THERE IS A FOREST OF STANDARDS. Someone has to write a book on standards; maybe one called “Standards Explained.” Who needs to adhere to particular standards? Which ones are voluntary?” [a] We use standards routinely and perhaps unquestioningly in day-to-day manufacturing operations. The selection of appropriate standards is essential for optimal product performance and for cost-effective manufacturing. Used incorrectly, standards can be stumbling blocks to successful manufacturing. They may provide a false sense of security or allow the manufacturers to “pass the buck” toa hapless supplier.
Standards should be considered in context. Technical standards specify such attributes as product characteristics, performance, safety profile, test methods, or terminology.  Standards may include protocols for product assembly, levels of contaminants in chemicals, the composition of materials of construction, airborne particles, airborne molecular contamination, cleanroom construction, and employee behavior/activities during specified manufacturing procedures. In analytical testing, standard samples traceable to a knownsource, such as NIST, may be used.
A standard implies a requirement, i.e. “thou shalt”  in contrast to a guideline or recommendation, i.e. “thou shouldst.” At the same time, complex standards, covering an array of manufacturing situations with multiple variables, may effectively be open to interpretation. Horizontal standards set forth general principles and guidelines; but the details are left to the user. With horizontal standards, in-house procedural documentation is essential. Vertical standards call out requirements for specific procedures, often in agonizing detail. As one might expect, it is very difficult to obtain the consensus needed to write verticalstandards. 
Horizontal standards may be very complex. For example, ISO 10993-17 defines and documents consistent protocols for evaluation of toxicological risk factors so that limits can be set for specific leachable substances in biomedical devices.  As a horizontal standard, it is intended for use in deriving standards and setting limits where vertical standards do not exist. 
Standards are not the result of divine intervention. Standards are a reflection of the status of technology, performance requirements, as well as the skills, knowledge, background, and prejudices of the people designing the standards. Standards may be based on performance, consensus, historical experience,and/or executive edict.
Trade organizations as well as national and international standards organizations may establish standards. Military organizations set requirements or specifications. Aerospace companies establish detailed specifications to be used internallyand by suppliers; these are often cited, but they may not be public.
Where no standard fits the specialized critical cleaning or critical niche application, an EPA standard or a military or aerospace standard may be adapted. As such, it is crucial to establish a consistent protocol that is accepted by the pertinent people, organizations, and agencies. It is crucial that the rationale as well as the actual procedural changes be scrupulously anddefinitively documented.
Why is this so important? Suppose you work with an outside analytical laboratory, one where everyone knows about the agreed-upon modification. All is well, until a change in the lab or the lab analyst results in an incorrect protocol. Another problem may arise if someone, perhaps a quality inspector or even a purchasing agent, takes it upon himself or herself to make the requirement more definitive by omitting the required modification. Careful documentation, while tedious, is nearly the best solution. The absolute best solution is to set up a separate, formal consensus standard.
Safety and Environmental
You may be impacted by standards from unexpected sources. Air emissions requirements and process equipment requirements constitute compliance standards that companies must meet. People involved in the design, manufacture, and critical cleaning of products should regularly assess the potential impact of safety and environmental requirements. Regulatory standards restrict or even eliminate the use of effective cleaning chemistries. In some cases, the ideal chemistry from a performance standpoint may have an unfavorable worker safety profile or may be considered an environmental hazard. This is not surprising in that aggressive cleaning agents have the potential to be reactive not only with contaminantsbut also with the worker or the environment.
Plan ahead. All too often, in our consultancy, we see environmentally-challenged chemicals used in critical cleaning of the prototype. The assumption is that somehow, a miracle chemical will be discovered by the time the product is in full production. It is far more productive to look at cleaning and contamination control as well as safety and regulatory restrictions, as part of product development. Sometimes, the product can be slightly redesigned to allow effective use of less-aggressive cleaning agents. If this is not possible, it may be feasible to use well-contained cleaning systems. However, such systemsusually constitute an appreciable capital expense and careful process design.
An environmental regulatory ban or process restriction is not the only unexpected standard. Insurance companies may also set requirements for materials of construction that are, effectively, standards. The goal is to protect property, not necessarily to achieve the ideal setting to minimize contamination. Local fire departments may set standards restricting certain process activities. If such issues are addressed early in the product development stage, many contamination problems can be avoided.
Why use standards
The manufacture of critical products could not occur without standards. Standards provide a level of assurance of performance. Standards can serve as a competitivemarketing tool.
Standards also provide a common language. This common language allows companies in various locations that are engaged in several different manufacturing processes to communicate successfully with each other or with a common customer.
Standards may be developed in response to what is euphemistically referred to as catastrophic product failure. As devices become smaller and with more well-defined surface characteristics, proactive development of standards is desirable, especially where there are critical end-use requirements.
Of course, adhering to certain sets of standards may be required by internal company policy, customer requirements, design agency requirements, governmental mandates, and, last but not least, to meet stated product requirements.
Standards are tools for communication, comparison, and quality assurance that enhance simple or complex, multi-step manufacturing. It is important to factor in all applicable standards, including safety and environmental regulations. Standards are also fluid; and we cannot take them for granted. If you are positive you know what a standard is and why you adhere to every standard in your manufacturing, a quick web search is likely to provide food for thought. In our next column, we will discuss questions to ask about your own set ofstandards and the issue of relevance.
(a) Thanks to Paul Nesdore, Editor of “Controlled Environments Magazine®” for his thought-provoking questions.
B. Kanegsberg, E. Kanegsberg, and D. Albert. Controlled Environments, (October,2005).
Barbara Kanegsberg and Ed Kanegsberg are independent consultants in critical and precision cleaning,surface preparation,and contamination control.They are the editors of “Handbook for Critical Cleaning,”CRC Press.Contact them at BFK Solutions LLC., 310-459-3614;email@example.com;www.bfksolutions.com.