An inspection is a snapshot of the physical conditions observed at the site at a particular point in time, whereas an audit is a comprehensive evaluation of the entire program. Learn what it takes to manage an effective laboratory inspection and audit program in an effort to maintain compliance.

1. Lab Inspections vs. Audits:
What’s the Difference & Why Does It
Matter?
Tony Gemmellaro, Triumvirate Environmental

2. Meet Your Moderator
Sylvia Leaphart

3. During this Webinar
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✓ There will be a Q&A session at the end of the
presentation – submit your question(s) anytime
throughout the webinar.
✓ Slide deck and webinar recording will be sent to you
tomorrow.

4. Meet Your Presenter
Tony Gemmellaro

5. Agenda
Inspections vs. Audits
Specialty Inspections & Audits
Good Inspecting & Auditing Skills
Examples of Observations or Findings
5 Scenarios

6. Overview
6
An inspection is a snapshot of the physical
conditions observed at the site at a particular point
in time, whereas an audit is a comprehensive
evaluation of the entire program. Learn what it
takes to manage an effective laboratory inspection
and audit program in an effort to maintain
compliance.

7. What Constitutes an Inspections/Audit?
Inspection
• snapshot of the physical
conditions observed at the
site at a particular point in
time.
• useful tool for identifying
non-compliance issues that
are occurring at the time of
the inspection.
Audit
• comprehensive evaluation of
the entire program.
• reviews the current
arrangements that are in
place to ensure that the
program is operating
effectively.

8. Differences between Inspections/Audits
Inspection
• Snapshot
• Limited amount of time
• May not identify underlying
causes for observed
deficiencies
• Usually carried out using a
checklist
• May miss issues that take extra
time to find
• Usually qualitative (not scored)
Audit
• Comprehensive
• Extended length of time
• Will identify underlying root causes
for observed deficiencies
• Usually carried out using an audit
protocol
• Able to drill down until all issues are
identified
• Presents an accurate picture of
program
• Usually quantitative (scored)

9. Inspection/Audit Programs
Types of Audits/Inspections
• Regular self-inspections conducted by designated employee(s) on a
routine basis (daily/weekly)
• Supervisor self-inspection conducted by the supervisor on a
weekly/monthly basis to reinforce regular employee inspections
Site/Department Inspection
• Performed quarterly by a site team of employees, supervisors and site
management representative(s)
Periodic External Audit
• Performed annually by auditor outside of the site operations (e.g.,
Corporate staff, another site, an outside consultant)
Inspection Follow-up
• Ensure corrective actions are taken to eliminate identified deficiencies

10. Poll Question
What are the goals of your current laboratory/facility
inspection or audit program?
a. Tool to find issues and assist with compliance
b. Share successes or challenges
c. Corrective actions (CAPA’s)
d. Employee, management, and PI involvement
e. Other

11. Agenda
Inspections vs. Audits
Specialty Inspections & Audits
Good Inspecting & Auditing Skills
Examples of Observations or Findings
5 Scenarios

12. Specialty Inspections and Audits
Laboratory Safety
• Biosafety
- Bloodborne Pathogens/rDNA Ordinance
- Biosafety Manual/Policy
• Chemical Safety
- OSHA Lab Standard/Hazard
Communication
• Radiation Safety
• SDS Program (Product SDS/All Chemicals)
• Chemical Management/Inventory
- Flammable Limits
- Chemicals of Interest

13. Example:
Biosafety Inspections and Audits
• Designated Biosafety Officer/Biosafety Committee(s)
• Written Risk Assessments
• Biosafety Manual and Exposure Control Plan
• Training Records
• Engineering Controls (BSL-2, BSL-3 labs) and PPE
• Waste Disposal Procedures and Practices
• Spill Management (small vs large scale)
• Medical Surveillance and Incident Investigation SOP
• Compliance with Regulations

14. Specialty Inspections and Audits
Occupational Health
• OSHA Log 300/OSHA Log 300A (needle sticks)
• Worker’s Compensation/Return to Work Policy
• Ergonomics (lab, office, manufacturing, facility)
• Treatment/Prevention Program:
- Animal allergens, respiratory protection, Shots/Vaccines:
Hepatitis B, TB, measles, flu shots, Potassium Cyanide or
hyrdrofluoric acid exposure
• Incident Reports/Incident Investigation/CAPA

15. Specialty Inspections and Audits
Facility Safety
• Pressure safety (fermentation/bioreactors)
• Electrical safety/arch flash
• Fall protection/working on ladders
• Hoisting and rigging
• Hot work
• LOTO: Control of Hazardous Energy
• Machine guarding
• Permit required confined space
• Powered Industrial Trucks (PIT)

16. Specialty Inspections and Audits
Emergency Response/Fire Prevention
• Emergency response
- Emergency Action Plan (EAP)
- Evacuations
- Medical response (CPR/AED/First Aid)
- Spill response
• Emergency response team/emergency contacts
- Emergency coordinators, incident commander,
floor wardens, assembly area leaders
• Fire prevention

17. Example: Fire Safety
• Alarms
• Smoke detectors and heat detectors
• Sprinkler protection systems and
water mains
• Chemical deluge systems
• Fire pumps
• Exits/aisles/passageways
• Evacuation procedures posted
• Emergency lighting
• Fire fighting equipment
• Inspection tags

18. Specialty Inspections and Audits
Environmental Programs
• Hazardous and universal waste management
• Hazardous and universal waste
• Biomedical waste
• DOT Hazmat registration/ DOT Security Plan
• Emergency planning and community right to know act
• Stormwater pollution prevention (EPA)
• Spill Prevention and Control Countermeasure plan
(SPCC)
• Air pollution control, water polluction control
• Toxic Substance Control Act (TSCA), e.g. PCBs
• Industrial Wastewater/ MWRA and EPA

19. Example:
Chemical Storage/Hazardous Waste
• Tanks/drums physical condition
• Fire detectors/fire fighting equipment
• Sprinkler protection systems
• Self-inspections of storage areas
• Adequate venting of storage areas
• Adequate spill equipment and supplies
• Adequate emergency eyewash/showers
• Chemical deluge systems where appropriate
• Adequate bunding/diking of above ground storage tanks
• Underground tanks tested/removed as appropriate
• Appropriate signage (flammable materials/no smoking)
• Separation of non-compatible materials (eg,
acids/bases)

20. Poll Question
What keeps you awake at night?
a. Reactive chemicals that may cause a fire
b. Laboratory acquired infections
c. Ergonomic issues related to material handling,
laboratory repetitive strain injuries (RSI), or potential
back injuries.
d. Other

21. Agenda
Inspections vs. Audits
Specialty Inspections & Audits
Good Inspecting & Auditing Skills
Examples of Observations or Findings
5 Scenarios

22. Good Inspecting and Auditing Skills
• Set the ground rules right from the start
• Ask open-ended questions:
- How would you..
- Explain to me your procedure for…
- Tell me about…
- Stay away from “Yes” or “No” questions
• Listen attentively
• Manage your time effectively/set priorities
• Be flexible but firm
• Hold end of day status meetings daily to assess inspection/audit progress, re-
evaluate schedules, inform site of findings to date

23. Document Review
• Gathering of documents
• Review of documentation
• Verification of documented information
• Request for any missing documentation
• Interviews with responsible individuals
• Take photos

24. 8:00pm - 8:15pm Introduction
8:15pm - 8:30pm Goals of inspection/audit
8:30pm - 8:45pm define Responsibilities
8:45pm - 9:00pm Management support
9:00pm - 9:45pm Elements of an Program
9:45pm - 10:00pm Inspection/Audit Process Flow Chart
10:00pm - 10:20pm Break
10:20pm - 11:15pm Physical Inspection / Scenarios
11:15pm -11:45pm Safety Program
11:45pm - 12:00noon Discussion/Questions
Set an Agenda

25. • Identify areas (labs, mechanical spaces)
• Bring maps, checklist and supplies (PPE,
flashlight)
• Review fire safety, emergency response
(postings), hazardous chemical storage,
workplace equipment, electrical systems,
ergonomic factors, forklifts, PPE, signage
• Interview employees
Physical Inspection

26. Agenda
Inspections vs. Audits
Specialty Inspections & Audits
Good Inspecting & Auditing Skills
Examples of Observations or Findings
5 Scenarios

27. Examples of Observations or Findings
Some of the major risks or frequent “violations”
discovered during an inspection or audit at your facility
may include the following:
• Labeling, PPE
• Sharps left on benches (razor blades, needles)
• Blocked grills in biosafety cabinet
• Working with BSL-2 material in open bench, creating
aerosols
• Negative behavior
• Other

28. Photos
Slide 34

29. Slide 35
BSL-2 Laboratory

30. Sealed Centrifuge Cups and Rotors
Slide 37
Engineering Controls

31. Sealed Systems
Large Fermentation Vessels
Slide 38

32. See Anything Wrong?
Pallet blocking fire alarm pull alarm

33. See Anything Wrong?
Pallet blocking emergency egress

34. See Anything Wrong?
Flammable storage cabinet blocking electrical panel

36. Personal Protective
Equipment (PPE)
Gloves, lab coats,
glasses, goggles
Respiratory protection
[BSL-3] for spill clean-
up (PPE)
Examples of Personal Protective
Equipment

37. Signage - CAUTIONMinimum Personal Protective
Equipment (PPE) Requirements
Lab Coat
Safety glasses
with
side shields
Special Hazards or
Precautions
Lab Supervisor
Lab Contacts
No Eating or Drinking CAUTION
RADIOACTIVE
MATERIALBIOHAZARD
y:labsignscaution.ppt

38. Poll Question
What are some of the liability issues with laboratory or
facility areas?
a. Exposures to chemicals or biological agents
b. Slips/trips/falls
c. Fire hazards
d. Protection of students or the student is
immunocompromised student
e. Other

39. Agenda
Inspections vs. Audits
Specialty Inspections & Audits
Good Inspecting & Auditing Skills
Examples of Observations or Findings
5 Scenarios

40. Goals for Inspections and Audits
• To promote compliance with
institution/company standards
and local legislation
• To provide a uniform application
of company standards
• To assist in the implementation
of management systems
• To ensure continuous
improvement

41. Define Roles and Responsibilities
Management
• Demonstrate clear leadership and commitment to EHS issues
• Provide resources and authority to the EHS rep to implement
the requirements of the standards and laws in a timely fashion
EHS
• Be aware of new and proposed regulations and how they
impact their site’s operations
• Conduct an annual audit of site EHS systems, develop action
plans to correct deficiencies and report findings to site
management
Employees
• Follow all site EHS rules
• Have a basic understanding of the hazards, controls, safe
work practices and appropriate PPE
• Report any injuries or illnesses

42. • Situation:
You are conducting an audit of a large primary chemical manufacturing facility. The head
engineer is the person who you will be interviewing to determine what processes are in place to
ensure that all engineering projects are reviewed for EHS issues/concerns.
• Information you have:
– Site’s Management of Change SOP (GMP oriented)
– There is little to no mention of EHS in the SOP
– The safety rep has not signed off on the SOP
• Questions to ask?
Scenario 1:
The Reluctant Engineer

43. • Situation:
You are about to interview the site manager of a large secondary
manufacturing and packaging site to determine management’s commitment
to EHS. The site manager has given you about 10 minutes of his precious
time.
• Information you have:
– The whole site has been working 3 shifts every day for the last 30 days to
meet their production quotas.
– There is little to no mention of EHS in documents you have seen so far.
• What Questions would you ask?
Scenario 2:
The Stubborn Site Manager

44. • Situation:
You are interviewing a supervisor in the production area to determine compliance with the
Hearing Protection Program.
• Information you have?
– The production room is a hearing protection designated area.
– 5 out of 10 employees observed during the physical inspection are not wearing hearing
protection in designated areas.
– 3 out of 10 are wearing them improperly.
• What questions would you ask?
Scenario 3:
The Clueless Supervisor

45. • Situation:
You are interviewing employees in the microbiology lab to see what their understanding is about
the training they have received in bloodborne pathogens.
• Information you have?
– The Microbiology Lab handles ATCC cultures(BSL-1 and BSL-2) and some human blood samples
for clinical trials.
– There are no BSC’s in the lab and there do not appear to be biohazard spill kits.
• What questions would you ask?
Scenario 4:
The Overly Helpful Employee

46. • Situation:
You are the lead auditor on a three person audit team, who is interviewing management
representatives in the conference room to see what their understanding is about their role in
showing management commitment.
• What Happens?
– Two in your audit team start arguing over the interpretation of one of the standards in front of the
management team.
– They seem to act as if the managers are not even in the room and continue to argue.
Scenario 5:
The Three Stooges

47. What Do You Do?
• Interrupt the current “conversation” by using your lead auditor status. Change the subject.
• Tell the auditors and managers that the team will discuss the issue offline.
• Ask a different question and re-engage the managers in answering the question.
• Apologize privately later to the managers.
• Privately afterwards remind the other auditors how to behave in front of others.
Scenario 5:
The Three Stooges

48. Summary
• Clearly articulate policies and procedures
• Assures effective inspection/audit programs
• Implement regulations
• Facilitate research and teaching
• Determine appropriate strategies to minimize or manage the risks
• Communication is the key

49. Questions?

50. THANK YOU!
Tony Gemmellaro
Sr. EH&S Consultant
agemmellaro@triumvirate.com
Call Us!
1-888-834-9697
www.triumvirate.com