Outside contractors

In any of these cases, there will be a contract between the two parties and perhaps the use of certain subcontractors. This section discusses some of the safety aspects of such contracts. It then turns to methods which can be used to assure that the contractor has the tools and the ability to perform safely in the plant. 

---

Fire Protection Association (1977b) Guide to Fire Precautions with Outside Contractors, London. 

In weighing the pros and cons of inside staff versus outside contractors, the most useful determinant is long-range cost-effectiveness. It s easy to underestimate the true cost of using employee resources, since these expenses are "buried" within ongoing business. 

The collection and tabulation of data will provide an opportunity to become familiar with the company and will generate a good understanding of the operation of the plant. Much of the data will be needed to establish the models needed to size the various areas of the plant. For instance, hours worked should be analyzed to identify shift work, direct and indirect effort, and the normal and overtime activity. Outside contractors may be employed, and this contribution will need to be determined, sometimes by visiting the contractor s facilities. When expansions are being planned, it may be necessary to discuss the contributions that outside contractors make to the factory and assess the increase which they can accommodate. 

Internal personnel will normally undertake boiler plant operation. Maintenance work may be by either internal personnel or outside contractors. Service contracts will be available from equipment suppliers covering all items of the boiler plant. Recently, companies have started offering contract energy-management schemes. These may be designed to suit individual applications and will be tailored to customer requirements. They may take over the operation of an existing plant or, if necessary, include for a new replacement plant. They will usually operate over a 3-10-year contract period. Dependent upon the terms of contract, all fuels, electricity, repairs and replacements may be covered. 

If a work request is received that requires an outside contractor, the work order should immediately be assigned and issued to the contract maintenance liaison supervisor or other designated representative once the shutdown is approved. Do not hold until the outage assignment meeting. 

Depending on the size of the CRO and the nature of the trial, the system may be acquired in one of the following ways (1) developed in-house by the organization s staff with off-the-shelf commercial software, (2) outsourced to outside contractors, (3) with open source/free software (OSS/FS), and (4) purchased from e-clinical proprietary vendors. 

Also, electronic SOPs and protocols must be available to staff at all test sites for multisite studies. If the electronic documents are to be available at several sites, the validation phase of the system must include functionality testing at each site. Documentation of system validation needs to be available at each test site as well. Electronic SOPs must have a limited life span when printed to avoid the use of an outdated document. This may be achieved by stamping each SOP hard copy Printout not valid after date xx/xx/xx . This practice helps to ensure that system users will not retain printed SOPs long after the electronic SOP is revised. For company SOPs that are to be followed by an outside contractor who has no access to the electronic system, an alternative stamp may be used on the hard-copy SOPs that will be provided to the contractor that defines the date printed or indicates that the SOP is valid for use in a particular study. Whatever procedure is used, it must be clearly documented in an SOP. 

A transmission tax is similar to a sales tax. It is levied whenever there is a transfer of funds. If an outside contractor hired an electrical subcontractor who in turn paid an electrician to perform a job, there would be three transmission taxes paid. One would be incurred when the corporation for whom the job was being performed paid the contractor. Another would occur when the contractor paid the subcontractor. The third would occur because the subcontractor paid the electrician. If the transmission tax were 7%, then the total transmission tax would be over 21%. (See the section on compound interest in Chapter 10.)... 

Maintenance may be handled either by employees hired especially for that job or by an outside contractor. The latter is most economical when workers in most trades are needed only occasionally. The company does not need to hire these workers full time, but still has their talents available when they are needed. Even in a large plant where a number of employees skilled in each maintenance trade are needed full time, contract maintenance may be used as a supplement at times of turnarounds (a planned time when large continuous plants are shut down to do preventive maintenance, repairs, and inspections) or especially heavy demands. For instance, during the turnaround of a 140,000 bbl/day (22,000 m3/day) Tidewater Oil Company refinery, the number of maintenance personnel rose from a preshutdown level of 181 to 924 men.48 Fewer men could have been used, but the downtime of the refinery would have been increased. In this instance the plant contracted for all of its maintenance. 

The following information must be included in the program for employers who produce, use, or store hazardous chemicals in the workplace (1) the means by which MSDSs will be made available to outside contractors for each hazardous chemical, (2) the means by which the employer will inform outside contractors of precautions necessary to protect the contractor s employees both during normal operating conditions and in foreseeable emergencies, and (3) the methods that the employer will use to inform contractors of the labeling system used in the workplace. 

An analyst, a metrologist, or a qualified contractor can perform the calibration, though all must follow the company s prescribed standard operating procedure (SOP) and acceptance criteria. The cost effectiveness of using outside contractors or an internal metrology department is dependent on company size and the number of HPLC systems in the laboratory. 

Arrange qualified outside contractors for periodic testing and emergency maintenance of specialized fire and explosion protective systems. 

Commercial pharmaceutical companies frequently use pay-as-you-go strategies. Examples include buying R8rD ideas from biotech companies ( external innovation ) and paying outside contractors to conduct experiments and cHnical trials. Some virtual pharma companies purchase almost all of their R8rD from outside vendors (see Maurer [2005] for a detailed description.)... 

Whilst most of these activities can or will be carried out by outside contractors, there must be a member of staff, or even a small team, responsible for ensuring that the contractors meet their obligations of their contract with the company. 

In March 1978 the City commissioned an outside contractor to design a remedial program. Hooker participated in the study and offered to pay one third of the then-expected cost of remedial work which was estimated at 840,000. 

The cover letter should provide the name and address of the sponsor. If the sponsor is using outside contractors or manufacturing sites at other locations, the cover letter should provide their addresses and identify their functions. 

Inadequate SOP for review and evaluation of cahbration reports from outside contractors. [FDA 483, 2001]... 

Furthermore, calibration data and results provided by an outside contractor were not checked, reviewed, and approved by a responsible Q.C. or Q.A. official. 

A written plan which outlines the method that will be used to inform employees, workers and outside contractors of hazardous chemicals to which they may be exposed while working on the site. 

An appropriation estimate, whether prepared in-house or by outside contractors, must clearly identify the project, its location, and the quality of the estimate. It should be issued in the form of a formal, stand-alone, report or package addressing and documenting the following areas ... 

---