Contractor Manual Pfizer Kalamazoo Sites

Pfizer Kalamazoo Contractor Manual – Version 2.0 – Last Revision Date: 08/23/10

Contractor Manual
Pfizer Kalamazoo Sites

1

**In Case of Emergency Dial 1-2-3 on a Company Phone or 269-833-4799 on a Cell Phone**

Pfizer Kalamazoo Contractor Manual – Version 2.0 – Last Revision Date: 08/23/10

1.0Introduction

2.0Pfizer Resources/Contact Information

3.0Site Access

4.0Procurement

5.0Security

6.0Emergency Procedures

7.0GMP/GLP

8.0General Work Information

9.0Supplier Non-Compliance Process

10.0Environment, Health & Safety Topics

11.0Site Permitting

12.0Basic Safety Requirements

1

**In Case of Emergency Dial 1-2-3 on a Company Phone or 269-833-4799 on a Cell Phone**

Pfizer Kalamazoo Contractor Manual – Version 2.0 – Last Revision Date: 08/23/10

1.0Introduction

Welcome to the Pfizer Kalamazoo Sites. Pfizer seeks to engage suppliers that are dedicated each day to maintaining an accident-free work place. Safety is our #1 concern. There is never an acceptable reason for compromising safety. The following document has been prepared for Suppliers, their sub-suppliers, visitors and delivery persons servicing the Pfizer Kalamazoo sites. It is very important that contractor work is conducted in a safe and environmentally sound manner. This manual is intended to be a breakdown to sort out the site policies so that contractors can determine if a policy or program applies to their particular work. Suppliers will still be responsible for assuring that all applicable programs and policies are followed.

Suppliers shall ensure that all contractors have reviewed the sections of this document that are applicable to the work they perform. This document does not relieve the Supplier of their responsibilities to comply with all applicable federal, local, state regulations, laws, ordinances, or statutes.

Pharmaceutical research and manufacturing operations are potentially hazardous. Throughout our sites, Pfizer engages in a broad range of activities. Many of these activities involve the use of known hazardous, flammable, or toxic chemicals, and/or drug compounds, each with its own set of hazards and risks. Contractors must be aware that numerous hazards exist throughout our sites, and that the hazards vary widely from lab bench to lab bench, floor to floor, building to building and project to project.

It is important to remember that whether working at an active production facility, in a research laboratory, or even an office, it is every contractor’s responsibility to seek out and understand workplace safety precautions, and to take those actions that will allow them to work safely in their assigned work areas. Each contractor’s individual responsibility is to exercise educated, sound judgment and use his/her own experience and expertise to incorporate Environment Health & Safety considerations into everything they do.

Pfizer is committed to achieving full compliance with all federal, state, and local regulations, as well as Pfizer Corporate guidelines. These guidelines apply to all Pfizer suppliers.

In addition, Contractors must also be aware of emergency procedures and contact information contained in the Emergency Procedures Handbook Kalamazoo.

1.1Pfizer Representative - The Pfizer Representative is a Pfizer employee who, through appropriate delegation of authority, is operationally administering the business agreement (contract) with an outside firm or independent contractor for specified services or results. The Pfizer Contact will be the ongoing liaison should questions/issues arise.

1.2Contractor – A contractor is an individual employed by a Supplier to perform a specified services within Pfizer to support business operations, specific projects or tasks.

1.3Contractor Safety Representative - An individual assigned by the Contractor who is responsible for the Contractor’s safety program and performance. This person has the responsibility, power, and authority to stop his/her company’s work when and where unsafe activities or conditions exist. To qualify, as a Contractor Safety Representative the individual must have completed, at a minimum, an OSHA approved 30 Hour General Construction Safety Course and five years construction experience.

1.4Sub-Supplier - A Supplier or his/her employee(s), whose contract is subsidiary to a prime contract between Pfizer and a Supplier.

1.5Supplier - A supplier is a non-Pfizer business entity (including independent contractors) under contract to provide individuals to perform specified services or results on a temporary or long-term basis. The firm will be responsible for the performance and status of its workers as well as any and all employer related obligations, regulations and laws.

1.6Visitor - Individual who is on site for less than 5 consecutive days, has not attended a Site Orientation Training within the past year, and is escorted and supervised 100% of the time while at a Pfizer facility by a badged Contractor, or a Pfizer employee.

2.0Pfizer Resources/Contact Information

2.1Badging Information (Gateway)

Kalamazoo Contractor Administration:
KCA Help Line: 269-833-7048Fax: 269-833-2500
KCA email:
KCA website:

2.2Contractor Safety

Contractor Safety Staff
269-833-7048 KCA Hotline
269-833-7283 / Sr. Construction Safety and Compliance Professional - Training, Maintenance & Services
269-833-0516 / Sr. Construction Safety and Compliance Professional - Capital Projects & Services for VMRD (Downtown and Farm)
269-833-0798 / Sr. Construction Safety and Compliance Professional - Capital Projects Portage Site
269-833-6120 / Sr. Contractor Management Professional - Pre-Qualification, Sub-Supplier Approvals & Incident Data

2.3Contractor Types

New Contractor Types: (Allow up to 4 business days to process this request.)

• Outsourced
• Professional/Technical
• Temporary

2.4Visitor Badge Types:

A normal visitor badge can be obtained for company employees coming on site for meetings, etc. The request for a visitor badge must be made by a Pfizer colleague through the IVisitor system. Visitors must be escorted 100% of the time.

2.5New Contractor On-boarding Process

Prior to any contractor receiving a Pfizer issued access badge, the supplier or individual that the contractor is employed by must be qualified according to criteria set forth by Pfizer Procurement. These criteria are considered outside the scope of this policy. A signed approved contract between the supplier that is to supply contract personnel (contractor) and Pfizer must exist before a Contractor badge is issued and subsequent site access is granted. An approved Purchase Order (PO) is not a contract.

Prior to any sub-supplier receiving a Pfizer issued access badge, the supplier who is subcontracting the work to the supplier (and its employees) or individuals must complete Sub-Supplier Qualification information to the contractor safety group for Sub-Supplier approval. Sub-Supplier Qualification documents are located on the KCA websites.

2.6Existing Contractor Off-boarding Process

The supplier responsible for the contractor must use the Supplier Gateway system to notify the contingent workforce coordinator of termination of a contractor. A Pfizer representative may also notify the contingent workforce coordinator via e-mail at . The Pfizer representative, or supplier responsible must also ensure the following assets/materials are returned in a timely manner to the appropriate area.

Contractor ID badge—Return to security

Contractor parking permit—Return to security

Pfizer owned keys—Return to security

Pfizer owned telecommunication devices such as radios, pagers or cell phone—Return to communications group

Pfizer owned uniforms or other garments—Return to laundry

Pfizer LAN ID and password—Automatically deactivated when contractor is off-boarded

2.7Existing Contractor Badge Renewal

Renewal Requirements

All Kalamazoo Pfizer Contractor Worker (CW) badges are valid for a maximum of one year from date of issue.

If the contractor’s services are no longer needed, or they have been terminated by the hiring supplier, the Pfizer off boarding procedures will be initiated via the Supplier Gateway, and all Pfizer property in the contractor’s possession will be retrieved, according to established Pfizer procedures.

2.8Extension of End Date

All Pfizer Sponsors that are responsible for contractors shall extend their contractors end dates according to the length of services needed.

2.9New Contractor Badge Types: (Allow up to 7 business days to process this request.)

CMU – Construction, Maintenance, Utilities

DEL – Delivery

OSW – Outsourced Service

PTS – Professional/Technical Services

PTW – Project Temporary Worker

SEC – Security

TCW – Temporary Contract Worker

2.10Quarterly Renewal

All Pfizer Sponsors are also responsible for performing quarterly renewal of all contractors.

2.11Substance Abuse and Background Check Requirements / Contingent Worker #117

Pre-assignment drug testing, background, criminal and debarment checks are mandatory for all new contingent workers, contractors, and suppliers who perform work for Pfizer. Conducting tests and screening is the responsibility of the individual supplier, and is subject to periodic audit by Pfizer. This is part of the Contingent Worker Procedure #117, If there are any questions, please contact your Pfizer Procurement Specialist.

3.0Site Access

3.1Contractor Responsibilities Regarding Sub-Suppliers

A Sub-Supplier is defined as any agent, representative, consultant, advisor or other third party employed or used by the Contractor in the performance of the Work.

Sub-Suppliers are to be pre-qualified according to Pfizer Standards, by the Kalamazoo Contractor Administration group, prior to site access being granted. The Sub-Supplier representative must complete the Sub-Supplier Prequalification Form (available on the KCA website below). The information contained in the form must be reviewed and approved by the requesting supplier representative, approved, and submitted to KCA for final approval.

Prime contractors that use Sub-Suppliers shall be responsible for the Sub-Supplier’s adherence to all the Pfizer requirements, which are contained in the Qualification Form.

The Kalamazoo Sub-Supplier Qualification Form is available on the Pfizer Kalamazoo Contractor webpage:

3.2General Information

Any person entering a Kalamazoo location is required to receive some type of orientation. The type of orientation received will depend on the classification of the visit.

The visit classification and its associated type of orientation are as follows:

A Contractor on site for more than 5 workings days in a year, either a planned or un-planned scenario, will complete the New Contractor Site Orientation Test.

A Contractor on site for less than 5 workings days in a year will receive a Compliance Information for Visitors Brochure. If the Contractor anticipates multiple visits during a calendar year, for any reason, they must complete the New Contractor Site Orientation Test.

Fire, EMS or Police personnel, while performing official functions or in case of an emergency, will require no training for access to the Kalamazoo site.

A Routine Delivery person will receive the Site Orientation Training.

A Non-routine Delivery person will receive a Delivery Driver Safety card.

A Visitor who anticipates less than 5 visits per year will receive a Compliance Information for Visitors Brochure.

A Visitor who anticipates more than 5 visits during a calendar year, for any reason, will then be considered a Contractor and complete the New Contractor Site Orientation Test.

Special Circumstance Worker (SCW) - A non-colleague who’s Site Access is requested to perform setup, troubleshooting, or consultant work and/or a service contract for a purchased instrument or equipment. This may also include an individual who possess the expertise necessary to perform specialty “work” at a Pfizer facility in KalamazooCounty. A person using a SCV is expected to only be on site short term, where a new contractor badge would be impractical. This person must also be escorted 100% of the time. Special Circumstance Worker (SCW) can only be requested by a Pfizer employee.

A Regulatory Agency Inspector will receive a Compliance Information for Visitors Brochure and must be escorted 100% of the time.

The Orientation Test includes basic information on GMP, facility safety practices, emergency response procedures, and hazard communication and Pfizer’s expectations for conducting business in a safe manner.

The Contractor Site Orientation Test is a True/False and multiple choice test and uses the Orientation Guide for Contract Workers as reference material. This test may not be taken more than 3 times initially. If the test is failed 3 times, a time frame of 6 months must pass before taking the test again, unless special considerations are in place. Once the contractor successfully completes the New Contractor Site Orientation Test, the contractor will be issued a badge.

All Site Orientation training is provided in English only.

The badges are the property of Pfizer Plant Security and must be returned to Plant Security upon completion of the job or when the contractor no longer works at the site. Any lost badges must be reported to the supplier representative or Pfizer Representative, who is responsible for notifying Security and obtaining a new Contract Access Badge.

Area Specific Gowning Requirements

There are numerous areas throughout the Kalamazoo Site that have specific gowning requirements. The gowning requirements are clearly marked at all entry points to those areas. Questions regarding area specific gowning requirements should be referred to the Pfizer colleague who acts as the contractor sponsor.

4.0Procurement

4.1Qualification Requirements

1. All new suppliers of services must be qualified prior to commencing work. The supplier qualification process ensures that suppliers are capable of meeting commitments; can satisfactorily comply with Pfizer’s technical, delivery, service, quality and safety requirements; and are financially secure.
2. Suppliers of non-critical goods or services, where there is a very low risk of damage to Pfizer property or financial loss, may be qualified at the discretion of the Requestor.
3. Procurement is responsible for ensuring that suppliers of materials and services have been properly evaluated and qualified in advance of the purchase transaction. The Supplier Pre-Qualification system enlists the support of Finance and Safety. The Supplier Pre-Qualification system is the repository for all pre-qualification documents and supplier qualification status.

4.2Qualification Process – Supplier of Services

1. The supplier must complete the Pfizer Pre-Qualification System data and submit for approval.
2. Once the Supplier has submitted the form, the Pre-Qualification system will complete an automatic review of the Supplier's responses compared to Pfizer’s acceptable criteria. Any exceptions from Pfizer acceptable criteria will be forwarded to the functional approver (Finance or EHS). Written justification and approval will be required for all exceptions. If all issues have been resolved, Procurement can process the final request and update the supplier status.

4.3Pfizer Acceptable Criteria

1. Finance: Pfizer On-Ramp Supplier Report from D&B must have a score that is not considered“high risk.”
2. EHS:
3. Three-year Experience Modification Rate (EMR) average should be at or below 1.0.
4. Three-year average of OSHA TRR should be at or below industry average for supplier’s NAICS code.
5. Three-year average of OSHA LWR should be at or below industry average for supplier’s NAICS code.
6. Person responsible for Safety is clearly identified.
7. No willful or repeat OSHA Citations within last three years.
8. Written safety program is available for review.

1. Insurance: Procurement verifies that acceptable Pfizer limits are met for type of work and that a current Certificate of Insurance (COI) is attached to the Pre-Qualification system.
2. Periodic Review
3. Financial reports are required to be updated annually.
4. EHS data is updated annually – the EMR upon expiration and OSHA rates must be updated in the Pre-Qualification system after the calendar year, within the OSHA 300A posting deadline of February 1st of the next year.
5. Insurance certificates must be updated annually prior to expiration.\
6. Non-Qualified
7. The supplier may be removed from the Pre-Qualified status if they repeatedly do not meet Pfizer’s requirements. The affected areas and Procurement will make this decision jointly.

5.0Security

5.1Weapons and Firearms

5.2Coverage

This policy applies to all employees. This policy also applies to others who conduct business with or on behalf of Pfizer including but not limited to agency or contract personnel, consultants, vendors, and customers.

5.3Policy

Pfizer is committed to providing a safe work environment. Compliance with this Policy requires that all individuals on Company premises, in Company vehicles, conducting business with or on behalf of Pfizer, or otherwise representing Pfizer not be in the possession of firearms or other weapons. The term “weapon” refers to any firearm or other instrument that could cause death or serious bodily harm, or that could place one in fear of death or bodily harm.

Any violation of this Policy may result in disciplinary action up to and including termination of employment, loss of access privileges, termination of the services of a consultant, customer, vendor, contractor and/or their associated firm, or other action the Company deems necessary including referral of such violations to appropriate law enforcement authorities.

5.4Exceptions

There is an exception for Law Enforcement officials, and security personnel who have been granted written authorization by the Vice President of Global Security to possess a firearm or other weapon.

There is an exception for participation in business related sporting events that involve the use of firearms or other weapons. Employees may participate, (but can not be required to participate), if such participation has been authorized in advance by site management or senior division management. In addition, where the sporting event is sponsored by Pfizer, employees must comply with all other applicable Pfizer policies, such as the Global Policy on Interactions with Health Care Professionals, in inviting guests and must obtain in advance from their guests a signed form of release satisfactory to the Legal Division or Corporate Human Resources. In all cases, the consumption of alcoholic beverages before or while using a firearm or other weapon is prohibited and there must be strict compliance with all applicable firearms laws and safety requirements. Firearms or other weapons may be transported in Company vehicles only for the limited purpose of going directly to and from such sporting events.

5.5Reporting Procedure

All employees and others covered under this policy are responsible for establishing and maintaining a safe work environment that promotes professionalism and is free of threats and violence. This responsibility includes being alert to situations in which firearms or other weapons may be present in violation of this Policy, and in good faith immediately notifying appropriate Company personnel of any incidents or concerns. Therefore, the Company expects you to notify your Supervisor, Human Resources representative, or Site Security Officer of any such concern. In cases where there is a threat of immediate harm, the report should be made to the Site Security Officer.