Laboratories quality management plan

26 Pages·1992·7.7 MB·English

by  Ontario Ministry of the Environment. Laboratory Services Branch.

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QUALITY
MANAGEMENT
PLAN
JUNE 1990
Environment
Envi ronnement
Ontario
Jim Brad'ey, Minister/ministre
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LABORATORIES QUALITY MANAGEMENT PLAN
7
p
—a
Report Prepared by:
Laboratory Services Branch
Ontario Mi:nistry of the Environment
\
JUNE 1990
a
RECYCL&BI1
Copyright: Queen!s Printer for Ontario, 1990
This publacation
may be reproduced for non-cominercial purposes
attribution.
with
LOG 90—2711-001
MINISTRY OF ENVIRONMENT LABORATORY SERVICES
QUALITY PLAN
APPROVED BY:
C. Ronan, Director
\O C\o
DATE:
'
1)
c
CONCURRED WITH
Villard, Assistant Director
S.
Crowther, Manager
C. Kanert, Manager ½
water Quality
Inorganic Trace Contaminants
S. Villard, Manager
organics
Drinking water Organics Trace
Laboratory Chief
w. C&6k,
London Regional Laboratory
S. MacBeth, Laboratory Chief Manager
Kingston Regional Laboratory ]Llities and Special Projects
Thunder Bay: Regional Laboratory
Section:
INDEX
MINISTRY LABORATO RIES Page: 1 of 2
QUALITY MANAGEMENT PLAN Date: 26 February 90
Revision:
1
INDEX
1. QUALITY MANAGEMENT PLAN
1.0 SCOPE
1.1 SIGNIFICANCE
112 BACKGROUND
1.3 STATEMENT
1.4 GOALS
1.5 OBJECTIVES
1.6 STRATEGY
1.7 BRANCH-LEVEL DOCUMENTATION
2. STAFF QM RESPONSIBILITIES
2.0 INTRODUCTION
2.1 DIRECTOR
2.2 SECTION MANAGERS AND REGIONAL LAB CHIEFS
2.3 QUALITY ASSURANCE OFFICE
2.4 OTHER BRANCH AND REGIONAL LAB STPFF
2.5 CENTRAL/REGIONAL LABS QA COMMITTEE
2. '6 QA COORDINAT ION COMMITTEE
2.7 SECTION TECHNICAL COMMITTEE
Sect ion:
INDEX
MINISTRY LABORATO RIES Page: 2 of 2
QWLITY MPNAGEMENT PLAN Date: 26 February 90
Revis ion:
1
3. GLOSSARY OF QM TERMS
3.1
QUALITY
3.1.1
Data Quality
3.1.2 Project Quality
3.1.3 Quality PlannIng
3.1.4 Quality Management
3.1.5 Quality Assurance
3.1.6 Quality Control
317
Performance Monitoring
3.2 AUDITS
3.2.1 Audit
3.2.2 System Audit
3.2.3 Performance Audit
3.3 CONTROL
3.3.1
Simple Statistical Control
3.3.2 Complex Statistical Control
Section:
QMPLAN
Page: 11
MINISTRY LABORATORIES
QUALITY MANAGEMENT PLAN Date: 26 February 90
Revision: 1
1. QUALITY MANAGEMENT PLAN
1.0 SCOPE
ThIs Quality Management Plan (QMP) for the Ontario
Ministry of the Environment, Laboratory Services Branch
(LSB), and Regional Laboratories establishes formal
responsibility on the part of the Section Managers, the
Regional Laboratory Chiefs, the Quality Assurance Office,
and staff, to develop and implement a comprehensive,
verifiable Quality Assurance Program for the Central and
Regional Laboratories. Particular, it requires them
to implement Quality Management Systems (QMS) whIch will
ensure that staff are advised of their specific duties to
maintain and docuwent analytical data quality.
1.1 SIGNIFICANCE
Top_down assignment of respons ibilities, and tasks is
critical Strong
in a management system.
management support is considered to be the essential
ingredient which guarantees the success of a QMP.
This QMP, and the corresponding Section Quallty
Management Systems, establish a documsecniteedn tmisetcsh anism for
communication and action. Managers, and
technicians have clearly defined roles designed to ensure
data
the validity and integrity of the being! generated.
1.2 BACKGROUND
LABORATORY CLIENTS
partners in program development, management and data
As
interpretation, laboratory staff and clients must clearly
identify three elements affecting quality!:
i) a succinct statement of project objectives;:
I
1
I
Section: QMPLAN
MINISTRY LABORATO RIES Page 2 of 11
QUALITY MANAGFMENIT PLAN Date 26 February 90
Revision:
1
Ii
ii) specification of the procram sampling and I
elements required to meet the program
analysis
Data Quality Obiectives (DOOs);
iii) identification of the primary sources of data I
uncertainty, and evaluation of their re] ative
importance in data interpretation.
I
These elements have an integrated impact on the quality
of analytical data produced They affect project design
and the selection of appropriate field and laboratory I
operations.
Data quality, and therefore data interpretation, is
affected I
by:
a) the variability of the environment being sampled
and examined; I
h) the: uncertainty or bias introduced by the
sampling process; I
c) the uncertainty or bias introduced during field
operations; I
d) the: bias introduced by s ample transportation and
storage prior to analysis;
I
e) the uncertainty or bias introduced by sub—
sampling for analytical purposes;
I
f) the uncertainty or bias introduced by analytical
sample pre—treatment or preparatlon;
I
g) the uncertainty or bias of measurement!.
It is apparent that the interaction of these factors will
affect the interpretation of data and the quality of I
individual results Given a sufficiently large data set,
it may be possible to determine and specify the relative
significance of all these factors!. The bias due to the I
analytical process must be minimized if the! impact of the
other factors is to he measured and, ultimately,
control led. I
I
Section: QMPLAN
MINISTRY LABORATORIES Page: 3 of 11
QUALITY MANAGEMENT PLAN Date: 26 February 90
Revision: 1
-——
Therefore, the quality of laboratory operations is a
priority, concern.
It is essential that systems be established tich
define
the
level of quality to be achieved; the processes to be
followed and the procedures required to document and
that quality.
report
1.3 ANALYTICAL QUALITY POLICY STATEMENTS
The Quality Management Plan (QMP) operates within the
following
policy statements:
1.3.1 All analytical services provided by LSB and
Regional laboratories in support of programs of the
Ontario Ministry of the Environment (ONE), shall
produce data of known quality which are
appropriate to the particular program requirements
and the nature of the analytical tedhnology
available for the types of samples involved.
1.3.2 The quality of all
analytical data will be
supported by appropriate documentation acceptable
to the scientific community at large, and gathered
in
accordance with established ministry protocols.
1.3.3 The quality of the data will be achieved within the
framework of an ongoing Quality Management System
whereby staff responsibilities and operational
procedures are defined, documented, and 'subjected
to
audit on a regular basis.
13.4 Laboritory Manager., Regional Laboratory Chiefs and
Quality Assurance Office staff are responsible for
the implementation of this Plan.
I
I
Section:! QflPLAN I
MINISTRY LABORATORIES Page!: 4 of 11
QUALITY MANAGEMENT PLAN Date: 26 90
Revision:
1 I
1.4 QUALITY MAt4AGEMENT! GOALS
1
The goals of this Plan are as follows:
ensure that the quality of analytical data is 1
1.4.1 To
it
that
documented, and meets program quality
as defined by the DQOs developed by I
client
and laboratory staff.
1.4.2 To ensure that the process for determining program I
DQO5 is consistent withln LSB and the Regional
and that
i ny. I
1 4 3 To ensure that alelf feaccttiivvei tlQeusa leixtyp ecAtsesdu rawnitceh inP rotghrea m
framework of an
are identified and addressed. I
1.5 QUALITY MANAGEMENT OBJECTIVES I
To achieve the above goals, the Plan has the following I
objectives:
1.5.1 To ensure all necessary protocols and procedures,
are documented, known to staff, and available for I
scrutiny.
1.5.2 To ensure all ana!lytical systems are operated in I
accordance with established QA/QC protocols, that
are sufficient to quality, and that
these
timely correctlve action is taken to resolve
I
prob lems
1.5.3 To ensure regular reports on the quality of
laboratory operations are prepared for: management I
actlon as required!.
1,5.4 To implement a process of independent audits of I
laboratory methods, records, and system
performance, in order to verify that quality is
being maintained,
I
1.5.5 To develop mechanisms for reporting QA/OC and
project_specific data quality inforration
related
I
to laboratory clients and to assist in data
interpretation.