POSTPURCHASE PHASE

9.3 POSTPURCHASE PHASE

9.3.1 Site Preparation

Users should study the site preparation guide from the vendor. Careful planning is required to ensure that the necessary preparations to house the new instrument in the laboratory have been completed prior to installation. Insufficient site prepa- ration causes major inconvenience and long delays in the installation process. It is a waste of time and money to have the service engineer show up in the labora- tory but not be able to do anything, due to poor site preparation. It is a common mistake to underestimate the effort and time required for site preparation.

Following are the key considerations for site preparation: ž Physical dimensions. Make sure that there is enough space to accommodate

the instrument and accessories and that the bench is strong enough to support the instrument. The door should be wide enough for a large instrument to pass through.

ž Suitable operational environment. Proper temperature, humidity, and vibra- tion control must be maintained for the instrument. ž Utilities. Some instruments require one or more of the following utilities: high-voltage or high-current supply, special electrical plug to handle the high voltage and current, gas (helium, nitrogen, and air) supply, com- puter network connection, special ventilation and enclosure, water supply and drainage. Example: The installation of an inductively coupled plasma spectrometer requires a high electrical current supply and a special elec- trical plug. Installation of LC-MS systems may require installation of a

PROCUREMENT, QUALIFICATION, CALIBRATION

nitrogen generator. Engineering work to put in these necessary utilities takes some time.

ž Health and safety requirements. Special licenses are required to operate an instrument that uses radioactive substances (e.g., the radioactive sources for the electron capture detector) In some countries, even the radioactive device used to reduce static charge for balances may require a license to operate. The x-ray sources for a crys- tallography system also merit close scrutiny.

ž Electrical safety. Most common commercial instruments have been certified for electrical safety by an organization such as UL (Underwriters’ Labora- tory), CE, or CSA (Canadian Standards Association). However, certain less common instruments or custom-built instruments may have to go through

a certification process at the time of installation. Certification required for electrical safety may take time to complete. A protective shield or cas- ing may be required for automated systems with robotic arms for sample manipulation, to protect operators.

9.3.2 Qualifications

Instrument qualification is required to establish the functional capability and reli- ability of a system for its intended use in a suitable environment. Instrument qualification can be divided into three stages: installation, operation, and per- formance qualifications. A qualification protocol that provides details about the system, the scope and constraints of the qualification, qualification tests, test procedures, and acceptance criteria should be available for review and approval before qualification begins. Sufficient time should be provided for review and approval. The protocol should also contain an exception log to record any out- of-specification results, investigation, and problem resolution.

Installation Qualification. Installation qualification (IQ) is a process to establish that the instrument was received as specified and installed properly according to the design requirements in an environment suitable for its operation. Proper installation is the first step to ensure proper functioning of equipment. Typical IQ activities include:

ž Verify the hardware and software delivered against the shipping list. ž Inspect for visible damage. ž Verify the software and firmware versions. ž Document the model, configuration, and serial numbers of the system com-

ponents. ž Document the model, configuration, and serial numbers of the computer

system. ž Download all files in the application/control software and verify. ž Assure proper power-up or startup of the system components.

POSTPURCHASE PHASE

ž Establish proper communication between the system components and com- puter control.

ž Set up an instrument logbook. ž Calibrate the system modules if necessary.

Operation Qualification. Operation qualification (OQ) is the process of estab- lishing that the instrument or system modules operate according to the functional requirements in a suitable environment. For an HPLC system, operation of the pump, injector, and detector will be tested at this stage. Typical OQ tests for HPLC modules and a UV–Vis spectrophotometer are as follows:

HPLC

ž Pump: flow rate accuracy and gradient accuracy ž Detector: linearity of response, noise, drift, and wavelength accuracy ž Injector: precision, linearity, and carryover ž Column heater: temperature accuracy

UV-Vis Spectrophotometers

ž Wavelength accuracy and reproducibility, stray light, resolution, photometric accuracy and reproducibility, noise, baseline flatness, stability, and linearity

In additional to testing the system components, a functional challenge that tests the system software operation and security should be undertaken. A prede- termined set of instructions can be input into the system step by step. The system responses are then compared to the expected outcomes of the instruction to deter- mine any problems with its execution. Some vendors will provide a standard set of data that can be processed by the system to verify its data-handling capability.

Performance Qualification. Performance qualification (PQ) is a process to dem- onstrate that an instrument can fulfill the requirements outlined in the user require- ments. The PQ can be demonstrated by running a typical application in the user requirements which requires the system components to function together prop- erly to deliver the expected test results. The flow of the sequence of events from requirements preparations to system delivery (or system building) to instrument qualification, and the relationship between the requirements and the qualification processes, are outlined in Figure 9.2.

9.3.3 Data Review and Summary Report

There may be times when some test results fail to meet acceptance criteria. The nature and cause of the failure must be investigated. Based on the results of the investigation, the impact of the failures can be assessed. The cause of the failure can be instrument related or due to operator error. Once the cause of the failure has been identified, action can be taken to rectify the problem. The test should

PROCUREMENT, QUALIFICATION, CALIBRATION

User requirements Performance qualification

User define

Functional specifications Operation qualification

Users and vendor Vendor

Design specifications Installation qualification

Validation Plan

System

Hardware development Software development

Vendor

Figure 9.2. Relationship between requirements and qualification processes.

be repeated to demonstrate that the system’s operations can fulfill the acceptance criteria. The failure, the investigation, the actions to rectify the failure, and the retest must be documented in the exception log.

After the qualification testing, a summary report should be written to summa- rize validation activities with a conclusion as to whether the instrument is suitable to be put into routine use. The report should highlight the objective and scope of the validation project, all the qualification test results, test exceptions, and a recommendation for system acceptance. All the test procedures, test results, and the summary report must be reviewed and approved by quality assurance and/or management before product use.

The entire qualification process has to be documented. If it is not documented, it is just a rumor! The records should be stored in a secure place because the records are the only proof that the qualification has been carried out. Systematic filing allows fast and easy access of records during an audit. Rapid record retrieval helps to convey a positive impression to auditors that the system is under control. It would a pity if all the hard work had been done but the records could not be presented quickly and efficiently during an inspection.

Users should get involved in the qualification process whenever possible. The qualification exercise provides a very good learning opportunity for users to work with the service engineer and learn more about the system’s design and functions. Users will gain valuable experience with regard to operation and maintenance of the instrument.