BSL-3 Audit Process
Pre-audit Activities
1) Audit Application: WBHT is notified of any bio-risk management audits via the client’s respective ITQ (Invitation to Quote) procurement process.
2) Review of Audit Application: WBHT conducts a review of the ITQ documents, including evaluation of any potential conflict of interests.
3) Determination of Audit Time: The audit process comprises pre-audit, audit and post-audit related activities and is at least 10 man-days. Minimum time needed for the on-site audit is 2 man-days. The actual man-days needed depends on several factors such as complexity and risk level of the facility, etc.
Planning Audit
After WBHT is engaged by the client, the following steps will be carried out:
1) Audit Plan: The audit plan will be sent to the client at least one month before the audit. Audit Plan will include the audit objectives, audit scope, audit criteria and identities of auditors.
2) Audit Preparation: WBHT is to request engineering and biosafety related documents and failure scenario test reports from the client. Obtain endorsement from client for “Confidentiality and Information Management Agreement.”
Conducting On-site Audit
1) Conduct Opening Meeting
2) Conduct documentation review, personnel interview, physical inspection and engineering failure scenarios testing.
3) Conduct Closing Meeting
Post Audit Activities
1) Issue Audit Finding List.
2) Follow-up with auditees on the closure of corrective actions.
3) Issue Full Audit Report.
Use of WBHT’s Name and Logo
- The audited client is not permitted to use WBHT audit report or WBHT’s name and logo in any communication media such as brochures, social media platforms, internet and any form of advertising or documentations.
- The audited client shall not make or permit any misleading statement regarding the audit.
- The audited client does not use or permit the use of an audit report or testimony or any part thereof in a misleading manner.
Policy of Impartiality
World BioHazTec (WBHT) is the recognized legal entity in charge of all activities pertaining to bio-risk management auditing. WBHT Management and employees understand how crucial it is to preserve objectivity during the auditing process. We are dedicated to making sure that throughout our activities, all outside parties – including potential clients, are treated justly and equally. Our Policy of Impartiality can be accessed via the following link.
Management of Complaints
This section describes the management of complaints from the audited client to the Auditing Organization (AO).
Receipt of Complaint:
- Complaints maybe received via email, messaging application, phone call, etc.
- An acknowledgement of receipt will be sent to the complainant within 3 working days.
Complaint Evaluation:
- The Audit Manager assesses the complaint’s validity to determine whether the complaint relates to the audit activities that it is responsible for and determines the required level of investigation.
- If the complaint is outside the organization’s scope, the complainant is informed accordingly.
Investigation and Decision-Making:
- The Audit Manager will lead the investigation to gather relevant information and assess evidence.
- A resolution proposal is prepared within 7 working days.
- In cases requiring more time, the complainant will be informed of the extended timeline.
- Investigation and decision on complaints shall not result in any discriminatory actions against the complainant.
Communication of Decision:
- The decision to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not previously involved in the subject of the compliant.
- The decision and corrective actions taken will be communicated to the complainant in writing.
- If the complainant is unsatisfied, they may escalate the complaint.
Confidentiality and Impartiality:
- All complaints are handled confidentially.
- Investigators must be independent of the subject of the compliant.
- The AO shall determine, together with the audited client and the complainant, whether and, if so to what extent, the subject of the compliant and its resolution shall be made public.
Closure, Record Keeping and Continual Improvement:
- All records are maintained for at least 5 years.
- Preventive actions will be implemented to avoid recurrence.
World BioHazTec is an Accredited Provider (AP) of the International Association for Continuing Education and Training (IACET). As an IACET Accredited Provider, World BioHazTec offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Information.
