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Laboratory Water Suguna Management System Ver 1.0 / SOP / FQL / P1 - 01 Page 2 of 2

determined limits set by the laboratory. communicating to the laboratory staff the manner in
which laboratory testing is to be conducted.
FRecords: Can be electronic or paper. Examples
include chain of custody paperwork, sample Adherence to the quality manual by laboratory staff is
results, QA/QC data, audit results, calibration necessary to ensure both quality and consistency.
records, etc. Recognizing the Laboratory Manual may not cover all
situations and variables arising from the laboratory
FStandard Operating Procedure (SOP):
setting, any significant departures must have the
Document describing specified steps taken in a approval of management and must be appropriately
method. This method can be a specific analytical documented. The management within the laboratory is
procedure or a policy controlling a more generic responsible for the quality and integrity of all data
aspect of the work performed (e.g. training records, generated in the laboratory. The management,
handling complaints or using balances).
collectively, assures this quality through adherence to
the laboratory manual, quality assurance plan, and
QUALITY ASSURANCE AND QUALTIY
through the development and adherence to standard
CONTROL SYSTEMS
operating procedures.
This section explains what is meant by Quality and
Quality Assurance System and how this will impact on Each member of the laboratory should have clearly
and improve working in a laboratory. This clearly identified and documented responsibilities (Job
indicates that achieving quality means fulfilling Description). Quality Manager has ultimate
requirements. The requirements may come from responsibility for implementing the quality system.
customers and in some cases from regulatory Quality Assistant Manager reports directly to the Quality
authorities. Quality is everyone's responsibility; it must Manager and is responsible for maintaining and
be built in at every stage of the process, through developing the quality procedures used in the
planning and implementation right up to the point of laboratory. Laboratory analysts responsible for
reporting analytical results. following all quality procedures and identifying
opportunities for improvement. The standard and non-
A Quality Control System directs and controls an standard or modified method must be sufficiently
organisation with regard to quality by putting in place validated by the laboratory before being used to report
standard operating procedures (SOPs) to which data. When the laboratory develops methods for its
everyone operates in a consistent manner. This, in own use, the laboratory has a procedure for its
combination with regular internal checks (audits), a introduction. Non-standard methods are those
system of investigating problems (anomalies) and methods not taken from authoritative, validated
constantly identifying opportunities for improvement will sources. A non-standard method has not undergone
reduce the occurrence of unreliable results. The validation, such as a collaborative study or process to
Laboratory Quality Manual is the essential source for evaluate the method's performance capabilities.

Prepared by : Approved by :
10 Director - Technical