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03. Document & Data Control Procedure1.0PURPOSE1.1To establish a procedure to:iAllow review, update and approval of documents prior to use;iiEnsure relevant versions of the documents are available at all locationsessential to the functioning of the Quality Management System.iiiProvide control over obsolete documents to prevent unintended use;ivTo identify and control any relevant documents of external origin, e.g.national standards or client contracts & drawings;vProvide control of recordsviProvide control of notices and other temporary sources of data includinghand-written informationviiEstablish a process for computer back-up2.0RESPONSIBILITY2.1The MR (Management Representative) is responsible for administering thisprocedure.2.2All Managers are responsible for implementing this procedure.3.0CRITERIA3.1To ensure all managers have access to the latest documents3.2To ensure all managers know how to confirm the validity of a document3.3To prevent error through loss of documents or use of incorrect documents3.4To ensure customer documents are kept confidential and are accounted for.4.0PROCESS4.1Document identification for QMS (AS9120: 4.2.3)4.1.1This procedure covers the whole of the Quality Management System (QMS)as stored on the company computer server:iQuality ManualiiProceduresiiiWork InstructionsRevision: 6 – Date: October 8, 2014MCI 03 Document and Data Control.docISOtec – Making your business better – www.isotec1.comPage 1 of 5
03. Document & Data Control ProcedureivForms & Records4.1.2All QMS documents have a consecutive Revision No. and a Revision datewhich are shown in the document footer.4.1.3All documents start at Revision: 1. whenever there is a change to document,the revision number is advanced by one, the revision date of that document ischanged to the date of the change and the reason for the change is noted inthe change history.4.1.4The latest revisions of all the documents of the QMS are kept on a computerdirectory called ‘AS9120’ on the MCI server. The directory is accessible toboth internal employees and Field Sales Engineers. The files are read-only toprevent unauthorized editing of the documents. These documents should belegible and easily identifiable. All managers may read or print thesedocuments. When a document is superseded, the computer file is moved to adirectory that is clearly identified for superseded files only.4.1.5Printed copies of the QMS are allowed but these are not controlled. Only thecopy of the QMS on the computer directory is controlled. It is theresponsibility of all managers to ensure that they are using the latest copy ofthe documents.4.2Preparation, Revision and Approval of QMS documents (AS9120: 4.2.3)4.2.1It is the responsibility of all personnel to identify activities that requiredocumentation within their area of operation. This may occur due to the needsof the business, as part of the audit process or as part of the corrective andpreventive action process.4.2.2The responsible Manager prepares and reviews the necessary changes to theQMS and circulates his draft for comment as necessary. On completion of thefinal draft, the manager forwards the documents to the MR for approval whoalso re-approves documents.4.2.3The MR is responsible for approving the QMS by:ireviewing all new documents;iiif approved, updating the computer directory with the new document;iiiCommunicating to relevant users to inform them of the reviseddocument;ivEnsuring that a record is kept of all superseded documents on thecomputer. These must be kept separately from the current QMS to avoidaccidental use.Revision: 6 – Date: October 8, 2014MCI 03 Document and Data Control.docISOtec – Making your business better – www.isotec1.comPage 2 of 5
03. Document & Data Control Procedure4.3Regulations, Technical Specifications, etc (AS9120: 4.2.3)4.3.1The MR keeps a copy of any relevant Regulations, Technical Specificationsor National Standards. The MR will notify all managers when a document issuperseded. Obsolete standards may be kept but are clearly marked as“Obsolete”. Managers may keep their own copies of these documents butmust ensure they have the latest revision.4.4Quality Records (AS9120: 4.2.4)4.4.1The Quality Records are listed in section 5.0 of each of the procedures.These specify the records generated by the quality system, location filed,minimum retention time and manager responsible. It is the responsibility ofthat manager to index the records as necessary for easy retrieval and todispose of the records accordingly. Supplier created records such as a MFGcertificate of conformance are retained here at MCI and not at the supplier.4.5Customer Drawings (AS9120: 4.2.3)4.5.1When customer drawings are received in connection with a product:iAlways check with the customer that you have the correct drawingreference number and revision leveliiRecord the drawing # & rev on any MCI communication such as quoteand sales orderiiiAttach a copy of the drawing to the sales orderivFile a copy of the drawing in the drawing file, referenced by customername4.5.2Unless the customer gives alternate written instructions, all customerdocuments and data received must be treated as intellectual property andkept confidential and stored properly to prevent loss or damage.4.6Control Of Notices And Other Temporary Sources Of Data (AS9120:4.2.3)4.6.1The posting of office memos such as for administration purposes need not becontrolled.4.6.2However, notices that provide information concerning the quality system orproduct are discouraged and should be controlled in accordance with thisprocedure. Such notices might include information that could be misleading ifnot kept up to date; e.g.: A list of approved vendors4.6.3It is human nature to make quick reference documents and post them in easyto reference places. Where these notices contain data that could be revisedRevision: 6 – Date: October 8, 2014MCI 03 Document and Data Control.docISOtec – Making your business better – www.isotec1.comPage 3 of 5
03. Document & Data Control Procedurethrough the controlled quality management system, then they pose a risk thatthe data may become obsolete and then be used in an erroneous way.4.6.4In order to provide control over these potential sources of error, the followingrules must be used for posting notices:iOnly the MR may post noticesiiThe MR must sign and date each notice and provide a copy to the“Notices” file. The copy in the Notices file must note how many copies ofthe notices have been posted and where.iiiThe MR may also note important issues of a temporary nature ondepartment whiteboards.ivThe MR must ensure that the QMS is promptly revised to agree with thecontents of any posted notice. Similarly, the MR must ensure that thesenotices are revised or removed as necessary when they becomesuperseded by changes to the QMS.4.7Personal Files and Records (AS9120: 4.2.4)4.7.1Managers may print temporary copies of documents and records for their ownease of use. However, these documents are not controlled and managersmust know where to find the official records and documents so as to be ableto ensure that any information used is accurate.4.8Computer Data Back-up (AS9120:4.2.4)4.8.1All essential data files will backed up on the main server on a regular basis.4.8.2Where possible, use a “multiple media” rotation system for back-ups so as toensure that back-up records are maintained for various dates over the lastfew months. This will allow older “undiscovered” errors to be recovered fromearlier back-ups.4.8.3At least one piece of the back-up media will be stored in a secure location offsite as security against theft or fire in the office.4.8.4The MR will occasionally attempt a back-up recovery to demonstrate that theback-up system will work if required.Revision: 6 – Date: October 8, 2014MCI 03 Document and Data Control.docISOtec – Making your business better – www.isotec1.comPage 4 of 5
03. Document & Data Control Procedure5.0Quality RecordsRecord NameResponsible PersonLocationCurrent QMSSuperseded QMSCustomer drawingsCert. of ConformityMRMRCSEMRComputerComputerDrawing filePO Drawer6.0IndexmethodDoc No.Doc No.By customerMfg / PO#Minimum RetentionUntil superceded3 yearsUntil superceded7 yearsChange HistoryRevision DateLevelDescription of Change123456Initial releaseAdded References to the AS9120 standard.Paragraph 4.5.2 clarified to conform to new ISO 9001:2008 updatesUpdated document to conform to the AS9120 Rev A standard.Updated document to reference the JEDEC quality standard.Removed Reference to the JEDEC standard22 Oct 0426 Aug 0817 Nov 201031 Aug 201131 Jul 201207 Oct 2014Revision: 6 – Date: October 8, 2014MCI 03 Document and Data Control.docISOtec – Making your business better – www.isotec1.comPage 5 of 5
08.10.2014 · Document & Data Control Procedure Revision: 6 – Date: October 8, 2014 Page 2 of 5 MCI 03 Document and Data Control.doc ISOtec – Making your business better – www.isotec1.com iv Forms & Records 4.1.2 All QMS documents have a consecutive Revision No. and a Revision date which are shown in the document footer. 4.1.3 All documents start at Revision: 1. whenever there is a change to document .
