Signature of Quality

Signature of quality (SoQ) is another approach and is illustrated by the following case example. 

The commitment of the company to the values and standards laid out in Our Credo drives management to strive continually for excellence in a number of overlapping areas. Based upon the principles of the Baldridge Award, the Quality Management team of Janssen-Cilag developed a self-assessment process known as Signature of Quality . The process is supported by a checklist on a carefully constructed questionnaire in five interdependent areas ... 

Signature of quality (SoQ) It is a self-assessment process supported by a checklist covering customer focus, innovation, personnel and organizational leadership, use of technology and environment and safety issues. It is useful in FIT SIGMA for estabhshing a company health report. 

A list of signatures of all the relevant staff has to be included in the quality manual in order to identify them in the documentation of the quality system. 

Among many fascinating properties, quasicrystals with high structural quality, such as the icosahedral AlCuFe and AlPdMn alloys, have unconventional conduction properties when compared with standard intermetallic alloys. Their conductivities can be as low as 450-200 (Qcm) [7]. Furthermore the conductivity increases with disorder and with temperature, a behaviour just at the opposite of that of standard metal. In a sense the most striking property is the so-called inverse Mathiessen rule [8] according to which the increases of conductivity due to different sources of disorder seems to be additive. This is just the opposite that happens with normal metals where the increases of resistivity due to several sources of scattering are additive. Finally the Drude peak which is a signature of a normal metal is also absent in the optical conductivity of these quasicrystals. 

Approved by — each page of the SOP provides a space for the signature of the quality assurance manager approving the SOP to prevent unauthorized changes. 

The appropriate signatory to meet compliance requirements would be the director of quality control. Additional signatures from quality assurance are not necessarily required but would provide an opportunity for regulatory oversight. 

Final approval, should be provided by the director of quality control, with a supporting quality assurance counter-signature. 

Similar to the methods validation protocol, it is recommended to obtain approval signatures from both the director of quality control and quality assurance because of the regulatory criticality of a method transfer exercise. 

List of other batches and products possibly affected, the results of their investigations, and any required corrective actions The comments and signatures of all production and quality personnel participating in the investigation and who may have approved any reprocessed material following additional testing... 

These few remarks show that the quality of the crystal must be carefully checked before any attribution of structures of the reflectivity spectrum to absorption mechanisms is made at the observed frequencies. Conversely, observation of unexpected strong reflectivity, possibly related to the presence of various thin dips68 in the low-energy wing of the reflectivity, will appear strange if we do not consider the back-face contribution with the dips being signatures of various types of bulk absorption such as impurities. Another, very characteristic dip, with width proportional to kT [hence very sensitive to the temperature see Fig. 2.9 (arrow)], is attributed to phonon-assisted... 

The amount by which a given optical isomer rotates the plane-polarized light is a characteristic signature of that compound or substance. When measured under a set of standard conditions this quantity is termed the specific rotation, alpha, and written in square brackets [ ]. It can be used as a measure of the purity or authenticity of an essential oil in analysis and quality control procedures. This is discussed further in Chapter 5. 

Column entry fields for dates, times, and events (e.g., initial installation and calibration, updates, column changes, errors, repairs, performance tests, quality control checks, cleaning, and maintenance, plus fields for the name and signature of the technician making the entry). 

In summary, while a study has to fulfil certain requirements, such as the presence of a study plan approved by dated signature of the Study Director before the start of the study, and while it has to undergo some control through inspections by the Quality Assurance, there may be instances where certain of these requirements would become nearly impossible to be fulfilled. Where a study is, however, of so short experimental duration, that it would be practically impossible to schedule the respective inspections, and where the administrative workload would become much higher than the workload for the actual conduct of the study itself, then, GLP would by right be considered a burden only. Therefore the requirements of GLP are adapted by the Principles to short-term studies in a way that allows for a certain alleviation of the workload for Study Directors, study personnel, and Quality Assurance. 

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the Study Director and verified for GLP compliance by Quality Assurance personnel as specified in Section 2.2.i.b., above. The study plan should also be approved by the test facility management and the sponsor, if required by national regulation or legislation in the country where the study is being performed. 

Release for Sale should require the examination and certification by Quality Assurance of consolidated records of processing, packaging and quality control, to ensure compliance with the Master Formula, compliance with all procedures, acceptable yields and reconciliations and compliance with product specifications. A check list system should be used forthe collected documents to verify that all are present The release should include the dated signature of the person authorised to approve the distribution of the batch (see also Contract Manufacture). 

All decisions made by the quality control department pursuant to section C.02.014 are attested to by the signature of the head of the quality control department, or an authorized alternate, and are dated. 

Quality control, after sampling and inspecting the material, if the material complies with the specifications, shall remove the section of the card with the words AWAITING INSPECTION and add the words EXAMINED, SUITABLE together with the signature of the person responsible for the examination. The raw materials are then transferred for storage. 

Quality control disposition accepting or rejecting the material, including the date and signature of the responsible person ... 

---