Procedure Title

Document and Data Control

Procedure

Procedure No. 301

Print Name Title Date

Prepared by Louise Naughton Quality Assurance 09/04/09
Consultant

Reviewed by Niamh Mooney Asst Fire & 09/04/09

Safety Officer

Corporate Joe Hoare Estates Officer 09/04/09

Authorisation
Health Services Executive Date: 9th April 09
Estates Department Rev: 1
Procedure for Document and Data Control Page 2 of 4

INTRODUCTION
The purpose of this procedure is to define the control of Management System documents and
data.

Scope
The Organisation has established this procedure to control all documents and data that relate
to the Quality Management System The company review the contents of this procedure during
internal audits. Documents and data can be in the form of any type of media such as hard copy
or electronic media.

Responsibility

It is the responsibility of the Estates Officer of the Estates Department to ensure that this
procedure is implemented.

Secretary – Maintain correct documentation issue/ version in circulation as per the

circulation list.

All Personnel: To maintain the contents of the procedures, to review new procedures
and to initiate changes when necessary to existing procedures.

PROCEDURE

The following flow chart provides an overview of the control of documented processes
employed in the Organisation.
Health Services Executive Date: 9th April 09
Estates Department Rev: 1
Procedure for Document and Data Control Page 3 of 4

Responsibility Process step Records/ Associated Processes

Corrective and
C/PAR Preventative
Originator 1. Need for a document identified Procedure no Action Form
304

Scretary 2. Document issued

Corrective and
3. Document and data Internal Audit Preventative
Auditor control system reviewed Procedure No Action Form
305
Yes

4. Documentation
No
adequate

Corrective and
Preventative
Action Form
5. car/par C/PAR
issued Procedure no
304
Master Document
List

Process Notes
1.0 Documents required by the Organisation and the Management System are identified
developed, implemented and maintained by relevant functions and/ or authorities within the
Organisation. Documents are available for anybody to view on the server, but can only be
changed by the Quality Management Representative or delegate.
2.0 The master documents are maintained on the server. When a document is revised or
amended the amended version is reviewed by all relevant staff and signed off by the
Manager of the area using the Corrective and ‘preventative action form. The new master
document is then set up on the server. The obsolete document is moved to the obsolete file
on the server and is marked “obsolete”.
3.0 The corrective and preventative action system is the mechanism employed for exercising
control over documents. The Management Representative or delegate ensure that each
document is reviewed for adequacy prior to being issued.
4.0 Internal audits, external assessments and employee and HSA suggestions are used to
review the adequacy of existing documentation.
5.0 Inadequacies are documented as a C/PAR on Form. This form is used to review, update, re
approve documents as necessary. Closing the C/PAR indicates that the change details of
the document are clearly identified on the C/PAR and that the issue date (revision status) of
the document is correct and that the Master document List has been updated. The revised
document is subsequently set up on the server for each employee of Estates to view.
6.0 Documents and data that are controlled electronically are back up automatically on a
server. Files are password protected where required.
Health Services Executive Date: 9th April 09
Estates Department Rev: 1
Procedure for Document and Data Control Page 4 of 4

REFERENCES :
Corrective and Preventative Action Procedure no 304
Internal Audit Procedure no 305
Computer Server

APPENDICES
Master Document List