Documentation standards qualification

OQ testing should only be conducted after the IQ has been successfully concluded. The scope of the OQ should be dehned in the Validation Plan. System Testing can be repeated or referenced to reduce the amount of OQ testing required, provided supplier documentation standards fulfill user qualification requirements. The OQ should cover ... 

The user is responsible for the entire validation. One part of this overall validation process is to obtain documented evidence about the proper development according to documented standards. To have this assurance, a vendor assessment program should be developed that may include formal written procedures for the selection, evaluation, and qualification of vendors. 

A documentation standard for the PQ test plan can be found in the IEEE standard 829-1998, presented in Table 20.4. The key sections of a PQ test plan are the features to test and those that will not be tested and associated with the features to be tested are the written notes of the assumptions, exclusions, and limitations to the testing imdertaken. The assumptions, exclusions, and limitations of the testing effort were recorded in the appropriate section of the qualification test plan to provide contemporaneous notes of why particular approaches were taken. This is very useful if an inspection occurs in the future, as there is a reference back to the rationale for the testing. It is also very important as no user can fully test a CDS or any other software application. 

Installation and operational qualification (acceptance testing) should follow standardized procedures and the results should be documented. Installation qualification consists of checking the instrument and documentation for completeness. For complex software, the completeness and integrity of the installed program and data files should be checked. 

Draft documents have been produced describing job profiles (duties and responsibilities), and proposed requirements for Gold Standard Qualifications. 

ACI Committee 355 published the State-of-the-Art Report on Anchorage to Concrete in 1991. This was the first of a two-volume set whieh emphasized behavior and did not include design methods and procedures. In 2000, ACI Committee 355 published the ACI Provisional Standard, Qualification of Post-Installed Mechanical Anchors in Concrete (ACI 355.2-00) and Commentary (ACI 355.2R-00). This document prescribed testing programs and evaluation requirements for post-installed mechanical anchors intended for use in concrete rmder the design provisions of ACI 318/318R-02. It was designated an ACI Standard in 2001 and has since been updated twice, most recently in 2007. 

The standard requires purchasing documents to include, where applicable, the title or other positive identification, and applicable issue of specification, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. 

Installation qualification (IQ). IQ demonstrates that the equipment/system has been installed correctly at the user site according to vendor standards. The vendor should install the equipment to demonstrate to the buyer that all the components are operating properly. The qualification process includes appropriate documentation of the system components, physical installation and hook-up, and a performance check to verify that the individual components operate and can communicate with each other. System component information, such as serial numbers, type of use, and user performance requirements, should be included in the metrology database for easy tracking and scheduling of maintenance and/or calibration. 

Defined maintenance procedures should include model or manufacturer specifics and a list of parts to be inspected, cleaned, lubricated, replaced, and/or calibrated. The replacement part numbers, cleaning solutions and lubricants, and calibration standards, along with the manufacturer s maintenance procedures to be followed, should be specified. Documentation is easily managed by creating a one-page checklist of instructions or performance parameters that can be checked off as each task is completed. Any issues or comments can be captured directly on the checklist. Provisions for failure or out-of-tolerance notification need to be clearly defined, as the equipment cannot be put back into service until the performance has been verified by conducting a performance qualification. 

The standard of any facility of operation is highly dependent upon the quality of the design and, therefore, the staff employed to undertake the work. A design qualification protocol, or report document, should detail and record the disciplined, structured approach followed. This will provide a useful lead into the installation qualification (IQ) stage. 

When new equipment is purchased or there is a change in the manufacturing site, qualification exercises are performed as part of the validation process. Qualification (installation qualification, operation qualification, and performance qualification) for any equipment or facility is an extreme process which involves testing, verification, and documentation to assure that the particular equipment or facility is per the specification and meets the appropriate standards as defined by vendor and required by manufacturing and engineering personnel [14]. 

Once satisfied that the instrument is operating in accordance with its own specification, the end user should ensure that it is fit for purpose for the applications intended. This step is called Operational Qualification, OQ. This process would include writing the Standard Operating Procedure (SOP) and training staff in its use. Further testing may be required to ensure that the instrument performance is in accordance with National and Corporate standards if not carried out in IQ. Frequently, instruments are used with accessories or sub-systems, e.g. sipper systems or other sample presentation devices. Challenge the analytical system with known standards and record what you did. It is necessary to ensure that they work in the way intended and that documented evidence is available to support their use. 

Finally, during the qualification of the facility, all systems are tested, calibrated, and cleaned. The mechanical and service infrastructure must be qualified. The operational qualification will involve practice runs. All documentation must be finalized. This includes standard operating procedures, batch records, and equipment logs. 

The hardware strategy should consider the preferred use of standard hardware components and the potential need for custom-made hardware. The category of hardware components required to meet user and design requirements will provide a guide to the level of hardware specification, design documentation, and development and testing records and will influence qualification activities. 

In addition to inspection and calibration of instrumentation carried out as part of an SAT, the need for recalibration of critical instruments prior to IQ, OQ, and PQ should be reviewed and the decision documented in the respective qualification report. All site calibration activity should be conducted in accordance with quality standards and the respective engineering procedures. Any remedial work should be undertaken under document control, and where necessary, evaluated under change control. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

Another element of qualification is the quality audit. Will one be required, and if it is, to what extent A quality audit can be conducted from the sponsor s office through the use of an audit questionnaire. Again, this can be extensive 20-plus page request for information related to the vendor s documentation practices, equipment lists, service capabilities, facility layout, materials control, and personnel credentials, or a three-to-four-page questionnaire identifying such critical requirements as the financial information and industry standards to which the vendor complies. (For an extensive discussion on internal audit programs, see Chap. 12, The Internal Audit Program. )... 

Operational Qualification (OQ) is a QA approved document designed to check that the individual components operate according to specification. Pumps will be tested with calibrated flow meters to confirm that they perform to the set specification. Calibration standards will be used to assess other instrumentation such as Refractive Index (RI) or Ultra Violet (UV) detectors. Gradient performance will be checked to confirm that the solvent delivery system and mixer is working to specification. Once complete and approved by QA and Technical Management, the equipment will now be made available for use. 

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