Attachment D-4_Definitions.pdf

Attachment D-4

Definitions The section provides clarity in the use of FDA words or terms that may have conflicting meanings in the commercial sector. The following words or terms will have the same meaning throughout the IDIQ SOW. Terms are italicized if they have a definition in this list.

Acceptance Testing. A procedure which ensures that full operation can be demonstrated before a scheduled maintenance or unscheduled service call can be completed. To carry out acceptance testing, instrument performance is compared to a performance standard (criteria for determining whether an instrument is non-performing or has been returned to full operation).

Acceptance testing could consist of requirements specified in a quality management program such as (1) method-specific performance qualification tests, (2) instrument specific operational qualification tests, or other tests such as (3) calibration tests, (4) comparison with recent, prior performance data, or (5) comparison to OEM specifications. The nature of the acceptance testing to be performed must be specified before service begins. In the absence of a performance standard, acceptance is documented by the signature of the instrument point-of-contact.

Center. The major sub-divisions of the FDA. Each Center is responsible for specific aspects of FDA’s mission. FDA Centers includes the Center for Veterinary Medicine (CVM), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), the National Center for Toxicological Research (NCTR), the Office of Regulatory Affairs (ORA) and the Center for Tobacco Products (CTP).

Center Project Manager (PM). Individual at each FDA Center who collaborates with the COR and the instrument points-of-contact.

COR (Contract Officer’s Representative). An individual at each FDA Center who officially represents specific FDA Centers in the execution and oversight of the programmatic aspects of the contract.

Component. Depending on context, may refer to a removable section of an instrument (examples: power supply module, motherboard), or a wholly self-contained unit of an instrument which is itself made up of several components (example: auto-sampler).

Component Removal & Replacement. A process conducted by the FDA instrument point-of-contact or their FDA designee. An acceptable OEM component is first shipped to the site. Upon arrival, the current component is removed from the instrument and replaced by the acceptable component. The replaced component is then shipped back to an address designated by the contractor.

Component Shipment & Exchange. A process conducted by the FDA instrument point-of-contact or their FDA designee. The instrument itself or an instrument component is shipped to an address designated by the contractor. An acceptable component is then shipped back to the site and replaced on the instrument by FDA.

Domestic Manufacturer. Service or repair of all domestic manufacturer of equipment used in performing critical FDA laboratory operations.

Emergency Repair. Service or repair of an instrument used in performing critical FDA laboratory operations. Accelerated three business day on-site response is desirable for emergency repairs.

Field Service Report (FSR). Documentation of completed services (maintenance or repair).

Includes a full description of all procedures that were carried out, parts and components installed, and tests conducted to verify subsequent instrument performance and operation. This would include descriptions and results of acceptance testing. This documentation must be provided before a service call can be deemed complete.

Eligible Instrument. An instrument listed on the current master equipment list (MEL).

Equipment. Any electrical or mechanical device, apparatus or instrument used in a laboratory or similar setting to support or perform research, method development or analysis.

Full Operation. The quality of meeting a current performance standard, i.e., not being a non-performing instrument and not being a non-operational instrument.

Instrument. A device whose purpose is to carry out measurements based on the physical or chemical properties of a sample. May contain electrical, electronic, or electro-mechanical components. Includes firmware loaded on components intrinsic to the instrument. Includes data system software loaded on a dedicated computer workstation used to control the instrument’s operation and acquire data from it.

Instrument Type. A generic category. Under this contract, includes mass spectrometer, liquid chromatograph (high pressure or ultrahigh pressure), nitrogen generator, gas chromatograph, etc.

Instrument Point-of-contact. One designated FDA employee who is responsible for a specified instrument on the MEL. POCs will initiate or receive communications involving the contractor, the COR, the Center PM, or the third-party servicing contractor.

Maintenance Protocol. The specific actions, acceptance tests, documentation, performance standards and service level required for scheduled maintenance on a covered instrument.

Maintenance Services. Carried out in response to an instrument’s requirement that maintenance be carried out by a specified date under an instrument specific maintenance protocol. Carried out by an OEM certified or qualified maintenance engineer who carries out procedures and/or installs acceptable parts or acceptable components required under the maintenance protocol.

Maintenance services include documentation of completed maintenance services (FSR).

Master Equipment List (MEL). A list in spreadsheet form which contains all information about each instrument eligible for maintenance and repair services called for under this contract. The data elements comprising the MEL are listed in Section J-1.

Original Equipment Manufacturer (OEM). The commercial entity which designed and built the instrument. May not correspond to the commercial entity from whom FDA purchased the instrument. The terms OEM, factory and manufacturer all refer to the same entity.

Preventive Maintenance. Maintenance services which are required a specified number of times a year, and by a specified date, so they can be scheduled in advance by the contractor.

Quote or Estimate for T&M. An outcome of troubleshooting, used by the Center Project Manager for purposes of approving or denying an ad hoc service request, and by the Contractor for processing purchase orders.

Repair Services. Services carried out after a service request in response to an instrument becoming non- performing or non-operational. Carried out on-site by an OEM certified or qualified repair engineer who carries out procedures and/or installs acceptable parts or acceptable components required so the instrument is returned to full operation. Repair services include acceptance testing and documentation of completed repair services (FSR).

Service or Services. Unless otherwise stated, “service” or “services” include technical support, diagnostic & troubleshooting, component removal & replacement, component shipment & exchange, maintenance services, or repair services.

Service Request. A formal written communication originated by an instrument point-of-contact, with approval of the Center PM, to the Contractor so that services may be initiated and provided to FDA.

Service Request Form (SRF). Formal, written documentation of a service request. It is used to communicate and track all activity related to each service request for instrument repair and maintenance services.

Service Level. One of three possible levels describing how soon an on-site response is needed for servicing instruments or equipment. The three service levels are: three-business days, seven-business- days, or not time critical (twenty business days). The FDA instrument POC specifies the service level suitable for the service type in the SRF when placing an initial request for service.

Service Type. One of three categories of service: Repair Service, Preventive Maintenance or Both Repair and Preventive Maintenance. The FDA instrument POC determines the service type and specifies it in the Service Request Form (SRF) when placing an initial request for service.

Site. A single physical location identified by a corresponding street address at which instruments are located. Examples: laboratory building or research facility. Each Center and Office may operate scientific instruments at more than one site.

Technical Support. Communication by telephone, email or remote diagnostics (if allowed by FDA IT security officer) between the instrument point-of-contact and a third-party service provider in order to instruct the instrument point-of-contact on carrying out procedures pertaining to a non-performing or non- operational instrument.

Timeliness of Response. The time to respond on-site to a request for service within the applicable service level.

Attachment J-5