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					  Perspectives on QA Audits/
               Martin Beran – QA
             John Roncoroni – FRD
               Van Starner – SD
IR-4 National Education Conference
Phoenix, AZ - March 1, 2006
     Martin Beran
 IR-4 Western Region
Quality Assurance officer
       U.C. Davis
        Those Darn Findings
• The Pseudo-Antagonistic and Poly-
  Unsaturated Architecture of QA Findings
• I Have No Idea What QA is Asking Me?
• How Am I Supposed to Respond?
• Who Gets a Copy of My Responses?
            QA Obligations
• Researchers Need to
  Know What the Issue Is
• Findings Should be Clear
• Avoid Accusatory Tones
• Offer Solutions to
   These Findings Say it All
• You did not have your SOPs on site at
  the time of the application. According to
  the GLP regulations, SOPs should be
  immediately available. I recommend a
  copy of your current SOPs be placed in
  your truck.
                 One More:
• Part 4E, Test Substance Records - I cannot
  seem to locate test substance storage
  records for the period of 2/11 – 3/29/05. Test
  substance storage records are needed from
  the date of receipt to the date of the last
  application. Please insert additional records
  if available into the FDB.
     Findings that are Weak Sauce
• Luke Skywalkers‟s training records did not
  include any reference to GLP training.
• Any impromptu GLP training Skywalker
  might have had should be added to Part 2B
  of the FDB. This can be in the form of a
  copy of his ongoing Jedi training record or a
  separate sheet of paper with any informal
  GLP training documented.
        Weak Sauce Continued

• Your Crop Destruct statement is
• Please explain how and when the
  treated apples were destroyed. You
  simply stated that the row was taped
  off. Please document the measures
  you took to ensure that the apples did
  not enter the food chain.
• Did they answer the
• Did they provide the
  necessary information
• Has the FRD carried
  his corrections over to
  the FDB

• I get a lot of these:
• OK
• Noted
• Study director will
• How dare you
            Note to Study Director
• The plot layout consists of one row of 14 plants.
  The Protocol states that samples should not be
  taken from hops on the ends or the edges and they
  must be taken from at least five hills. Since the
  researcher has only one row to sample from, this
  seems to be a Protocol Deviation. Did you mean to
  write in the Protocol that hops could not be taken
  from plot edges? This means that plots need to be
  more than two rows of hop hills. No response
  needed from the researcher.
                  More Notes:
• The Chicory samples from the TA01 trial seemed
  to be quite different in appearance from the –DS05
  samples. The Tatooine root samples were at most
  finger thickness compared to the Death Star
  samples which were round as a turnip. Even
  though Amendment #4 mentioned a potential
  difference in residue, the physical difference in the
  Tatooine samples was stark enough to be brought
  to your attention.
Routing FDB Findings
Routing CPI Findings
         Additional Points
• Sending Corrected
  Pages Along with
  the Audit
• The Quality Control
• Communicate with
  the Auditing QA
Response To My Responses?
    John Roncoroni
 IR-4 Western Region
Field Research Director
       U.C. Davis
               Finding #1
• The GLP status of the test substance
  was not know “at the time of receipt,” and
  there was no record of a communication
  to the Study Director, who sent an email
  on July 28. Suggest changing to “No”
  (not known at time of receipt). Most time
  there is a GLP assurance in the letter
  from the supplier, but not in this case.
              My Response
• “Technically I was taking the registrant‟s
  word that they would actually send a
  Certificate of Analysis to Dan Kunkel at HQ -
  see page 3 part 4. Section 13 of the
  protocol states that „the registrant will
  provide a Certificate of Analysis to IR-4
  headquarters.‟ Not necessarily to the FRD.”
           Registrant Letter
• “This test substance, which was obtained
  from production lot no. ABC123, has been
  found to have an active ingredient
  concentration of 9.3%. A certificate of
  quality has been forwarded to the attention
  of Dr. Dan Kunkel at IR-4 Headquarters.”
            Finding #2
Part 6, page 14:
 48.4 x 233.823 = 11317.033
Please correct this and the GPA and send
the corrected page back to HQ.
            My Response
• The numbers in part 6 page 14 (and
  actually on the page before also) are:

          48.4 x 2333.823 = 112957.03

     (reviewer is off by a factor of 10) !
              Finding #3
• Part 6 page 28 of 30:
      Show % deviation from Protocol
  rate. This is asked for in instructions for
  this page.
          My Response
• Clarification added:
     Note: I think that 100.39% indicates
  that I was 0.39% over the protocol rate
  and is clear for the reviewer to
             Finding #4

• Part 5 page 14 of 20:
      The non-applicable ID# has been
  lined out but there is no error code.
             My Response

• This is a field ID that is on a page that is
  copied – my answer is I have found in
  the past that there really is no
  appropriate error code - I will use WE for
  wrong entry.
              Finding #5
• Page 5, pages 7-9:
   On page 7, there is a notation of the GPS
   reading used for the water valve used as
   a permanent landmark. If you will be
   relying on that reading, versus the valve
   itself, we should add the GPS unit to the
   list of GLP exceptions in Part 1C. If the
   valve has some kind of unique ID, that
   could be used for future trials.
          My Response
• I am relying on the valve as the
  permanent marker. The valves are far
  enough apart that the GPS will identify
  this valve as opposed to others.
   Van Starner
IR-4 Headquarters
  Study Director
  Rutgers Univ.
    Current IR-4 Guidance
• San Antonio Results Document (9/27/02):
   Q: How do we correct raw data that we no longer have in our
   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

• IR-4 Advisory #2003-01 (4/25/03):
    “Responding to FDB QA Findings”
    Current IR-4 Guidance
• Instructions from QA auditor in audit cover
  “Return the audit with your original responses and any
  corrections, clarifications or altered copies of your data
  pages to IR-4 HQ QA. The HQ QA will then forward
  the responses and any corrected pages to the Study
  Director and Testing Facility Management. Please
  keep a copy of the audit for yourself, and send copies
  of the responses to your Regional Field Research
  Coordinator. Only one mailing, your original
  response, needs to be sent to HQ.”
Who is the target for your
    Field Coordinators?
The Study Director!
 By 40 CFR Part 160.33, the Study Director:
• Represents the single point of study control
• Has overall responsibility for the technical conduct of
  the study
• Is responsible for interpretation, analysis,
  documentation, and reporting of study results
• When you receive an audit for review
  and response:
      Don‟t take it personally that QA has “dinged”
        your work, BUT….
     Consider how you can best respond to
        assist the Study Director in finalizing the
        And Remember!
Before a final report can be finalized,
signed and submitted to EPA, EVERY QA
finding must be completely addressed to
the satisfaction of the SD, QA and
FINDING: “Meteorological data not complete;
last data is for 31 July 2003. Please update
meteorological data.”

RESPONSE: None – FRD only signed the
bottom of the page of audit findings.
FINDING: “Part 6H – a brief description of
procedure used in cleaning spray equipment is
asked for here, not the SOP followed. Please
provide this information.”

RESPONSE: “Prior to use, equipment is
washed with clean potable water. Tanks are triple
rinsed and flushed as are the lines, nozzles,
strainers, and nozzle screens. Equipment is
inspected for leaks or obvious wear prior to
calibration and use. Clamps are ………………….”
FINDINGS: “Part 6C – incomplete error
documentation; all cross-out entries need to be
initialed and dated and the error code added.
Lined out spaces need to be initialed and dated
on Part 5G, 5H, 7B, 7D. Part 7B – crop destruct;
entry needs to be initialed and dated.”

RESPONSE: For all three: “Acknowledged”
FINDING: “Parts 4 and 9 contain several
photocopies that lack one or all: Field ID #,
date, initials, location of originals”

RESPONSE: “No action needed, thanks
for the suggestion.”
“No response necessary from Field Research
Director – Study Director should address.”
FINDINGS: “ Please line-out unused parts
of Parts 1C, 2A, 4C (page 1 and 3), 5G, and
5H.” A minor error is seen in Part 6, page 27
of 35. Total pass time was 41.5 seconds. 41
seconds has been used in calculations. This
has given a lower % deviation of +3.65. It
should be +4.76%.”

RESPONSE: For both: “OK”
FINDING: “Part 7A, sample collection/storage;
you failed to mention whether row ends were
sampled from, and whether five or more hills were
sampled from. This needs to be added to the
sampling description.”

RESPONSE: “Protocol states: „Avoid
sampling from plot edges/ends,‟ so we complied
with the protocol.”
FINDING: “Part 6C, pg. 2 and 4 of 32: please
cross out field ID of trial that does not belong in
this FDB. In the future, only one field ID per
page, please.”

RESPONSE: “Opinion – not written rule.
If it‟s not written, it doesn‟t exist.”
FINDING: “Part 7B. Crop destruction
section needs to be filled out with appropriate

RESPONSE: “Acknowledged.”
              Final Thoughts
- Overall, responses to QA audits have been improving
significantly, as has the consistency of QA findings, etc.
 - There is still room for improvement on both sides, and
it‟s through training events like these that we can re-
emphasize, face-to-face, the need to communicate,
provide clear direction, and use a neutral (vs
adversarial) tone in order to expedite responses and the
entire review process.

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