DOCUMENT CONTROL PROCEDURE

Transcription

1 Page 1 of 14 Purpose: To provide a process outline for the review, approval, release, control, retention and disposal of any controlled document. As an integral process the procedure ensures conformance to Flextronics Automotive Inc. s quality management system objectives and requirements. Scope: This procedure defines the various types of controlled documents in use with references to other controlling procedures that may exist to manage them. Additionally, it outlines the general management process all controlled documents must follow in order to ensure that only the latest revision document is available for use and that obsolete information is removed and dispositioned appropriately. This procedure, in conjunction with ADM018 Generating & Control of Engineering Change Notice, encompass the change control process. Refer to flow chart at the end of the document for a summary of the procedure. Responsibility: Anyone who issues, reviews, approves, references, or handles any controlled part/ document whether the part/ document is internally or externally generated. TABLE OF CONTENT 1. DOCUMENT CLASSIFICATION & APPROVAL REQUIREMENTS DOCUMENT NUMBERS / PART SPECIFICATION (DRAWINGS) DOCUMENT SUBMISSION AND RELEASE DOCUMENT STORAGE DOCUMENT DISTRIBUTION DOCUMENT REVISION DOCUMENT OBSOLESCENCE... 11

2 Page 2 of DOCUMENT CLASSIFICATION & APPROVAL REQUIREMENTS For the purposes of this procedure the term document will be used to refer to any specifications, drawings, actual documents or processes that must be controlled. Documents can be hard or soft copy or any other media. All controlled document changes (including release) will be processed in accordance with this procedure and in conjunction with ADM018 (ECN Change Control procedure). Approvals, as noted in definition below, are as required by ADM018. Controlled documents are categorized as detailed below. Each document type has a corresponding review and approval process. See fig. 1.1 for Team Member & Management approval requirements and fig. 1.2 for a Controlled Document Listing and related procedures. Type I: Type II: Review and approval by selected Product Team Members and Management Members. Type I documents typically involve a change to production materials, components, CAD data or, generally, changes that can impact the customer and their requirements. Type I documents also involve Prototype. Prototype changes involve changes to prototype materials, components, processes, CAD data/drawings and, in general, changes that are not production intent (i.e. not PPAP level). Prototype changes are generally performed with customer knowledge; however customer approval is not necessarily required. Whenever there is doubt as to a documents change type, Type I will be used as the default. Review and approval by selected Product Team Members and the Management Members. Type II documents are product related, but do not directly or necessarily affect production parts or processes. They are, in general, the production support documents developed as part of the product development process (PDP). Type II documents can also be processed under a Type I change that will be known to impact the Type II document. Type III: Review and approved by Product Engineering Manager only. Type III documents are generally administrative system documents that are not related to any specific product or service. Typical examples are the various management system procedures, work instructions, forms and personnel administrative requirements. They may also involve customer specifications and requirements that are not related to a specific product (for example a customer product design manual or a customer supplier manual). Upon approval, Document Control is responsible to notify all employees of the changes through . Type IV: Note that, in general, customer generic and international specifications do not require release through the change control process unless they are linked to a customer specific product requirement (i.e. initially handled through the product change evaluation PCE process). These types of specifications typically include customer generic specifications (e.g. testing, packaging or labeling etc) ISO Standards, AIAG, ANSI, ASTM, IPC specifications or certification/ accreditation body and associated normative documents and corporate requirements. When any such documents are revised Document Control shall update and send notification to all departments through a general announcement. Department mangers / supervisors are responsible to review, determine applicability and ensure their respective personnel are updated and/ or trained as required. Supplier initiated, review and approval by the selected Product Team Members, Electrical Eng. Supervisor and additional Program Managers depending upon on the product or component usage. Approval is also required by the Management Members as detailed in figure 1.1. Supplier initiated changes involve changes in component parts that Flextronics Automotive Inc. has no design control over or input into. They are essentially off the shelf materials such as standard electronic components. If there is sufficient doubt that any supplier initiated change can: impact the customer or conformance to customer specifications (fit, form, function or reliability), require any testing or validation, have any piece price impact, require any

3 Page 3 of 14 manufacturing processing changes, require documentation updates, etc, then the change request shall be processed as a Type I change. TEAM MEMBER & MANAGEMENT APPROVAL REQUIREMENT Fig. 1.1

4 Page 4 of 14 DOCUMENT TYPE DEFINITIONS DOCUMENT TYPE TYPE I TYPE II TYPE III TYPE IV CONTROL S ADM018 ADM114 ADM018 ADM114 ADM018 ADM114 ADM018 ADM114 RELATED S PEN PEN PEN144 ADM105 N/A TYPICAL DOCUMENTS Production Print/ Specification Production CAD, PCB Gerber, Math Data Production Bill of Material Production Software, testing software Production Manufacturing Process Changes Prototype Internal & Customer Product Specification Internal & Customer Product Standard Design/Process/ Tester FMEAs Process Flow Diagram Control Plan Manufacturing Plan, GOP Test/Tester / Calibration Document Operator Instructions pertaining to specific products Internal & External Manuals (e.g. Supplier Manual) Procedures General Work Instructions Forms Generic Customer Standards/ Specifications Supplier Initiated Changes (PCNs). Only Applies to Commodities that Flextronics Automotive Inc. Does not Have Design Control / Input Over. Fig. 1.2

5 Page 5 of DOCUMENT NUMBERS / PART SPECIFICATION (DRAWINGS) 2.1. All controlled documents shall be assigned a document number (unless otherwise noted) The originator of a new document shall request a document number from Document Control in accordance with work instruction Requests for document numbers for non-procedural documents are initiated in accordance with procedure PEN144. Document numbering is based on categories as defined in Group Code Listing Document numbers for Procedures are initiated in accordance with procedure ADM The Document Control Department is responsible for issuing new numbers and maintaining a listing of all current document numbers and their revision levels. The listings are located in the Part Number Database and Document Control department folders that reside in the designated network drives Customer / International / Industry Specifications and Standards, Certification or Accreditation Body, any associated normative documents and Corporate Documents will be stored or filed under their respective document number. The same storage or filing methods as used for all other documents shall apply Documents not under the direct control of Document Control shall be created, stored and maintained in accordance with respective departmental process and procedures. Typical examples of such documents are: finance/ sales administrative, PPAP records, laboratory test reports etc. Also, refer to Archiving and Record Retention Procedure ADM011.

6 Page 6 of DOCUMENT SUBMISSION AND RELEASE 3.1. All controlled documents shall be released through the ECN process (ADM018) and submitted to Document Control Document Control shall stamp submitted hard or soft copy specification (Type I and select product related Type II) documents as MASTER COPY on the document. For documents with more than one sheet, the stamp will be placed on the first page in an area clear of text. The color of the ink stamp shall be red for copy control purposes (refer to step #5.4). For all Type III document soft copies (internally generated), Document Control shall place an Uncontrolled Copy watermark on the documents. Note: Forms (201 group code) are not subject to any type of Document Control stamp Documents submitted to Document Control that are awaiting approval shall reside in a location that clearly indicates their pending status (reference ADM018) Type II & Type III (internal) documents submission Soft copy document submissions to document control shall be submitted in their native format (i.e. MS Word/ Excel etc, not Adobe). Documents that are likely to be distributed outside of Flextronics Automotive Inc. (i.e. specifications, manuals etc) shall be available for employees as read only.pdf formatted soft copy files. The native file(s) of the.pdf controlled document(s) shall be retained by document control in the case document revisions are required Drawings submission Hard or soft copy drawings submitted to Document Control shall be released and identified as a Type I ECN controlled document (this includes prototype) Hard or soft copy drawings submitted to document control and under the control of Flextronics Automotive Inc. are to be submitted with signatures, which reflect the actual or electronic signatures of the individuals that generated, checked and approved the drawing(s) Customer Drawings that are created by Flextronics Automotive Inc. for the customer shall be submitted to document control and stamped REFERENCE. This REFERENCE copy will be deemed the master copy until such time that the customer returns either written notification of acceptance or a returned and signed drawing indicating approval of the drawing If the customer returns a signed drawing, this drawing shall supersede and replace the REFERENCE copy maintained by Document Control If the customer provides written confirmation indicating their agreement with the REFERENCE copy on file, Document Control shall file the communication (typically with the approving ECN), and identify the drawing as the MASTER COPY Customer specification submission Customer product related specifications submitted to Document Control, in any media, shall be released as a Type II ECN. Customer generic specifications and standards shall be released as a Type III ECN when required (see notes Type III under Section 1). Note: End users should verify with Program Managers if the customer specifications are at their latest revision before/during working on a project.

7 Page 7 of 14 Program Managers should ensure all team members are referencing to customer specifications with latest revision The review and approval process shall be completed within 2 working weeks for customer standards and or specification changes. Necessary actions due to the changes will be initiated as required Document Control shall create and maintain a Customer Specification Listing that can be accessed through the Flextronics Automotive Inc. Document Control Webpage Other Standards and Specification (Type III), once determined as having been revised by a user (refer to #6.2), shall be submitted to or notification sent to Document Control. Document Control shall then process the revised document in accordance with this procedure. The Type III documents referred to here include: Generic Customer Standards and Specifications, International/ Industry Standards and Specifications, Certification/ Accreditation Body Documents and any associated Normative documents.

8 Page 8 of DOCUMENT STORAGE 4.1. Master controlled documents will be filed in specified/ designated locations reserved for Document Control be they hard or soft copy. Softcopy electronic data will reside on the designated computer network drives in the specified structure folders as required. With the exception of CAD/Math model data and product software files, which can only be accessed by Document Control personnel, all softcopy electronic data are write protected and can be accessed by all employees via Document Control Webpage (refer to Section 5) All documents will be stored and maintained in accordance with procedures ADM011 and ADM Any Master controlled documents, which are stored as hard copy, removed from the Document Control area shall be signed out upon removal and signed in upon return Obsolete or previous revision documents shall be handled as outlined in Section 7.

9 Page 9 of DOCUMENT DISTRIBUTION 5.1. Controlled distribution of selected Type I documents (drawings, CAD/Math data, software) will only be made via the Document Control Data Request with approval from Engineering Manager/Supervisors (reference work instruction ) Selected Type II documents that impact production operations (GOPs, Test Procedures etc ) will be distributed to manufacturing site via sharenet upon ECN approval. Distribution will also be controlled via the Document Control Data Request with approval from Engineering Manager/Supervisors (reference work instruction ). Designated product team members in manufacturing site will be responsible to implement the changes. Notification of ECN approval will also be automatically generated via to team members. Team members (with the exception of manufacturing site) can review any such documents via Document Control Webpage or data request as noted in step Distribution of newly released or revised procedures, work instructions and forms (Type III) shall be done in a manner that effectively reaches individuals whom the changes will affect. In general, Document Control will send all party notification of approval for Type III documents via . Department Managers and Supervisors are responsible to ensure their respective personnel are fully aware of the changes and arrange necessary training or orientation as required Controlled distribution copies shall be manually stamped, in red, with DO NOT COPY on the document or contain a watermark indicating UNCONTROLLED COPY, typically for softcopy. For documents with more than one sheet the stamp will be placed on the first page in an obvious location. The color of the DO NOT COPY ink shall be red, for copy control purposes Controlled documents that are to be used or sent outside of Flextronics Automotive Inc. should be obtained from Document Control for control purposes (per step 5.1). For internal use purposes it is permissible to obtain documents from the intranet web site. For control purposes if any of the Document Control required stamps (MASTER COPY, DO NOT COPY, REFERENCE COPY, UNCONTROLLED COPY, PRODUCTION APPROVED) are not in RED stamp ink (as opposed to laser printer ink), the document will be considered uncontrolled.

10 Page 10 of DOCUMENT REVISION Note: 6.1. The specified review and approval process shall be followed to revise documents (reference ADM018) to ensure changes have not caused unintended effects on the baseline. The Document Control database shall be updated to reflect the latest document revision. Revision levels should be apparent on the document or the document must be identified in a manner sufficient enough to allow it to be traced back to the document control system to ensure the correct revision level It is the responsibility of the users of Type III documents to periodically check (should be verified annually as a minimum), through appropriate means, that the latest document revision is currently on hand. If the document has been revised the user shall either provide a copy to or notify Document Control that the document has been revised. Document Control shall then process in accordance with this procedure. The Type III documents referred to here include: Generic Customer Standards and Specifications, International/ Industry Standards and Specifications, Certification/ Accreditation Body Documents and any associated Normative documents Submission and storage of revised documents shall comply with all sections of this procedure Recipients of a notification of change via an approved ECN shall return, destroy or mark the document OBSOLETE and archive the obsolete document. The need to retain obsolete documents outside the control of Document Control should be reviewed with the Quality Management System Management Representative to ensure that the record is required and is properly secured to prevent inadvertent use. Any individual or location archiving controlled documents will be subject to audit.

11 Page 11 of DOCUMENT OBSOLESCENCE 7.1. Obsolete documents shall be removed from the specified Master Document file and identified as OBSOLETE. This applies to both hard and soft copy documents Obsolete documents will be archived in secured designated locations for the required retention periods as defined in procedure ADM011. Archiving may consist of storing hard copy documents or soft copy storage on a reliable storage medium (i.e. CD, DVD, computer network drive folders, server etc.) in accordance with procedures ADM011 and ADM925. Access to obsolete and archived documents will be strictly controlled by Document Control The only exception to points 7.1 and 7.2 above shall be for Type III documents. Internally generated Type III documents may, when required, be left on the Master Document file provided they are identified as obsolete and provide reference to the document that supersedes and now governs the subject matter. This is done to prevent a mass update of numerous documents that may make reference to the now obsolete document Additionally, customer generic or international / industry standards and specifications may remain accessible for information or legal purposes as they continue to remain part of an active design record. Typical examples would be Laboratory Management System testing standards and/ or specifications that remain active as product was tested to a particular standard / specification or its respective revision level. While accessible these documents shall be stored in appropriately identified folders and not with the latest revision of the document, and be appropriately identified.

12 Page 12 of 14 Flowchart Originator requests document # from Doc-Ctrl WI Originator submits documents to Doc-Ctrl and issues ECN to release document ADM018 Doc-Ctrl stamps documents Master Copy or Uncontrolled Copy and stores in specified location awaiting for ECN approval Doc-Ctrl stores documents in designated network drive upon ECN approval ADM011, ADM925 Doc-Ctrl distributes documents upon request, documents are stamped Do Not Copy WI Document revision required Doc-Ctrl stamps obsolete documents Obsolete and archives in secure designated locations ADM011, ADM925

13 Page 13 of 14 Records: All Document Part Number / Procedure / Specification Database Listings - Maintained daily and updated as required. All other documents and records per ADM011. Definitions: ECN Engineering Change Notice PDP Product Development Process CAD Computer Aided Design PPAP Production Part Approval Process EMS Environment Management System Related Documents: ADM011 Archiving and Record Retention Procedure ADM018 Generating and Control of Engineering Change Notice (ECN) Procedure ADM105 Establishing and Revising Procedures ADM925 Network Data Protection Procedure PEN144 Part/Document Number Request and Issuance PDP Manual Laboratory Management System Manual Group Code Listing Document Control Part Number Request Work Instruction Document Control Data Request Work Instruction Flextronics Global Services Newmarket Health and Safety Manual Flextronics Global Services Newmarket EMS Manual Revision History: Rev. Description of Change Date ECN# Originator Sign-off 05 Delete Refer to the Record Retention Jan 15/ Rick Ash Schedule Attached in Page 3 of 3. Delete Flow Chart 06 Delete form #201260; Update logo Feb 07/ Fern Mok G H Update to new format, revise content, added Controlled Document Matrix to body as a Word Table instead of.xls attachment to hard copy. Enhanced Related Docs section Updated section 3. in order to reflect current work practices. Inserted new section (4.) to reflect requirements for submission of drawings. Updated 7.2 to reflect use of alternate medium for archiving process. Deleted reference to form # Mar 11/ Ron Finlay July 15/ Brian Sneek

14 Page 14 of 14 J Update Records section. May 12/ Brian Sneek Update body of document to allow for electronic submission & retention of documents / drawings. K Update #4 Drawing submission June 2/ Fern Mok Add # 5 Customer Specification release and update Update Document Type table to add Type V and VI documents L Update section 3.3 and 4.1 Sept 29/ Brian Sneek M Update document structure and clarify Nov. 10/ T. Geller wording Update Related Documents and Records sections N Update Step #8 to include bullet 8.3. Dec. 11, T. Geller P Q R Update procedure for redefined ECN types based on CI initiative and organizational changes, update company name. Update procedure to improve definition of 3 rd party Type III documents. Added #3.6.4 and #6.2 Update # 5.2, remove reference to production management, add distribution of documents to manufacturing site Reference Flextronics Global Services Newmarket EMS & Health & Safety Manual Remove reference to supplier manual S Notes added to #3.6.1 Customer specification submission Oct. 9, E2007 Fern Mok Jul. 15, E2008 Tom Geller Nov 12, E2010 Fern Mok Sep 23, E2011 Fern Mok