Supporting Documentation

The manual sets out the policy in each area, not the detailed instructions as to how procedures are carried out. 

Note that some organizations may not use the terminology used in this book and may not distinguish between SOPs and WIs. Standard Operating Procedures provide details of how a series of operations are carried out. An example of a SOP would be the detailed instruction for carrying out a particular analytical method. Work Instructions give details of how a specific operation is carried out. What might be classed as a WI is how to operate a particular instrument, how to estimate measurement uncertainty or how to calibrate a piece of equipment. 

You may have included some other documents with the SOPs and WIs because they are also held in your area of the laboratory. These could be, for example, guides for carrying out particular activities, such as method validation, and international guidelines on how to achieve reliable results. Some areas of activity may be covered by legislation copies of the relevant documents will be kept locally as it may be referenced in the SOP. Equipment manuals are also kept locally. 

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Air Quality Criteria forTead Supplement to the 1986 Addendum, U.S. EPA, Environmental Criteria and Assessment Office, Washington, D.C., 1990. Technical Support Document to Proposed Airborne Toxic Control Measure for Emissions of Toxic Metalsfrom Non-Ferrous Metal Melting, State of California Air Resources Board, Stationary Source Division, Sacramento, Calif., 1992. 

Guidelinesfor Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, Office of Drug Evaluation and Research (HFD-100), FDA, RockviUe, Md., 1987, pp. 3, 4. 

Technical Support Document Revisions to the Malfunction and Diagnostic System Requirements Applicable to 1994 and later New California Passanger Cars, Eight-Duty Trucks, andMedium Duty Vehicles with Feedback Fuel Control Systems (OBD-II), California Air Resources Board, Sacramento, Sept. 14,1989. 

The lines of communication that were established in the toller selection phase can be formalized in the contract stage. The contract should spell out the persons to contact and under which circumstances they must be contacted. Detailed and continuing exchange of information is necessary in order to optimize the administration and performance of the tolling contract. The parties may want to come to agreement and include the following in the contract or supporting documentation to enhance communication ... 

Staple all five pages of each report together. Do not submit supporting documentation or other materials with your Form R submission. 

All other correspondence, inspection reports, approved contractor/ subcontractor invoices, and supporting documentation... 

Provide supporting documents and diagrams for the system being investigated. iiid the systems with which it interacts... 

I am particularly indebted to Dr. Howard Lambert of Lawrence Livermore Laboratory and FfA Associates for providing the PC computer codes FTAP (fault ti ee code), POSTER (post processor), IMPORT (importance calculation), MONTE (Monte Carlo error determinadoni, and supporting documentation and instructions. 

Some organizations divide their quality system documentation into three levels a quality manual, a set of operating procedures, and the support documentation. 

The problem with this approach is that the term supporting documentation fails to convey what might be included. In many cases the supporting documentation has been limited to the work instructions but in reality there are many different types of documents that are needed to produce quality products (see Part 2 Chapter 5). 

In addition to the documents that serve product manufacture and installation or service delivery, documents may also be required for maintenance and operation. The product descriptions, handbooks, operating manuals, user guides, and other documents which support the product or service in use are as much a part of the design as the other product requirements. Unlike the manufacturing data, the support documents may be published either generally or supplied with the product to the customer. The design of such documentation is critical to the success of the product, as poorly constructed handbooks can be detrimental to sales. 

Produce procedures that govern the generation, proving, and publication of product/ service support documents, such as handbooks, operating instructions, etc. 

Purchaser-supplied product is a product or service (such as transportation) owned and provided by the purchaser to the supplier for use in meeting contractual requirements. The quality or ESH/PSM issues around these relationships include ensuring that the product or service received meets the appropriate standards and requirements, that the product is returned in the appropriate condition and that supporting documentation is available as needed. 

The FDA s Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances makes some speeifie referenees to ehiral drug substanees. The requirements are similar to those in the EU. Elueidation of the... 

U.S. Department of Energy. (1995). Technical Support Document Energy Efficiency Standards for Consumer Products Refrigerators, Refrigerator-Freezers, At... 

California Air Resources Board. (1991). Employer-Based Trip Reduction A Reasonably Available Transportation Control Measure. Executive Office. Sacramento, CA Author. California Air Resources Board. (1995). Evaluation of Selected Projects Eunded by Motor Vehicle Registration Fees, Revised. Technical Support Document. Sacramento, CA Author. 

Whether electrostatic technology is superior to magnetic device technology is debatable. What is of interest is that, in a 1998 marketing and technical support documentation pack from a major electrostatic unit manufacturer, most of the information supplied related primarily to cooling water applications rather than boilers. The boiler data, such as there was, concerned only smaller, simple systems (e.g., HW boilers and steam ovens). 

EPA. 1988d. Reference dose (RfD) Description and use in health risk assessment. Vol. I, Appendix A Integrated risk information system supportive documentation. U.S. Environmental Protection Agency, Office of Health and Environmental Assessment. EPA 600/8-86-032a. 

Schroeder, P.R. and Gibson, A.C., Supporting Documentation for the Hydrologic Simulation Model for Estimating Percolation at Solid Waste Disposal Sites (HSSWDS), Draft Report, U.S. Environmental Protection Agency, Cincinnati, OH, 1982. 

Industrial Chemical Prioritization and Determination of Critical Hazards of Concern. Technical Annex and Supporting Documents for International Task Force (IIF)40, Industrial Chemical Hazards Medical and Operational Concerns. UASCHPPM Report 47-EM-6154-03. US Army Center for Health Promotion and Preventive Medicine, Aberdeen Proving Ground, MD, 2003. 

EPA. 1994b. Technical support document Parameters and equations used in integrated exposure uptake biokinetic model for lead in children (v0.99d). EPA/540/R-94/040, PB94-963505. 

ATSDR. 1996a. 1995 CERCLA priority list of hazardous substances that will be the subject of toxicological profiles and support document. Atlanta, GA US Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry. 

All members of staff of a laboratory are responsible for ensuring that they are familiar with the quality management system, as set out in the Quality Manual and any supporting documentation. They are expected to follow the... 

U ren, S.C. 1983. Acute toxicity of bis(tributyltin)oxide to a marine copepod. Mar. Pollut. Bull. 14 303-306. U.S. Environmental Protection Agency (USEPA). 1986. Initiation of a special review of certain pesticide products containing tributyltins used as antifoulants availability of support document. Federal Register 51(5) 778-779. 

U.S. Environmental Protection Agency (USEPA). 1987. Tributyltin. Technical support document. Position document 2/3. Mimeo. 152 pp. Avail, from U.S. Environ. Protection Agency, Office of Pesticides Programs, Registration Division, Special Review Branch, 401 M Street S.W., Washington, D.C. 20460. U.S. Navy (USN). 1984. Environmental Assessment of Fleetwide Use of Organotin Antifouling Paint. U.S. 

Technical Support Documents for Water Quality-Based Toxics Control (1991) EPA 505/2-90-001. Office of Water, US EPA, Washington... 

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