(asterisks below indicate: additional training committee or QA comments and/or possible
topics for future training by the training committee)
FIELD DATA BOOKS
— GENERAL
- DATA COLLECTION
- Q: Are there specified codes for errors? Many overlap; what is distinction between WE and EE, specifically?
A: Error codes are listed in the Field Data Book (FDB) instructions.
*consider eliminating EE code (these codes are often over-used)
- Q: When lining out a page or part of a page, what else is needed besides the line?
A: Initial and date.
*if dealing with a correction, initial, date and explain; if dealing with lining out a section or page, simply initial and date (no explanation needed)
- Q: When using true copies, where should the location of originals be specified?
A: If the original is in an IR-4 FDB, the location of the original must be specified where prompted for on the bottom of the copied page. If the original is not in an IR-4 FDB, the location of the original must be specified somewhere on the copy.
*not limited to bottom of the page, can use stamp on other areas of the page; use bottom prompt if available.
- Q: How do we correct raw data that we no longer have in our possession?
A: Make the correction on a copy of the raw data and forward with the responses to HQ QA (updated as per new procedures). Contact the Study Director if there are any questions about responding to QA findings, or
contact the QA who performed the audit with questions of intent
- COMMUNICATION
- Q: How do we handle e-mail in the FDB?
A: Print out, initial and date, place in Part 3 of FDB, after the communication log; *may be helpful to add a short note in the log that indicates e-mail hard copies are included after the log
- PAGE NUMBERING
- Q: How do we handle pagination of late added pages, such as sample receipt forms, additional data in response to findings, etc.?
A: Usually by using the previous page number + A, B, C, as appropriate. E.g., 2 inserted pages after page 8 of 10 in a section would be pages 8A of 10 and 8B of 10. If the FRD still has the original FDB, then he/she may choose to re-paginate the entire section (see instructions at beginning of FDB).
*Also add a note on the first page of the section indicating the pages added, initial and date (repagination is not required)
- Q: Can you explain the method of pagination that is wanted (i.e. part 6A page 1-4, 6b 1-3, etc.)?
A: We changed this a few years ago – each section is paginated consecutively without regard to the subsections. E.g., Section 6 may have 30 pages. 6A would be p. 1 of 30, 6B would be p. 2 of 30, 6C would be pp. 3, 4, and 5 of 30, etc.
- MISCELLANEOUS
- Q: Can the field ID # prompt be more to right to accommodate stamps? Is the field ID# needed on all pages (i.e. chain of custody, etc.)?
A: The field ID# prompt has been on the left and on the right, but now is in the top center of each page of the blank FDB. The important fact is that the field ID# and page# must appear on each FDB page, prompted for or not!
- Q: What’s the latest on electronic notebooks and IR-4?
A: Still years away.
- Q: Why is there redundancy in requests for info within the FDB?
A: Test substance lot #=s are requested repeatedly because additional shipments are sometimes made to the FRD=s. Redundancies are needed to insure accurate data are captured throughout trials, but we=re willing to consider streamlining if specific requests are made.
- Q: Can IR-4 eliminate pages such as CV and temperature records to streamline the FDB? The FRD’s are already putting in their own forms.
A: A few people do use our temperature tables. The risk of eliminating a page such as the CV page is that FRD=s may neglect to insert the information if not prompted. We can consider how to accomplish this for future years= FDB=s.
- Q: *Why does the FDB ask for SOP used and then for a description of the procedure?
A: Request for a description was added after reviewing several EPA inspections.
- Q: *When inserting pages with data from a number of freezers, can we highlight the freezer used for that trial? Can we use highlighters to locate directions to plots on the field maps?
A: Some kind of added emphasis is good (such as brackets), but highlighters don=t photocopy well. DO NOT use highlighters!
- Q: *What about when there is inconsistency between the protocol & the FDB?
A: When this occurs, the protocol takes precedence. The communication log is a good place to enter required information that doesn=t fit elsewhere. Please notify the Study Director or the Regional Field Coordinator when instances of this are found, so that the problem can be corrected in future years= FDB=s.
- Q: * Can we assume NA = not applicable?
A: Yes. See the error codes in the FDB. ANot available@ must be spelled out.
- Q: *Does a signature (initial) at the bottom of a page cover all entries on that page?
A: Yes, as long as all of the data entries were made on one date by one person. Entries by different people must be initialed and dated. Entries made later must also be initialed/dated.
- Q: *What do we do if there is not enough space in some sections?
A: Additional pages may be added. If this is a recurrent problem in certain sections (like sample collection 7A), let us know and we=ll try to fix this.
- Q: Take more care to reduce erroneous findings (i.e. QA says data missing when it is present).
- Q: Can the FDB be modified to have different section/pages for herbicides/fungicides/insecticides?
A: We have designed customized pages for airblast sprayers because they are calibrated much differently than other sprayers. We don=t have the resources to do much additional customizing. Suggestions to improve specific sections of the FDB are always given consideration.
- Q: FDB’s should arrive early and prior to test substance arrival.
A: We have put the blank FDB on our website; you can now print out pages when needed.
- Q: Part 10A has empty space, but no real fields to fill in. Do we need to cross out and initial?
A: No, there is no prompt for information.
- Q: Do we need to calibrate GPS equipment for accuracy under GLP’s and keep a maintenance log?
A: Record calibrations and maintenance just as for other equipment. If appropriate, include as a GLP exception in the FDB. *GLP issue – proper use and checks for accuracy – subject for Training Committee
— SIGNATURE/PERSONNEL
-
- Q: *Do we need signatures from temporary labor; there are no books pages to document training of casual labor?
A: Signatures are needed only from people who record data or participate in study activities such as spraying, timing sprayers, and harvesting.
- Q: *For whom do we need CV information – weeders, harvesters, pass timers, etc.?
A: The same people who must sign the FDB must also provide CV=s, which must indicate GLP training. Weeders, maintenance spray applicators, etc., do not need to provide this information, but for someone involved in critical field activities, such as harvesting samples, this information is needed.
— PLOT LAYOUT
-
- Q: What are GLP requirements regarding plot markers? Can we use GPS coordinates?
A: Requirements are indicated in the protocol. Yes, use of GPS is stated in the FDB. This does not preclude the need for physical markers as required by the protocol.
- Q: * When Part 3 documents multiple trials, QA sometimes has a problem. Are there any guidelines?
A: As of 2002, multiple trials within a study may be documented on a single, original communications log, but multiple studies must be documented on separate logs.
- Q: *Why is it necessary to note the last page in part 3? The pages are numbered.
A: This has been corrected.
- Q: *Is it sufficient to include 2 measurements to permanent markers in the plot plan?
A: Yes, measurements from at least 2 plot corners to one or more permanent markers are sufficient.
— LOGS
-
- Q: *What do we do when data are not collected by FRD (i.e. from grower for maintenance & cultural practices)?
A: In addition to the source of the data and the date received, note as a GLP exception in FDB Part 1.
- Q: *What about chemical storage – when the trial is finished, do we keep it and use it or send it back?
A: Depends on MFG (see #40).
- Q: *Our nearest weather station is sometimes a long distance from the trial site. What can we do?
A: If there is no weather station at the trial site, then it is especially important to be sure that sprays have dried before leaving the location if rain is imminent. If there is a weather station at the trial site, then it should be noted on the map in 5C.
— TESTSUBSTANCE
-
- Q: Are we allowed to use prior year’s FDB pages to record test substances received before the FDB for the current year?
A: Through 2002, you can do this. Starting in 2003, you can go to our website to print out the pages you need, if current year FDB’s have not been received.
- Q: Can the registrants identify GLP containers (boxes) on the outside warning not to separate packing material, GLP paper work, etc. from the test substance?
A: We discuss this with the registrants every year to make improvements. Call the SD if you have any questions.
- Q: Send reasonable amounts of test substance not too little or too much.
A: We try to estimate a reasonable amount (with a little extra) to request from the MFG=s, but it=s up to them how much they actually send. We’ll try to get a better idea from FRD’s during the draft protocol stage about the quantity of test substance needed.
- Q: *Part 4 B what is acceptable documentation to verify GLP status (test substance)?
A: There should be specific mention of GLP certification on the label or on the shipping documentation that accompanies the test substance.
- Q: Should we photocopy the container label?
A: We don=t recommend this.
- Q: Part 4 B Can we record the tracking number instead of inserting the bill of lading #? Tracking # & bill of lading # are not treated the same.
A: Record/insert both in the FDB if available. These are raw data that link the test substance to the GLP-certified batch kept by the manufacturer.
- Q: Part 4 B verify date test substance placed in storage & COC.
A: Unsure what the issue is here.
- Q: *What do you want regarding the condition of the test substance?
A: 4ACcondition of container(s), 4BCdescription of test substance itself
- Q: *We’ve got a problem with the disposal or shipment of manufacturer containers. How long do they need to be kept?
A: Containers must be kept in storage (either by the FRD or the MFG) until the study has been completed (petition sent or study canceled). Do not discard until Study Director=s approval has been obtained. (This is a GLP regulation C there=s no way around it unless safety is an issue, such as with a leaking container.)
- Q: Can you target test substance arrival near time of use?
A: This is difficult to improve on because the MFG=s often prefer to send out all of the test substance at once, rather than having to keep checking a schedule. As a result, many times everyone gets the test substance at the time that the southern-most trials need to have it. When we send requests to MFG’s, we indicate different dates needed for different FRD’s, but we have no control over when it is sent out. Do not return the shipment to the MFG.
- Q: Sometimes there is no GLP certificate on packing material container so it has to be tracked down. The test substance receipt (paper) is not always available from the carrier.
A: When this happens, contact the Study Director.
- Q: We’re concerned with use of adjuvants from different sources. Could a single source (company) be I.D. for providing adjuvant so all are the same?
A: When practical, we can try this.
- Q: Could the shipper fill out &/or provide information required on test substance?
A: Contact the Study Director if inadequate information is received.
— APPLICATION
-
- Q: *When can we round numbers?
A: Do not round until you=ve reached your Afinal answer.” Rounding procedures should be specified in your SOP’s.
- Q: Part 6I B why include material remaining in the calculation?
A: This is not required in current FDB=s.
- Q: *Calibration/Recalibration: How soon is Aprior@? Why can’t the time period between calibration or recheck and application be 48 hours?
A: Calibration/re-check on the day of the application or the day before is acceptable (new protocols now indicate this). Two or more days before is a deviation. This is an arbitrary decision that we=re comfortable with (any boundary we set could result in someone wondering Awhy not one more day?@).
- Q: *When we calculate the rate of application, do we use speed calibration times or actual pass times?
A: The actual application rate should always use the actual pass times.
- Q: *Can we have a sheet with formulas and fill in the blanks for post application calculations?
A: The current FDB=s include example formulas in 6J (there=s no room in 6I). FRD’s can insert their own pages with formulas/calculations, as long as all necessary parameters and units are captured.
- Q: *Section 6I: Does the FDB require both a “high/low” range bracket and “%” of required rate number?
A: 6I asks whether the actual rate was within B5% to +10% of the required rate. We don=t need to know the range. You=re welcome to include such data if it is helpful in filling out the form and determining whether or not a deviation has occurred.
- Q: Part 6 B Can we get airblast sprayer calibration forms, etc.?
A: Airblast forms are now available. Contact your Regional Field Coordinator.
- Q: *Please clarify the rain/irrigation info in part 6J where do we initial and date, and what goes on page?
A: Whoever enters the data should initial/date. Any rain and irrigation before harvest should be entered, regardless of whether subsequent applications were made prior to the first rain/irrigation event.
- Q: *Are weather records required from 1st application to harvest?
A: For annual crops, the protocol now requires weather records from planting to harvest. For perennial crops, the protocol requires weather records for one month prior to the first application. (See item 77)
— HARVEST
-
- Q: *How specific do we have to be in describing sampling procedures?
A: Please be very specific. In addition to information about meeting protocol requirements (e.g., sampled from high and low, sheltered and exposed, etc.), any information about how the crop is physically collected is useful (Is it cut off a vine? Is it dug with a trowel out of the ground?). *Topic for future training session.
- Q: *Requirements on dry ice may be different depending on shipper (field study director). Some FRD’s are constantly written up on this, because of the requirement for a ratio of 3:1 dry ice:sample in Part 8
A: We have changed the protocol wording. Let us know whether there is an improvement in the number of QA findings.
- Q: We need better protocol consistency for sample weights.
A: Notify the Study Directors if you find inconsistency among protocols with the same crop. There are federal guidelines for the amount of sample needed.
- Q: Sample storage temperature range B Bravo!! NCR (no comment required) (change 2001).
- Q: Some info expected in book is not asked for (i.e. sample receipt page, cover page). The FDB needs to prompt to document notification of residue lab of sample shipment.
A: 8A now prompts for this.
- Q: Sometimes the shipping procedures for fresh samples (frozen) & fresh samples for processing (2 different places) in the same study are confusing.
A: Contact the Study Director if the protocol is unclear.
- Q: After we notify the lab prior to shipping, how specific do we have to be in Notes & Communications.
A: Completing page 8A should eliminate QA findings about this.
- Q: Lab receipt notification: what if we get no confirmation?
A: Contact the LRD; if no confirmation can be obtained, contact the Study Director. Lab receipt can be placed at the end of Part 8 or in Part 3. Documentation of a phone conversation with the lab is sufficient.
- Q: Could the lab send an e-mail to the FRD indicating samples have been received?
A: Yes.
- Q: Part 7a page 1 B there is insufficient info to verify protocol compliance for sampling.
A: This section has been extensively changed in the 2002 FDB=s.
PROTOCOLS
— GENERAL COMMENTS
-
- Q: Protocol specificity B the more specific the better.
A: Yes, up to a point.
Objective? Why do we always test the worst-case use patterns rather than the likely typical commercial use patterns?
We nearly always test the Aworst case@ use pattern in our trials so that the tolerance is set at a level higher than residues from legal uses would occur.
- Q: We need to see draft protocols to avoid unrealistic situations at the time of actual trials.
A: We=ll be putting these on our website. Please look them over and send comments to us before we sign them! Remember: we are generally seeking national tolerances and worst-case residues.
- Q: Container disposal notification: need to adhere to this better or make it a system based on FRD sending in a list for Study Director review.
A: FRD should send to HQ a list which identifies test substance, batch/lot#, and trials in which it was used, and SD’s will respond.
- Q: Can the protocol include a list of conflicting chemistries (for station personnel maintenance sprays and to know fields to avoid)?
A: This will vary from study to study. Depending on the chemistry, some Study Directors would prefer to be contacted if there is any doubt. Some protocols will include such information.
- Q: Protocol & FDB should both ask for info (i.e. pesticide, maintenance) that will be needed for petition (i.e. maintenance pesticides, from start of trial in planting of crop).
A: See Part 20 of the protocols. In FDB, break between plot history and test plot maintenance (during the trial) is less important than being sure that all of the information is there.
- Q: Section 11 B the six tree minimum plot size is a problem; buffer spec=s need clarity (what does Athe plots@ mean?).
A: We=re trying to meet the federal guidelines with this. Contact the Study Director if there will be a problem. A plot is one treatment; every plot in a trial must be separated from every other plot in that trial by the minimum distance required in the protocol.
- Q: In draft protocols the word Adraft@ hides language.
A: OK, we=ve changed this.
- Q: Protocols need to be more applicable to regions and cultural practices.
A: We need to test the Aworst-case@ uses. In cases where it would be more practical to have different label instructions for different parts of the country, we can vary the use pattern from trial to trial. Contact the Study Director and the Regional Field Coordinator to discuss this.
- Q: The color of protocol copies that we get is very offensive.
A: Sorry – yellow is the best non-white color to use for copies, and we don=t have a choice of shades of yellow.
- Q: There should be few bugs in final protocols.
A: Insecticide protocols will always have a few bugs in Part 2.
- Q: We’d like to have the ability to use a mutual non-treated control across several studies to save space.
A: This can be discussed with the Study Director on an Aas needed@ basis.
- Q: Why does the FDB ask for: Test crop system B seeds (date received)? if transplants B seeds lot #? (e.g. strawberries, peaches)
A: This is included in the FDB to meet federal requirements. We realize that this information is often unavailable.
- Q: The note for conducting multiple trials at the same site should be in section 15 instead of section 24.
A: Actually, we=ve put it in Section 10 now.
- Q: Weather B 1st application to harvest in protocol. Please define the time period of weather data B it may need to be larger than from first application to harvest.
A: Agreed, and we=ve changed the requirement in our more recent protocols and FDB=s (see item 53).
- Q: We suggest bolding some important or different parts/words of the protocol.
A: OK, but too much bolding eliminates the highlighting effect.
— TIMING
-
- Q: We sometimes don=t receive them on time; get draft protocols to FRD’s ASAP.
A: OK.
- Q: Can we get them by January 1?
A: We=re working to improve our efficiency with protocols. Often we=re held up by registrants not responding to our request for comments. Also, Rutgers University (where the Study Directors work) is closed between Christmas and New Year=s Day.
— USE PATTERN/APPLICATION DIRECTIONS
-
- Q: Can you list GPA, # applications, intervals, etc., in table with rate, not buried in a paragraph somewhere.
A: We want to keep the table simple, but we’re willing to consider some changes. Please read Section 14 as well as Section 15 when preparing to apply the test substance. We will consider changes for 2003. It is required that you read and follow the entire field phase of protocols.
- Q: We would like more info about type of application (broadcast vs directed vs foliage, etc.).
A: When specific restrictions are warranted, we include them. We don=t want to take away all of the judgment of the field researchers regarding nozzle set-ups, etc. We rely on your expertise. Notes from the ’98 San Francisco training may be helpful. If you don’t have a copy, contact HQ. Contact the SD with any questions.
- Q: Protocol directions sometimes don=t match local use patterns.
A: Contact the Study Director. Often we are doing this to meet the Aworst-case@ scenario, but sometimes different use patterns are appropriate for different locations.
- Q: Can we get clearer explanations of application type: foliar, foliar-directed, band, broadcast.
A: See the Attachment to this document – application type definitions.
- Q: Can we get standardization of terms used to describe or define Aapplication type@ (i.e. foliar directed)?
A: We=re trying. Contact the Study Director if there are inconsistencies. (See Attachment)
- Q: *When we’ve performed a calibration re-check, do we use the results from the new calibration or the original calibration?
A: If the results of the recheck are within 5% of the calibration, then use the results of the original calibration. If the results of the recheck indicate >5% variation from the original calibration, then do two more checks and determine a new average output. The bottom line is-the application rate must be based on a calibration consisting of three runs.
- Q: Section 15 B please clarify rate as Aper@/@for each@ application for multi applications.
A: The rate is always expressed as the rate per application.
- Q: *Why do we sometimes have to collect samples at 0-day PHI’s?
A: We require a 0-day PHI only when growers need a 0-day PHI or if these data are required by EPA residue guidelines. Please let the spray dry before going in and harvesting or sampling. Note the time elapsed from application until sampling and/or make a statement that the plants were dry.
- Q: Conflicts occur between the amount ai/A, and the corresponding conversion to product/A.
A: If you see any inconsistency, contact the Study Director.
- Q: Application, PHI and harvest time should be consistent.
A: If there is a typo, contact the Study Director.
- Q: *Which is used to figure PHI B harvest date or sampling date?
A: Harvest date.
— SAMPLE HARVEST
-
- Q: More clarification is needed with sample size and number (# of fruits vs lbs); # of plants vs # of areas in a plot.
A: We=ll try. If in doubt, contact the Study Director.
- Q: Clearly identify unique aspects of certain locations (i.e. sample sizes, types).
A: We try, but if we=ve failed to make it clear, contact the Study Director.
- Q: Section 17 sample collection B wording should be carefully prepared for each project.
A: Generally, the federal requirements are specific to the crop. When there are study-specific requirements, we list them. Occasionally an extra requirement from an old study creeps into a new protocol where it isn=t necessary. If it looks wrong, contact the Study Director. We strive to keep our HQ crop library updated.
- Q: Section 17 B sample weight vs quantity.
A: If you can tell that the protocol sampling requirements will create a problem, contact the Study Director.
- Q: We’re concerned about sample pitting. How does industry remove pits vs IR-4? The removal of pits can affect the integrity of study.
A: Samples must be analyzed without pits. Some registrant labs prefer to remove pits from frozen fruits in the lab to avoid crop matrix loss if done fresh. IR-4 labs prefer to receive pitted fruit. In these kinds of studies (also crops that are shelled), we try to follow the preference of the lab doing the analyses, as per protocol.
- Q: Can we get FDB pages with specificity of sampling, etc., to agree with the protocol?
A: We can=t customize the FDB=s for each study.
- Q: Sample weight vs amount of sample needed.
A: See above.
- Q: The amount of sample is sometimes a problem (i.e. 12 radish roots are not equal to 5-6 lbs), sometimes the protocol is too specific in size of plot and amount to harvest (i.e., 50% of plot, cantaloupe vs greens).
A: See above. We’ll try to improve the protocols. Contact the Study Director before harvest if you have any questions.
- Q: Can we get a freezer temperature requirement that is more logical or achievable?
A: The protocol wording was changed for 2002. Most of our locations have freezers that can be set [0 degrees F; if yours can=t, contact the Study Director. (see protocol Section 19)]
- Q: We need commercial crop processing procedures (i.e. onions).
A: Contact your Regional Field Coordinator and SD. The RFC has contacts with growers/processors in the region as well as other FRD=s (keep the Study Director in the loop so that we can improve our protocols).
- Q: The weight and number of pieces of products do not match (i.e. 5 lbs cilantro; 20 lychee weighing 5 lbs). More clarification is needed with sample size and number (#=s vs lbs; # of plants vs # of areas in a plot).
A: Inform the Study Director so that we can fix the problem.
- Q: Freezer storage temperature B what is a deviation?
A: Defrost spikes and somewhat longer-term spikes for entering or removing samples are exempt from deviations. Protocol Section 19 has been changed.
- Q: Sometimes our method of cleaning samples does not match the protocol (i.e. soft dry clean brush, we used a towel).
A: Try to inform the Study Director in advance if your preferred method of cleaning does not meet the protocol requirements. We will strive to make protocols more flexible to allow different “cleaning” methods, but the method used must be documented in the FDB.
- Q: More clarity is needed regarding cutting samples and not contaminating with residue
A: This has not been a problem for us, but we have made some changes to the protocols.
— CHANGES
-
- Q: Please notify us ASAP when changes occur.
A: OK.
- Q: Sometimes we only receive 1 protocol change, not all of them. It can lead to being written up.
A: Many changes (especially deviations) are specific to a single trial. All of the IR-4 QAU=s and RFC=s know that it is not HQ policy to copy all sites on every protocol change. You should no longer be written up about this, unless you are missing a change relevant to your own trial. RFC=s should receive a copy of each protocol change relevant to their region, and LRD=s should get a copy of every change in their studies, until the ASR has been submitted.
- Q: Protocol amendments sometimes occur too late depending on area where the trial is located.
A: It happens. Contact the Study Director.
QA AUDITS
— QA=s have improved over time.
— QA=s should make sure what we are doing (protocol/notebooks) meets GLP regulations and ultimately can be totally reconstructed by seeing notebook.
— COMMUNICATION
-
- Q: Should QA note which comments are required to be responded to and which ones are suggestions.
A: Yes.
- Q: Desire 2-way interaction on any potential problems relating to QA audits. Some do and some do not.
A: QA tries, but it can be difficult at times, thus they may just have to ask the question.
- Q: Very clearly state comments for better understanding of how to respond.
A: If you do not understand a finding, i.e., what it means, contact the QAO for clarification
- Q: QA should reference part number in QA audit of trial, so it can be found quickly.
A: Will do.
- Q: QA comments should be positive and constructive, not adversarial nor easy nor subjective nor overly critical.
A: QA=s goal is to continue to improve inter-working relationships and (we) expect the same in responses to audits.
- Q: Can QA call FRD when writing report to clear Aminor questions@ reducing findings (in writing)?
A: When possible, but we don=t want to cross the line of Study Director responsibilities.
- Q: When can QA use e-mail or phone for Aminor findings@ at the time of QA. Can QA call FRD & ask minor questions?
A: QA can=t decide Aminor@ findings.
- QA should separate Afindings@ and Asuggestions@.
- Q: Be kind/professional in responses to QA.
A: Yes. Thanks.
- Q: Tone of QA comments – showing professional respect?
A: See above, try to acknowledge the effort119. Indicate when trial is conducted properly.
- Q: Be careful about the wording of findings (i.e. “this is a protocol deviation and must be addressed” vs “this may be a protocol deviation, please contact SD”). Do not dictate to FRD/SD what deviations are.
A: QA has become aware of this.
- Q: QA may not always be correct and may be opinion.
A: See above.
- Q: In plot histories, accept entries as stated Ano pesticides used@ means just that.
A: OK.
— CONSISTENCY
-
- Q: Consistency of interpretation across different QA officers: make sure all QA=s play in the same field B uniformity; consistent QA reactions or responses (i.e. ink color (red), use of GPS)
A: Comment applies at all levels. QA meets regularly to discuss consistency issues, and *recommends other groups do the same.
- Q: QA using Anew@ rules for Aold@ trials. Grandfather in notebooks under that year’s rules or have list or checklist of things QA will look for prior to notebook submission.
A. Can=t make that distinction. Hopefully will be less of a problem in the future.
- Need some standardization between QA=s. Seems some items/issues are open to personal interpretation and preference (see item 123).
- Q: Sometimes we have QA findings from untimely delivery of protocols (i.e. FRD did not get chance to comment on draft protocol).
A: QA has nothing to do with it. Protocols are now posted on our website for more timely review of drafts; however, once protocol is approved, QA must monitor based on protocol.
- Q: QA is for GLP issues not technical issues (i.e. back calculations).
A: QA=s verify that the protocol was followed.
- Q: If calculations are being disputed, QA needs to show their own calculations.
A: QA will do so.
- Q: Why does the program need QA consultants?
A: Program productivity sometimes dictates that some of the work needs to be out-sourced, as determined by the PMC and 30-month timeline.
- Q: Is there a quota system for findings (like DPS)?
A: Yes. (Just kidding!)
- Q: Where does QC end and QA begin?
A: Ideally, when the FDB passes from the RFC to QA, but quality reviews are a continual process.
- Q: Field facility SOP=s need to be provided to QA prior to visits.
A: This is RFC responsibility.
- Q: Regardless of audit source B rules in force at time of study should be rules that govern the FDB for its life.
A: See above.
- Q: Comments are sometimes outside protocol/GLP/compliance issues (e.g. application method).
A: Must follow the regulations.
- Q: Can QA make changes to FDB copies and raw data?
A: QA can=t do.
- Q: Audits B consistency needed for routing of QA audit responses.
A: Cover page for QA audits is discussed at QA/HQ meetings; positive changes have been made.
- Q: Contract QA have different standards from IR-4 standards, QA consultants more accusatory.
A: Consultants will be dismissed if they don=t act appropriately.
- Q: What documentation satisfies confirmation of test substance receipt?
A: FDB page, label, shipping form must be verified on day of receipt (an MSDS is supplemental, but if you receive it, insert it in the FDB).
- Q: Sometimes QA is not familiar with field techniques.
A: QA is learning; it is an exchange.
- Q: We would like QA to sit down and educate FRD’s on what is important to meet GLP requirements – some do and some don=t.
A: Need to continue forum for exchanges.
- Q: Please send a sheet (page) indicating corrective action needed so we can easily see what needs action.
A: This exchange can only occur between the Study Director and the FRD.
- Q: We are interested in comments and suggestions on SOP, etc., that relate to findings in EPA audits.
A: QA is working on a document highlighting information from EPA audits. *Topic for future training sessions.
- Q: Multiple QA FDB audits – answers given by FRD should be reviewed by Anext@ QA.
A: QA has regular meetings to discuss these issues.
- Q: Field training is needed for QA=s who have more of a lab background.
A: See above.
145. Q: *Is calibration/standardization of stainless steel weights needed? Some QA=s ask for it.
A: Yes – required periodically. This should be addressed in facility SOP’s. Suggest weighing standard weights immediately after scale/balance has been serviced and calibrated; record and keep results.
Attachment
TYPES OF APPLICATION
SOIL BROADCAST
The uniform application of the test substance across the plot
When applying a herbicide as a soil broadcast application the target is the soil surface. Boom height for this application is measured from the nozzle tip to the top of the soil surface. For raised beds the top of the bed is the target. Suggest flat fan nozzles.
FOLIAR BROADCAST
The uniform application of the test substance across the plot
When applying a herbicide as a post-emergence foliar broadcast application the target is the crop plant canopy. Boom height for this application is measured from the nozzle tip to the top of the crop canopy. Use average height of the crop canopy to account for the naturally occurring variability in plant height. Suggest flat fan nozzles
FOLIAR DIRECTED
The application of test substance equivalent to the entire plot width is concentrated onto the crop within the row. There should be several nozzles per row. Suggest hollow cone nozzles. Airblast applications to trees are also considered foliar directed sprays.
BANDED
Insecticides or Fungicides: The application of test substance equivalent to the entire row width is concentrated onto the crop.
Herbicides: The application of test substance uniformly to a portion of the row width. When applying a banded application the target is the soil surface.
Boom height for these applications is measured from the nozzle tip to the top of the soil surface. Since the height of the nozzle influences band width the band width should also be measured at the soil surface. For raised beds the top of the bed is the target. Suggest even fan nozzles.
FURROW APPLICATION
In furrow applications are highly concentrated sprays or drenches made to the crop planting furrow. This usually involves the application to the open furrow before the furrow is closed with soil. Suggest a narrow angle flat fan tip or solid stream nozzles
ROW MIDDLES
The application of test substance between crop rows; these are banded herbicide applications between mulched or unmulched beds and are not concentrated. This is often performed with shields or hooded sprayers to avoid contact with the crop. Suggest wide angle (110 degree) even fan nozzles if one nozzle can cover the entire middle, or several flat fan wide angle nozzles.
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