辉瑞公司EHS风险评估调查问卷

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04 Purpose:

This questionnaire is designed to support the risk review of current or potential third-party suppliers of research 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 systems Instructions for Use for Suppliers:

This questionnaire contains 3 sections:

?Section 1 – Information about your facility

?Section 2 – Risk Management Information

?Section 3 – Documentation for risk review

IMPORTANT: Please complete a separate questionnaire for each facility that Pfizer has requested information from The questionnaire is designed to be answered with YES/NO responses and brief comments 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 named below.

Your completed response should also contain images – for example we request maps, site layouts, process flow 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; preferably as a pdf file or alternatively as PowerPoint or Visio documents

The 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 review

Please contact the following Pfizer individual if you need assistance to complete the Questionnaire

Name:

Pfizer Location:

Email:

Phone – Office/Mobile:

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

1.3 Documentation/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, 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 that 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 responsible for the EHS subject areas listed below, showing reporting relationships to senior site management:

a. Assuring compliance with regulatory requirements

b. Community relations

c. Fire safety

d. Maintenance of fire safety systems

e. Emergency planning

f. Crisis management

g. Maintenance of pollution control equipment h. Waste management

i. Assessing/controlling chemical exposure risk j. Occupational health

k. Maintenance/calibration of safety critical equipment l. Assessing and controlling process safety risk

m. C ommunication with customer regarding EHS n. Operation of wastewater treatment plant

Process Information:

Process Flow diagram showing key steps and equipment used for Pfizer processes operated at facility (where applicable).

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

aid 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 in fatalities, workers being hospitalised,

Yes No fires, 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 following risks by selecting YES or NO responses to each management process:

Does your company have a Corporate EHS person or group? Yes No

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04 Section 3: Documentation for Risk Review:

Please be sure to include the following items as part of the completed Pre-Review Questionnaire

1.Site Layout Plan (refer to Section 1)

If available provide a site layout plan including boundaries, building locations, buildings used or likely to be used for Pfizer projects, tank farms, hazardous storage locations, high hazard processing areas (eg hydrogenation), effluent treatment plant, waste storage locations and incinerator (if applicable).

2.Map of facility surroundings (refer to Section1)

Please send map showing the facility and surroundings. Indicate all potential areas of concern that 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.

3.Provide an organization chart indicating colleagues responsible for the EHS subject areas listed below, showing

reporting relationships to senior site management:

a. Assuring compliance with Regulatory requirements

b. Community relations

c. Fire Safety

d. Maintenance of Fire safety systems

e. Emergency planning

f. Crisis management

g. Maintenance of pollution control equipment h. Waste Management

i. Assessing/controlling chemical exposure risk j. Occupational Health

k. Maintenance/calibration of safety critical equipment l. Assessing and controlling process safety risk

m. C ommunication with customer regarding EHS n. Operation of wastewater treatment plant

4.Process Flow diagram showing key steps and equipment used for Pfizer processes operated at facility (where

applicable)

Please have the following documentation available during the on-site review

(do not send as part of the Pre-Review Questionnaire)

1.Major licensing/operating permits showing limitations, operating and discharge parameters

2.Letters/reports from EHS Regulators

3.Summary of risk controls in place to prevent major accidents

4.EHS Training records, Injury reports, investigation records, inspection records for last 2 years

5.Insurers reports

6.Change Management procedures and change management records. Where possible, Pfizer project

management records showing how hazards assessed, scale-up and process modifications assessed

7.Emergency plans prepared in anticipation of major incident scenarios

8.Emergency procedures – action to be taken by incident response team and workers

9.Insurance documentation – for example Employer’s Liability, Buildings/equipment, Business Interruption

10.Air monitoring and wastewater discharge records

11.Records providing evidence that waste is transferred to responsible waste contractors and that final disposal

methods are confirmed as acceptable (eg chain of custody documentation and disposal site audits)

12.Written programs and supporting records for Confined Space, Hot Work, Hazardous Energy Isolation programs

13.MSDS and other chemical hazard communication examples

14.Exposure risk assessment procedures, proactive exposure assessment records, exposure monitoring records

Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS-M04

15.Records demonstrating that exposure control equipment (eg LEV/snorkel, laminar flow booth) are maintained in

effective working order

16.PPE training program and records

17.Records showing maintenance/calibration schedules and evidence that maintenance was done to assure

mechanical integrity of process plant (eg pressure testing) and safety critical systems

18.Schematics/drawings showing typical reactor venting and emergency pressure relief arrangements ,zones of

flammable atmospheres

19.Process safety training records