A standard may be understood as a document that contains guidelines, rules and requirements set out for a service, product or a process. It is created after a mutual consensus between relevant stakeholders, and is normally approved by an acknowledged body. The main purpose of having a standard is to create a substantial degree of order in a certain framework. Standardisation may be understood as the creation, issuance and implementation of a standard.
Standards and standardisation are relevant in international trade, health and safety as well as consumer rights. In international trade, they assist in the elimination of trade barriers; sellers are able to take their goods to different markets around the world more freely (ANSI, 2011). When a manufacturer has adhered to a recognised standard, consumers can be assured about the quality of a certain product even if it was manufactured outside their own country. They need not worry about the reliability and safety of the commodity either. Disputes over specifications can also be easily resolved. By doing this, technical barriers to trade can be eliminated.
Standards are often updated depending on the level of technological development (UNIDA, 2006). They often reflect the status of science and experience within a certain field. Businesses can develop their products on the basis of these specifications, and therefore have a worldwide market. By achieving this, standards tend to act as mechanisms for technology transfer. International trade can also be facilitated through standards because they provide governments with a mechanism for assessing the environmental, health and safety legislations in their own country so as to make them more reliable and safe.
Standards are crucial in promoting the health and safety of workers because they ensure that the service or product under analysis will not destroy lives or property (Sanders, 1990). Standardisation involves analysis of products, services and processes for possible misuse, and thus prevents occurrence of the same. For instance, foods can be assessed for presence of poisonous substances, or electrical devices can be assessed for the presence of lead or other dangerous chemicals.
If standards did not exist, then consumers may have been exposed to these products without proper knowledge. Safety does not only include the safety of consumers; workers are also involved in it too. For instance, there are flame-proof standards for mining equipments; they ensure that miners are protected from fires when carrying out their tasks. Additionally, when workers are using medical devices, they can also be protected from exposure to harmful radiations through relevant standards (Skipp & Heydn, 1997).
Preservation of consumer rights is also another critical benefit of using standards. Standards often ensure that the product under consideration has fitness for purpose (Thareja & Thareja, 2007). It should be able to carry out a certain purpose under particular conditions. Many consumers tend to be dissatisfied when their expectations about a certain product or service are unmet. This subjects them to lower quality or other deficiencies. Standards allow producers or sellers to identify the optimum criteria for performance and conform to those conditions.
Standards ascertain that consumers are not subjected to unfair trade practices or deceptive advertising. They work by protecting them against dangerous products as well. If standards did not exist, then consumers would be subjected to untruthful information from large corporations. Issues such as the correct packaging and labelling of products can also be facilitated through the standardisation process. It is likely that buyers may also have been billed incorrectly or their personal information may have been misused by organisations. Standards ascertain that these issues do not occur.
Business excellence models: Malcolm Baldrige Award and Deming Award
Malcolm Baldrige award was created in order to promote the awareness of quality, and share information concerning the benefits and strategies involved in quality provision. Conversely, the Deming award was created in order to commend companies that have made major advancements in quality control.
This award is much older and more prestigious than the Malcolm Baldrige Award because it was established immediately after the Second World War. The Baldrige award focuses on private and for profit organisations alone while the Deming award dwells on both private and public organisations. The geographical areas that use these awards are also different. Deming is based in Japan while Baldrige focuses on companies in the US (Balvir, 2011).
The main difference between the Baldrige award and the Deming prize is its understanding or definition of quality. The Baldrige award defines quality from the customer’s perspective, so the customer is the driver in this process. The award requires that firms liaise with their customers in order to get feedbacks that can lead to improvements. Organisations are also expected to know what their consumers want in order to cater to those wants in the form of products.
Quality in the Baldrige award is also created by forging a long term relationship with one’s clientele in order to ease their maintenance, use, and delivery of the product or service. On the other hand, quality is understood as a way of conforming to specifications in the Deming Prize. This means that the prerogative is on the producers to drive change or meet these quality expectations. It is assumed that customers will always be satisfied if a producer has adhered to those specifications. Therefore, one can say that for the Deming prize, quality is defined by statistical quality control rather than customer satisfaction.
In each of these awards, there are usually grading criteria, which are determined by the orientation of the award. Results are a big deal for the Baldrige award while the actual process is granted lesser consideration. However, the reverse is true for the Deming prize. These assumptions essentially define what is given more precedence during grading. Leadership is more important in the Baldrige award while management is the central focus in the Deming award.
Issues such as leadership technique or style, allocation of resources and policy are graded for Baldrige since the focus is on the strategies for quality improvement. However, for Deming award contestants, one must illustrate sound management through interdivisional cooperation, quality control diagnosis and explicit scope of managerial authority. Since leadership is harder to define than management, then it can be stated that the Deming Prize is more rigid in its application.
In grading, a lot of precedence is also given to information analysis in the Baldrige award, but this is not true for the Deming prize. In the latter category, collection and dissemination are of greater importance. Baldrige award contestants need to analyse their distributor’s or subcontractor’s data. Customer data analysis is also graded. The organisation under consideration needs to demonstrate use of information on services and products.
While information use is also analyzed under the Deming prize, it is important to note that emphasis is usually on the technical aspects of information management. For instance, assessment of the speed of information transmission and prevalence of actual information transmission is normally done. Furthermore, the statistical component of information analysis is also graded. In the Baldrige award, the different functions or departments that use the information are given more precedence. For Deming prize contestants, no one is expected to demonstrate that distributors’ or customers’ feedback were actually used (Thareja & Thareja, 2007).
Baldrige and Deming awards both look at results as a grading criterion. However, their approach to this component is also substantially different. For Baldrige, companies need to demonstrate that they have reduced the claims and complaints made against the quality of their products or services (Hendricks & Singhal, 1996). They need to show that they have reliability as a suitable quality in their offerings, and that rejection, scrap or reworks are kept at a minimal level.
Deming prize contestants also need to illustrate that they have dealt with defects; however, the major difference between the two is that instating measures to overcome defects is more important in this latter award than measuring the actual number of defects. Furthermore, measures of costs, safety, profits, delivery time and environmental concerns are looked into as part of the product outlook. Once again, a statistical component is imminent in results grading for the Deming prize, while more customer –related concerns are covered by the Baldrige awards.
Quality assurance standards
All three standards (ISO 17015, GMP, and HACCP) are designed in order to safeguard the safety and health of consumers. If products can pass all the tests involved in these standards and procedures, then it can be ascertained that they are of good quality (Feldman, 2005). Additionally, all quality assurance standards have a series of steps that will determine whether the product will be accredited or not. They are also internationally recognised.
ISO 17025: 2005 is narrower in scope than the other guidelines because it is designed to cover a smaller range of industries and sectors. These refer to forensic science, general analytical work, and calibration services. However, these industries are divergent, so it is difficult to define exactly what the requirements are when dealing with them. During creation of this standard, it was imperative to get to a consensus among the stakeholders involved, so one could not be too specific. Conversely, HACCP is a pharmaceutical and food safety quality assurance model that is more specific than ISO 17025. Good manufacturing practices are many in number, but their guidelines are specific when focusing on a particular type of practice (EU, 2011).
Hazard Analysis and critical and control points are governed by preventive principles rather than end point inspection of the product (Miller & Miller, 2000). ISO 17025 for laboratory work entails compliance across the entire workflow process. The same thing can also be said about good manufacturing practices. These quality assurance standards are implemented under the assumption that being proactive is more important than being reactive. By eliminating risks at each step of the production process, one can be assured of a safe and high quality product (International Organisation for Standardisation, 1993). However, it should be noted that HACCP covers the whole manufacturing process, and so does GMP. However, ISO 17025 standards are more limited in their scope because they only involve laboratory processes; no manufacturing is covered here.
The seven principles of HACCP deal with procedural components of the production process. For instance, principle one talks about doing a hazard analysis of the food or drug hazards, while principle four talks about establishing control limits in which one can have a maximum value that is permissible for any hazard (Newcomb, 2010). Therefore, practical or specific components like buildings or equipments have not been mentioned explicitly in the standard. The impetus is placed upon the manufacturer who must define where the critical points will be.
This makes HACCP less prescriptive than GMP. For Good Manufacturing Practices, the components or points that will be the focus of inspection have been specifically laid out. For example, building facilities, equipment, and raw materials are some of the areas that need to be checked by firms that adhere to GMPs (FDA, 2011). This makes the standard more prescriptive. ISO 17025 standards have also explicitly stated the areas that need to be inspected or analysed. The sampling plan, sampling identification, and record keeping are some of the components that ought to be targeted during preventive actions (Farrant, 1997). Therefore, these parts have already been chosen for the laboratory analyst.
All three standards require taking preventive actions after scrutinising the system. In ISO 17025, this needs to be done by controlling non conforming laboratory tests. In HCAPP, this occurs through corrective actions when the critical limit has been exceeded (Sperber & Stier, 2010). In GMP, this entails identifying raw materials that do not meet control standards, or using complaints in order to check whether certain products have met their specifications.
Business excellence models (BEMs) and quality assurance standards (QAS) both strive to promote quality in organisations; however, quality assurance models do this in the form of certification while business excellence models give awards to the best performers. Therefore, the BEMs recognise the best of the best while QAS are used by any organisations. In fact, this kind of focus explains why BEMs cover a wide range of industries while QAS are limited to particular industries. For QAS, the focus is on risk elimination, while this only forms a small part of the grading criteria in BEMs. Nonetheless, both strategies emphasise the importance of having an organisation-wide or holistic approach during implementation as this gives full-proof results.
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