QMS & EMS London

The largest study of theatre cancellations was performed in 2006 at 123 VHA facilities with 9 surgical specialties. Of 329,784 cases, 12.4% were canceled, and investigators assigned cancellations to 1 of 6 broad categories of cancellation reasons (Table 3). These 6 cancellation categories are similar to another study, which grouped cancellations into: (1) patient; (2) capacity constraints; (3) work-up; and (4) required specialized personnel unavailable. Unless a predetermined and accepted classification system is used prospectively, cancellation data obtained from administrative databases may not provide enough meaningful explanation to understand root causes.

How well a surgical suite runs depends on whom you ask. Nurses working in the operating theatre may understand efficiency as individual knowledge and experience applicable to the care of the patient as well as preventing problems before they occur, whereas managers understand efficiency in terms of production per unit of time or completing assignments as planned. The hospital administrator may want the highest "throughput" of cases with the least total cost, and the surgeon often wants first-case-of-the-day block time, rapid turnover, a low cancellation rate, and cases that start on time.

From early in their careers auditors are taught that it is not the person but the process they are interested in. However, this approach does little to allay auditees’ concerns and audits continue to be perceived, at best, as a mild imposition and, at worst, a tortuous interrogation.  The technical aspects of conducting an environment audit are well defined, most notably by ISO 19011. It is often, however, the more intangible elements of human and social interaction that influence the quality and outcomes of an audit. Consequently, building rapport is a key skill for an auditor and an open dialogue needs to be established early in the process. 

Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Contained dust collection equipment is used in pharmaceutical facilities for a variety of reasons, from environmental compliance and employee health and safety to preventing cross-contamination of materials in multi-product manufacturing facilities. Given these concerns, and the fact that many pharmaceutical dusts are potent and/or hazardous, contained dust collection systems are found in the majority of pharmaceutical processing facilities today. Such systems typically utilize safe-change containment for both the filter cartridges (bag-in/bag-out) and the discharge system underneath the collector (continuous liner technology). 

Researchers working to design new materials that are durable, lightweight, and environmentally sustainable are increasingly looking to natural composites, such as bone, for inspiration.  Bone is strong and tough because its two constituent materials, soft collagen protein and stiff hydroxyapatite mineral, are arranged in complex hierarchical patterns that change at every scale of the composite, from the micro up to the macro. 

The European Medicines Agency divides the ICH harmonised tripartite guideline in five main paragraphs:  Pharmaceutical Quality System Management Responsibility Continual improvement of process performance and product quality Continual improvement of the pharmaceutical quality system Glossary

Quality Assurance is a vital part of drug development in the small pharmaceutical environment. It is the department which is responsible for ensuring that all the appropriate procedures have been followed and documented so that clinical progress can be made. Today we are analysing two representative quality management directives in Pharmaceutical Industry.

Manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs. Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. In spite of the fact that it is mandatory from the government and regulatory bodies, it is also a fact that quality of a pharmaceutical product can not be adequately controlled solely by pharmacopoeial analysis of the final product. Today quality has to be built in to the product right from its inception and rigorous international environmental, safety and regulatory standards need to be followed.

The interest in quality management in healthcare has increased in the last decades as the financial crises in most health systems generated the need for solutions to reduce costs while maintaining quality of care. The development of quality management procedures has been closely linked with healthcare reforms. Starting in the early nineties quality management issues took impulse in reform legislation only 15 years later.