Quality
System Essentials
The Quality
System Essentials (QSE) are the building blocks of any organization’s
Quality Management System. Documentation of policies, processes
and procedures related to each QSE form the laboratory’s quality
manual. Ontario Laboratory Accreditation (OLA) has based the requirements
for accreditation on twelve QSE.
1) Organization
This QSE addresses
management’s commitment to quality. As well as developing a mission
and vision statement, management must take a leadership role in
developing policies and supporting the planning and implementation
of each QSE .
2) Personnel
Laboratories
require clearly defined job qualifications; job descriptions; and
processes for selection, orientation, training, competency assessment
and performance development plans in order to obtain and retain
the highly qualified personnel.
3) Equipment
The laboratory
should state the quality expectations for the equipment that is
used. In addition to manufacturer’s instructions for calibration,
maintenance and use, the laboratory must follow any regulations
and accreditation requirements. Specified processes for using and
troubleshooting equipment as well as obtaining service and retiring
equipment is required.
4) Purchasing
and Inventory
Critical supplies
and services must be identified and criteria for quality must be
established with vendors. These activities are conducted in partnership
with the purchasing department. Processes for purchasing, receiving
purchased items and for managing inventory must be in place.
5) Process
Control
Each discipline
must identify and define all the processes in its operation. For
each step in the process, well-written procedures that are understood
and used by staff are key to ensuring consistency in performance.
The Laboratory should use appropriate quality control measures to
detect errors and process controls where required to prevent errors.
6) Documents
and Records
Documents include
written policies, process descriptions, procedures and blank forms.
Records are
the completed worksheets, forms, labels etc. that capture the information
obtained, activities performed, or results. Both documents and records
need to managed and archived.
Policies are
statements of intention; "what to do"
Processes describe
how policies are carried out; "how it happens"
Procedures provide
instructions; " how to do it"
7) Information
Management
The commitment
to quality across the path of workflow includes the management of
information between services within the organization as well as
external agencies.
8) Occurrence
Management
The purpose
of occurrence management is to capture and analyze information to
identify systematic problems, determine root causes and correct
the problems.
9) Assessment
Assessment of
quality is essential to achieving it. Participation in external
(e.g. QMP-LS EQA) and scheduled internal audits ensures that the
quality system is meeting the stated requirements. Quality indicators
must be identified and monitored for all operations and actions
must be taken when unacceptable performance is demonstrated.
10) Process
Improvement
Once systems
are in place, there is a need for continuous improvement. Sources
of information for improvement opportunities include; customer feedback,
internal audits, occurrence analysis, external assessment, literature
reviews etc.
11) Service
and Satisfaction
The laboratory
should be committed to providing a quality service by meeting "customer"
expectations. External and internal (e.g. patients, physicians,
employees, peers) service satisfaction can be measured and feedback
given on the basis of findings. Process improvement plans can be
developed for operations that require improvement.
12) Facilities
and Safety
The health care
organization must provide and maintain a safe work environment for
employees, patients and visitors, in compliance with all applicable
standards and regulations.
