Tobacco Documents Online

Progress Report Evaluation of VentOation Systems February 15, 1993 Comparability - expresses the confidence with which one data set can be compared to another. Comparability is best expressed as a percentage. Table (1) describes each major measurement parameter that has been taken at this point in the development of the research protocol. The table also includes a reference as to the measurement instrument used•to collect the parameter along with specific values of precision and accuracy. 4.2 Sampiing Procedures The data collected from this research project falls into two major categories; data that is collected to arrive at a research protocol otherwise known as "exploratory" data and that data which is collected specifically for support of the research protocol otherwise known as "protocol driven" data. This distinction is significant since exploratory data is not subjected to the rigors of data continuity (completeness) and archiving that protocol driven data has to satisfy. Data originates from either continuous monitoring equipment or from grab sample devices. All data irrespective of where it originated will be compatible with a uniform database format (see Section Task 5). 4.3 Sample Custody Chain-of-custody procedures are necessary to ensure that all data obtained is ~y collected, logged, and maint'ained in a very controlled way in order to ensure the N validity of data. Responsibility of this task falls to the designated QA/QC personal. The CA QA/QC team consists of the principal investigator or his/her representative, the %] CD GB N C Physiaal Systems Tasks 8

Pro9re" Ropod Evaluation of VentB.tion Syst.ms Fe6ruary 15, 1993 principal researcher, the quality control representative and the data archivist. The responsibility of team members is as follows: Principal Investigator - determines the type and frequency of data needed to satisfy the research protocol. Principal Researcher - is responsible for conducting the research according to procedures outlined in the protocol. All data will be logged with a consistent label and forwarded to the data archivist. Quality Control Representative - ensures that quality assurance guidelines and procedures are being followed. He/she is present at the being and end of a data cycle to insure data integrity. This person is not the same as the principal researcher. Data Archivist - logs all data on a daily basis to the project database. Their responsibility is to manage the project database providing one master that cannot be corrupted. In addition, the data archivist merges all data into a consistent digital format with an appropriate file header that designates; date of collection, time of collection, experiment classification and comments. 4.4 Calibration This section deals with the calibration procedure for each instrument. Along with the detailed procedures describing the type of calibration (e.g., multipoint, zero,and span), information provided includes both frequency planned for recalibration and a listing of the calibration standards to be used and their source(s), including traceability procedures. N N tV C1T ~ ® Physical Systems Tasks 9

Progress Report Evalwtion of Ventillatioo Systems February 15, 1993 In general, field calibration will consist of a zero/span calibration done twice daily, once early in the morning prior to beginning data collection and at the end of data collection to validate that calibration has been maintained. If for whatever reason this° second check identifies that a recalibration is necessary, the data collected during that period will be flagged as such to be taken into account when the data is analyzed. 4.5 Data Validation Data validation is the process whereby data are fiftered and either accepted or flagged for further investigation based on a set of criteria. Validation is performed to isolate spurious values since values are not automatically rejected. 4.6 Internal QC Checks Internal quality control checks will consist of the calibration standards as described under section 4.4 of this document. In addition a quality control representative will be on-site throughout the course of the project to ensure that all quality assurance guidelines and procedures are being followed. 4.7 Performance and System Audits The system audit consists of evaluation of all components of the measurement system to determine their proper selection and use. This audit includes a careful evaluation of quality control procedures. System audits are normally performed prior to or shortly after systems are operational; however such audits should be performed on a regularly scheduled basis. Physical Systems Tasks 10

Progress Report Evdwtion of V.ntilatfoa Syst.ms February 15, 1993 After systems are operational and generating data, performance audits are conducted periodically to determine the accuracy of the total measurement system or its component parts. 4.8 Corrective Action Corrective actions are of two kinds: on-the-spot or immediate to correct nonconforming or repair equipment; and long-term, to eliminate causes of nonconformance. 4.9 QA Reports Quality Assurance reports will be issued by the quality control representative on a quarterly basis to the principal investigator. This report will detail an assessment of overall success of data collection with emphasis on data accuracy, precision and completeness. The report will focus on significant QA problems and recommend solutions. Performance of instrumentation and quality of data is monitored and controlled as data is collected. TASK 5 DATABASE DEVELOPMENT The data recording capabilities of all instrumentation acquired so far has been reviewed. Several of these instruments have internal software to generate data files. Acquisition software is now being developed that will enable combining data from all ~ instruments into a single database. ~ i~+ C1t ~ ~ ~ Fr W Whysical Systems Tasks ~ ~

Progross Report Evaluation of Ventiiation Systsros Fetiruary 15.1993 TASK 6 TESTING AT RICHMOND A paper is included in appendix D. The measuring procedure has to be further developed. The measurements reported in the paper will be repeated to evaluate the precision of the results. Other combinations will also be studied. Finally similar measurements will be done in the two test rooms in RDF Il. TASK 7 ACQUISITION AND DEVELOPMENT OF INSTRUMENTATION The basic instruments have now been purchased and a list is included under the QAQC section (Table 1). We are still discussing the kind of data logger, which will be needed at RDF. Pfiysicai Systems Tasks

Progreaa Report Evaleation of Ventilation Systema Febnl,ary 15, 1993 1 a 1919 gIg 9 19 9I9 ~ 9 gIg~~ ~ g jgggggg l~ ~Ig g!g g j g g a g ig ~ _ ~ 9919 gIg 9 !9 911 911991 gg ~ ~ ~ ~ ~ ~ f ~ ~ ~IggIgg 9 191 9 ^ ~ ^i' E °c 9 gig g~g 9 ~75 9 ~Ig gI ~ ~ 7L1991,99 8 e 3 !q :y ! g i x 3 Ji 87 ~ g , cc js s I f~ O• IQ ~ v~ ~ I^' if 1 O I ni y y e N u „ l~ ~ ~ ~ s~ Iy W U ~ ~ ~ u O ~ ~ ~> ~ Zr bI bl b ~ CI gi a, g gi f g X a. •.. In ;Lr iniv i b i a 1 Y E la I ' _ 1•f,6) ° o Y« Y 9 s w pJV pid t ~lU 111 '9 UIt1 U E ~^ ~ 0 0 i 0 0l0 oi ~ 'V!o $ $~ oo g $io ool $ o^°°o ~ oolo o ~ ~ o~ co «i~H 0 0l' l I ~ E I ~ - V 1 / . ~ jIffl 1. E ~.~ I ~ sls a N R~IN R~~ ~~~ r+ o ~M61 ~lo S R~a _ o 3 3 g c~t o ° ° R,"' i a" $' o o ai i o'15 ~, II , g $i- 3l s ^: I 31s E $ ~It ~ ~i > > i~ s ~ ~~ ~a II EC, Ia7 LF~= I~ . ~ ~ ~ I I I I I' ~ ~ g # ~ E Q e~~ y a = m ~ ~ iii ¢ N i, ~ s ~ ~ ~ ~ U- ' j N s ~ E Physical Systems Tasks 13