elsmar. November 17. The ID number is derived from the listing in the PartMast.xls file. 2004 Is Document Being Obsoleted? No Yes Document to Trash or History File As Defined Document Control Clerk Document Control Clerk Document is Available In Book Shelf Example Flow Charts Elsmar.xls file. ID numbers are not reused once a document is removed from control. Controlled Documents of External Origin are identified by a "Controlled Document" stamp inside the front cover and an ID Number hand written beside it.Example External Documents Control Sub-System External Document Received (Any Area) EXCEPT Prints Forward to Document Control Clerk Departmental Manager Document Control Clerk Review and Approval by Departmental Manager Does Document Exist? Yes Update Document Cross Listing Review Reason With Requestor Identify Document Document Control Clerk Create Document ID in Cross Listing In PartMast. Document Control Clerk Document Revised? Yes Order/Receive Document No No Action Document Control Clerk Check for Latest Revision Approval For Acceptance No Approval? No Update Document Cross Listing Document Control Clerk Document Control Clerk Yes Rules: Controlled Documents of External Origin are maintained by the Document Control Clerk. 2002 Cayman Business Systems Rev: Release Print: Wednesday.com .The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 22 .

4. End Production Evidence Book Contents PreProduction Production Post-Production Retention Time. 2.Base Rules: 1. Storage Location.com . Evidence Book Base Contents Defined By W-02002H 'Evidence Book Contents Page'. November 17. 3.com Slide 23 Cayman Business Systems Elsmar. Actual additional contents determined by change details and Customer Requirement(s). Removal of any document from the evidence book requires an 'Inquiry Sign Out Sheet' R-02002C. New Evidence Book Initiated Only For New Part Number. PPAP documents are derived from W-02002G outputs.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 23 . Destruction Method per R-16001 Product and/or Process Change Product and/or Process Change 2002 Cayman Business Systems Rev: Release Print: Wednesday. Changes to Process and/or Product Initiates New W-02002H 'Evidence Book Contents Page'. Example Design Process Records System (Configuration Management) Initiate Evidence Book New W-02002H Begin Production New W-02002H NOTE: Other than the actual warrant. 2004 Example Flow Charts PPAP As Necessary Elsmar.

accounting when an A. and kept in. November 17. 2004 Example Flow Charts Elsmar.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 24 .R is required) Program Manager W-02002W 'Evidence Book Contents Page' Initiate New Evidence Book W-02002G 'Four Phase APQP Evidence Book Statement of Work Determine Program Team Members Track Program to Beginning of Production Hand-Off to Manufacturing Engineering Manager at start of production.com Slide 24 Cayman Business Systems Elsmar.com .From Purchase Order Review Process Engineering Manager No Assign 'Responsible' Resource R-05001E 'PPAP Change Request' New Part Number? Yes Example Planning Process System Engineering Manager Assign Program Manager W-02002F 'Cost Tracking Log' (Issued from. 2002 Cayman Business Systems Rev: Release Print: Wednesday.

November 17. XXXX Review Controller No OK? Yes Controller: Sign Off On Purchase Order Other Engineering Manager Prototype SF Number Assigned Enter In R-02002B Prototype Part Production Summary To Planning Process Flow Chart Engineering Manager Purchase Order 2002 Cayman Business Systems Rev: Release Print: Wednesday.PO Source Example PO Review System To PO Source Purchase Order To Controller Discrepancy Review Controller: Reviews for Discrepancy Against RFQ Package or existing Purchase Order No Discrepancy If Current Production.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 25 .com Slide 25 Cayman Business Systems Elsmar. 2004 Example Flow Charts Elsmar.com .

The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 26 . only the 'applicable' sequence elements (as determined by the nature of the change) will be addressed.com Slide 26 Cayman Business Systems Elsmar. Quote Review Sign-Off 4. Copy of Quote Quote Review File Process Definition W-02001A Responsible Engineer Controller Form 005 'Quote Review Sign-Off' Controller R-03001A RFQ . Cost Analysis 3. Manufacturing Feasibility Sign-Off 5. Eng. Specification(s). Delegates A Responsible Engineer Engineering Manager No Appropriate Info? Yes Responsible Engineer Quote: E-Mail or Letter Controller PUR290Sa 'Manufacturing Feasibility Sign-Off' Engineering Manager 2002 Cayman Business Systems Rev: Release Print: Wednesday. Process Definition 2. 2004 Contents: 1. W-05002 Print Changes W-02001B Inquiry Register Engineering Manager Log Inquiry & Assign Number Need Additional Information (Print(s). Mgr. but seldom received.Cost Summary Example Flow Charts Elsmar.RFQ Source NOTE: DFMEA Requested. November 17. NOTE: Quote No Quote Need More Information May occur at various points. Etc. To Engineering Manager RFQ Print DFMEA Example Quotation Review System NOTE: For print changes.com .

2004 Example Flow Charts Elsmar. Product Dev. QA lab Update Product Dev. Operating Systems Manual Update PPAP File 2002 Cayman Business Systems Rev: Release Print: Wednesday. 3. November 17.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 27 .com Slide 27 Cayman Business Systems Elsmar.com . Operating Systems Manual Update Product Dev.Examples of Document Change Triggers Control Plan Change FMEA Change Process Flow Diagram Change Update Operating Systems Manuals 1. Chief Met. 2.

2004 Example Flow Charts Elsmar. November 17.Example Dock Audit System XXXX Review (Trigger) Assign Champion Responsibility TBD Make Plan Include: 1. Package Quantity 4.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 28 . Labeling Correct Label Correct Number of labels Correct label positioning Other or 'Special' Identification 2. etc. Attachments (e.com Slide 28 Cayman Business Systems Elsmar.com . Packaging Material / Container 5. Certs. General Product Condition 3.g.) Responsibility TBD Choose Measurable Responsibility TBD Choose Sampling Plan Perform Audit Accept Responsibility TBD Reject R-13001 Control of Non-conforming Product Reseal Box and Return to Pallet 2002 Cayman Business Systems Rev: Release Print: Wednesday.

4.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 29 . Disposition Quality Records are defined in: XXXXXX. White-out on a quality record is a very questionable practice. Retention Location 4. Identification 2. November 17. and implement / communicate it. Person Responsible 3.product. Location 4. Storage 5.should include an evaluation for quality records requirements.xls 2002 Cayman Business Systems Rev: Release Print: Wednesday. deterioration or loss Annotate Record: 1. Post-Retention Disposition Enter Record Into Master List Responsible Authority for Record Determine Methods of: 1.you don’t go back. feedback from a process or system may drive the need for ‘new’ quality records. Remember that records typically start out as forms. Retention Location 4. These may be (only a few examples) taking of data. Any planning you do . Responsibility 5. Revision Status 3. Indexing 3. Person Responsible 3. traceability or status related. Identification 2.2. Retention Time 5. I advise you to establish a company policy. 2004 Example Flow Charts Elsmar. process or other system .16) Department Managers Identify Quality Record Quality Systems Manager Record Assigned: 1. which states where and when white-out may be used (if anywhere). The point is planning now is very important. Those forms must be controlled just as procedures / flow charts are. Disposition Quality Systems Manager Maintain: 1. Collection 2. If you are going through implementation.4 Control of (Quality) Records (4. you probably already have quality records defined . Retention Time 5. In addition. Access 4.com .com Slide 29 It is important that you can show that you determine what is and is not during planning stages. Cayman Business Systems Elsmar. Master List of Records 2. Maintenance to prevent damage.

November 17. • On-The-Job . WIL be assessed during the registration and subsequent audits.Generally training which will help in the future. • Systems / Procedure Changes .2 Training (4. it never happened. You must address all types.2.An example would be training on how to run a machine.18) On The Job Department Manager Determine Job Affecting Quality Assign New or Existing Employee To Job Individual Needs Assessments Determine Individual Training Needs Supervisor Determine Qualifications and/or Training Necessary To Perform Job Document Requirements In Job Description & Job Posting OJT . this has to be ‘communicated’.New Hire Schedule Supervisor Training Needs Documented Yearly Review Employee Trained? Yes Employee Trained? Yes No No Supervisor Or Specialist Trains Employee Employee Performs Assigned Job Departmental Manager Updates Training Record Employee Scheduled For And Attends Training 2002 Cayman Business Systems Rev: Release Print: Wednesday. The ‘typical’ Big Five are: • Orientation .6. • Individual Needs .Basics given when someone starts their employment.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 30 .Whenever a procedure or system is trained. Training records and their control is absolutely a top priority and will.com . An example would be managers training for someone • Elective Records: No records. Cayman Business Systems Elsmar. 2004 Example Flow Charts Elsmar. not maybe.com Slide 30 Note that there are different types of training.

2004 No Example Flow Charts Elsmar.Example Preventive Maintenance System Preventive Maintenance Schedule Developed on a Yearly Basis for Key Equipment Preventive Maintenance Procedures And Checklists Developed Per Vendor Recomendations and Knowledge / Experience On Machine / Equipment. Equipment / Machine Delivered To Production/Eng Once Activity Completed Reactive Maintenance Production / Eng Opens Workorder for Repairment.M. Recorded on Checklist And Signed off . P. November 17. PM Database Updated.com Slide 31 Cayman Business Systems Elsmar.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 31 . Correct Performance? Yes Normal Production 2002 Cayman Business Systems Rev: Release Print: Wednesday. Evidence of P. Maintenance Repairs Machine / Equipment.M.. Performed Per Schedule and Established Procedures.com .

67 Continuous Improvement.com Slide 32 Cayman Business Systems Elsmar.Evaluation SPC CP and CPK Stability Index Trend Analysis Yes Stable / Normal CPK >= 1. Action Plan Example Flow Charts Elsmar.com . 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 Action Plan to Improve CPK.Preliminary Process Requiremnts New Process Process Capability Ongoing Process Controls Yes Ppk >= 1.67 No Re . November 17. Continuous Improvement.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 32 .67 No Yes No Chronic Unstable PPK >= 1.

6 IM&TE Quality Technician Collect From Manufacturing Area Calibration Due Master List Gives Location Suspect IM&TE Calibration Laboratory Any Personnel Transport To Lab Calibration Source Internal Quality Pull Appropriate Technician Work Instruction External Arrange For Calibration per W-11025 Outside Calibration Quality Technician Within Calibration Tolerance? Yes Can Be Adjusted? Yes No R-11001C Out of Calibration Review No Can Be Repaired? No Yes Internal/ External? Internal R-23001A Toolroom Work Order External Quality Technician Inspect and Calibrate per Work Instruction Seal Adjustment (Where Appropriate) After Adjustment Quality Technician Complete Appropriate Work Sheet Tag Device "Out Of Calibration" Quality Technician Enter Results Into Gagetrol Software R-11001A Scrap Measuring Device Update Gagetrol Software Return Device To Service R-06001 Purchasing Complete PO Form Place Calibration Sticker on Device 2002 Cayman Business Systems Rev: Release Print: Wednesday. November 17.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 33 .com Slide 33 An example Inspection. Measurement and Test Equipment calibration control system.com . 2004 Example Flow Charts Elsmar.7. Cayman Business Systems Elsmar.

. November 17.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 34 . Don’t over complicate the issue. This was a problematic area for some companies . Remember. even small companies. But .. if applicable 2002 Cayman Business Systems Rev: Release Print: Wednesday.try to convince some auditors. One client was a small trucking company.com . A trend line. reviews statistical technique to include as a Quality Record. not statistical process control (for some reason this used to be misunderstood regularly by auditors but isn’t much of a problem these days). A bar graph. An example might be an analysis of nonconformances over time.8. They insisted they had no need. Most companies are already doing some type of data analysis. The point of 8. This has not really changed. As long as you could show you evaluated the need for statistical techniques and found none (typically during a management review meeting) you didn’t have to do any.1 is to make sure you evaluate where data analysis would benefit your company.especially small companies.com Slide 34 The standard assumes a high reliance upon management by data analysis (acting on data). this reads statistical techniques. The key to their compliance was ISO 9001:1994 specifically required a company to “. Cayman Business Systems Elsmar. Statistical techniques can be simple stuff. I pointed out that they tracked delivery time. identify the need for…” statistical techniques.1 Statistical Techniques ‘Management’ is Defined as Departmental Managers and Other Management Management Determines a Need for Statistical Technique(s) to Control or Verify Process Capability or Characteristic Management Determines Method and Acceptability of Sampling Technique Management Prepares / Revises Instructions Defining Requirements Data Collected at Specified Interval Responsibilities Defined in Instruction Data Reviewed and Analyzed Record Filed and Retained for Period Specified in Instructions Process Improvement Mgr. And they reacted to ‘bad’ trends. I have to agree that every company does have such a need. 2004 Example Flow Charts Elsmar.

This is really part of your corrective action response system. 2004 Example Flow Charts Elsmar. customer complaints. all are tracked in 1 database. etc.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 35 . Cayman Business Systems Elsmar.Key: Box colour / line weight indicates responsibility Audit Manager Assigned Auditor 8. November 17.2 Internal Audit (4. Time. I recommend using Access or other database software and that you make your own database. production. Take a read through http://Elsmar. • A method of escalation when findings are not acted on.com/Audit/ for more details on Internal Audits.at least 1 year.com . Canned software seldom has the flexibility which you will find you need.com Slide 35 Your internal audit system should include: • Schedule . The key to this methodology is well thought out ‘defect’ categories.2. • Trained auditors • Much of the response to a nonconformance should go through a system like your corrective action system.17) Formulate Yearly Audit Schedule Yes On Time? No Schedule Follow Up Escalate Schedule Audit And Assign Auditor Determine Appropriate Follow Up Audit Date Track Follow Up Contact Auditee Agree on Follow Up Audit Date Perform Audit Ensuring Implementation Of and Effectiveness Of Reaction No Plan Individual Audit No Audit Plan Exists? Yes Contact Auditee Agree on Date. That is nonconformances found in audits (internal and external). Scope of Audit Nonconformance / Corrective Action Report OK? Yes Yes Perform Audit Nonconfor mance? No Close Audit & File Results Update Audit Schedule Management Review Input 2002 Cayman Business Systems Rev: Release Print: Wednesday. preferably 2 years. Many companies use one database to track nonconformances from all areas.

2002 Cayman Business Systems Rev: Release Print: Wednesday. If you don’t you will find you are requiring corrective actions for every nonconformance which will quickly overload your system and have everyone up in arms. but also audits (internal and external). 2004 Identify Need for Corrective Action Close Out Nonconformance / Corrective Action Report Verify Effectiveness of Permanent Corrective Action(s) Implement Permanent Corrective Action(s) Initiate Nonconformance / Corrective Action Report Establish Response Team (If Necessary) Describe the Problem Implement and Verify Interim Actions (Containment) Identify Potential Causes Select Permanent Corrective Action(s) No Root Cause? Select Likely Cause(s) Example Flow Charts Elsmar. etc. One reason is it touches on every requirement and fulfills it.2 in the Company Systems Manual for overall system specifics. You should follow the 8-D system. See section 8.com .14) This flow diagram illustrates the core elements of the corrective action investigative process from the point where the need for a corrective action is identified. but the Process Improvement Manager is the responsible authority for overseeing and administrating the Corrective Action system.com Slide 36 Important parts of a corrective action system include: • • • You MUST have ‘triggers’ and ‘escalation’ paths. Responsibility will depend upon the specifics of the identified need. Not just product.8. • • Take a read through http://Elsmar. That you have a method of ensuring evaluation of nonconformances for a determination of whether a partial or complete corrective action should / must be started.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 36 .2 Corrective Action (4. That you understand that you have multiple sources for nonconformances.5. November 17. Cayman Business Systems Elsmar. customer complaints. You MUST ensure every corrective action is evaluated for effectiveness.5.com/8D/ for more details on corrective actions.

14) Anyone? Decision to Request CA Requestor Initiate CA Form System Requirements Quality Manager is responsible for tracking corrective actions.com .2 Corrective Action (4.8. Quality Manager Log in CA Log Quality Manager? Assign CA Follow 7 Step Corrective Action Process 2002 Cayman Business Systems Rev: Release Print: Wednesday. November 17.5. or if (2) the CA becomes ‘bogged down’ or (3) is insufficient in the opinion of the QM. the CA will be escalated to the responsible person’s immediate superior.com Slide 37 Cayman Business Systems Elsmar.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 37 . The person assigned the CA has 7 days to give an initial response to the CA. If (1) a response is not obtained. 2004 Example Flow Charts Elsmar.

Congratulate Your Team 2002 Cayman Business Systems Rev: Release Print: Wednesday. Prevent Recurrence 3. experience and abilities which complement each other. Implement and Verify Interim (Containment) Action(s) Yes Identify Possible Solutions 8. Describe the Problem No Is the Potential Cause a Root Cause? 7. Use Team Approach Select Likely Causes 6.com Slide 38 The ‘D’ in 8-D stands for Disciplines Teams are important. A company as a whole is complex . 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.a set of systems with different functional experts in different areas. Quality affects manufacturing. You might want to take a read through http://Elsmar.com/8D/ for details on the 8-D Corrective Action / Prevent Recurrence process.com . Choose/Verify Corrective Actions 1.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 38 . Cayman Business Systems Elsmar. Quality affects design. Identify Potential Cause(s) 5. The areas complement each other and many have interactions. Why do you think this is so? Normally people in a company have skills. 2004 Example Flow Charts Elsmar. Implement Permanent Corrective Actions 2.The ‘8-D’ Corrective Action System Awareness of Problem 4. Design affects quality. November 17.

The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 39 .com Slide 39 Cayman Business Systems Elsmar. November 17.com .Thoughts About Databases 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 Example Flow Charts Elsmar.

The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 40 .com . 2004 Example Flow Charts Elsmar.including Supplier Rating and Approved Supplier List (Excel Spreadsheet) • Customer Concerns/Complaints (Excel Spreadsheet) • Nonconformances (Database) Internal External • Corrective / Preventive Action • Internal Audits Tracking (Calendar) (Excel Spreadsheet) Audit Forms (Excel Spreadsheet) (Database) • Management Reviews Tracking (Calendar) (Excel Spreadsheet) Meeting Form (Excel Spreadsheet) 2002 Cayman Business Systems Rev: Release Print: Wednesday.Items To Track NOTE: Parts of some of these may be included in the current MRP software system. November 17. • Receiving Inspection • Suppliers .com Slide 40 Cayman Business Systems Elsmar.

The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 41 . Installation ‘Report’ •‘Expectations’ Issues •Installation Problems 4.com Slide 41 Cayman Business Systems Elsmar. In-House Nonconformances •‘Expectations’ Issues •Nonconforming Parts 3. Customer Returns •‘Expectations’ Issues •Repair Analysis 6. Internal Audits •Process / Systems Related Issues •Business Standards Compliance Issues 2002 Cayman Business Systems Rev: Release Print: Wednesday.Master Inputs •Wrong Part •Nonconforming Parts •Count Wrong •Delivery CA Database ‘Expectations’ Issues Design Performance Maintainability Reliability Durability Supplier Problems Part Specific Problems 1. Customer Complaints •‘Expectations’ Issues •Personnel Issues Seven Base Input Screens 5. 2004 Example Flow Charts Elsmar. November 17.com . Receiving Verification (‘Inspection’) 2. Service Findings •‘Expectations’ Issues •Conditions of Use Issues 7.

com . 2004 Example Flow Charts Elsmar. then Weekly Reports Monthly Reports •Ad Hoc Reports 2002 Cayman Business Systems Rev: Release Print: Wednesday.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 42 .CA Database Outputs (General) •‘Standard’ Reports (Scheduled) Must Define Measurables.com Slide 42 Cayman Business Systems Elsmar. November 17.

If you do it may or may not be accessible by outside programs. This said. Relational There are canned stand-alone databases you can purchase. obviously. Supplier Data Part Data Nonconformance Data Corrective Action Data Internal Audit Data Flat-file vs.com Slide 43 Cayman Business Systems Elsmar. I recommend that over canned software.CA Database Files Considerations How you handle your corrective action system will. there are hardware issues. Some companies do not want to be beholden to canned software vendors. 2002 Cayman Business Systems Rev: Release Print: Wednesday. I want to say that your solution will be specific to your company. In addition. again. If you have someone who is OK programming Access.com . Some companies have no one proficient in Access (or other database software). if you would like to discuss your situation I’d be happy to talk with you. November 17. be dependent upon your current systems. 2004 Example Flow Charts Elsmar. You may or may not have a MRP or other ‘control’ software. But the solution will not come from a phone call alone.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 43 . However.

com Slide 44 Cayman Business Systems Elsmar. November 17.com .Common Database Fields • • • Customer Name / Number Product ID Serial Number 2002 Cayman Business Systems Rev: Release Print: Wednesday. 2004 Example Flow Charts Elsmar.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 44 .

November 17. Eng.Autorization to return material .ELECTRIC GATE . Eng.R.RE-INSPECT .A. 2004 OLD MATERIAL IS REJECTED (SCRAP) because of Design Changes Example Flow Charts Elsmar. .com Slide 45 Cayman Business Systems Elsmar.V/M or Electric Reject Revision .The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 45 .) NO FIELD Q.com .Gave a credit to the Customer To Include or to Replace with a Current Device Order RECALL IS ACCEPTED? YES Return for Analysis .Example Customer Recall System CUSTOMER RECALL Review with the customer (criteria. .R.Contact with Mfg.UNIT PROBE VERIFICATION (RE-TEST) . odj.RE-PACK WHAT TO DO? GOOD MATERIAL Warehoused waiting to be sold Corrective Action System Input 2002 Cayman Business Systems Rev: Release Print: Wednesday. Customer Service .M.

I have addressed Preventive Action within Clause_Interp_and_Upgrading.5. I suggest you take a read through it as you consider your system design. The Quality Systems Manager feeds back project outputs to Management Review. this map shows the ‘main’ points of the system. As with the other maps.com . As directed by Management.14) Management Review Process Nonconformance-Corrective Action System Customer Complaints System HelpDesk System Corporate Suggestion Program Process Control System The Quality Systems Manager is the responsible authority for Preventive Action. Risks to Company 3. these are Preventive Actions and should be identified as such. 2002 Cayman Business Systems Rev: Release Print: Wednesday.3 Preventive Action (4. Continuous Improvement and Preventive Action philosophies will be relayed to the entire organization through one or a combination of the following (non-inclusive) techniques: ° ° ° ° ° ° Paycheck Stuffers Banners Meetings Memos Formal Training Published Metrics No Inputs To: 8. Costs Develop Potential Preventative Actions Yes Present Preventative Action Projects for Management Review Project? No The person responsible for the project is assigned by the Quality Systems Manager and is responsible for the initiation of preventive action and application of controls to ensure it is effective.doc which is a part of this package. If you do FMEAs. Probability of Detection 5. November 17.8.The Cove! ISO 9001:2000 Level II Flow Charts Printed 11/17/04 9:10 PM Page 46 . Cayman Business Systems Elsmar. Existing Controls 6. 2004 Example Flow Charts Elsmar.com Slide 46 This is an example of a way to address the Preventive Action documentation (system) requirement.2 Systems Data Outputs Implement Preventative Actions Was Preventative Action Effective? Evaluate Potential of Identified Preventive Action Considerations: Analysis Data Outputs All Analyze for Trends ‘Bad’ Trend Identified (Potential Preventive Action) 1. Risks to Consumer 2. Probability of Occurrence 4. Who does what in your company (responsibilities) is company dependant.

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