Hsp38 Documents Records Control Procedure
Hsp38 Documents Records Control Procedure
PROCEDURE OBJECTIVES
SCOPE
All documents used to implement the QEMS are in scope. These include process
descriptions, policies, procedures, forms, templates, checklists, guidance notes, job
descriptions, organisational charts, documents of external origin or any other written
materials used to control how work is done, who has responsibility for doing it and how data,
events or opinions are recorded.
RESPONSIBILITY
The QEMS Manager is responsible for the communication, operation and maintenance of
this procedure. All individuals who use documents are responsible for ensuring they use the
current version and are responsible for raising Improvement Logs (as per the Problems,
Complaints, and Improvements Procedure) if they believe there are opportunities for
improvement.
DEFINITIONS
Documents:
All forms, procedures and templates used to provide instruction and guidance including the
completion of records.
Quality/Environmental Objectives:
A set of measurable objectives set by Top Management that if achieved will ensure that
customer and regulatory requirements are being met and that the QEMS System is operating
effectively.
ASSOCIATED DOCUMENTS
All associated documents referred to in this procedure are highlighted in bold and underlined.
All documents covered by this procedure, with the exception of documents of external origin,
must be loaded and stored into the Activ System. The Activ System will automatically update
the:
Created Date:
The date the document was first made available for use.
Updated/Modified Date:
The date the current document version was first made available for use.
Templates, forms, checklists and any documents used to record data, events or opinions are
stored in the relevant folder in the “Templates” tab. A list of all these documents, their status
and control history is automatically maintained in the “Templates Register”.
Policies, Procedures, Guidance Notes, Organisation Charts and any other written materials
used to control how work is done and assigning who has responsibility for doing it but do not
allow for the recording of data, events or opinions are stored in the relevant folder in the
“Records” tab. A list of all these documents, their status and control history is automatically
maintained in the “Records Register”.
If a document has a date by which it has to be reviewed for adequacy and appropriateness
then that date must be specified in the document control header in Activ. An automatic
notification of the review date for each individual document will be shown in the Activ
Calendar of the System Manager.
The sequence of actions followed to create a new document is specified by the flow chart in
Appendix A. The addition of new documents to the QHS Management System or the
modification of existing documents must be communicated to all individuals who use those
documents.
DOCUMENT ACCESS
With the exception of documents of external origin all documents must conform to the
following structure:
Title:
All documents must have a title which is either positioned at the top of the document on the
first page or in the document header.
Footer:
All non-pdf format documents must have a footer that conforms to the template in
Appendix B. All pdf format documents must have a footer that conforms to the template in
Appendix C.
DOCUMENT REVIEW
The adequacy of all documents must be reviewed at the Management Review meeting. The
frequency of such reviews must be specified in the Management Monthly Meeting Agenda.
Individual documents may have their own specific review schedules. These schedules must
be agreed at the Management Review meeting and recorded in the document settings in
Activ.
DOCUMENT RETENTION
Documents that are no longer required must be either deleted or moved to the Not in Use
folder in Activ. All references to them in processes must be removed. These documents can
be re-introduced to use provided Step 7 of this procedure is followed.
Records must be established wherever they are required by a process, procedure, policy or
other document used to specify how work is done in the QHS Management System.
Records must be legible, accurate and complete and should include any endorsement
required by the correct authorised signatories.
Records must be updated where information changes and the data, event descriptions or
opinions are no longer deemed to be valid. Updates should be endorsed by the correct
authorised signatory.
STORAGE OF RECORDS
Records must be stored in a secure location that is located to minimise risk of theft or
damage by fire, flood or other environmental effects.
Electronic records must be stored in Activ or other medium which are backed-up off site
automatically.
Records requiring restricted access should be stored in lockable cabinets (paper records) or
in electronic folders with restricted user access (electronic records).
Uncontrolled when printed Page 3 of 6
Horsleys Fields, King’s Lynn, Norfolk, PE30 5DD
RETENTION OF RECORDS
Records must be kept for a minimum of 5 years, with the exception of:
Archived records must be placed in a locked location and be clearly marked with the date to
be retained until.
DISPOSAL OF RECORDS
Records must be thoroughly shredded prior to disposal or placed in the Confidential Waste
bins for disposal via a recognised contractor.
New document or
modification to existing
document required to:
Provide a new
Reduce the Improve the Comply with Prevent problems
service/better meet Help achieve QSH
potential of a effectiveness of a regulatory/legislative or non-
Customer Objectives
hazard to harm Control Measure requirements conformities
requirements
Improvement Log
raised (if appropriate)
System Manager
actioned to investigate
Inform affected
Decision to amend/
individuals of No
create document(s)?
decision
Yes
Document(s)
Problems, Complaints amended/created
and Improvements
Procedure
New document(s)
added to Activ, old
documents removed
from all available
locations
Improvement Log
updated & closed (if
appropriate)
Document change/
addition discussed at
Management Review
End