How to Prepare for EPA Inspections Martin Beran Sherita Normington Western Region Quality Assurance
EPA Inspections in 2014 94 Total
Western Region EPA Visits
Inspection Frequency EPA selects your site based on: Last Date of Inspection Compliance History Types of Chemistries Number of Studies Submitted
Inspection Frequency Date of Receipt of Study Geographic Location Types of Studies Submitted Office of Pesticide Programs Work Plan
Inspection Frequency Never been inspected EPA must do inspections to meet the requirements of the GLPs and so that data from studies conducted in the United States are accepted throughout the world
Headquarters Preparation Headquarters receives email letter notifying them that a testing site will be inspected FRD/PI may be notified directly from EPA auditor Headquarters sends email notification to the FRD/LRD, Regional QA, and Regional Field Coordinator
Headquarters Preparation Letter indicates type of inspection: Office data audit followed by facility compliance inspection at the testing site Study data audit and facility compliance inspection both at the testing site
Headquarters Preparation Letter identifies studies being audited, data EPA wants, and where to send it All raw data supporting the studies identified in the letter Facility data Environmental, calibration maintenance records CV training records SOPs eqa coversheets or QA routing forms Contact information for study personnel
Headquarters Preparation Headquarters generally has 15 days to send certified copies for office data audit HQ QA or Study Director arranges for test and reference substance characterization data from registrants as requested by the inspection letter
Always be Prepared Update facility documents regularly SOPs CV, training records, job description Organization chart Facility map Routine maintenance and instrument verifications per SOPs File documents so easily retrievable
Trial Site Preparation Know your Master Schedule SOPs for the trials and current SOPs Raw data from the trial Field data book or analytical data Re-acquaint yourself with the trials Maintenance and calibration documentation Equipment verification documentation
Trial Site Preparation Facility map Organizational chart CV, job description and training records for all study participants and current employees Arrange for a conference room or office space where the inspector can work Find out what time the inspector will arrive
Regional QA Preparation Go through the trial notebooks and audit reports to acquaint yourself with the trials Arrive at the trial site the day before the inspection to help prepare for the inspection, go through facility s records, do a quick walk through of the facility and answer any questions the researcher(s) may have Determine who will sign the Notice of Inspection Determine who will take notes during the inspection
Helpful Hints Be Honest Treat Inspector with Respect Read your SOP on EPA Inspections Have Requested Documents Ready Answer only those Questions asked Rely on your QA
Helpful Hints Clear up any concerns the inspector has as soon as possible and before they leave The inspectors are not at your site for a gotcha moment
The Inspection The EPA requires an inspector to do at a minimum these three things at your site Show Credentials Provide a Notice of Inspection Inspect at Normal Business Hours In addition, they will also Describe visit as a Neutral Scheme inspection
The Inspection Greet the Inspector and take them to pre-arranged space Opening conference Appropriate personnel present Inspector shows credentials Notice of Inspection Good Laboratory Practice Standards 40CFR160 Books and Records 40CFR169 Discuss housekeeping issues such as restroom locations Inspector tells why they are doing the inspection and a history of the GLP program Inspector asks for a history of your site s GLP program
The Inspection Determine the inspector s agenda order of activities, tour, personnel the inspector may want to talk to Make sure someone is there to assist the inspector, this is often QA If they want to work alone, let them know how to get in touch with someone to assist with additional documents or questions
The Inspection If the inspector has already looked at your data, they may have questions. Answer any questions in a concise manner. The inspector will look at your master schedule and pick an on-going or recently completed study to see how you are currently doing things.
Inspector Comments ASR QA Statement not needed Maintenance records archived sooner Instrument identifier needed Label adjuvants like reagents
Inspector Comments Standardize your stopwatches Different SOP versions between copies Application calculation errors found in FDB Number the spray booms
Inspector Comments Calibration catches too similar PSI reading missing from FDB PSI read from different spray gauges PSI readings different in same appl.
Closing conference The Inspection Have all personnel present at the closing conference The inspector will ask for copies of documents during the inspection. You will be given an inventory of what they are taking. The Inspector will bring up any findings or concerns they have. Clarify any points where there may be discrepancies and provide supporting documentation You will receive a list of observations
This statement- Inspection Observation Form No Observed Adverse Findings -means the inspector did not have any compliance concerns and observed no potential violations.
What if you have findings? Respond in writing, including any supporting documentation to show corrective actions have been taken Provide time frame when corrections will be implemented if can t be fixed right away
And then you wait Close of Inspection letter