4.2 Description of Lab Audit Process
4.3 Flowchart of Compliance Process
EHS Safety Consultation Service or “lab audit” is a service provided by
to ensure compliance with applicable safety standards and regulations.
Inspections may be announced or unannounced and typically consist of a visual
inspection of laboratory facilities, a document review and, if applicable, a
review of agent inventories. These inspections may occur on a more frequent
basis as prescribed by governmental or granting bodies.
Issues needing corrections will be addressed using the “Lab Audit Results”process to document compliance.
4.2 Description of Lab Audit Process
1) Verbally inform Area Responsible Party (ARP)* of issue(s) at time of audit, inspection, or incident.
(NOTE: The ARP should
be notified of the audit
a) If known to “inspector”, suggest possible solutions.
b) Inform ARP that written notification of issue(s) will be sent.
c) Offer services of the appropriate EHS group to help resolve issue(s).
2) Notify ARP in writing of issue(s) within 7 working days of the audit, inspection, or incident:
a) Suggest possible solutions (consult with other content experts if necessary).
b) Offer services of the appropriate EHS to help resolve issue(s).
c) Give a time line for a response of 7 working days.
(NOTE: Some regulations may necessitate response times more stringent than above.)
d) Inform ARP of what is required in their response:
i) What action(s) were or will be taken to correct the issue.
ii) When was or will corrective action be complete.
iii) What actions are being taken to ensure that the issue does not recur.
3) If no response from ARP (or inappropriate/inadequate response) by the deadline, call and e-mail the ARP to verify receipt of memo and remind ARP of need to respond (explain/discuss what is missing in their response).
a) If the memo was received, give a new deadline (see 2c above).
b) If ARP did not get the memo, send or deliver copy with a new deadline (see 2c above).
c) Verbally reiterate 2b above.
4) If no response by the deadline in 3 above:
a) Send a second memo to the ARP.
b) Give a time line for response of 3 working days.
c) Attach copy of the first memo.
d) Make reference to all subsequent written or verbal communications.
e) Send a copy to the ARP’s department head/chairman.
f) Reiterate 2b above.
5) If no response by deadline in 4 above:
a) Report issue and activities-to-date to the appropriate UTMB safety committee for recommended action.
b) Communicate the committee’s recommended action, consequence of continued failure to correct issue, and risk to UTMB for failure to correct problem to:
ii) Copy to ARP’s department head/chairman.
iii) Copy to appropriate V.P.
iv) CC list may be modified/amended by the committee.
6) If no response by deadline established in 5 above
a) Report back to the appropriate UTMB safety committee for further action.
7) If at any stage above, an appropriate response is obtained:
a) Notify the ARP (and any persons copied in any correspondence) of the receipt of correspondence and appropriateness of ARP’s corrective action(s).
b) Schedule a special audit/inspection if warranted.
c) Look for satisfactory resolution of issue at the next regularly scheduled audit/inspection.
8) If a repeat of the same issue is noted at the next audit/inspection (either routine or special):
a) Go to step 5 above.
* The Area Responsible Party (ARP) is the Faculty Principal Investigator, Faculty Laboratory Director or Radioactive Material Permit Authorized User in research and clinical labs. In other areas, this is the person responsible for management of the area/activity.
Approved by Biological Safety Committee: September 4, 1998
Approved by Chemical Safety Committee: August 25, 1998
Approved by General Safety Committee: July 20, 1998
Approved by Radiation Safety Committee: July 21, 1998
4.3 Flow Chart of Compliance Process
Audit Flow Chart Part I
Audit Flow Chart Part II