3.1: Quality Systems in the Workplace and in Research Labs

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Jack O'Grady
Austin Community College

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Quality Systems in the Workplace

File:DMAICWebdingsI.png — Figure \(\PageIndex{1}\): Six Sigma DMAIC Diagram by Penfield, Wikimedia, CC BY 2.0). (Penfield, 2014)

“A Quality System is the organizational structure, responsibilities, procedures, processes, and resources that together ensure the quality of a product or service.” (Summers, 2010). The goal of all quality management systems is to encourage companies to: “…say what you are going to do, do what you say, be able to prove it and then improve it…” To meet the needs of the company, its customers, and the regulatory body, a quality management system needs to be accountable, dynamic, and efficient.

It is important to note here; not all quality management systems are the same. The type of system in any given company will depend on the size of the business, the nature of the firm, and the product they are selling. In cases when a company is producing a federally regulated product, the company must follow Current Good Manufacturing Practices (CGMP) governed by the FDA. Other quality systems, such as the ISO9000 system, and 5S system, are voluntary and assist a company with its business and production processes to achieve increased competitiveness and customer satisfaction. In this chapter, you will be introduced to a few of the most prominent and influential quality management systems found in bioscience companies, both regionally and nationally.

Quality Systems in Research Labs

Academic research labs are usually self and peer-monitored in their quality systems. Government oversight is rare because these labs are not producing any product for public consumption. Instead, academic labs focus on the pursuit of knowledge. Furthermore, quality procedures in the university setting are based on following the empirically established, time-tested methods of “good science.” In this regard, a certain level of quality is inherent in academic research. Results are judged through peer-reviewed publications and grant funding. The poor-quality research will be rejected by the scientific community (peer-review publication), and unsuccessful nonproducing projects fail to gain funding or will lose funding.

Research Labs Associated with industry

These labs adhere to the regulations and standards related to the product they are researching. The research department of a pharmaceutical company must follow the guidelines set out by the FDA and frequently submit to FDA inspections of their process and records, which may include research laboratory notebooks and research & development reports. Companies not regulated by the FDA may choose to implement a voluntary quality system such as ISO9000, 5S, or Six Sigma.