table of contents - pfizerkalamazoocontractoradministration.pfizer.com/files... · web viewas a...

Orientation Guide for CONTRACT WORKERS

Contract Workers

Lincoln OperationsRevision: 0

of 36

TABLE OF CONTENTS

CONTRACT WORKER ORIENTATIONALL LEVELS

SECTION A - GENERAL PAGE1. Company Access 9

2. Vehicle Admittance & Parking 9

3. Vehicle Safety 9

4. Smoking 9

5. Cafeteria and Snack Bars 10

6. Good Manufacturing/Laboratory Practices 10

7. Security 13

8. Substance Abuse Program 15

9. Prohibited Activities 15

SECTION B – HEALTH & SAFETY1. Emergency Reporting Procedure 16

2. Injury Reporting Procedure 16

3. Emergency Alarms 17

4. Fire Extinguishers, Fire Alarm Boxes, 17Safety Showers & Eye Wash Stations

5. Evacuation Routes & Assembly Area 17

6. Hazard Communication 17

7. Asbestos-Containing Materials 18

****In Case of Emergency Dial 2456****Revision 0

of 36

TABLE OF CONTENTSCONTRACT WORKER ORIENTATION

LEVELS II & III

SECTION C - GENERAL PAGE1. Equipment 20

2. Contracting Firm Vehicles 20

3. Dress Code 21

SECTION D – ENVIRONMENT, HEALTH & SAFETY1. Compliance 22

2. Chemical Safety 23

3. Electrical Hazards Classification 23

4. Fall Protection 24

5. Bloodborne Pathogens 24

6. Noise 24

7. Work Practices 24

8. Lockout/Tagout Procedures 25

9. Safety Permits 27

10. Personal Protective Equipment 28

11. Respiratory Protection 28

13. Waste Disposal 29

HOW TO USE YOUR BADGE 31

INDEX 32

INTRODUCTIONThis document has been developed to assist you in performing your work on Pfizer Corporation


of 36

premises. It provides you with an overview of specific procedures to be followed while working at the Lincoln site. Applicable federal, state, or local laws, and Pfizer procedures, policies and practices shall apply to all contract work. Willful disregard of any of the laws or policies sited will be cause for indefinite access revocation and removal from the premises.

CONTRACTING FIRMS RESPONSIBILITIES AND EXPECTATIONS

As a Contracting Firm, you are responsible to see that your subcontractors and/or agents comply with all applicable practices, policies and procedures.

Contracting Firms are expected to provide fully qualified workers who have been trained in all applicable federal, state, and local regulations. Pfizer will be responsible for providing training on site-specific topics.

Safety and quality are of utmost concern at Pfizer, and Contracting Firms are expected to maintain the same high standards of quality workmanship and safety performance. A poor safety record, or less than quality performance, will eliminate opportunities to bid on future contract work with Pfizer Corporation.


of 36

DEFINITIONS1. Contracting Firm :

A Contracting Firm is a non-Pfizer business entity (including independent contractors) under contract to provide workers for 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.

2. Contract Worker :

A Contract Worker is an individual employed by a Contracting Firm to perform specified services within Pfizer to support business operations, specific projects or tasks. The business entity involved in providing the Contract Worker shall be recognized as the employer of the Contract Worker.

3. Pfizer Contact :

The Pfizer Contact 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.

4. Level I Contract Worker:

A Level I contract worker is a non-Pfizer worker who provides technical or administrative support or other site services. Level I contract employee does not interact directly with production, manufacturing or laboratory areas.

5. Level II Contract Worker:

A Level II contract worker is a non-Pfizer worker providing non-maintenance or non-production services to production, manufacturing or laboratory areas.

6. Level III Contract Worker:

A Level III contract worker is a non-Pfizer worker who performs maintenance or construction work throughout the Lincoln site.


of 36

DEFINITIONS (Continued)

7. ABI:

Active Biological Ingredient

8. DPM:

Drug Product Manufacturing

9. TDC:

Training Documentation Card

10. Universal Precautions :

A system of personal protective equipment designed to provide the wearer with a barrier between their skin and potentially contaminated body fluids

11. Tyvek:

A generic term used to describe a type of chemical resistant suit

12. ANSI:

American National Standards Institute

13. Intrinsically Safe Equipment:

Equipment designed to prevent an internal source of ignition (such as a spark with enough energy to ignite flammable vapors) in flammable/combustible atmospheres


of 36

NOTES

Use this page to take notes or list any questions you may have during orientation training. Direct all questions to your Contracting Firm Supervisor or your Pfizer Contact.


of 36

CONTRACT WORKER

ORIENTATION

ALL LEVELS


of 36

SECTION A - GENERAL

1. Company Access

When possible access badges should be obtained prior to beginning work at Pfizer. Access badges will not be issued until orientation, safety, and trafficking training have been completed. Badges must be visibly worn at all times while on the premises and must NOT be traded or shared with other workers. Recommendation: The contractor needs to be escorted/oriented to the worksite until comfortable in the trafficking restrictions.

These badges are the property of Pfizer and must be returned to Security upon completion of the job. A lost badge must be reported immediately to your Pfizer Contact, who will notify Security.

Pfizer will be closed to Contract Workers on weekends and certain holidays unless approved in advance by the Pfizer Contact. Your Pfizer Contact will arrange with Plant Security for non-standard/holiday access.

2. Vehicle Admittance & Parking

As a general rule, Contract Workers will park personal vehicles in general parking areas only. Do not park in reserved or handicap spaces, on roadways or sidewalks, visitors parking, service drives near doorways, loading docks, dumpsters, or in an access route to or near fire hydrants. Contract workers are permitted to park momentarily next to job sites in order to drop off tools and supplies. Vehicles must then be moved into general parking areas.

3. Vehicle Safety

Speed limits and traffic regulations on the property are in place and must be observed. The speed limit on Pfizer property is 15 mph unless posted otherwise. Extra caution is required in areas where there are bicycles, ATV’s, forklift trucks, and pedestrian traffic.

Vehicles on Pfizer property must be in safe mechanical working condition at all times and must comply with federal and state requirements for brakes, lights, turn signals, horns, mufflers, etc. Unattended vehicles must be shut off while on Pfizer property.

4. Smoking

Use of tobacco products of any kind are prohibited outside designated areas. Your Pfizer


of 36

contact will inform you of those locations.


of 36

5. Cafeterias

The cafeteria is open to Contract Workers. Contract Workers are expected to use the cafeterias and snack bars only during regular service hours. Your Pfizer Contact will inform you of any restrictions.

Proper attire and a reasonable level of cleanliness are expected while in Pfizer cafeteria and snack bar.

6. The Federal Food, Drug and Cosmetic Act & Virus Serum Toxin – its impact on you as a contract worker or service provider for Pfizer

The United States Government enacted legislation that regulates the pharmaceutical and vaccine industries. These laws and regulations protect the public from companies who make and sell veterinary products using unlawful methods and under less than sanitary conditions.

Anyone working at a Pfizer site must be trained about these regulations and how you impact product quality through your actions or inactions. Your Pfizer contact (see the Pfizer contact definition on page 5 of this document) is responsible for arranging required on-the-job training or job-site training.

The consequences of not following the laws and regulations are significant. US Federal Investigators are authorized to inspect Pfizer facilities. Investigators may find violations that can result in consequences that include: jail time, plant closure, fines, and product recalls, economic devastation due to unavailable livestock drugs and vaccines.

Any individual found to have intentionally engaged in fraud or product adulteration can be held criminally liable under the Food, Drug and Cosmetic Act & Virus Serum Toxin Act.

7. G ood Manufacturing Practices or Good Laboratory Practices – to prevent patients from getting adulterated drugs the law requires that we follow GMPs and or GLPs.

Good Manufacturing Practices/Good Laboratory Practices are found in the U.S. Government document called the Code of Federal Regulations (CFR). Certain parts of the CFR are translated into specific Pfizer procedures, or Standard Operating Procedures (SOPs). SOPs describe processes used in the manufacturing, processing, packaging or holding of products. They have a formal approval process and a method for keeping them up to date. By following SOPs exactly without exception, we assure the Food & Drug Administration (or FDA) and United States Department of Agriculture (or USDA) that we follow Good Manufacturing Practices and or Good Laboratory Practices.

Following SOPs consistently assures that our products are made with high quality and


of 36

that they are the correct strength, purity, identity and efficacy. As contract employees working in or around Pfizer facilities, you must follow SOPs to ensure your health and to protect the product and processes you are working around from contamination. By following SOPs, we in turn fulfill the requirements of Good Manufacturing Practices and Good Laboratory Practices.

Your Pfizer contact or their authorized Pfizer designee is responsible for seeing to it the SOPs are made available to you and training is provided prior to working on a job!

Example of GMP Violations and Consequences: The north Chicago, Illinois facility of Abbott Laboratories had accumulated several violations of GMPs and failed to correct them. As a result, the FDA fined the company $500 million and many of the management staff are now in jail. This was for repeatedly failing to follow Good Manufacturing Practices and the Code of Federal Regulations.

8. The Importance of Training

The Code of Federal Regulations states the each person who works in a GMP facility shall have the education, training and experience to enable him to perform his assigned job function. Training shall be in the particular operations that the employee performs and in current Good Manufacturing Practices related to their job function. Therefore, you must take the training you are provided seriously.

Your Pfizer contact is responsible to assure that you receive the proper on-the-job training or work site training so you can perform your job in accordance with GMPs or GLPs related to your job function.

A positive attitude toward training is important. This means you will be actively involved in training sessions and apply the training on the job as required.

Upon completion of classroom style training you are required to provide the last 4 digits of your social security number, print your name, and write your signature, name of contract administrator, date and name of your employer on a Contractor Training Attendance Form. The Contractor Training Attendance Form provides any inspectors with evidence and documentation of the required training. You may also be asked to document other on-the-job training by signing other types of training documentation forms or by P-Cars, an electronic training recording system.

9. The Importance of Documentation – in the eyes of the government if you didn’t document it, you didn’t do the work or take the training session.

GMP and GLP regulations require that we document our work. As a contract worker or service provider your work may require that you print your name, write your signature, list the date of the work you performed and the name of your employer. When documenting these things do the following:


of 36

Write clearly and use black or blue ink. If making entries into work logs, do it immediately after the work activity

occurs. Fill in all blanks required; don’t leave blank lines. Use one line out for mistakes or incorrect entries; enter the corrected

information, initial it and date it. (do not erase, use white out, or cross out the mistake to the point where it can’t be recognized as it was originally written)

10. Employee and Product Protection - people are the biggest source of contamination in our work site!

For the reason above GMPs and GLPs include requirements to prevent contamination to our products and processes used to make, hold, test or distribute our drugs. To prevent contamination we regulate:

hygiene practices of people, the flow of people traffic in the site, restricted access in various areas, and housekeeping or cleanliness of the workplace.

A. Housekeeping and Cleanliness of the Workplace- physical contamination Examples of physical contamination are tools or materials that make their way into raw materials or product. Material or foreign objects left in equipment may dissolve in the process and become a chemical contaminant (a tape measure or gasket that dissolves in the process solvent). Product or materials contaminated in this manner may need to be destroyed.

Examples of activities to always keep in mind when working in production areas:

Tool control: Make sure all of your tools are accounted for when you finish a job.

Certain waste containers are designated for specific types of waste and can’t be used for general garbage. Be alert to labels on waste containers.

Teflon tape: Begin applying tape on the second thread and back from the end of the pipe. Teflon tape should not be exposed or come into contact with drug substances, additives or production processes.

Pipe dope: Adhere to all Pfizer Piping standards. Gaskets that come with equipment should be checked with the operating unit to

make sure that they are the correct ones. Duct tape should not be used in the manufacturing areas or on equipment used

in the areas. Duct tape or any other material that is not permanently attachment to machinery or tools may fall off and end up in product. Product that contains foreign material may require reprocessing or be destroyed.

Contract Workers are held accountable for littering or contributing to unsafe or unsanitary housekeeping conditions on the job site.


of 36

B. Flow of Traffic and Restricted Access to Certain Area in a Pfizer SiteWhen you enter a Pfizer facility you must be alert to the signs posted at entrances. Signs restrict access to people depending on what activities are going on inside that area. Some areas require extremely clean conditions in the air and on surfaces. Only highly trained individuals are allowed to enter these areas. Each area has different access restrictions.

Signs tell us the type of head covers, uniforms, beard coverings and foot covers that must be worn in a given area. This all helps to protect both you and the products from contamination from hair, fibers, skin cells, dust, dirt, vermin, germs and bugs.

Controlling contamination from insects and pests is accomplished by limiting where people consume food and drinks. Consumption of any kind of food or drink other than water is allowed only in building cafeterias, snack bars, or other designated areas.

Here are a few other restrictions that help maintain an environment free of contaminants in a GMP or GLP facility like Pfizer:

Beverages carried from vehicles to the work area (where allowed) should be sealed to prevent spillage if dropped.

Absolutely NO toothpicks or food, including gum, candy, snacks, or drinks are allowed in the manufacturing areas or laboratories.

Live plants are prohibited in manufacturing areas. Plants and soils can harbor many life forms (insects or microorganisms) that can be a source of product contaminates.

Doors and windows must not be propped open under any circumstances.

C. Hygiene Practices of Employees – More GMP RestrictionsIt is expected that contract employees will practice good personal hygiene and wear clean clothing that is appropriate for the job and the work area.

In some restricted manufacturing areas you are expected to wear hairnets, beard covers, shoe covers, and tyvek suits covering your clothing. Cosmetics, artificial nails, jewelry, watches or wedding rings may not be allowed. Be sure to follow the specific policies and SOPs for the area you will be working in.

All contract employees must report wounds and illnesses to their Pfizer Contact. Open lesions can impact product quality in areas with restricted access and controlled environments

11. Security

Pfizer has made a substantial investment in its people, its facilities, and its equipment. Our Security Services Team is charged with protecting those important resources.

Pfizer has a staff of security professionals who concentrate on site protection. This task, however, can be done much more effectively with your help.


of 36

By following a few simple security rules, you can ensure that Pfizer’s investment, as well as your Company’s people and property, receive the best protection:

Be ready to show your ID - We can best protect our site by controlling who has access to it. Security Officers will ask to see your identification when you enter a site or building. They may also request to check the ID as a “spot check”. Remember - they are doing their job just like you. A “spot check” doesn’t mean they suspect you of anything - it’s just a way to be sure they know you are authorized on the site.

Wear your issued ID - Unless the area you work in is specifically identified as an area where

the wearing of the ID is a safety issue, you must display the ID on an outer garment. Neck cords and badge clips are available at the gatehouses and lobbies. Store your ID Badge only in a secure location. Do not leave it unattended or in a vehicle overnight.

Don’t lend your ID to anyone or use an access badge to let others into locked areas - Some

areas are protected by automated card access readers. Do not enter these areas unless YOUR access card lets you in. One very important piece of information -- using someone else’s access card, or lending yours to someone, WILL result in you being asked to leave the premises.

Keys - Keys to Pfizer buildings and equipment must be checked out from Pfizer’s key Control Authority, or through your Pfizer contact. Return keys upon completion of project, or at the agreed upon date. Just like the access badge, store keys securely and do not loan keys to others. Report lost or stolen keys immediately.

Lock up your property - Pfizer cannot be responsible for the security of personal items or contractor equipment. If your equipment will be stored on the site overnight, please consult your contract administrator concerning an appropriate and secure storage area.

All items are subject to search - In order to protect the site properly, Pfizer reserves the right to inspect all vehicles, packages, bags, and other effects coming into or leaving the site, as well as those items when they are on Company property. Be sure you check with your contract administrator before bringing any questionable items onto the work site.

Report any suspicious activities - Don’t hesitate to report any suspicious activity to security or to a Pfizer employee. The Security Team would rather respond to a false alarm, than investigate a serious theft or incident.

Bottom line -- We need and appreciate your help in making our sites secure.

12. Substance Abuse Program


of 36

Contract Workers must participate in their Contracting Firm's approved substance abuse program that must include pre-employment/pre-access, for cause, random and accidental injury testing as defined by Pfizer’s substance abuse policy.

13. Prohibited Activities

The following activities, most of which constitute gross misconduct, are strictly prohibited on Pfizer property:

A. Possessing or using alcohol or illegal substances, or reporting to work while under the influence of either

B. Gambling or playing of games for money

C. Bringing weapons, firearms, ammunition, or incendiary devices on site or being in possession of such devices on company time

D. Using cameras without written approval of the engineering and facility director.

E. Duplicating, destroying, or copying Pfizer records, or removing such records from the property

F. Horseplay

G. Sexual harassment, including unwelcome sexual advances and other behavior which interferes with another's work performance or creates an intimidating, hostile, or offensive work environment

H. Stealing or pilfering from Pfizer, a Contracting Firm, or an individual

I. Using personal radios, earphones, tape recorders, etc.

J. Use of tobacco products outside of designated areas.

K. Collecting contributions, vending, soliciting, distributing notices, handbills, posters, or any other written or printed material for any purpose while on the Pfizer work site

L. Fighting

M. The presence of personal electronic devices (cellular phones, personal pagers, etc.) is prohibited in many production areas. Cell phones, personal pagers, and/or Personal Data Assistants (Palm Pilots, etc.) not approved for use in a potentially hazardous environment are not allowed and may be confiscated.


of 36

SECTION B – HEALTH & SAFETY

1. Emergency Reporting Procedure

In the event of a FIRE dial 2456 on any company phone.

In case of a Medical Emergency or Chemical Spill, dial 1-2-3 as directed for a fire.

When speaking with the Pfizer dispatcher remember to:

A. Stay CALM and speak clearly.

B. Give your name, the phone number your calling from, the building, floor number and room number, if known (also department and unit number), the type of emergency and any other information requested.

C. Do NOT hang up until told to do so. Allow the dispatcher to ask questions and guide the conversation.

D. Notify your Pfizer Contact as soon as possible.

2. Injury Reporting Procedure

Because any incident is potentially serious, it is Pfizer policy that all injuries be promptly reported and investigated. Contractor injuries are to be reported immediately to your supervisor and Pfizer contact.

Any injury involving chemical exposures should be directed to Medical Services or call 2456. Any emergency medical issue (such as those requiring ambulance transports) should be reported first to 2456. Non-emergency injuries can be handled via the contracting company designated medical provider. If there is any doubt as to the severity of an injury ALWAYS call 2456. Contractors should not call 911 for ambulance service. If calling from a cell phone, 441-2456 should be dialed for emergencies. All ambulance requests should go through 2456.


of 36

3. Emergency Alarms

Emergencies will be announced via a public address system.

The emergency alarms are:

FIRE – Buzzer/strobes activate with no accompanying voice announcement.

TORNADO – Repeating tone followed by voice indicating a tornado warning.

AREA-WIDE EVACUATION – Fire tones followed by voice indicating the need to evacuate.

4. Fire Extinguishers, Fire Alarm Boxes, Safety Showers & Eye Wash Stations

The Pfizer Contact will advise Contract Workers on the location of fire extinguishers, fire alarm boxes, safety showers and eyewash stations. This equipment is for emergency use only.

Contract firms must provide their own fire extinguishers for welding and burning projects and are not to remove fire extinguishers from Company buildings for non-emergency situations.

5. Evacuation Routes, Assembly Areas and Tornado Shelters

The Pfizer Contact will advise Contract Workers on evacuation routes, emergency assembly points and tornado shelter locations for the building and area they are working in. In case evacuation of a building is necessary due to fire, explosion, or other disaster, all Contract Workers are expected to know the evacuation routes and to assemble at assigned assembly areas. In the event of a tornado, Contract Workers are expected to know the location of the nearest area designated as a tornado shelter.

6. Hazard Communication

Pfizer abides by “Right-to-Know” regulations and makes information pertaining to the chemical hazards found at their workplace available to all contract workers. Limited training on this subject is provided during this session. Specific questions regarding Hazard Communication should be directed to your supervision or Pfizer Contact.

Contract workers needing or wanting Material Safety Data Sheets (MSDS) should contact their supervisor, Pfizer Contact, or a Pfizer employee/co-worker to obtain a copy of the MSDS.

Contract workers are expected to read labels, paying particular attention to information


of 36

that may be pertinent to their health and safety as well as that of their co-workers. Learn to recognize the various labeling systems used by Pfizer including the National Fire Protection Association’s Hazardous Classification System, the HMIS labeling system and ANSI – compliant labeling.

Pfizer also utilizes warning signs throughout their plants. Examples of those signs include but are not limited to Danger, Caution, Eye Protection Required, Hearing Protection Required, etc. Contract Workers are expected to be capable of identifying and understanding the meanings for posted warning signs and comply with all requirements and actions stated on those signs.

7. Asbestos-Containing Material

Pfizer Lincoln sites house many miles of process piping. Asbestos-containing material (ACM) has been identified in portions of the thermal system insulation at elbows and joints of piping.

Non-thermal system insulation ACM (i.e. ceiling and floor tile, laboratory bench tops, etc) has also been identified. Consult your Pfizer contact for additional information.

Contract Workers who will come in contact with ACM must follow all state and federal regulations pertaining to asbestos. Only properly licensed, trained, qualified individuals will be allowed to disturb any material containing asbestos. Contract Workers working with asbestos containing material (ACM) must notify their Pfizer Contact prior to beginning work with the material.


of 36

CONTRACT WORKER

ORIENTATION

LEVELS II & III


of 36

SECTION C - GENERAL

1. Equipment

Construction Contracting Firms must provide all necessary equipment to perform their job. Each firm must regularly inspect and maintain their equipment in good working condition.

2. Contracting Firm Vehicles

The following rules apply to all Contracting Firm vehicles on Pfizer property:

A. Riding in a vehicle shall be limited to a seat in the cab or to a seat secured to the bed, body, or floor of the vehicle. Seats must be anchored according to federal and state regulatory guidelines. While a vehicle is in motion, personnel within shall not extend any part of their bodies beyond the line of the vehicle bed as defined by its gates, barriers, and/or seat arrangement.

B. Materials being transported which extend beyond the sides or ends of the vehicle shall be properly secured and marked with red flags. All trucks transporting materials on Pfizer property shall be loaded in a secure manner to prevent any material from dropping off the truck onto the roadway.

C. Dump trucks, trailers, waste-hauling units or heavy construction equipment shall not travel with loading devices in an elevated position. Materials shall be placed on site only in locations authorized by the Pfizer Contact.

D. All vehicles or equipment requiring back-up signal devices must be in proper working condition.

E. Clearances must be checked when moving a high load or equipment.

F. When parking and leaving Contracting Firm vehicles, park in authorized areas and turn the engine off.

G. Fuel tanks on Contracting Firm vehicles or equipment shall not be filled while engine is running or in a hazardous area, such as where welding or other hot work is being performed. On-site fuel tanks require secondary spill containment and must be specifically authorized by the Pfizer Contact and Pfizer Environmental Health & Safety.


of 36

3. Dress Codes

All Contract Workers must conform to the dress code requirements of individual units/areas. For area-specific requirements, consult your Pfizer Contact.

Contractor’s performing work in production areas or when using production-related chemicals will be required to wear uniforms or lab coats, and safety glasses with side-shields. Pfizer will provide contractors with the clothing required to work in manufacturing areas. Contract workers not in compliance may be removed from the site.

If an area is under construction, or otherwise sealed off from the production or packaging environment, the Pfizer Contact can request a waiver of dress code requirements.

In summary, Contract Workers shall wear personal protective clothing and footwear that is appropriate for the work location and type of work being performed. Prohibited clothing may include, but is not limited to, canvas shoes, sneakers, slippers, tank tops, and shorts. Shirts and pants are required at all times.

NOTE: In order to protect both people and product, some areas have stricter dress code regulations than those mentioned previously. Examples include the Building 1 and Building 2 Biological manufacturing areas. All local requirements and procedures must be followed. Pedestrians must be dressed to code requirements to pass through a zone. If in doubt about dress code requirements …ASK!


of 36

SECTION D – ENVIRONMENT, HEALTH & SAFETY

1. Compliance

Pfizer establishes a high standard with regards to the environmental, health, and safety (EH&S) expectations of everyone who works on our site. We cannot expect our own employees to conduct themselves in a fashion that protects their own health and the environment without having this same expectation of visitors, temporary workers, vendors, and contractors.

The baseline of EH&S performance is established by governmental regulations. EH&S regulations are established at all levels of government – national, state, and city/county. As a contractor, Pfizer expects you to:

Know what regulations apply to your activities. Understand how to comply with the regulations, and Behave at all times in conformance with the regulations.

As a corporation, Pfizer has published a series of twenty-six environmental, health, and safety guidelines. Their name notwithstanding, the practices described in the guidelines are requirements that Pfizer and our partners must abide by. These above-and-beyond requirements are communicated elsewhere in your orientation.

At a site level, Lincoln has a large number of standard operating procedures, many of which relate to the protection of the environment or worker health and safety. Our orientation program is designed to communicate the relevant requirements found in local EH&S standard operating procedures.

Contract employees or contracted firms may be dismissed for failure to comply with governmental regulations or failure to abide by Pfizer Guidelines or standard operating procedures. Although it is Pfizer’s responsibility to communicate our company’s guidelines and procedural requirements, as noted above it is the contract firm’s responsibility to assess applicability of governmental regulations and then design compliance procedures and systems accordingly.


of 36

2. Chemical Safety

Hazardous chemicals are found throughout Pfizer. Specific information for individual work areas is available through the Pfizer Contact or the operating unit. Information on obtaining Material Safety Data Sheets (MSDSs) and the labeling system used by Pfizer are discussed in section B6 of this guide.

Contract Workers bringing chemicals onto the premises must maintain MSDSs on site for those chemicals and provide a copy to the Pfizer Contact. The Administrator will provide a copy to Employee Health.

Contracting Firms are responsible for logging annual chemical usage of regulated items whenever requested and for removing their unused chemical materials from Pfizer property.

3. Electrical Hazard Classifications

Many Pfizer facilities contain areas considered ‘hazardous’ according to the National Fire Protection Association (NFPA) Hazardous Classification System. The NFPA Hazardous Classification System is used to classify areas as to the potential for flammable or ignitable concentrations of certain substances (e.g., dust and vapor).

In hazardous areas:

The use of unapproved electrical devices or other ignition sources without a Hot Work Permit is NOT ALLOWED.

The use OR PRESENCE of unapproved electronic devices (cellular phones, palm pilots or personal pagers) is NOT ALLOWED.

A device is considered approved for use in hazardous areas only if it bears a label stating its approval and identifying the testing agency providing the approval.

It is allowable to use such devices in general purpose areas both inside (such as office areas) and outside of buildings within the site.

If you are uncertain how to proceed in a particular area ASK your supervisor, Pfizer Contact, or operating area representative.


of 36

4. Fall Protection

Individuals working at Pfizer on any walking/working surface, more than four (4) feetabove a floor surface that is not adequately protected by guardrails must have proper Fall Protection. Fall protection is generally achieved by using a personal fall arrest system consisting of an anchor point, lanyard and a full body harness. However, there are other methods to achieve adequate fall protection including safety net systems and guardrails.

5. Blood borne Pathogens (BBP)

Bloodborne pathogens can be found at Pfizer in research and development, in the animal health buildings and may be used in various testing throughout laboratories in Lincoln. Contract workers who are required to come in contact with BBP’s should be adequately trained in handling, clean-up and emergency procedures.

Waste created from the use of BBP’s should be considered biohazardous and will be identified with the following symbol:

Contract workers coming in contact with potentially contaminated fluids should be knowledgeable in the subject and use of “universal precautions” as they are expected to comply with this system of personal protection. “Universal Precautions” as defined by OSHA Standard 1910.1030 subpart b are “ an approach to infection control where all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.”

6. Noise

Chronic over-exposure to noise can cause hearing loss and other hearing disorders. At Pfizer, areas where noise levels can be expected to exceed 85 decibels (dBA) are considered high noise areas. High noise areas are marked with signs indicating that hearing protection is required. Hearing protection must be made available at the boundaries to all high noise areas. If the work you are doing will introduce a noise source (power tools, generators, etc.) you must protect yourself and alert any one else in the area to do the same. Your Pfizer Contact can help you identify high noise areas. You must inform your Pfizer Contact if the work or equipment you will bring on site will generate a noise hazard.

7. Work Practices

A. Areas and roads must be properly barricaded or roped off when hazardous work is in progress. When roads are to be barricaded, contact the Pfizer Contact who


of 36

will notify Security.

B. Sprinkler line shutdowns require a forty-eight (48) hour advance notice to the Pfizer Maintenance Department. No changes can be made or sprinkler heads covered until maintenance has been informed. Arrangements must be made with the Pfizer Contact early enough to allow notification.

C. Any work with suspected or known asbestos-containing material shall be carried out under the guidance of the Pfizer Contact.

D. Do not cut into insulated lines with a knife, hacksaw, etc. to remove insulation until a check has been made to see if they are traced lines.

E. Insulated lines, mechanical and electrical piping, and ductwork must not be walked on, sat on, or used as a support for scaffolding or ladders.

F. In the event a chemical spill of any size should occur, the Contract Worker should:

1. Immediately notify the operating unit and Pfizer Contact2. Call 2456 and report the spill.

G. Fiberglass ladders are preferred on the Lincoln site. All ladders must conform to federal and state guidelines and be visibly identified with the company name.

H. The use of powder-activated fastening tools is prohibited unless piston-driven.

I. Contract Workers shall not inactivate safety devices such as relief valves, deluge valves, gauge valves, electrical or mechanical interlocks, guards, electrical switches, alarms, etc. unless authorized by the Pfizer Contact or operating unit.

J. Any accidental or unauthorized interruption of lines, equipment, or any observed irregularities must be reported immediately to the Pfizer Contact and the operating unit.

K. Contract Workers shall not remove, reach or climb through, over or under barriers, ropes, tapes, or barricades without proper authorization.

8. Lockout/Tagout (LOTO) Procedures:

Lockout/Tagout (LOTO) procedures are used to control hazardous energy sources during service or maintenance where the unexpected release of energy could cause bodily harm. All contract workers performing procedures using LOTO are required to take site specific LOTO training. Contract firms are required to train their employees on the general principles as required under OSHA’s Control of Hazardous Energy Sources


of 36

standard.

Hazardous energy sources come in many forms including: Electrical Mechanical Thermal Potential Pressure Chemical HydraulicKey elements on Lockout/Tagout at Pfizer sites: Red locks used only for LOTO. Red American lock Company Series 1105 only. Every person must have personal control of all energy sources, by keeping key to

lock in their possession. Lock box may be used for complex LOTO operations. Tag must be used with lock. Tag on lock must contain persons name, date, and department (or company) Tagging only is not permitted at Pfizer Lincoln. Tags must be secured with the shank of the lock (no string, twist ties, plastic cabin

tie, etc.) Always test on/off switches to be sure system is de-energized All individuals having work duties on that piece of equipment must physically lock

out the equipment.


of 36

9. Safety Permits

The Safety Permit System at Pfizer consists of a series of step-by-step checklists that ensure certain jobs are performed safely. All contract workers performing procedures using permits are required to take site-specific permit training. Contract workers are to contact their supervisor to schedule this course. Pfizer’s current safety permits cover the following types of work:

Lockout/Tagout Procedures:This program is used to control hazardous energy sources when equipment or machines are being serviced, or maintenance is being performed.

Confined Space Entry:Tanks, vessels, pits, and dikes may all be considered confined spaces. The Confined Space Entry Permit identifies and controls the hazards associated with entering a confined space. A sign posted near the entrance identifies permit Required Confined Spaces.

Hot Work:Flammable solvents, chemicals, and other combustible materials are found throughout Pfizer. Hot Work Permits are required for welding, cutting, grinding, using electric tools, and other work that has the potential for starting a fire or causing an explosion.

Line Breakwork Permits:With miles of pipelines, it may be difficult to determine if a particular line contains harmful chemicals. The Line Breakwork Permit will identify any hazards and assure that all measures have been taken to guard against accidental exposure to personnel working on the system.

Energized Electrical Work PermitAn energized electrical work permit is required for any work that involves intentionally contacting live parts above 50 volts, or working within the prohibited boundary as defined by NFPA.

Five basic rules are to be followed for all permits:

1. The permit checklist must be filled out completely. Skipping a step defeats the purpose of the permit and could lead to an accident.

2. All authorized signatures must be obtained. This ensures that those signing the permit agree about the type of work to be done and are satisfied that the area is safe.

3. The permit must be posted at the job site so that it can be easily seen.


of 36

4. Each safety permit applies to one job being performed at a specific location at a defined time by certain workers. This means that permits CANNOT be shared by Contracting Firms and moved from job to job. If work needs to be done on another system, or on a different day, another permit needs to be obtained.

5. The permit must be returned to the office where it was issued upon completion of the job. It is very important that all people involved in the permit process know when the job is finished.

Safety permits are reviewed regularly and revised as necessary. Ask your Pfizer Contact for the most current information on Pfizer’s Safety Permit System.

10. Personal Protective Equipment

Unless posted otherwise, non-metallic hard hats and safety-toed shoes are required in all circumstances.

Additional personal protective equipment is required for work in many posted areas as well as for certain activities. Adherence to posted personal protective equipment requirements is strictly enforced. Failure to comply is grounds for dismissal from company property.

ANSI-approved safety glasses with side shields are the minimum protection required in all construction, production, laboratory and posted areas. Use of tinted lenses inside buildings is prohibited. In addition, goggles, face shields, or other approved face and eye protection shall be used where a hazard exists due to flying objects, particles, harmful contacts (i.e. chemicals), and other potentially hazardous exposures. All processing areas require safety glasses with side shields. Goggles must be worn when performing tasks that present splash hazards such as, but not limited to, hose connection/disconnection, open sampling of liquids, or line/equipment opening. In addition, goggles AND a face shield (or a combination device of both) are required for any processing task involving the open handling of corrosives.

11. Respiratory Protection

Your Pfizer Contact will identify whether respiratory hazards may be associated with the work areas you will need to access. If you need to use respiratory protection to do your job you must have medical clearance to use respiratory protection and training on its use. In addition, certain forms of respiratory protection will require fit testing. In most cases, your employer will be required to provide the respirator, medical clearance, training and fit testing. If you need to use the Pfizer breathing air system, your Pfizer Contact may provide a compatible respirator and will arrange for training specific to its use. You must inform your Pfizer Contact if the work or equipment you will bring on site will generate a respiratory hazard. If the work you are doing will introduce a respiratory hazard you must protect yourself and alert any one else in the area to do the same.


of 36

12. Waste Disposal

An almost infinite number of wastes may be generated by the activities of contractors, and given this variety; it is impractical to craft a concise policy that describes proper management of all contractor wastes. However, below are a few principles that provide guidance for many of the more common situations. If you should encounter situations not covered by this guidance, or if there is ambiguity on handling practices for any other reason, please discuss with your Pfizer Contact.

Dumpsters and trash cans may be used by contractors if approved by the Pfizer Contact. These receptacles are appropriate only for general solid refuse, including many types of construction debris. They may not be used for categories of waste described below.

Neither liquids nor containers of liquids may be placed in dumpsters. Liquids must not be discharged onto the ground or into storm sewer inlets or conveyances. In general, liquids cannot be discharged sanitary sewer inlets. If a contract firm believes sewer disposal to be an appropriate option, they must discuss the matter with their Pfizer Contact and get his/her consent before discharging the liquid.

Certain liquids contain solvents that evaporate if/when their containers are left open to the atmosphere. As a general rule, contract firms shall not open up such containers in an effort to evaporate the solvents. For example, enamel paint shall not be solidified by allowing the solvent to evaporate. Such a practice is permissible if the ‘solvent’ is water, for example in latex paint.

Many contractors bring on to the Pfizer site chemicals for use in their work. The contract firm maintains custody of full and partial containers of these chemicals and may not dispose of them at Pfizer, even if the material is unneeded or expired. Off site management and disposal is an obligation of the contract firms.

If a contract firm uses a chemical owned by Pfizer, the contract firm shall return custody of the containers to Pfizer when they are no longer needed. The Pfizer Contact shall manage full, partial, and empty chemical containers as appropriate, and they may consult with Pfizer EH&S for guidance on materials that need to be disposed.

Aerosol cans, whether full, partial, or empty, qualify as hazardous waste. As such, Pfizer requires contract firms to maintain custody of their own aerosol cans. As is the case with chemicals, the contract firm shall manage and dispose as appropriate their own aerosol cans.

As noted elsewhere, the Lincoln site strives for a very high level of environment performance. As such, contract firms are encouraged to look on their own for opportunities to reduce, reuse, and/or recycle waste materials that they are going to manage. In the case of wastes that Pfizer is going to manage, we may require that such


of 36

wastes be managed differently than described above. Your Pfizer Contact will identify such instances to each contract firm.

Supplemental #1

There are many hazards that exist in a biological or research area, due to the nature of the work being conducted. Those hazards include chemical, animals in cages, studies involving the use of bacteria and bacterial media, viruses, and needles and syringes.

Supplemental #2

Whenever a contractor comes into contact with a chemical from any source, you should go to the nearest safety shower and wash off the contamination for a full 15 minutes, even if the contaminant appears to have been removed before the end of the 15 minute period. Your Pfizer contact should advise you of the location of all safety equipment, including showers. The contamination should be removed as an initial method of first aid, especially if it irritates the skin. A Material Safety Data Sheet should be consulted to identify hazards that are associated with exposure to the chemical.

Supplemental #3

A permit-required confined space is one that meets the definition of a confined space and has one or more of these characteristics:

1. Contains or has the potential to contain a hazardous atmosphere,

2. Contains a material that has the potential for engulfing the entrant,

3. Has an internal configuration that might cause an entrant to be trapped or asphyxiated by inwardly converging walls or by a floor that slopes downward and tapers to a smaller cross section, and/or

4. Contains any other recognized serious safety or health hazards.

A Pfizer representative or an approved representative from the contractor’s firm must verify the atmosphere in a confined space prior to any entry into that confined space.


of 36

HOW TO USE YOUR BADGE

Hold your badge with either hand and slide your badge straight over the reader as smoothly as possible (see Diagram).

GREEN LIGHT indicates you are authorized to go in.

RED LIGHT indicates you are NOT authorized to go in.


of 36

INDEX

TOPIC PAGE

Asbestos Containing Material 18

Assembly Areas 17

Badge Use 31

Barricades 27

Bloodborne Pathogens 24

Cafeterias and Snack Bars 10

Chemical Spill Procedures 17

Chemical Safety 23

Chemical Production Area Access 23

Company Access (Badges) 9

Compliance 22

Confined Space Entry 27

Contract Worker - Definition 5

Contracting Firm - Definition 5

Contracting Firm Vehicles 20

Dress Codes 21

Electrical Hazard Classification 23

Emergency Alarms 17

Emergencies - Reporting Procedure 16

Environmental and Safety & Health Management System (ESHMS) 22


of 36

Equipment 20

Evacuation Routes 17

Eye Wash Stations 17

Face and Eye Protection 28

Fall Protection 24

Fire Extinguishers & Alarm Boxes 17

Good Laboratory Practices (GLPs) 10

Good Manufacturing Practices (GMPs) 10

Hard Hats 28

Hazard Communication 17

Hot Work 20, 23, 29

Index 32

Insulated Lines 25

Interruption of Lines or Equipment 27

Ladders 27

Line Break Work Permit 27

Lockout/Tagout Procedures 25

Material Safety Data Sheets (MSDSs) 17

Noise 24

Notes 7

Orientation Training - All Levels 8

Orientation Training - Level III 19


of 36

Personal Protective Equipment 21, 28, 29

Plant Protection 13

Powder-Activated Fastening Tools 25

Prohibited Activities 15

Pfizer Contact - Definition 5

Pfizer Labeling System 17

Respiratory Protection 28

Safety 27

Safety Glasses 21, 28

Safety Permits 27

Safety Shoes 28

Safety Showers 17

Smoking 9

Speed Limit 9

Sprinkler Line Shutdowns 35

Substance Abuse Program 15

Table of Contents 2, 3

Tobacco Products 9, 10, 15

Training Documentation Card (TDC) 6, 21

Training Responsibilities - Contracting Firm 5

Vehicle Admittance & Parking 9

Vehicle Identification Cards 9


of 36

Vehicle Safety 9

Waste Disposal 29

Work Practices 24

Working Hours 9


table of contents - pfizerkalamazoocontractoradministration.pfizer.com/files... · web viewas a...

Documents