Title: Records Control and Management
Author:
GHULAM MUSTAFA
Review by
Document Number:
Effective (or Post) Date:
Doc00-09
20-Jan-17
Approved by:
Dr. Ghulam Rasul Sial
Review date
25-Jan-17
Ghulam Mustafa
Comments: N/A
Change Log: N/A
APPROVAL OF STANDARD OPERATING PROCEDURE
Requires the signatures of the following persons:
Lab. Manager
Signature: ………………………………
Date: …………………………………….…
Head of Department:
Signature: ………………………………
Date: …………………………………….…
DISTRIBUTION LIST
Designation
Name
Signatures
Date
Master Copy
Lab. Manager
Supervisor Biochemistry
Supervisor Haematology
Supervisor Microbiology
Supervisor Blood Bank
Supervisor Histopathology
Supervisor Laboratory Reception
In charge Lab. Store
Revision History:
Revision Level:
Revision Date:
Revised By:
Brief description of revision:
Ittefaq Hospital (Trust)
(ISO 9001-2008 Certified)
UAN: +92 42 111 770 000,
LandLine:042 35881981 Ext 366- 367
Quality Management System
Records Control and Management
Document No.: Doc00-09
Version: 1
1.
General Policy
1.1. To demonstrate the implementation of the Quality Management System, Pathology Laboratory
adheres to strict control of records. All records are maintained by the department that is
responsible for the activity on record and are stored in a secure and easily accessible location to
prevent loss or damage. The retention period and disposition process for records are defined.
2.
Purpose
2.1. To assure that the records used by Pathology Laboratory employees are properly managed.
2.2. Records include reports, correspondence, diaries, quality records and technical records. Quality
records include the following: internal audit reports, management reviews, corrective and
preventive actions. Technical records include forms, worksheets, control graphs, inspection
reports, and test reports.
3.
Scope
3.1. This procedure applies to the management of records within Pathology Laboratory. Records
may either be hard copy or in electronic form.
4.
Responsibilities
4.1. Section Supervisors
4.1.1. Verify adequacy and accuracy of forms and worksheets used in their area,
4.1.2. Review reports for completeness,
4.1.3. Ensure employees are trained in record keeping.
4.1.4. Implement record management system in respective department,
4.1.5. Follow established record storage and disposal schedule.
4.1.6. Periodically assess the effectiveness of the record management system.
4.1.7. Maintains record system for quality records
4.1.8. Archives and disposes of quality records as established by record retention guidelines.
4.2. General Staff
4.2.1. maintains record system.
4.2.2. Serves as principal custodian for the data management.
4.2.3. Responsible for using the proper and approved forms and worksheets,
4.2.4. Responsible for following record management guidelines and securing records when in
their possession.
5.
Procedural steps
 Quality records are maintained to attest to the full implementation of the quality
Management System. The records are legible and securely stored as computer files or in
designated filing cabinets to prevent deterioration and damage. Such records are considered
confidential but are easily accessible for use and are made available for review upon client,
internal or external auditor request.
 The following are acceptable records: forms, reports, minutes of meetings, signed or
stamped documents, computer files or databases.
 Quality records are generated and maintained by the departments responsible for their
creation. All records must contain sufficient data to attest to satisfactory completion of the
recorded activity and at a minimum, must be signed and dated by the individual responsible
for completing the record.
 Pathology Laboratory retains records of original observations, derived data, and sufficient
information to establish as audit trail.
5.1. Records identification
5.1.1. Records are identifiable to the organisation, test, person or event to which they pertain.
5.1.2. Records are dated and signed to identify the person who established the record.
5.2. Recording and error correction
5.2.1. All work performed is recorded legibly. Work is recorded in such a manner that another
individual, competent in the same field, may repeat the work described solely from the
description written without additional explanation.
5.2.2. Entries contain the date, initials of person performing the work, signed and dated.
5.2.3. Entries are made in ink. No erasures are made. Space not used will be indicated with a
line.
5.2.4. Observations, data and/or calculations are recorded at the time they are made and are
identifiable to a specific task.
QSOP003
Page 2 of 4
CONTROLLED
Ittefaq Hospital (Trust)
(ISO 9001-2008 Certified)
UAN: +92 42 111 770 000,
LandLine:042 35881981 Ext 366- 367
Quality Management System
Records Control and Management
Document No.: Doc00-09
Version: 1
5.2.5. Data or information is not discarded without explanation. To discard, the data or
information is crossed out, initialled, dated and the reason for discarding indicated on the
corrective action and problem report form.
5.2.6. When mistakes are made and a correction needs to be made, each mistake is crossed
out with a single line and the corrected value or information is entered alongside. The
person making the correction initials all alterations to records. Similar measures are taken
with electronic records to avoid loss of the original data.
5.3. Electronic records
5.3.1. Electronic records and data files are backed up on a regular basis to safeguard against
the loss of information due to equipment malfunctions or human error. Instrument backups
are noted on the respective Function Verification and Preventive Maintenance Form.
5.3.2. If applicable backups for the database onto CD and/or tape media are performed daily,
weekly and monthly.
5.3.3. External labels of disk and diskettes or CDs are labelled to facilitate accurate filing and
retrieval of electronic records. Examples of information that may be included on the label
are:
5.3.3.1. Subject or functional title which identifies the information,
5.3.3.2. Inclusive dates of information contained on the diskettes or CDs.
5.3.3.3. Identification of the software program used to access the information.
5.4. Access
5.4.1. There is restricted access to all records to prevent unauthorized use and amending of
information.
5.4.2. Access to the Pathology Laboratory is restricted to authorized personnel or escorted
visitors.
5.4.3. Records are returned during normal working hours to principal custodian or alternates.
5.4.4. Electronic records have password or field protection, or read-only capabilities.
5.5. Filing and storage
5.5.1. Records are stored in dry and clean rooms. All records cabinets, containers and devices
are clearly marked/labelled to identify their contents. Records are indexed and grouped for
expedient retrieval. Record must not be stored in employees’ personal filing
devices/locations or other obscure locations that are not generally known.
5.5.2. Records pertaining to completed inspections and applications are filed in the Quality
Manager’s office.
5.5.3. Records are filed by the sample identification number
5.5.4. Quality records (e.g. audits, archived procedures and work instructions, corrective action
and problem reports, function verification and preventive maintenance charts) are filed in
the Quality Manager’s office.
5.5.5. Analytical worksheets are stored in the department where the testing takes place.
5.6. Record retention
5.6.1. The retention period for quality records is determined by contractual requirements, legal
considerations e.t.c.
5.6.2. Reports will be stored in a secure location with limited access.
5.6.3. Computer based files are archived and stored for record keeping.
5.6.4. The following information should be available in laboratory data files:
5.6.4.1. Date, place, time of sampling and name of person who collected,
5.6.4.2. Identification of sample,
5.6.4.3. Date of receipt of sample and date of analysis,
5.6.4.4. Laboratory and persons responsible for performing analysis,
5.6.4.5. Analytical technique and method used and quality control data,
5.7. Disposal of records
5.7.1. After the retention period is completed records will be destroyed or transferred to
another storage facility.
5.7.2. The Quality Manager is responsible for shredding all quality records that need to be
disposed of.
5.8. Archival of records
5.8.1. Laboratory Operating Procedures’ Records
QSOP003
Page 3 of 4
CONTROLLED
Ittefaq Hospital (Trust)
(ISO 9001-2008 Certified)
UAN: +92 42 111 770 000,
LandLine:042 35881981 Ext 366- 367
Quality Management System
Records Control and Management
Document No.: Doc00-09
Version: 1
5.8.1.1. Superseded and obsolete laboratory operating procedures and work instructions
(controlled copies) are archived as replaced. Archived hardcopy records are marked
“ARCHIVED”, dated and filed for the remaining time of the retention period.
5.8.1.2. The master list is updated and electronic files are moved to a directory titled
“ARCHIVED Records”.
5.8.2. Other Quality Records
5.8.2.1. Quality records (e.g. audit reports, reviews, Function Verification and preventive
maintenance forms, quality control charts, corrective actions) are archived per
calendar year. Only current year’s records are kept in the applicable areas.
6.
Quality Assurance and Quality Control
6.1. Pathology Laboratory employees must carry out records responsibilities as per procedures
established by quality assurance guidelines, Laboratory policy and procedure, and laws and
regulations. The Quality Manager will assist in understanding and meeting their quality
assurance records obligations.
7.
Records
7.1. Record Retention Guidelines
7.2. Function Verification and Preventive Maintenance form.
8.
References
8.1. Pathology Laboratory Quality Manual. Current version
8.2. BOS ISO/IEC 17025:2005 International Standard
QSOP003
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CONTROLLED