INTRODUCTION:

Naturally, unless those standards are acknowledged by all as being adequate gauges of quality, there is no point in saying that a product fulfils them. So-called National Standards Organizations were founded and given the task of creating precisely these accepted national standards in response to the demand for internationally recognized indicators of performance and quality. These national organizations are numerous now, and there are literally hundreds of goods for which recognized standards have been established.

In reality, the British Standards Institution's well-known "Kite Mark" was first used to protect consumers by certifying that goods had been produced in accordance with the relevant British Standard. The Kite Mark is essentially a method of product certification.

Yet, the adoption of national standards was not solely fuelled by consumer demand. For criteria like screw threads, pipe widths, and other specifications, industry "norms" or standards were established as early as the Victorian era, when it was understood that some form of standardization was necessary for the survival of British industry. Alongside the development of these standards came the idea of "inspection," and to fulfil this role and ensure that goods were produced in accordance with established norms and standards, specialized organizations like the Institute of Engineering Inspectors (incorporated in 1922)—now known as the Institute of Quality Assurance—were established.

The Rise of Quality Assurance Standards.²

The demands for inspection and certification increased along with the complexity of products produced industrially. After the end of two world wars and the rising sophistication of military and aeronautical equipment, the situation became especially out of control. There were issues with late delivery, incompatibility, and component failure in the United States in particular, where there were numerous complicated engineering projects underway (with components coming from many different suppliers).

A number of military standards (MIL standards) and later, in the UK, defines standards (DEF STAN 05-21/1, "Quality Control System Requirements for Industry") were created specifically for this purpose. As a result, it was realized that some sort of overall management control and coordination was necessary. The modern quality assurance standards were really based on these original military specs. These were vital because they made it possible to distinguish between the old quality control and inspection environment and the new quality assurance concept, which ensures total quality and control. The fact that the outdated inspection-based systems were no longer entirely adequate was acknowledged throughout industries, not only those related to the military and aerospace. At the time, large nationalized industries in Great Britain—such as British Gas, British Rail, The Coal Board, British Steel, etc.—were looking for a system that would allow them to have upfront assurance that any goods or services they purchased would be delivered on time, within their budget, and to a predetermined level of quality. Because of their size, these buyers understood that a system of quality assurance could give them the assurance they required (before making a financial commitment) and thus played a significant role in the introduction of quality assurance to British business.

British Standard 5750³

A British Standard for Quality Assurance (BS 5750, "Quality Systems") was produced in 1979 as a result of the creation of a government white paper on the topic. It included a summary of the controls that it stipulated must be implemented before a supplier can assert that it is a "quality assured" organization. An organization could not be accredited to BS 5750 until it had been inspected (and formally accredited) against the standard by an independent authority (such as the British Standards Institution), just like with the registration of products to a specific standard.

BS 5750 is a type of company certification, as opposed to the Kite Mark, which is a method of product certification. The standard outlines all of the "components" of the management system that are seen as essential to the final product's quality, as well as how they should be controlled.

Although the engineering sector continues to dominate, a number of organizations have established quality systems that are in line with BS 5750 standards, despite the industry's initially delayed adoption of the standard. In fact, BS 5750 has come under growing fire for its continued emphasis on engineering and industrial settings, as can be seen by a simple glance at the standard's index. Several non-engineering and service sector organizations, in particular, have sought a more widely based standard or guideline in recent years after realizing that the principle of quality assurance is in fact applicable to any organization.

A variety of QAS (Quality Assurance Schedules) have been developed to supplement and magnify the standard in an effort to take into account the opinions of these various industry sectors.

For instance, Schedule No. 8 contains certain extra standards and information on how to interpret the standard's criteria for these organizations and was prepared expressly for the service sector companies. The complete standard was rewritten in 1987, reissued, and had a considerable format change. The text has been updated to be exactly the same as the ISO 9000 and EN 29000 equivalent international and European standards.

In 1996, BS 5750 is scheduled for another significant update, and the ideal format and scope are currently the subject of very interesting discussion. It is important to highlight that the nuclear industry has had its own Quality System Standard for a while. The specification for a total quality assurance program for nuclear power plants in the UK is known as BS 5882, and it shares the same principles as BS 5750.

Components of Quality Assurance. ⁴

1.Setting up the system

There isn't just one way to set up a QA system. Every organization has unique issues that call for careful thought and preparation. However, a strategy must be created once the decision to establish a QA system has been made and the appropriate resources and facilities have been made available. A QA system can be created before the start of a new project, but it can also be retrofitted to an existing project. In the latter case, current practices must be assessed in light of any existing QA checks and processes as well as QA needs. It is preferable to improve upon existing practices and to only get rid of them if they are obviously inadequate. If too many changes are implemented too rapidly, especially if they are perceived to add to the workload, they are unlikely to be well received and will be poorly implemented. The QA programme must be viewed as realistic and practical, and it must not include tasks that are pointless, overly laborious, or difficult (WHO/UNEP/VKI, 1997).

The Quality Manual⁵

The management documents required to implement the QA program are included in the Quality Manual (ISO, 1990) and include:

· A quality policy statement, including objectives and pledges

· The project's organizational and managerial structure, its relationship to any parent organization, and any applicable organizational charts

· How management, technical operations, support services, and the quality system interact.

· Techniques for maintaining and controlling documentation

· Job descriptions for important employees and references to other employees' work descriptions.

· A list of authorized signatures

· Steps taken to ensure the traceability of all documents, information, and reports.

· The range of tests and calibrations the lab can perform

· Plans to make sure that every new project is examined to see if there are enough resources to manage it effectively.

· A mention of the techniques utilised for calibration, verification, and testing

· Protocols for handling calibration and test items

· Mention of the main apparatus and measurement standards used as references.

· A mention of the equipment calibration, verification, and maintenance processes

· Mention of methods for verification, such as inter-laboratory comparisons, proficiency testing programs, usage of reference materials, and internal quality control plans

· The steps that must be taken in the event any testing discrepancies or departures from documented processes are discovered.

· The complaint processes

· Policies to safeguard privacy and property rights

· Audit and review protocols.

Training ⁶

The entire team must be involved in the program's development. The management often commits resources, sets policies and standards, approves plans, delegated duties, and upheld accountability. The operating team offers technical guidance and knowledge, while the supervisory staff is in charge of developing and implementing the program. The operations staff must always be consulted regarding the feasibility of any changes that are suggested. They must also inform management of any issues or modifications that might have an impact on the program.

Standard Operating Procedures ⁷

Standard Operating Procedures (SOPs) are the written descriptions of all particular procedures, such as sampling, transportation, analysis, use and calibration of equipment, generation of reports, and data interpretation. They should include every pertinent step because they are the internal reference manual for the specific method. Anyone with the necessary training should be able to adhere to the SOP. Other SOPs should be cross-referenced as needed, and they should be identified by number. In cases where a commercially available method is utilised, method SOPs may come from organizations like the International Organization for Standardization (ISO), the British Standards Institution (BSI), the American Standard Technical Method (ASTM), or from the test kit's instructions. Since they don't need to be verified, these SOPs have the benefit of saving time when writing "in-house" SOPs. If they are utilized, they must be done so without alteration. If any modification at all takes place, the alterations must be documented. Sometimes “in-house” methods are preferred, and it is vital that such methods are properly verified. This may be done by reference to scientific literature or by “in-house” validation.

Short, simple sentences should be used to describe the technique. Equipment SOPs should outline the procedures to be followed for upkeep, cleaning, calibration, and servicing. With the exception of fully documented SOPs, method SOPs should contain all the information required to complete the procedure without referring to additional papers.

Any claims made about the acceptable ranges for measurement variables like temperature, weight, etc. should be within the bounds of the facility, i.e., not be too broad to alter the outcome but also not be too narrow to not be possible or essential. Any equations and evidence of statistical control should be included in the calculations. Where appropriate, acceptable ranges and criteria for data acceptance should be stated. Reagent, test, and other consumable disposal procedures should be described as well.

Some SOPs will be customized, such as those for office procedures. The SOP should be written by the individual who is most technically capable of performing the given operation. An SOP should have a clear title, a distinct reference, and a version number. The variables measured, the expected range of values, the method's restrictions, and the anticipated precision and accuracy should all be listed along with the SOP's purpose. All documents pertaining to the method's origin should be cited.All predictable risks associated with the procedure should be listed in the safety notes, along with steps to reduce those risks and emergency plans. Together with details like the grade, reference number, size, and company of origin, any particular training needed for the operator and special equipment needed for the technique (including all reagents and supplies needed) should be indicated. The SOP should include all aspects of sample handling, storage, recording, and disposal, including storage temperatures, sample splitting, traceability, and any other concerns. Where relevant, the style and format of the final data report should be included, as well as the reporting processes and any archive requirements.

The Quality Assurance manager ⁸

A QA manager must be hired for larger projects in order to properly manage QA. This manager will communicate with staff, manage data archives, carry out routine audits and reviews, and report on any QA issues. The manager is in charge of frequently auditing every part of the system to verify compliance, reporting on these audits and inspections to management, and making recommendations for changes. Regular facility and process inspections, sample and document tracing, and other similar tasks are part of these activities.

Several management challenges are reduced when QA is handled by a separate unit within an organization. A small organization may find it challenging to hire a full-time QA manager; in these situations, a capable employee should be given part-time responsibility for QA.

Auditing and checking compliance. ⁹

The QA system ought to be implemented after all the necessary documentation is in place. A series of audits covering all facets of the system should be carried out during this time by the QA manager. Data traceability is a crucial factor that may be verified by randomly selecting data and tracking them via all pertinent documentation to the sampling process. At the conclusion of the pilot phase, an assessment of the system that clearly identifies both its positive and negative aspects should be produced.

Applying for accreditation from a recognized QA system is one way to implement The ISO 9000 standard, which is readily available in many nations, is appropriate for the monitoring program as a whole. Although expensive, these solutions enable the QA program to be independently evaluated in comparison to a predetermined standard. Occasionally, official accreditation is required by regulatory and commercial authorities.

Maintaining Quality Assurance. ¹⁰

Each component of the system must be frequently checked for compliance in order to sustain the QA system. This entails evaluating the component pieces to check whether they continue to meet the original standards. This process has to be previously recorded. Management and the people in charge of the relevant work should have access to all audit reports. Any deviations from the necessary criteria must be remedied right away. The audit must be thorough, unannounced, and independent.

REFERENCE:

1. https://www.researchgate.net/publication/237287165

2. https://www.researchgate.net/publication/241318869

3. Briggs, R. 1996 Analytical Quality Assurance in Water Quality Monitoring. World Health Organization, Geneva.

4. HMSO 1994 The Microbiology of Drinking Waters. Report 71. Her Majesty's Stationery Office, London.

5. ISO 1984 Development and Operations of Laboratory Proficiency Testing Guide 43(E), International Organization for Standardization, Geneva.

6. ISO 1994 Quality Management and Quality Assurance - a Vocabulary. International Organization for Standardization, Geneva.

7. ISO 1990 General Requirements for the Competence of Calibration and Testing Laboratories. Guide 25. International Organization for Standardization, Geneva.

8. Shewhart, W.A. 1986 Statistical Method from the Viewpoint of Quality Control. Dover Publications, New York.

9. WHO 1992 GEMS/WATER Operational Guide. Third Edition, World Health Organization, Geneva.

10. WHO/UNEP/VKI 1997 Analytical Quality Assurance and Control. World Health Organization, Geneva.

Received on 27.03.2023 Modified on 13.04.2023

Res. J. Pharmacology and Pharmacodynamics.2023;15(2):73-76.

DOI: 10.52711/2321-5836.2023.00015