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1、_TITLE:DOCUMENT & DATA CONTROL1.0 Objective: Ensure that only the latest Quality Management System (QMS) documentation is in use. Ensure that the QMS documents are controlled as required. Ensure that mechanisms to safeguard data are in place and effective throughout the organization.2.0 Scope:This p
2、rocess covers all documentation within the QMS and the data generated from its implementation.3.0 Reference to ISO 9001:2008 & SAEP -1154:Clause 4.2.3Control of Documents (ISO 9001:2008)Clause 5.4.2.3Control of Documents (SAEP -1154)4.0 Procedural Details:4.1 The QC Manager (MR) and Project Manager
3、consulting other personnel as required shall review all new and amended documents for adequacy of requirements prior to submitting to customer. Form QP-001-06 shall be used. 4.2 The QC Manager shall review and approve all new and amended documents prior to issue. Form QP-001-06 shall be used.4.3 The
4、 Quality Plan and Processes shall be issued to, or shall be made available to all personnel whose work is essential to the effective implementation of the Quality Management System.4.4 All documents shall be uniquely identified by an issue reference to prevent obsolete information, process or forms
5、from being used throughout the company. The MR or his designated representative (Document Controller) shall maintain a list of all quality documents (QP-001-02).Issue:4.5 Upon issuance, a document control record (QP-001-03) detailing document reference, issue number and details of issue will be circ
6、ulated to the recipient of the document, and personnel receiving the document will signed off document control record form to indicate receipt and understanding of the issued documents.4.6 Signed document control record form shall be returned to the MR for filing.4.7 When any documents are issued, d
7、etails of the document and holder shall also be recorded in Document Issue and Control Log (QP-001-04).Amendments:4.8 Proposed changes to Quality Management System documentation shall be recorded on a Document Change Note (DCN: QP-001-01), which shall be subject to authorization by the MR, concerned
8、 parties must be satisfied that proposed changes is justified.4.9 When proposed change is rejected, the MR shall record the reason(s) for rejection on the quality form QP-001-01 and inform the requester. The rejected form is to be filed on the rejected document request file.4.10 Form QP-001-06 shall
9、 be used to record the review of document.4.11 The MR shall issue and distribute the amended document.4.12 Recipients of amended documents shall sign on the appropriate QP-001-03 to indicate that the purpose of the document is understood. This signature will also serve as proof that the recipient is
10、 in possession of the latest update of the document of the document in question.4.13 The completed form along with any obsolete documents shall be returned to the MR for action.Superceded /Obsolete Documents:4.14 The MR is responsible for implementing the removal of all obsolete documents in use and
11、 for their replacement with the amended issue(s) if applicable.4.15 The MR shall be responsible for the destruction of all obsolete documents except for those remove from the “Master Set”.4.16 Those removed from “Master Set” shall be filed in an Obsolete Documents File for reference. This is to prov
12、ide a historic record of amendments made.4.17 The MR is responsible for ensuring that all superceded documents are annotated as such to prevent inadvertent use. These documents are to be removed from appropriate points of use at the earliest opportunity after they cease to be required. Superceded do
13、cuments will then be handled as for obsolete documents.4.18 Completed Document Control Records detailing amendments shall be filed with the Master Copy of the obsolete document.4.19 These shall be maintained as Quality Records for a minimum of three years.Reference Documents:4.20 Some documents need
14、 to be retained for reference and will be listed in a Reference Index (QP-001-05) maintained by the appropriate department. The Reference Index will contain details of the documents, their location and issue status (if applicable).4.21 When a new edition of an existing reference is received, the app
15、ropriate department is to update the Reference Index and identify changes that are significant to the company. These changes shall be notified to the personnel affected.4.22 The Reference Index shall be updated whenever new documents are added, replaced or removed.Data:4.23 Department Managers are to identify computer data that would be detrimental to company operations if lost or destroyed. Individual PC back-ups are to be taken when required and stored in a secure place.4.24 The method and frequency of data back
