Control of Records
Version:
04
Page:
1 of 3
Issue Date:
12 December 2000
Authorised by: Marjorie Dickenson
WORK INSTRUCTION
1.
PURPOSE
The purpose of this procedure is to control the records that will demonstrate the effective operation of the
SimuLab quality management system, and conformance to specified requirements.
2.
SCOPE
This procedure deals with the control of records of all quality-related activities, and may also include any
records received from suppliers, customers or other external parties. These records may include, but are not
restricted to:
 Completed forms.
 Minutes of meetings including Management Review Meetings.
 Quality audit reports and schedules.
 Corrective & Preventative Action Requests.
 Customer complaints.
 Equipment maintenance and calibration records, schedule and inventory.
 Employee duties & responsibilities, performance evaluations and training records.
 Test method validation and verification data.
 Test method records, including all original observations and derived data.
 Quality assessment data.
3.
REFERENCES
AS ISO/IEC 17025:1999 – General requirements for the competence of calibration and testing laboratories –
Section 4.12
Form - Order Filing Register
4.
RESPONSIBILITY
Quality Assurance Manager
Customer Service Manager
NATA approved signatory
All managers
All personnel




Maintenance and control of quality records.
Maintenance and control of all test method records & reports.
Check test method records & reports.
Referral of quality records to Quality Assurance Manager when
appropriate.
 Completing records in a legible manner, and in accordance with
procedures and work instructions.
5.
ACTION / METHOD
SimuLab relies on efficient access to the right information. We need it:

As evidence of our policies and activities.

For general operational purposes.

To support decision making.

For litigation support.
Record management ensure that the right information can be accessed when required. We have legal,
professional and ethical responsibilities to create certain records and retain certain categories of records for
specified periods. Proper record management ensure that these obligations are met.
5.1.
Completion
Those performing quality activities will complete records as described in the relevant test
methods or work instruction. Entries will be typed, or hand-written legibly. Any mistakes that
occur in records must be crossed out, not erased, made illegible or deleted, and the correct
value entered alongside. All alterations to records shall be signed or initialled by the person
making the correction
03-004
WORK INSTRUCTION
5.2.
Control of Records
Version:
04
Page:
2 of 3
Issue Date:
12 December 2000
Authorised by: Marjorie Dickenson
General
Where records are stored on computer disk, the IT Manager will make regular back-ups onto
the company server. To avoid loss of intellectual property or critical records in the event of
fire or theft regular back-ups on tape or CD-RW will be stored off-site. These back-ups will
be suitably labelled to allow recovery from the latest back-up.
Paper records will be maintained in hard backed binders or steel filing cabinets to prevent
damage.

The Customer Service Manager will maintain all sample analysis records (including all
original observations and derived data) in the Job Number file. Job Numbers are
generated by the laboratory information management system (LIMS) called InfoLAB.
The LIMS InfoLAB assigns a unique Job Number. Jobs are numbered in consecutive
order. Individual samples retain their original sample identification numbers.

Other quality records will be retained locally while required for operational purposes,
and then archived. The department managers will refer relevant quality records no
longer required for operational purposes to the Quality Assurance Manager for filing
and storage.
5.3.
Access
The Quality Assurance Manager will ensure that these records are available for inspection
when required by authorised personnel or the customer (where contractually agreed).
Quality records may only be removed from storage with the written permission of the Quality
Assurance Manager.
5.4.
Indexing and identification
The files stored in the Customer Service area are filed in Job Number order and these files
are archived approximately six (6) monthly or when files become filled.
An index will be maintained for each type of record that is archived for long-term storage. An
archiving index may be based on form “Archive Index”.
An overall Quality Record Index will also be maintained to indicate where files are stored and
for how long and is attached to this Quality Procedure as Appendix 1.
Any person creating a new record must inform the Quality Assurance Manager who will:

Check the Quality Record Index.

Update the Quality Record Index.
5.5.
Retention
SimuLab management have controls for the disposal of records and for the separation of
active from inactive records. Quality and technical documentation will be retained and made
available for inspection for the period specified in Appendix 1. At the end of the retention
period the Quality Assurance Manager will ensure that quality records are destroyed. Where
cost-effective and practicable, paper will be recycled, and computer data erased to permit
reuse of the media.
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SIMULAB logo here
Control of Records
SimuLab Pty Ltd
Version: 04
Page:
3 of 3
Issue Date:
Authorised by:
WORK INSTRUCTION
Description of Record
Location Held
Retention Period
12 December 2000
Marjorie Dickenson
Personnel Responsible
Quality Management System
Minutes of Management Review Meetings
Corrective & Preventative Action Requests
Customer Complaints
Audit Reports
Test Method Validation & Verification Data
Calibration / Maintenance Logs
QC data/ Charts
Standard Log
External Maintenance Records
External Calibration Records
Employee Records
Correspondence / Faxes
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Quality Assurance Office
Human Resource Office
Customer Service Office
Indefinitely
5 years
5 years
5 years
5 years
Indefinitely
Indefinitely
5 years
5 years
Indefinitely
Indefinitely
Indefinitely
5 years
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
Human Resource Manager
Customer Service Manager
Sample analysis records
Customer Service Office
5 years
Customer Service Manager
Standards
Manuals
Accounts Office
Accounts Payable
Indefinitely
Indefinitely
Quality Assurance Manager
Quality Assurance Manager
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