Section: Process Control / Subject Title: Process Control Policy
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.
KeyElements:
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.
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.
Pre-analytical Process
The department uses appropriate and validated pre-analytical processes and procedures for proper test request, specimen collection, transportation, receiving and accessioning.
Analytical Process
The department uses appropriate and validated analytical processes and procedures for proper testing review and laboratory interpretation.
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.
Post-analytical Process
The department establishes and maintains processes and procedures for results reporting in compliance with patient confidentiality and post-test specimen management. Reports shall be issued to attending and/or requesting physicians only.
Related Documents
Document Title / Document NumberProcess 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
Record of Edited Revisions
Manual Section Name: Process Control
Page Number / Item / Date of Revision / Signature of ApprovalAnnual Review / May 1, 2004 / Dr. T. Mazzulli
Annual Review / May 4, 2005 / Dr. T. Mazzulli
Annual Review / July 23, 2006 / Dr. T. Mazzulli
Annual Review / August 13, 2007 / Dr. T. Mazzulli
Annual Review / June 16, 2008 / Dr. T. Mazzulli
Annual Review / June 16, 2009 / Dr. T. Mazzulli
Annual Review / May 31, 2011 / Dr. T. Mazzulli
Annual Review / May 31, 2012 / Dr. T. Mazzulli
Annual Review / May 31, 2013 / Dr. T. Mazzulli
UNIVERSITY HEALTH NETWORK/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.
S:\MICROBIO\Microbiology\New Manual\Live Manual\Quality Manual\Process Control\Process Control Policy QPCMI00000.doc