SWIM Revision, Development and Document Control

1.0Principle

To establish the elements of a quality system to write, revise, review, distribute, maintain and retain controlled documents of the Transfusion Ontario Standard Work Instruction Manual (SWIM).

2.0Scope and Related Policies

2.1

/ Applies to all SWIM procedures and is intended for use by facilities with a hospital TML.

2.2

/ Document control software may be used to ensure appropriate archiving.

2.3

/ A SWIM Working Team (SWT) performs document control activities.

2.4

/ Controlled documents for SWIM include procedures contained in:

/ Section PA / Pre-Analysis

/ Section RT / Routine Testing

/ Section GM / Gel Methods

/ Section NRT / Non-Routine Testing

/ Section SP / Special Procedures

/ Section RP / Reagent Preparation

/ Section CSP / Component Selection and Preparation

/ Section IM / Inventory Management

/ Section QCA / Quality Control/Assurance

/ Section A / Administration Policies and Procedures

2.5

/ The document control system provides for back up of all electronically stored controlled documents and a method for filing and archiving all controlled documents.

3.0Specimens – N/A

4.0Materials

Supplies: SWIM Change Control form (A.001F1)
SWIM Acknowledgement of Receipt (A.001F2)

5.0Quality Control

5.1

/ The SWT controls procedure replacement, additions and removal of procedures, and updates to the master index.

5.2

/ SWIM users use procedure manuals that are maintained in controlled locations at each user hospital. Master documents are stored at the Ontario Regional Blood Coordinating Network (ORBCoN) in Ottawa.

5.3

/ The SWT maintains the change file for each guideline and the electronic file of the procedure.

5.4

/ Each document change and rationale supporting the change is documented on A.001F1. Changes are reviewed and approved by the SWT prior to implementation.

5.5

/ All approved and current documents should be available to the laboratory personnel in the hospital TML departments. Document(s) that have been subsequently revised must be immediately removed from point of use and replaced with the revised document. Acknowledgement of this action must be sent to the SWT. The acknowledgement is archived by the SWT.

5.6

/ A listing of all controlled documents, current revisions and effective dates is maintained by the SWT.

5.7

/ All records of change and each official revision of a document is maintained in a Master Manual file.

5.8

/ A back up file is maintained of all electronically controlled documents.

5.9

/ All controlled documents, change request forms and outside correspondence relating to the procedures are retained and archived.

6.0Procedure

6.1

/ To initiate a revision to a current procedure or to submit a subject for development of a new procedure:

6.1.1

/ Complete A.001F1 – SWIM Change Control form and submit it to the ORBCoN office.

6.1.2

/ The SWT will submit the request to the SWIM Team chair and send an acknowledgment of receipt to the originator.

6.1.3

/ The SWT will create or revise a procedure or send an explanation of why the procedure will not be revised or developed.

6.2

/ Receiving a revised procedure:

6.2.1

/ When a revised procedure is received, complete the acknowledgment of receipt and return it to the SWT at the ORBCoN office. (Form A.001F2)

6.2.2

/ If the procedure is to be used as a Standard Work Instruction, the appropriate responsible parties must review and sign in the designated place at the end of the procedure and initial each page.

6.2.3

/ Appropriate documentation must be maintained to document staff training and (if applicable) competency for the new or revised procedure.

6.2.4

/ File the new or revised procedure in the SWIM.

6.2.5

/ Remove the obsolete procedure immediately and store in a secure archived document site.

7.0Reporting – N/A

8.0Procedural Notes – N/A

9.0References

9.1

/ Nevalainen DE, Callery MF. Quality systems in the blood banks and laboratory environment,Bethesda, MD: American Association of Blood Banks, 1994: module III.

9.2

/ Delaney S. Beyond SOP’s: developing an effective document control system program,Bethesda, MD: American Association of Blood Banks, 1997.

9.3

/ CAN/CSA Z902-04 Blood and Blood Components, Mississauga, ON: Canadian Standards Association, 2004.
/
Ontario Regional Blood Coordinating Network
Standard Work Instruction Manual / A.001
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