Departmental Policy Departmental Procedure Instructions/Forms. UCVM DIAGNOSTIC SERVICES UNIT Document Control Procedure

Transcription

1 hi Departmental Policy Departmental Procedure Instructions/Forms UCVM DIAGNOSTIC SERVICES UNIT Document Control Procedure Classification Information Management Approval Authority Diagnostic Services Unit Manager Implementation Authority Diagnostic Services Unit Manager Table of Contents Purpose 1 Scope 2 Definitions 3 Procedures 4 Responsibilities 5 Instructions/Forms 6 Related Procedures 7 History 8 Effective Date April 28, 2010 Latest Revision April 28, 2010 Purpose 1 To describe the process used by the UCVM Diagnostic Services Unit (DSU) to manage controlled documents. This includes the creation, revision, approval, storage, distribution, retirement, archiving, and destruction of controlled documents. Scope 2 This procedure applies to DSU personnel. Definitions 3 In this procedure: a) Approved Master Document is an original signed document. The approval signature indicates approval for issuance and use. An Approved Master Document may be reproduced for distribution by the DSU manager or designate. b) Change Control refers to a formal process used to ensure that changes to a Controlled Document are introduced in a controlled and coordinated manner. c) Controlled Copy is a photocopy of an Approved Master Document prepared by the DSU manager or designate for distribution to appropriate areas. The copy bears a copy number on the front page and is marked Do Not Copy. d) Controlled Document refers to Standard Operating Procedures (SOP) and forms that have controlled distribution and are subject to Change Control procedures. e) Issuance is the date that a Controlled Document is finalized and issued to a department. The document does not become effective for use until the Effective Date. The electronic version is the official version of these procedures. Page 1 of 6

2 f) Effective Date is the date that a document becomes effective for use. The time difference between the Issuance and Effective Dates is to ensure adequate time for personnel training prior to procedure implementation. g) Revision History is the listing of the documented changes made to a Controlled Document. Procedures General a) Photocopying a Master Document by anyone other than the DSU Manager or designate is prohibited. b) Photocopying a Controlled Copy of a Standard Operating Procedure by anyone other than the DSU Manager or designate is prohibited. c) Controlled forms may be copied by all DSU staff for the purpose of recording information. d) All Controlled Documents are subject to revision control. Only the current version is to be used and use of any obsolete document is prohibited. e) Controlled Documents may not be provided to persons who are not employed in the DSU without prior authorization by the DSU Manager or designate. 4.2 New Documents a) An individual initiates a new document as described in SOP Q Change Control Procedure. b) The DSU Manager or designate: 1) Assigns a unique number to the document being created as described in SOP Q-0002 Identification of Controlled Documents. A new document will have a revision number of 00. 2) Records the title and the document number in the electronic document inventory log. 4.3 Revisions to Existing Documents a) An individual initiates revision of an existing document or requests removal of an obsolete document from circulation as described in the SOP Q-0004 Change Control Procedure. b) The DSU Manager or designate: 1) Provides an electronic copy of the approved document for editing if requested. 2) Provides a hard copy for editing if requested. The hard copy will be clearly marked as an uncontrolled copy. 3) Attaches the edited copy to the Change Control Record prior to closing out the Change Control. 4.4 Approval of New or Revised Documents a) The DSU Manager or designate: The electronic version is the official version of these procedures. Page 2 of 6

3 1) Performs final formatting and editing as required for standard DSU or University of Calgary format, consistency, spelling, grammar, etc. 2) Creates a hard copy Master Document by printing the finalized copy. 3) Forwards the Master Document to the author for signature. NOTE: University of Calgary-format SOPs have a separate approval form for the approval signature. 4) Signs as the approver. 5) Assigns the effective date to the document once it is approved. 6) Saves the finalized electronic document to the appropriate approved documents folder. 7) Updates the electronic document inventory log. 4.5 Document History File (DHF) and Inventory Update a) The DSU manger or designate prepares a Document History File for each controlled Standard Operating Procedure and form as follows: 1) Labels a file folder with the document number, but not the revision number. 2) Attaches a Document History Log (FQ-0001A) and Document Distribution Record (FQ-0001C) to the left side of the Document History File. 3) Updates the information on the Document History File each time a document is processed according to an approved Change Control. 4) Attaches the Change Control for that document to the right side of the Document History File. 5) Inserts the approved new or revised Master Document into the Document History File without securing it. 6) Stores the Document History File in a secure location. 4.6 Document Distribution a) The DSU manger or designate: 1) Determines the quantity of copies required. 2) Prepares Controlled Copies for distribution by copying the Master Document(s). 3) Labels each page of the controlled copy with Do Not Copy. 4) Sequentially assigns a copy number on each controlled copy made. 5) Prepares and attaches a Procedure Training Record (FQ- 0001B) to each Standard Operating Procedure (plus The electronic version is the official version of these procedures. Page 3 of 6

4 associated forms) being issued. 6) Records the relevant information as applicable for that document on the Document Distribution Record already installed in the Document History File. 7) Ensures that the controlled copies are transferred to the relevant area. NOTE: DSU SOPs using the University of Calgary procedure format include a line in the footer stating that The electronic version is the official version of these procedures. Because all controlled documents in circulation within the DSU are copy controlled, the DSU paper copies of controlled copies will also be considered to be official versions. 4.7 Procedure Training Record (PTR) a) Individuals are responsible for completing the PTR issued with the relevant procedures. b) Managers and area supervisors ensure that all personnel who are required to follow the procedure have read the SOP and signed the associated PTR prior to performing the procedure. 4.8 Document Retirement, Archival and Destruction a) The DSU manager or designate: 1) Logs the return of each document on the appropriate Document Distribution Record. 2) Destroys all obsolete Controlled Copies of documents. 3) Stamps or writes RETIRED over the Effective Date of the superseded Approved Master Document in the Document History File. 4) Adds the returned Procedure Training Record for each controlled document to the Document History File for that document. 5) Strikes through the remaining space on the Document History Log, dates and initials the entry. 6) Stamps or marks the Document History File label on the folder as ARCHIVED. 7) Stores the archived documents in a designated, secure file location. 8) Moves the electronic copy of the document to the folder for archived documents. 9) Updates the electronic document inventory log. 4.9 Periodic Document Review a) Every approved Controlled Document is subject to review by the owner/authoring department at a minimum of once every two years. The electronic version is the official version of these procedures. Page 4 of 6

5 b) The DSU manager or designate initiates the review process by preparing a Document Review Form (FQ-0001D) and forwarding it to the authoring/owning department. c) An individual with appropriate knowledge and experience reviews the document and determines whether or not it is fit-foruse in its current state. The review includes: 1) Any controlled forms associated with the document. 2) Verification that all information including the procedure, material lists, and referenced documents are current and relevant. 3) Recording the assessment in the appropriate sections of the form. d) If no changes are required, the reviewer places a check mark beside the appropriate box on the Document Review Form, signs and dates the form and returns it to the DSU manager or designate. e) If the document requires revision, the reviewer initiates a Change Control Record (FQ-0004B) and returns it with the signed and dated Document Review Form. f) The DSU manager or designate files the completed Document Review Form in the Document History File 4.10 Storage of Current and Archived Documents a) Approved current and archived Master Documents are stored in an appropriate secure location to prevent accidental damage, loss or unauthorized removal. Responsibilities The DSU manager or designate is responsible for: a) Assigning numbers to new and revised documents. b) Final formatting and editing of draft documents. c) Ensuring correct Change Control procedures are followed. d) Assigning Effective Dates to new and revised documents. e) Controlling electronic versions of new and revised DSU documents. f) Creating a Document History File for each Controlled Document. g) Updating the document inventory log. h) Distribution, retirement, archiving, and destruction of Controlled Documents. i) Storage of current and archived Master Documents. j) Forwarding electronic versions and sign-off sheets for new or revised documents using the University of Calgary format to the University of Calgary Access and Privacy Coordinator. 5.2 Managers and supervisors are responsible for: a) Ensuring that personnel are trained and have read the Standard Operating Procedure and signed the Procedure Training Record prior to performing the procedure. The electronic version is the official version of these procedures. Page 5 of 6

6 5.3 Individuals using controlled documents are responsible for a) Verifying that the current version of the document is used. b) Determining the need for new procedures, revisions or deletion of documents in their areas. Instructions/Forms 6 FQ-0001A Document History Log FQ-0001B Procedure Training Record FQ-0001C Document Distribution Record FQ-0001D Document Review Form FQ-0004B Change Control Record Related Procedures 7 Q-0002 Identification of Controlled Documents Q-0003 Preparation of Controlled Documents Q-0004 Change Control Procedure History 8 Revision # Change Control # Summary of Change 00 CC New document. The electronic version is the official version of these procedures. Page 6 of 6