Audit Preparedness Session

1. Audit Preparedness Session 28 July 2011

2. Scope of Session • What you must know with regards to each audit element • How to respond to auditors to show that you comply to each of those elements

3. Types of Audit Findings • Positive Aspects – “Good job!” • Areas for improvement (AFIs)– will need to be addressed by labs and improvements shown at the next surveillance audit • Category A findings– non-compliance to the SMS that might result in accidents or incidents in the laboratories • Category B findings–non-compliances to legal and other requirements • For non-compliance findings, PI must inform OSHE of corrective actions to be taken. Follow-up audit within one month to verify.

4. The Audit Elements • Occupational Health and Safety Policy • Risk Assessment • Legal and Other Requirements • Objectives and Programmes • Roles and Responsibilities • Training • Communication • Documentation and Document Control • Operational Control • Emergency Preparedness and Response • Performance Measurement and Monitoring/Internal Audit • Incident Reporting

5. Occupational Safety and Health Policy • Defined by management and shows commitment to the SMS • Are all lab members familiar with department’s OSH Policy? • Is the hardcopy filed together with your other SMS documents? The policy consists of 3 principles (‘pillars’) Prevention of Ill-Health and Injury Legal Compliance Continual Improvement

6. Risk Assessment • Every routine and non-routine activity must have a risk assessment • Lack of risk assessment for any lab activity/experiment immediately gets a non-compliance finding • The lab member who conducted the risk assessment and even those users of the experiment/lab activity can be ‘interviewed’ on its contents • Must be familiar with Severity and Probability rankings:

7. Example: Cold Room RA Why is severity 2 and not 3? Must be able to explain to auditors

8. Example: Centrifuge RA Why do you implement additional risk controls? Note: The aim of a risk control measure should be to either reduce the likelihood of occurrence (probability) and/or the severity of potential injury or damage (severity).

9. Legal Requirements What You Need to Know: • Why a legislation does or does not apply to your lab • What your lab does to comply with it • What the licence requirements are

11. Workplace Safety and Health Act • Your lab is a ‘workplace’ • Everyone has the responsibility to ensure a safe workplace • Housekeeping in order? • Any dangerous practices or arrangements observed? • Are safety signages prominently displayed? • All lab members aware of safe handling of hazardous substances? • Accidents/incidents must be reported by law • Do you know who the first aiders are? • Risk assessments to be carried out for every routine and non-routine activity

12. Legislations Involving Chemicals: • Petroleum And Flammable Materials (PFM) Regulations • Chemical Weapons Convention (NACWC) • Poisons Act • Environmental Protection & Management Act • Environmental Public Health Act • Sewerage and Drainage Act • Misuse of Drug Act • Arms and Explosives (Amendment) Act • General Requirements: • Maintain and update Inventory List with inventory check every 6 months. • Maintain, update and make available Safety Data Sheets. Ensure validity of SDS within 5 years. • Liquid chemical must be stored within a secondary containment tray that can capture 20% of the total chemicals stored in a tray. • All chemicals to be disposed through toxic industrial waste collector.

13. Petroleum & Flammable Materials Regulations • Where do you keep your PFM and how much do you keep? • Maximum allowable quantity of PFM: (0.8 litres/m2) 500 litres max for MD7 1, 3, 4, 5 400 litres for MD4A Level 2 and MD7 Level 2 200 litres for MD4A Level 1 including amount in flammables cabinets (170 litres) and solvent wastes • Are all stock bottles of flammable liquids kept in the flammables cabinet? • Is the flammables inventory list updated? • Annual declaration of amounts to OSHE • Licence to store PFM held at the University level and administered by OSHE. • Note: Glacial acetic acid has a flash point of 40°C and thus is considered a Class III PFM – storage in flammables cabinet with plastic secondary container

14. Chemical Weapons (Prohibition) Act (NACWC) • The only chemical that falls under this act in the department is Triethanolamine • Must be locked and logged. Disposal must be declared to OSHE. • Annual declaration to OSHE • Licence to store CWC chemicals held at the University level and administered by OSHE

15. Poisons Act • All regulated poisons to be locked and logged, including freezers and fridges. If stored in cold room, then it must be lockable as well. • Annual declaration to OSHE • Licence is held by SoM Safety Office. • However, Poison Licence shall not be required if the poisons are purchased from local vendors. As an additional measure, keep chemicals with prominent toxicity symbols together with your other poisons. Some, like beta-mercaptoethanol, APS, are used daily and can be kept inside the fume hood with a secondary container (small beaker etc. Good practice to label the container ‘Caution: Toxic’)

16. Environmental Protection and Management Act (EPMA) • Applies to: • Hazardous Substances - Includes concentrated acids and bases, phenols, formaldehyde • Ozone Depleting Substances – department does not use these substances • For Hazardous Substances • Lab members can be asked to describe health hazards of a specific chemical in the lab • Stored separately from incompatible substances and with secondary containment • Good practice to label ‘Hazardous’ on storage areas or individual bottles • All personnel handling the hazardous substance must have received training to: • Know the hazards involved (risk assessment), • Handle safely so as not to affect people and environment • Deal with spills and leakage. • Annual declaration to OSHE • Licenceis held by SoM Safety Office. Local vendors will require a copy of the licence.

17. Environmental Public Health Act • Applies to waste disposal • All Toxic Industrial Waste (includes lab chemicals and biohazard waste) must only be collected by NEA-licensed waste collectors • Are biohazard and chemical/cytotoxic waste disposal procedures adhered to (refer to respective SOPs)? • Are bottles of liquid waste properly labelled and stored with secondary containment? • Be aware of chemical incompatibilities (tables of incompatible chemicals can be found on the departmental safety website) • No licence requirement

18. Environmental Public Health Act Good practice: Waste bottle affixed with both departmental waste disposal and hazard warning labels.

19. Sewerage & Drainage Act • Regulates the discharge of effluent into public sewer. • Only buffers of pH 6 – 9 and10% bleach. • All solvents or buffers containing solvents must be collected and disposed by TIW contractors. • No licence requirement

20. Misuse of Drugs Act • Regulates the use of controlled drugs (check against Regulated Chemicals Identifier). Even includes chemicals like Potassium Permanganate, Acetic Anhydride, Acetone and Diethyl Ether under the Third Schedule • Must be locked and logged • Controlled Drugs Permit held by SoM Safety Office.

21. Arms and Explosives Act • Regulates Explosive Precursors: Hydrogen peroxide, sodium nitrate, sodium nitrite, perchloricacid • Stock bottles stored under lock and key or in the spark-free fridge? • Are usage logs kept and updated? • Ensure that any EP that has expired and that is unsafe for storage is immediately removed from the licensed premises and disposed to the licensed toxic contractor. • Licence is held by SoM Safety Office.

22. Summary of Licence Requirements for Chemicals

23. Fire Safety Act • Fire Emergency Preparedness • What to do in case of fire? • Where is emergency assembly point? • Fire Prevention • Are extinguishers and fire alarm points unobstructed? • Are passageways at least 1.0 m wide? • Are easily combustible materials placed on top of the flammables cabinet? • Are combustible materials kept to a minimum? • Is there ≥ 50 cm clearance from the ceiling? • Are all exit lights functioning?

24. Fire Safety Act Emergency Assembly Point – across the road from MD11

25. WHO Guidelines for Biosafety • Correct Biosafety Levels posted on BSCs? • Doors posted with appropriate hazard signs? • Biohazard wastes stored in covered bins and marked with biohazard symbol? • Are those using human-derived cell lines inoculated against HBV and/or HCV? • Liquid biological wastes properly decontaminated before disposing down the drain?

26. Singapore Guidelines on the Release of Agriculture-Related Genetically Modified Organisms (GMOs) • Not applicable to department

27. Objectives and Programmes • Does lab implement safety objectives and programmes in line with Departmental OSH Policy? • Must update every year following an audit/inspection or to improve safety practices Fill up your lab’s form and file it in the SMS folder. Edit if necessary.

28. Roles and Responsibilities • Roles and responsibilities should be defined for the essential audit elements • Those named in the register should be prepared to describe how they carry out their duties

29. Training • All lab members to have received the appropriate structured training (OSHE, SoM, Departmental) • In addition, should also have lab-specific training • All records must be present • How does PI assess competency of lab user after training?

30. Communication • How are safety matters communicated within the lab and from department? • Are there records of such communication? • Who is responsible for updating the lab on safety matters? • Any safety issues in the agenda of lab meetings?

31. Documentation and Document Control • Who is responsible for maintaining the SMS documents/records? • Who ensures that all documents are up-to-date and how are obsolete copies removed from circulation?

32. Operational Control • Basically what they want to see implemented in the lab. Includes: • Are lab SOPs adhered to? • Applicable licences in place? • Inventory / storage control with logs • Security /administrative control (e.g. keys to controlled chemicals) • Labelling (especially of hazard categories) • Maintenance programme (Cold room, BSCs and fume hoods by dept) • Occupational health programme (vaccinations, health surveillance) • Personal protective equipment (long-sleeved lab coats, pants, covered shoes, face shields/goggles) • Waste disposal • Decontamination / neutralization

33. Emergency Preparedness and Response • All lab members aware of actions to take in the event of fire/fire drill? • Do you know who your first aiders are and how to get hold of them? • Do you know who is in charge of maintaining the first aid boxes? • Actions in the event of chemical/biological spill? • Who maintains spill kits?

34. Performance Measurement and Monitoring/Internal Audit • Includes: • Equipment maintenance reports • Lab inspection checklists • Medical surveillance records (Booster shots, specific pathogen monitoring, etc.) • Calibration scheme and calibration records • Accident/Incident reports • Internal audit and corrective action reports

35. Incident Reporting • Are all lab members aware of: • Reportable Incidents: • Minor cuts and bruises • Slips, trips and falls • Animal bites, needle stick injuries • Chemical, biological spills • Glassware related incidents • Near misses • Reporting Procedure • PI/Safety Lead → Safety Committee → OSHE (via AIRS within 24 hrs – WHO REPORTS?)