23 International Quality Documentation Standards

Sudhanshu Joshi

1. Introduction

The value of a standard, that is to say a document in which the agreed requirements of a product or process for a given purpose are formulated, and the benefits that standardization can confer, are taken as recognized by all but the most incorrigible and sentimental of individualists.

A standard may prescribe or recommend one or more of the following features (Lloyd, 1959):

1. Dimensions or other magnitudes (size, shape, weight, &c.), to reduce unnecessary and wasteful variety and secure interchangeability;

2. Performance or quality, to ensure that a final product is fit for the job for which it is designed;

3. A method of test, to facilitate and improve the comparison of materials or products;

4. Terms and symbols, to provide a common and intelligible technical language;

5. Procedure or practice in the form of a guide or code setting out the most efficient way (usually the simplest way) of preparing, using, and maintaining a product or service.

1.1. The Evolvement of Standardization

Standard units of measure (dimensions, time, currency etc.) and standard formulas have been with us since Greek and Roman times, and no doubt earlier still in the ancient civilizations of Asia; medieval craftsmen developed their standards of workmanship, with the help of their guilds; military and mercantile interests were forced to standardize their ordnance and equipment, however rudimentarily and often with poor results. It was not, however, until the industrial revolution was well advanced that the need for national standards, as we now know them, began to be recognized in industry, largely by the pioneers at the turn of the century like Whitworth, Skelton, and Barry in this country. These were the kind of men who were instrumental in ensuring that the rapid technological advances of our own century should be matched by the services of national standardizing bodies like the BSI, aimed at the simplification and elimination of uneconomic diversity of materials, products, and procedures and the prevention of unnecessary waste. With the steady expansion of world trade and increasing national interdependence in cultural and other spheres (despite intervening wars), ever closer co-operation became essential in National Standards Associations (ISA), the forerunner of what is now the International Organization for Standardization (ISO), and, to match our modern age of electricity, the International Electrotechnical Commission (IEC)—both having in common the aims of promoting increased efficiency and interchangeability through simplification and standardization.

2. Global firms, Competitions and Process documentation

Increasing global competition shrinks profit margins. To survive in this turbulent environment, companies need to manage their processes effectively. The importance of process-oriented approach to the success of any business is very well documented (Garvin, 1995; Hammer, 2002; Zairi, 1997). A good management of process is very much dependent on how well it is understood. In turn, understanding of a process requires it be documented (Teece, 1998). Process documents can be classified into two: process flowchart/diagram and process map. Once developed in manufacturing environments, process documents are used in all types of organizations today (Davenport and Short, 1990). Some of these were blamed of being too technical and some others were blamed of being too simple to adequately represent the process under study (Symons and Jacobs, 1997). However, process analyzers never forgo them and improved over time. Today, process documents are the most commonly used tools for analyzing and improving business processes. They are also useful for process standardization. However, their use for standardization purposes has not been adequately addressed.

3. Defining Process Quality Documentation

Process documents can be classified into two: process flowchart/diagram and process map. These two basically serve the same purpose. However, process maps are used more often than process flow charts in recent years. One of the reasons for this trend is that many techniques used by industrial engineers for process flowcharting require the use of complex notational conventions that are often difficult for non-engineers to use effectively (Symons and Jacobs, 1997). The fact that flowcharting and data flow diagramming do not model interactions between activities is another reason (Savory and Olson, 2001). This was a serious shortcoming, because interactions are one of the most significant areas for improvement efforts (Hammer and Champy, 1993; Savory and Olson, 2001). Other disadvantages of data flow flowcharts/diagrams are: limited vocabulary; imprecision about the details of sequence and concurrency; list of only activities that occur if everything functions perfectly; no reveal of unproductive work due to errors, defects, and omissions; no identification of activities carried out as a result of failures found during test and inspection; and no visualization of costs and quality (Savory and Olson, 2001). Later, process maps were developed to overcome these disadvantages.

In terms of the level of detail, both process maps and flowcharts can be documented at macro and micro levels. Macro view illustrates the sequence of the main steps in a process. This may also be called as “single level process flowchart.” Symons and Jacobs (1997) indicated that simple, single level process flowcharts are frequently inadequate as a tool for in-depth process analysis. The second level, which is called micro view, is the map of one of the steps in the macro level. A micro level can become a macro level in its own right, as more detailed process analysis is needed. In addition to the micro and macro levels, Symons and Jacobs (1997) proposed a third level for an in depth process analysis. This level provides a brief explanation of any step in a micro view and a list of the process variables (e.g. machines). According to Symons and Jacobs (1997), the list of process variables is needed to gather and classify information in order to adjust the process and obtain a more consistent and higher quality product.

4. Purpose of Documenting a Process

The purposes of documenting a process Organizations may document their processes for the purpose of improvement, standardization, reengineering, and description. Some readers might also view standardization and re-engineering as an improvement. Considerable empirical evidence supports the notion that understanding of how a process operates is necessary before attempting any process related initiative (Teece, 1998). In turn, deep process understanding is often required to accomplish codification (Teece, 1998). In fact, Rohleder and Silver (1997) observe that appropriate flow diagrams are excellent devices to understand a process. The questions of “what is understanding?” and “how do we know whether we understand a process or not?” may come to mind at this stage. A review of the relevant literature suggests that understanding is to be knowledgeable about objects that make up an item. It is also being knowledgeable about causal relationships among these objects (Boykin and Martz, 2004; Bryde, 2003). In other words, it is the ability to see what kind of changes occur in an item as a result of changes on the interactions among its components. Standardization is an important benefit of process documentation. Well-defined process documents can be used to develop standard operating procedures (Bae, 1993; Symons and Jacobs, 1997). Standard operating procedures will help to achieve consistency in operations. In addition, they provide some administrative advantages. These include reducing conflict among current employees and training new hires regarding how a job should be performed. Process maps are most commonly used for process improvement purposes. Detecting value adding and non-value adding activities and simplifying work processes are the main reasons for using process documents for improvement purposes. Any process can be improved whether it has problems or not. As process documents give a clear picture of the process, process analyzers can easily see problems and improvement alternatives. The problems that can be detected by documentation are: overly complicated or unclear processes; a process producing defective output; unnecessary transportation/movement of products, workers, or customers; unnecessary inspections; waiting; duplication of effort; and unnecessary record keeping and data collection (Rohleder and Silver, 1997). After problems are identified and removed, a process is re-designed. Another use of process documents is for reengineering purposes. Reengineering is the fundamental rethinking and radical design of business processes to achieve dramatic improvements in critical measures of performance such as cost, quality, service, job satisfaction and speed (Hammer and Champy, 1993). In order to redesign a process, its current status must be understood well. Because of this, it must be documented. Process documents can also be used to describe a process. Description is used for training employees and sharing the process with other organizations.

5. Importance of Quality Documentation Standards in Operations Management

One of the key strategic decisions in operations management and in providing a competitive product is applying the correct quality techniques to assure that parts continue to meet the specified quality and design requirements throughout the product’s life cycle in a lean management fashion (Biswas and Sarker, 2008; Browning and Heath, 2009; Chan and Kumar, 2009; Grewal, 2008). As suggested by Butcher (2006), a great function of product design is to be able to project and embody the future rather than the present, where true added value comes from. Competition in the marketplace demands that companies develop and manufacture complex products with higher performance and quality at a lower price than before to stay competitive. Product life cycles have decreased, thus creating the need to develop new product development/new product manufacturability (NPD/NPM) processes and manage design change in a shorter period of time with no compromise on quality assurance (Pikosz and Malmqvst, 2000; Summers and Scherpereel, 2008; Swink, 1999, 2000). Leading manufacturers in their respective fields understand the importance of this and have developed new product and change quality control systems that maximize profitability for their organization. Song and Parry (1999), for example, created and tested a contingency model is used to examine the moderating affects of product innovativeness on new produce performance. Their model linked measures of product innovativeness, product synergy, development proficiency, product competitive advantage, and product performance. The model performance suggested that increases in product innovativeness weaken the influence of product synergies and development proficiencies on product performance. Through the four phases of the product’s life cycle different types of quality techniques will be required. In the development phase, extensive reliability testing and research will be required to assure design compliance to the quality and design requirements. As the product moves into the growth cycle, more focus will be placed on process quality and supplier quality. In the mature product phase and the end of life phase, quality becomes a process of optimization and cost reduction. As suggested by Dudek-Burlikowska and Szewieczek (2007), through all four cycles a critical aspect of product quality is determining the part quality sensitivity to minor changes and how those changes affect product quality and reliability. Competitive advantage goes deeper than just the quality of parts and products. Summers and Jones (2002) pointed to several areas to address when developing competitive advantage but for this comparison analysis, the author of the present study will only focus on the process of maintaining part quality and reliability as the component travels through a design change process.

This document provides guidance for the development, preparation and control of quality manuals tailored to the specific needs of the user. The resultant quality manuals should reflect documented quality system procedures required by the ISTA Accreditation Standard. The Q-documentation consists of at least the following three levels or parts also referred to as Document Hierarchy:

6.1 Quality Manual (Q-Manual) + annexes or appendices (comprising approximately 10-30 pages) The purpose of a Q-Manual is to outline the general policies and procedures for staff, customers, accreditation bodies and/or legal bodies to provide an overview of the laboratory’s quality system.

6.2 Documented quality system procedures such as Standard Operating Procedures (SOPs)

Standard Operating Procedures describe standard procedures in a concise manner to provide sufficient information to carry out the work concerned. The volume depends on the size of the laboratory, number of tests, number and qualification of staff and kind of equipment in use.

6.3 Other quality documents such as working instructions, forms, and reports working instructions give details on the standard procedure concerned. This may be e.g. species related information on a specific test method. Forms, checklists, reports related to a standard procedure should be provided where appropriate. Working instructions or specimen forms may be directly attached to the respective SOP if applicable.

Figure I : Document Hierarchy (Source: ISTA, 2010)

Exhibit I : Evolvement of Good Manufacturing Practices

	Good Manufacturing Practices
History	Established in 1970s. Attainment is the responsibility of senior managers – participation and commitment of staff in all departments and levels, including suppliers is required
Quality management synopsis	“To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented System of Quality Assurance (QA) incorporating Good Manufacturing Practice (GMP) and thus Quality Control (QC). It should be fully documented and its effectiveness monitored” (GMP, 2004)
Application	Manufacture of Goods and recently Service Developers are also moving towards GMP (including investigational products Prototypes used in testing and various stages).

(Source: McAdam,2007)

Exhibit II : Comparison of International Quality Standards: Their divergence and agreement

Quality Standards	Background	Problems
ISO 9000 Standards	The quality of North American automakers and suppliers has risen dramatically since these manufacturers realized in the late 1970s that vehicles made in Japan were selling well because they broke down less frequently than their USA counterparts. This improvement in quality was not achieved by concentrating solely on the quality of their products, but also by creating and maintaining a corporate culture which promoted quality. Thus far, this process has been guided through the standardization of their requirements using sets of quality guidelines developed by the International Organization for Standardization as a starting point. These days, the quality of the big three auto-makers is on a par with that of the Japanese. It appears unlikely that automakers will repeat their past mistakes and relax their quality standards if profits continue to rise. At the same time, ISO 9000 series registration assures customers that the products manufactured by their suppliers are produced under equivalent quality conditions. Since 1979, when ISO 9000 quality assurance standards were established, more than 40,000 manufacturing facilities have been registered in Europe (Devos et al., 1996). Although USA manufacturers have slowly responded to register their companies under this standard, there is a growing sentiment among some industries that the USA government will eventually give ISO registered contractors preferential treatment when awarding major contracts. The number of ISO 9000 registrations in the USA and Canada jumped to 3,600 companies in 1994, up 1,500 from 1993 and from 400 in 1992 (Davies 1994). In the last international ISO 9000 survey, the Mobil Survey, at least 127,389 ISO 9000 certificates had been issued in 99 countries worldwide up to the end of December 1995. This was an increase of 32,163 certificates over the end of March 1995 when the total was 95,266 in 89 countries	A major pitfall of ISO 9000 certification is that it does not necessarily guarantee a high-quality product, but only a consistent level of output quality. Critics also claim that the standard is too general to be very useful to specific industries and that adherence discourages creativity and free thinking, thereby setting back the quality movement. Certification is too costly for many small businesses, and skepticism about the administration of the programme in the USA has led some European companies to refuse to accept USA firms’ ISO 9000 certifications. Furthermore, there is a need for creating a single organization to accredit ISO 9000 registrars world-wide. Moreover, the certification does not ensure that a company has quality conscious employees or that customers accept its end product, but it does provide a framework in which a firm can work towards its quality goals (Ferguson, 1993). Some agencies are known to be more stringent than others. Certification by a company’s home country registration body does not necessarily guarantee acceptance in another country; however, with expanding support for the ISO 9000 standards, this problem should eventually be solved. Also, earning ISO registration involves registration – and consulting fees that can easily exceed $40,000, and the audit process can take eight to 18 months of preparation (Nichols, 1993). While the certification process succeeds in improving relationships between customers and suppliers, the add-on registration process apparently only serves to advertise the company and to provide an external review of its procedures. Companies’ preoccupation with ISO 9000 registration might cause them to lose sight of the quality standards’ objectives
ISO 9000 composition	ISO 9000 is composed of three quality standards that are models for quality assurance: ((1) ISO 9001: an international standard model for quality assurance in design, development, production, installation and servicing. (2) ISO 9002: an international standard model for quality assurance in production, installation and servicing. (3) ISO 9003: a model for quality assurance in final inspection and testing. In addition, it contains two sets of quality management systems guidelines: (1) ISO 9000: selected guidelines for the different 9001, 9002 and 9003 standards. (2) ISO 9004: guidelines for internal concerns of quality with technical, administrative and human factors views.
The American QS 9000	When the QS 9000 requirements were introduced in the USA in 1994, most companies believed the automotive standard would only concern first-tier suppliers to the big three. New data strongly indicates that a number of tier two and three suppliers may be among those companies seeking QS 9000 registration. Since the regulation may affect more than 20,000 first-tier production parts and service suppliers as well as their suppliers, a larger number of companies than expected will need to comply with the standard by the deadline, set for 31 December 1997	Not Generalized and acceptable by other countries
QS 9000 Composition	QS 9000 includes ISO 9000 standards as well as guidelines from the automotive industry. The big three argued that ISO 9000 had limitations, including a lack of a continuous improvement mandate, product quality guidelines, and worldwide reciprocity agreements. However, QS 9000 addresses these and other issues. An additional reason for developing QS 9000 was to standardize terminology. For example, there were often multiple terms for the same concept and single terms with various meanings. Also, a diversity of standards across countries, industries and companies, especially tier one suppliers, made unified quality difficult. Other problems were conflicting documentation requirements and various rating schemes. So in 1988, automotive task forces met to expand and improve ISO 9000. Eventually, the task force used Ford’s Q101 Quality System Standard, Chrysler’s Supplier Quality Assurance Manual, and General Motors’ NAO Targets for Excellence, together with the ISO 9001:1994 standard, to develop QS 9000 (quality system requirements, QS 9000 manual)
Purpose of QS 9000	The purpose of QS 9000 is to define expectations for quality systems for internal and external suppliers of production, service, parts, and materials. The goal for QS 9000 is the development of quality systems that provide for continuous improvement, while emphasizing defect prevention and the reduction of variation and waste. The QS 9000 is made up of three principle sections. The first incorporates ISO 9001: 1994 as a base set of requirements and is supplemented by the big three’s own interpretations. The second section includes specific requirements relating to the production parts approval process, continuous improvement, and manufacturing capabilities. Section three outlines areas where Chrysler, Ford, and General Motors do not agree and details their specific requirements.
The French EAQF	In 1987, the French automakers Renault, Peugeot and Citröen agreed on a common document, outlining the procedures that gave their suppliers the total responsibility of quality, referred to as the Assurance Qualité Fournisseurs (AQF) (Gorgeu and Rene, 1996). This common document later evolved into a more elaborate standard, called Référentiel d’Evaluation d’Aptitude Qualité Fournisseurs (EAQF), which classifies suppliers into different grades of conformance to preset criteria.	Synchronization with existing Standards
Versions of EAQF	The 1990 version of EAQF covered 20 sections for a total of 173 requirements relating to the quality control of, respectively, product conception, process conception, production, and external suppliers. The latest 1994 version includes two additional sections on security and the financial aspects of quality	Synchronization with existing Standards
German VDA 6	The German Verband der Automobile industries: Band 6 (VDA 6 standard) was developed as an improvement to the ISO 9000 series in September 1993. The improvement addresses the cost aspect of quality, as well as product safety and reliability. Furthermore, it allows for a differential attainment of conformance to the standard, classified as A, AB, B, or C level of conformance. The future version VDA 6.1 furthermore will include requirements that mimic QS 9000 standards.

(Adopted from: Selen, 1997)

7 Animation: Quality Documentation Standards (U-tube) https://www.youtube.com/watch?v=aZOMa2Qgn4s

8 “Standardization” in processes

The ‘Big Five’ are of course the International Federation for Documentation (FID), the International Council of Scientific Unions—and especially its Abstracting Board (ICSU/AB), the International Federation of Library Associations (IFLA), the United Nations Educational, Scientific and Cultural Organization (Unesco)—especially its Department of Documentation, Libraries and Archives, and the International Organization for Standardization (ISO)— especially its technical committee (46) for documentation, the committees for paper, terminology, photography, data processing, office machines and (in process of formation) printing technology. At the national level these are joined with, respectively and especially, Aslib, the Royal Society, Library Association, DES and BSI Documentation Standards Committee OC/20. Linked with these central bodies are large organizations with a special subject focus who nevertheless have a wide interest in information standards, such as International Atomic Energy Authority; broad bodies with a particular interest, such as ICAO and pictograms, or NATO and commodity codes; regional organizations such as European Standards Co-ordinating Committee (CEN) for the thirteen Western European countries or Comecon for the CEMA Warsaw Pact countries; and all manner of smaller centres with a special interest, such as the International Cartographic Society or the International Council for Reprography. These are supplemented by a network of tripartite and bilateral agreements between individual countries, such as UK/USA, UK/Poland, UK/USSR, UK/France/Germany.

Suggested Readings:

(a) Greasley(2009): Operations Management. Wiley.

(b) Monks(1996): Schaum’s Outline of Operations Management. McGraw-Hill Education

(d) Heizer and Render (2008): Operations Management. Prentice Hall.

(e) Foster and Sampson (2015): MyOMLab with Pearson e-Text.-For Managing Supply Chain and Operations.