Qualification verification

A qualification verification certificate should be referenced, verifying that all individuals performing the OQ protocol are qualified to perform this protocol. This may be included as part of an overall IQ/OQ protocol. 

Table 7 Key Issues for Qualification, Verification, and Individual Validation...

Acceptance criteria must be key to achieve appropriate qualification, verification, and individual validation. Acceptance criteria may be consist of various specifications of intermediate and finished products for medical devices. Acceptance criteria also may control parameters for operation of processing equipment and utilities used. 

Qualification Verification. Again, the process validation protocol should reference all items that support the validation the procedures, personnel, methods, and equipment. This section therefore lists and summarizes the various installation, operational, and performance/process qualifications completed for the equipment used in the process validation. These qualifications should list each by equipment name and number and qualification and type. A typical verification section is illustrated below. 

Whatever the approach, consideration should be given to avoiding duplication of effort, and where possible qualification verification and test procedures should use or reference system acceptance and engineering inspection and commissioning documentation. 

During qualification testing there may be instances in which the acceptance criteria for a particular qualification verification or test is not met. This must be identified (usually as a deviation) and the corrective action recorded, complete with plans for any retesting that may be required. The implementation of any resulting corrective action must be formally documented and test reruns approved and allocated a new test run number. 

Design qualification verification that the proposed design is suitable for intended use. 

Installation qualification verification that insta-1 lation complies with the approved design, manufacturer s recommendations, and/or user requirements. 

Operational qualification verification that the equipment performs as intended throughout anticipated operating ranges. 

Performance qualification verification that the equipment and/or process can perform according to preapproved specification consistently. 

Z359.7 Qualification Verification Testing of Fall Protection Products... 

Qualification, verification and validation of models Qualification refers to the development of the conceptual model. Qualification means that the model needs to be interpreted with a sufficient confidence level. Knowledge incorporated into the model must be re-used without loss or bad interpretation by actors coming from different domains and involved in other decision processes in the enterprise (Chapurlat and Braesch, 2008, 715). Verification checks that the code does what was intended and that the model represents reality. The verification and validation (V V) definitions used in this report are adopted from the 1998 American Institute of Aeronautics and Astronautics (AlAA) Guide (2) "Verification is the process of determining that a model implementation accurately represents the developer s conceptual description of the model and the solution to the model. Validation is the process of determining the degree to which a model is an accurate representation of the real-world from the perspective of the intended uses of the model". Although V V are processes that collect evidence of a model s correctness or accuracy for specific scenarios, V V cannot prove that a model is correct and accurate for all possible conditions and applications. It can provide evidence that a model is sufficiently accurate. Therefore, the V V process is completed when sufficiency is reached. 

Most users require extensive composite qualification testing programs to assure acceptable end use product properties. The magnitude of the qualification depends entirely on the end use requirements and may range from extensive testing of laminates and final parts made from several production lots of fiber, to a single lot laminate evaluation or test coupon verification of properties. 

For a typical assembly, first part qualification begins with a rigorous dimensional check and painstaking prefit of all details on the bond tool. The assembly details are placed on the tool without adhesive, close contact between bond surfaces is verified and any detail or tool interference is corrected prior to proceeding. This is followed by fabrication of a verification film , or a simulated bond cure cycle of the assembly to allow measurement of the adhesive bondline thickness. 

This requirement poses something of a dilemma when purchasing subcontract labor because it cannot be treated the same as product. You still need to ensure, however, that the labor conforms with your requirements before use. Such checks will include verification that the personnel provided have the requisite qualifications, skills, and knowledge and they are who they say they are. These checks can be made on the documentary evidence provided, such as certificates, but you will probably wish to monitor their performance because it is the effort you have purchased, not the people. You will not be able to verify whether they are entirely suitable until you have evaluated their performance. Subcontract labor could be classified as product released prior to verification being performed and so you need to keep records of the personnel and their performance during the tenure of the contract. 

Installation qualification involves performing checks to ensure that the correct equipment or system has been installed and/or connected, including all necessary controls, monitors, instrumentation, or ancillary services. These checks should include verification that relevant operator manuals or instructions have been received from the supplier and that any applicable calibration steps have been identified. 

Inspections by owner include inspections, verifications, and audits of the construction of piping systems, which include fabrication, welding, heat treatment, assembly, erection, examination, and testing, in addition to the construction organization s documented procedures, personnel qualifications, and quality control records. 

Design Qualification (DQ) This provides documented verification that the design of the facilities, equipment, or systems meets the requirements of the user specifications and GMP. 

Installation Qualification (IQ) This provides documented verification that the equipment or systems, as installed or modified, comply with the approved design and that all the manufacturer s recommendations have been duly considered. 

Performance Qualification (PQ) This provides documented verification that the equipment and ancillary systems, when connected together, can perform effectively and reproducibly based on the approved process method and specifications. 

Calibration, in current Good Manufacturing Practices (GMP) terminology, refers to instrument qualification or performance verification... 

Calibration, in current Good Manufacturing Practices (cGMP) terminology, refers to instrument qualification or performance verification of the HPLC. Note that neither any internal instrumental adjustment nor detector response curve for quantitation is intended here as in the common usage of the terminology. In most pharmaceutical laboratories. 

Similar to method validation, it is important to be able to demonstrate that analytical instrumentation is fit for its intended purpose and that it is calibrated and maintained in an appropriate state of readiness. The verification of instrument qualification (see Chapter 8)... 

Design qualification (DQ)—documented verification that the proposed design of the system is suitable for the intended purpose. 

Installation qualification shall include the verification that user manuals, technical manuals, and instrument calibration reports of the computerized system are available, complete, appropriate, relevant, and up to date. 

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]. 

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