ASL-QSP : 16

Procedure ED. NO. / REV NO. : ‘01’ / ‘00’

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Control of Records
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A. Purpose:
To establish the procedure for control of quality & technical records so as to ensure that they are kept in secured,
easily retrievable and fit for use condition.
B. Scope:
All activities associated with ACI Sourcing (BD) Pte.Ltd.
C. Responsibility:
It is the responsibility of all staff to understand the details and any associated roles and responsibilities in adhering
to this procedure.
D. Cross Reference:
ISO / IEC 17025 :2017; Clause No. 4.13,
QM Section 4.13

E. Procedure:

E1: Laboratory has identified the various technical records to be maintained and the same is given in the “master list of
records”. These records are kept in both hard and soft copy versions and it is ensured that the same are legible. The records
are stored in a suitable environment that there is no distortion/damage/loss and records are retrieval easily till they are
disposed of. All the records are given unique identification number and indeed so as to ease the access and retrieval of the
records. The retention period for various types of records are accessible by the authorized personnel only and are held
secure and in confidence.

E2: Laboratory retains records of original observations, derived data and sufficient information to establish an audit trail,
calibration records, staff records and a copy of each test report issued, for a defined period. The records for each test
contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test to
be repeated under conditions as close as possible to the original. The records include the identity of personnel responsible
for the performance of each test and checking of results. All the data generated is recorded at the time of analysis like
readings, observations, calculations with details of sample identification and test method followed.

E3: The entire raw test data generated is recorded at the time of testing. This includes readings, observations and
calculations with details of sample identification and test method followed. Data is entered in register or work sheets by the
authorized personnel, whenever mistake occurs in the technical records, each mistake in the technical records is crossed out
and not erased or made illegible or deleted. Correct values are entered alongside. All such alterations of records are singed
or initialed and dated by the person making the correction. In case of records stored electronically, controlled access is
ensured to avoid loss or change of original data through the use of password.

PREPARED & ISSUED BY REVIEWED BY APPROVED BY

SIGN & DATE

DESIGNATION QA EXECUTIVE SR. EXECUTIVE DIRECTOR/ COO

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Identification of records-
The various quality and technical records are generated using controlled formats bearing unique identified.

Quality records:
The quality records include the following:
a) Internal /External Audit reports
b) Management review meeting minutes
c) Record pertaining to review of contracts, subcontracting
d) Customer feedback
e) Complaints
f) Improvement
g) Records of corrective action and preventive action.

Technical records:
The technical records include the following:

a) Sample codification
b) Raw data records of various sections
c) Personnel and training records
d) Equipment records- calibration, maintenance etc.
e) Environmental records
f) Control of non-conforming testing/calibration
g) Uncertainty of measurements
h) Chemical stock records
i) Quality check data like inter-laboratory comparison, PT participation and intra-laboratory data like retesting, QC
charts and intermediate checks
j) Sample disposal records

Collection, filing, storage, maintenance, access and disposal of records:

The custodian of the quality and technical records being generated by the laboratory arranges for the collection of the
respective records from the different sources and file them in the chronological order. All technical records pertaining to
routine testing like observation and raw data sheets, calibration of equipment, environmental records are maintained by
the Asst. Manager laboratory, records pertaining to procurement of chemicals, glassware, and calibration of equipment
from outside agency are also maintained by Asst. Manager laboratory. All the quality records are maintained by QA
Executive.

Authorized persons only have access to technical records store.

All the records are stored in a suitable environment that there is no distortion/damage/loss and records can be retrieved
easily till they are disposed off.

PREPARED & ISSUED BY REVIEWED BY APPROVED BY

DESIGNATION QA EXECUTIVE SR. EXECUTIVE DIRECTOR/ COO

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The quality and technical records are disposed after the retention period accordingly.

Type of Record Retention Location Responsible Person

Record Period Sign.
Quality All quality record mentioned in 3 years QA Dept.
Record the manual and procedure
Raw data of various section 4 Month QA Dept.

Personnel training record 1 Year QA Dept.

Equipment Record 1 Year QA Dept.
Environmental Record 1 Year QA Dept.
Non-conforming work record 1 Year QA Dept.
Technical Uncertainty of measurement 1 Year QA Dept.
Record
Chemical stock record 1 Year QA Dept.
ILC,PT 1 Year QA Dept.
Retesting, QC chart 1 Year QA Dept.
Sample Disposal 4 Month QA Dept.
Reports 5 Years QA Dept.

PREPARED & ISSUED BY REVIEWED BY APPROVED BY

DESIGNATION QA EXECUTIVE SR. EXECUTIVE DIRECTOR/ COO

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The master list of records along with identification, location/mode, and responsibility to maintained is documented as per
ASL- FORM 40.

Record of Retain Sample storage :

When a test and reporting of this test is completed, put all the control samples & report in the boxes and prepare the
packing record separately.
When box is full, write the Carton No., packing date, disposal date onto ASL- FORM 41 with authenticated sign of
the person responsible for packing (packed by). Execute photocopy of the ASL- FORM 41 and put one copy into
designated file or maintain the tracking of report into computer. One copy of ASL- FORM 41 should paste onto the
Carton.
Store the Carton in “Storage Room” at designated place.

Control of data in electronic media.

In case of electronic data, the same is controlled as given below:

a) All document generated by the laboratory in computerized system are automatically stored in a hard disk.
b) Saved data in the hard disk are daily transfer to another two portable hard disk for secured backup.
c) Only authorized persons are allowed to access the data base.
d) Unauthorized access is prevented through use of personalized passwords.
e) The report generation procedure is through the local server and its access controlled by the authorized person only.

Associated Documents:

NAME / TITLE OF RECORD FORM NO.

Master List of Record ASL-FROM -38
Retention Period of record ASL-FROM -39

PREPARED & ISSUED BY REVIEWED BY APPROVED BY

DESIGNATION QA EXECUTIVE SR. EXECUTIVE DIRECTOR/ COO