1、Form TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management of SuppliersProcedure NumberEHS-M04Purpose:This questionnaire is designed to support the risk review of current or potential third-party suppliers of rese

2、arch and manufacturing services to Pfizer in the following ways:Enable Pfizer reviewers to form an initial assessment of risk and plan their on-site review.Enable Pfizer s third party suppliers to prepare for on-site review of their risk management systemsInstructions for Use for Suppliers:This ques

3、tionnaire contains 3 sections:Section 1 Information about your facilitySection 2 Risk Management InformationSection 3 Documentation for risk reviewIMPORTANT: Please complete a separate questionnaire for each facility that Pfizer has requested information fromThe questionnaire is designed to be answe

4、red with YES/NO responsesbrief andcomments or lists of information.Please respond“ YES” only if you are able to provide objective evidence during the on-site review.Please provide the information requested electronically, by inserting text/editing this document and emailing it back to the contact na

5、med below.Your completed response should also contain images for example we request maps, site layouts, proces diagrams. You may also choose to answer some questions by providing diagrams, tables of information, process flow diagrams etc. Please provide the additional information electronically; pre

6、ferably as a pdf file or alternatively as PowerPoint or Visio documentsThe final page of the questionnaire (Section 3) lists the additional information that should be sent with the completed questionnaire. It also lists documentation to have available during the on-site reviewPlease contact the foll

7、owing Pfizer individual if you need assistance to complete the QuestionnaireName:Pfizer Location:Email:Phone Office/Mobile:Confidential1 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management

8、of SuppliersProcedure NumberEHS-M04Section 1: Information about your facility1.01 Facility/ContactInformation:Supplier Name:Facility Address:1.02 Individual completing form:Name:Email:Job Title:Phone:Date completed:1.03 Site contact for EHS review (if different from above):Name:Email:Job Title:Phone

9、:1.1Manufacturing and Research services available at facility:Drug Product Bulk ManufacturingDrug Product Primary PackagingDrug Product Secondary PackagingDrug Product Formulation DevelopmentChemical Manufacturing PlantChemical Pilot PlantBiological Manufacturing PlantBiological Pilot PlantAnalytica

10、l Research ServicesMedicinal Chemistry Drug Discovery R&DParallel Chemistry Drug Discovery R&DHigh Throughput Screening Discovery R&DOther? (please specify)1.2General Facility Information:How many employees work at the facility?How many contract workers typically work at the facility?Does the facili

11、ty work operate on a shift basis?YesNoIf yes, please explain the hours of coverage:Confidential2 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management of SuppliersProcedure NumberEHS-M041.3Do

12、cumentation/Information Requirements:Please provide the following information/documentation as part of the Pre Review Questionnaire if possible:Site Layout Plan:If available provide a site layout plan including boundaries, building locations, buildings used or likely to be used for Pfizer projects,

13、tank farms, hazardous storage locations, high hazard processing areas (eg hydrogenation), effluent treatment plant, waste storage locations and incinerator (if applicable).Map of facility surroundings:Please send a map showing the facility and surroundings. Indicate all potential areas of concern th

14、at may be impacted by an incident on-site. For example, sensitive environmental receptors (eg surface waters, water used for drinking and washing), housing, schools, hospitals, neighbouring high hazard businesses etc.Organisation Chart(s):Provide an organization chart indicating colleagues responsib

15、le for the EHS subject areas listed below, showing reporting relationships to senior site management:a. Assuring compliance with regulatory requirements b.Community relationsc. Fire safetyd.Maintenance of fire safety systemse. Emergency planningf.Crisis managementg. Maintenance of pollution control

16、equipmenth.Waste managementi. Assessing/controlling chemicalexposure riskj.Occupational healthk. Maintenance/calibration of safety critical equipmentl.Assessing and controlling process safety riskm. Communication with customer regarding EHSn.Operation of wastewater treatment plantProcess Information

17、:Process Flow diagram showing key steps and equipment used for Pfizer processes operated at facility (where applicable).Confidential3 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management of

18、SuppliersProcedure NumberEHS-M04Section 2: Risk Management Information2.1RegulatoryCompliance:Briefly describe how regulatory compliance requirements are identified and facility compliance monitored. How is senior management assured of compliant operations?List major (maximum 5) EHS permits and lice

19、nses required and maintained for operations. Indicate expiry dates if applicable:Name of PermitPermit No.Expiry DatePermit CoverageWhich Regulatory/Government agencies oversee EHS compliance of the facility?Does the facility have systems and expertise available to assure compliance with YesChemical

20、Registration requirements (for example REACH, NONS, Chinese)?Has there been any Regulatory action leading to official notice of non-compliance or Yesprosecution in the last 5 years?NoNoIf yes, please provide more information for each, including penalties (if any) and actions taken to prevent repeat:

21、2.2Community Impacts:List major accident scenarios anticipated in emergency planning?Does the facility s site Emergency Plan include actions to be taken to protect the localcommunity/environment if an incident has an impact off-site?YesNoDoes the facility communicate on EHS issues with the local com

22、munity?YesNo2.3 EHS Management System:rdYesNoIs the facility certified to ISO 14001, OHSAS 18001 or similarparty3certification?If yes, please list certifications held, date obtained and certifying authority:Does the facility have a system to investigate accidents and incidents?YesNoDoes the facility

23、 have a system to investigate near miss accidents and incidents?YesNoProvide injury/accident and work related illness data for the last 3 years, eg number of cases resulting in onsite firstConfidential4 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01D

24、ate Effective30OCT07SupersedesNew FormApplicable toEHS Management of SuppliersProcedure NumberEHS-M04aid treatment, onsite or offsite medical treatment, lost time accident. If possible include key root causes of common injuries, accidents or illnesses:Have there been any incidents on site resulting

25、in fatalities, workers being hospitalised,YesNofires, explosions, large spillages/releases of hazardous chemicals in the last 5 years?If yes, please provide more information for each, including actions taken to prevent repeat:Please rate your facility risk management systems for each of the followin

26、g risks by selecting YES or NO responses to each management process:Fire/explosion risk associated with handling flammable materials:YesNoSystematic risk identification and control by risk assessment programWritten risk control proceduresTraining program to ensure workers understand risk controlsMos

27、t common risk control used is preventing flammable atmospheres forming by engineered systemsManagement process to ensure suitable equipment selected and usedRegular inspection and checking to assure risk correctly controlledRisk to workers health from exposure to hazardous substances:YesNoSystematic

28、 risk identification and control by risk assessment programWritten risk control proceduresTraining program to ensure workers understand exposure risk controlsMost common risk control used is preventing or controlling exposure by engineered systemsManagement process to ensure correct protective equip

29、ment selected and usedRegular inspection and checking to assure risk correctly controlledRisk of harm to the environment by spill or release of harmful material:YesNoSystematic risk identification and control by risk assessment programWritten risk control proceduresTraining program to ensure workers

30、 understand risk controlsMost common control used is built-in spill containment, release preventionManagement process to ensure correct equipment selected and usedRegular inspection and checking to assure risk correctly controlledRisk of fatalities, injuries or significant facility damage from emerg

31、ency situations:YesNoSystematic identification of reasonably foreseeable emergenciesWritten emergency proceduresTraining program to ensure workers understand emergency proceduresAutomatic fire/spill detection, alarm and mitigation systems providedManagement process to ensure suitable emergency equip

32、ment providedRegular inspection and checking to assure risk correctly controlledDoes your company have a Corporate EHS person or group?YesNoConfidential5 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable

33、toEHS Management of SuppliersProcedure NumberEHS-M04If yes, please list their responsibilities:If yes, does Corporate EHS conduct regular inspections or audits at your facility?YesNoIf yes, please list significant issues found on the previous 2 inspections/audits:Does the facility have a periodic EH

34、S self inspection program?YesNo2.4Labour Practices:This will be discussed during the onsite visit. It may be helpful to schedule a meeting with the site HR Manager for approximately 15 minutes.2.5Managementof Change:Does the facility have a formal written program requiring expert EHS assessment and

35、approval of the following changes?Types of changes:YesNoIntroducing new productsIntroducing new research projects/manufacturing processesProcess/procedure changeEquipment changeBuilding/infrastructure changeDoes the Change Management procedure cover non-GMP/GLP/ISO 9000 areas?YesNo2.5Fire Life Safet

36、y, Accident Preparedness and Response:List general fire prevention precautions in force at the facility:AreaControls (eg detection, alarms, suppression (extinguishers, sprinklers etc)Chemical storageSolvent storagePlan/Pilot Plant/Lab/Kilo labused for Pfizer activitiesNon Pfizer Manufacturing/LabsWa

37、ste handling/storageList full-scale emergency response resources available for a significant incident; for example on-site or off-site capability. What is the response time for response from off-site (e.g. fire brigade)?Does the facility have a documented Emergency Response Plan?YesNoDoes the facili

38、ty hold periodic practice emergency response sessions and/orYesNoevacuations?Confidential6 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management of SuppliersProcedure NumberEHS-M042.7Business

39、 Continuity and Loss Prevention:Briefly describe the back up arrangements for the following scenarios:ScenarioBack up arrangementsPower outageCooling failureHVAC failureScrubber failureNitrogen supply failureRaw material supply failureCritical equipment failureTransportation disruptionHas the facili

40、ty been closed due to weather or natural disaster in the last 5 years?YesIf yes please provide details below:Is the facility in an area known to be at significant risk from natural disasters eg Yes flooding, earthquakes, extremes of temperature, heavy snowfall?If yes please provide details of risk a

41、nd precautions below:2.8Emissions Controls:NoNo3List 5 most important discharge limits (specify substance, limit and location, eg VOC,incinerator)10mg/m to air:SubstanceDischarge Limit (include units)Location (eg building or vent)List typical pollution control equipment in use to prevent or control

42、emissions to air:List 5 most important discharge limits (specify substance and limit) to water:SubstanceDischarge Limit (include units)Confidential7 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS

43、 Management of SuppliersProcedure NumberEHS-M04Where is waste water from the facility discharged?DischargeYesNoSurface water eg watercourse such as stream or riverPublic sewerOther (please give details):List typical pollution control equipment in use to prevent or control emissions to water:Does the

44、 facility routinely exceed discharge limits for air or water?YesNoIf yes please state any improvement plans:Does the facility have a fire water containment system?YesNo2.9Hazardous Materials Handling:Please summarise the types of hazardous materials stored and handled onsite together with the approx

45、imate inventory:Types of MaterialsStored onsite?Approximate inventoryCommon chemicals stored onsite thatYesNo(include units)demonstrate hazardCorrosivesFlammableToxic volatileWater reactiveAir reactiveEcotoxicIrritant/sensitiserBriefly summarise spill prevention and containment practices in the foll

46、owing areas:AreaSpill prevention and containment practicesLoading and unloading areasChemical/waste storage areasChemical handling areasProcess areasDoes the facility have a procedure to ensure that chemicals are stored under correctYesNostorage conditions and segregated appropriately?Confidential8

47、of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management of SuppliersProcedure NumberEHS-M04Does the facility have areas of known soil/groundwater contamination on the facility?YesNoIf yes pleas

48、e list contaminants, area of facility affected and current remediation plans, if any:2.10 WasteManagement:List major hazardous waste stream categories (up to 5) segregated and collected (e.g. solvent, chlorinated solvent, solid chemical waste, biological waste etc). State approximate annual quantiti

49、es and final disposal method for each category.Waste streamAnnual quantitiesDisposal method used (eg landfill, incineration)(eg solvent, biological etc)(include units)Does the facility check that waste contractors are licensed and suitable to handle waste(e.g. inspecting licenses of waste contractor

50、s or an inspection of disposal site)? YesNo2.11 GeneralSafety:Does the facility have formal programs* for:By formal program we mean written procedures, forms to complete prior to and after work activities, special equipment (eg to determine hazardous conditions or evacuate personnel), defined respon

51、sibilities for colleagues, training and records:Types of changes:YesNoConfined Space EntryIsolation of hazardous energy and breaking into process lines (“ Lock Out Tag Out” or“ LOTO” )Hot WorkWorking at ElevationsContractor Safety2.12 Industrial Hygiene and Occupational Health:List 5 most hazardous

52、materials to health handled on site (provide chemical names and exposure limits):SubstanceExposure limit (include units)Confidential9 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS Management of

53、SuppliersProcedure NumberEHS-M04Briefly describe methods typically used to controls chemical exposures to employees in the following operations:AreaMethods used to control employee chemical exposuresWeighing/subdividing raw materialsCharging solids to equipmentRecovering solids from suspensionChargi

54、ng and discharging dryersList arrangements to deal with medical emergencies, eg injuries or chemical exposures:Does the facility have a program to provide periodic medical surveillance for employeesYesNoworking in hazardous areas (eg areas of potential chemical exposure)?If yes please state who prov

55、ides this service (eg medical department onsite or external medical facility) and the services provided (typical medical tests performed):2.13 Process Safety:List typical precautions in place to prevent ignition of flammable dusts and vapors in the following operations:AreaPrecautions in place to pr

56、event ignition of flammable dusts and powdersSolvent storageReactor chargingSolvent transfersCleaningDispensingDrying/milling/blendingSolvent granulation/coatingLaboratory/process development &scale-up workDoes the facility have a preventative maintenance/calibration program for processYesNosafety c

57、ritical equipment?If yes, list factors used to decide which equipment is process safety critical?If your facility completes reaction chemistry identify which of the following types of processes are run at your facility (list the precautions to prevent major process safety accidents for the reaction

58、type of most concern to you):Performed onsiteReaction typePrecautions/controls in placeYesNoAminationBrominationChorinationCyclisationConfidential10 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew FormApplicable toEHS

59、 Management of SuppliersProcedure NumberEHS-M04HydrogenationHydrolysisNitrationOxidationPolymerisationSulphonationIf other more hazardous reaction types are completed onsite please list them below, together with precautions and controls in place:Do you have equipment and expertise in reaction hazard

60、s and calorimetry on site?YesNoIf no, how do you obtain and interpret process safety data? If yes, please list equipment and resources available on-site?Confidential11 of 13ConfidentialForm TitleSupplier EHS Pre Review QuestionnaireForm NumberF-EHS-M04-02Version01Date Effective30OCT07SupersedesNew F