TML/MSH Department of Microbiology Policy QPCMI000.

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Quality Manual
Section: Process Control Subject Title: Process Control Policy
Prepared by: QA Committee Original Date: November 1, 2003
Issued by: Laboratory Manager Revision Date:
Approved by: Laboratory Director Annual Review Date:

Policy
The department has established a mechanism to design, develop and review all operational and
quality processes.

Purpose
To provide direction for the design, development, implementation and review of all the quality
and operational processes of the department.

Responsibility
The department management has designated individuals responsible for the design, development,
implementation and review of quality and operational processes. All staff of the department have
a responsibility to follow established processes and procedures that govern process control.

Key Elements

Non-Test Method Implementation:

For non-test method implementation, the department:
• Identifies and procures the necessary resources
• Documents the process and supporting procedures
• Validates that the process works as intended
• Monitors process performance through established quality indicators

Test Method Implementation:

For test method Implementation, the department:
• Identify and procure the necessary resources
• Document the testing process and supporting procedures
• Validate that the test method and process work as intended
• Establish and maintain the quality control program for the test method
• Use statistical tools to monitor test method performance

Process Design
The department identifies the processes in its quality system and operations and defines them
through flowcharting.

Process Validation
Designated staff undertake validation of processes prior to implementation to assess that they
work as expected and meet customer needs, document and approve the validation and retain this
documentation on file.

TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not
controlled and should be checked against the document (titled as above) on the server prior to use.
TML/MSH D epartment of Microbiology Policy QPCMI00000 Page 2 of 2
Quality Manual
Section: Process Control Subject Title: Process Control Policy

Changing an Established Process

The department uses appropriate tools to design, develop and review changes to established
quality and operational processes with consideration to both the quality system essentials and the
path of workflow.

Quality Control Program

The department establishes and maintains a quality control program to verify test method
performance.

External Quality Assessment

The department participates and maintains processes for regulatory and voluntary external
quality assessment programs.

Related Documents
Document Title Document Number
Process Design Process
Process Validation Process
Non-Test Method Implementation Process
New method evaluation Process QPCMI04000
Microbiology Specimen Process Flowchart QPCMI02000
Pre-analytical Process - Specimen Collection
Pre-analytical Process - Documentation of STAT Notification
Pre-analytical Process - Specimen Transport
Pre-analytical Process - Specimen Receiving
Pre-analytical Process - Specimen Accessioning and Processing
Analytical Process
Post-Analytical Process
Quality Control Program Process QPCMI05000
External Quality Assessment Process QPCMI07000

TORONTO MEDICAL LABORATORIES/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not
controlled and should be checked against the document (titled as above) on the server prior to use.

T:\Microbiology\New Manual\Live Manual\Quality Manual\Process Control\Process Control Policy QPCMI00000.doc