Quality Policy

Technical Safety Services is committed to providing quality field testing and certification services by exceeding the defined needs and expectations of our customers. This includes building relationships with both the customer and vendor that will improve quality in areas of controlled environment testing and certification services.

TSS has further implemented the quality system by developing internal Standard Operating Procedures (SOPs) that describe every aspect of the business from scheduling to data collection to QC and billing. These SOPs are compliant with the national and international standards that govern certification, controlled environment performance testing, and calibration. TSS is committed to keeping current with these standards and revising the SOPs as the industry changes.

Every employee is responsible for the operation and maintenance of the quality system by taking part in the following:

• Initiate action to prevent the occurrence of product, process, and quality system nonconformity
• Identify and record any product, process or quality system problems
• Initiate recommendations or provide solutions through designated channels
• Seek continuous improvements in quality

We maintain all training, calibration, warehousing and testing records in accordance with ISO guidelines, and welcome regular audits from our clients.

Testing and Certification Standards

All testing is performed by highly trained professionals in accordance with established TSS SOPs. These SOPs are compliant and updated to remain current with federal and international guidelines for Current Good Manufacturing Practices and Quality systems, ISO, IEST, ANSI, NSF, ASHRAE, and OSHA standards as well as CFR 210 & 211 & the USP 1116.

Test Equipment Calibration

Reliable testing and certification results are critical in a controlled environment and depend on accurate readings from the test equipment. TSS adheres to strict equipment calibration requirements from ANSI/NCSL Z540-1-1994 and ISO guide 25. Calibration records are kept in accordance with federal and international guidelines in both paper and electronic form and are NIST traceable. This program is operated and maintained by the Calibration Engineer.

Technician Training & Monitoring

TSS service technicians are highly trained professionals that specialize in providing total system service and support. All technicians have extensive training and experience in the practices and test procedures established by ISO, NEBB, NSF, and IEST. TSS sends all technicians through NSF accredited biohazard safety cabinet field certifiers training and has more NSF accredited field certifiers than any other company in the world.

• All technicians receive ongoing training in the field from our Field Service Supervisors and journeyman technicians.
• TSS has developed a comprehensive training program, [TSS Training Institute], that provides in-depth training on all SOPs as well as client training on provided services.
• TSS technicians also receive training directly from the manufacturers.

This program is operated and maintained by the Training Manager.

TSS Training Institute

Core technician program
    Orientation
    General safety & blood borne pathogens
    Safety in the laboratory
    Current Good Manufacturing Practices
    Customer service
    General gowning
    Electronic data collection
    Standards
    Project Management
    Train the TSS trainer

Biological Safety Cabinet & Hood Certification
    Air cleaning hoods
    Biological safety cabinet certification
    Small scale decontamination
    Electrical troubleshooting
    Hood service, mechanical troubleshooting
    NSF prep.
    ASHRAE

Controlled Environment Room Performance Testing Training
    Clean room documentation
    Clean Room Main Test Battery
    TAB – Proportional balancing
    Microbiological monitoring
    Compressed dry air sampling
    TAB – NEBB, CPT
    Supplemental tests
    TAB – System validation

Instrumentation
    Basic test equipment
    Calibration
    Specialized test equipment
    Incubators
    Large scale decontamination
    Autoclaves

Client Classes
    Basic Controlled Environment Room Testing

Technical Writing Services

The Technical Writing department is integral to the quality systems at TSS. TSS Technical Writers provide thorough data quality review and analysis. Through ongoing training, all writers have a solid understanding of federal and international guidelines for Current Good Manufacturing Practices, Quality systems and client-defined standards. Additionally, writers regularly observe and participate in field-testing and provide documentation support to the field staff.

All data processed through formal reporting receives a high level QC covering all aspects of data collection, criteria application and calculations. The QC and reporting processes are outlined in TSS SOPs and each writer is thoroughly trained on the content therin. In addition, each writer is familiarized with technical service procedure SOPs, enabling them to provide meaningful feedback and direct follow up to clients. Additionally, the TSS Technical Writers are poised to provide a variety of Technical Writing services to support internal as well as client Quality System requirements. This includes preparation and review of validation documentation, developing and revising SOPs and creating testing protocols.

The final TSS report product is a single document that coaleces the raw field data with the analyzed results. The reports clearly explain the testing procedures, standards, criteria (where applicable) and final results of the TSS field product. Additionally, TSS reports include AutoCad® diagrams representing the relative sampling locations (including TAFs, Non-viable and Viable sampling and CDA), copies of all the field notes and data sheets generated on-site during the tour, as well as copies of the most recent calibration certificates for the instruments used during the test tour. These documents are designed and executed to withstand harsh audit scrutiny.