**1. Introduction**

Definitions of quality within the literature are manufacture and user based. W. Edwards Deming believed the definition of quality has a user based perspective in that the product fulfils the needs and expectations of the customer [1]. Philip Crosby believed the system of quality, was prevention, and conformance to requirements and was manufacturing based ([2], p. 116). A mixture of both concepts derived from Deming and Crosby can be highlighted through David Garvin's perspective on the quality concept. He identified five approaches: *The transcendent,* a perspective that states quality cannot be defined exactly. *The product based view*, a perspective that states quality can be measured exactly through the desirable characteristics a product should possess. *The user based view,* stating that the customer judges quality. *The manufacturing based approach,* conveys production requirements and finally *the* 

*value-based approach*, whereby quality is defined in relation to cost and price [3]. All of these principles are easily applicable to the dairy industry.

Increasing consumer demands for high quality dairy products puts a burden on dairy producers to manufacture top grade product that is free from microbiological, chemical and physical contaminants. To comply with regulatory guidelines routine inspections are carried out from milk intake to finished product [4]. While milk composition is nutritionally important to consumers, its composition and safety is equally important to milk producers and processors [5], as the quality demands of the product will influence processing parameters and final yield [6]. Inspections are based on randomised sampling and process control samples, where analysis can occur hourly on the production line and on bags of finished product, all of which are outlined in a company's SOP and analytical test matrices. Test matrices are simple tools for visualising how often and for what analysis, a sample of product should be tested.

Total quality management (TQM), is an application of quality management principles that are applied to all aspects of a business. The food safety management system (FSMS) is an integral part of the TQM in any food manufacturing company [7], including dairy manufacturing plants [8], examples of which include, HACCP, FSSC (Food Safety System Certification Standard), IFS (International Food Safety Standard), SQF (Safe Quality Food) and ISO (International Standards Organisation). HACCP [9], is a global quality assurance system, ensuring products are produced in the safest way possible and are compositionally stable for product formulations [10]. The HACCP system is widely used across the Irish dairy industry. TACCP (Threat Assessment Critical Control Point) and VACCP (Vulnerability Assessment Critical Control Point) are relatively new concepts. Where HACCP prevents food safety issues [11], TACCP identifies deliberate infidelities to a food product [12], finally VACCP assesses how vulnerable various points are along the process chain [13]. The general scope of VACCP is that raw material supply chains are protected, and TACCP protects all aspects contributing to raw materials from intake to consumer; both go hand in hand [13].

Significant gaps however, can be seen across the dairy FSMS globally. For example, melamine is a crystalline compound made by heating cyanimide [14], in 2008, the Sanlu Dairy Company in China were responsible for adding melamine to watered-down milk. Melamine is rich in nitrogen and the addition of the poisonous substance was to increase the apparent protein content in the product. More than 290,000 people, mostly infants ingested the contaminated product, six infants died, before the Chinese government issued a product recall [15]. More recently, Lactalis, a multinational French dairy corporation, was involved in a contaminated milk scandal at the end of 2017, when infants ingested formula which was contaminated with *Salmonella agona* at their production plant in Craon [16]. Both of these scandals involved flawed quality management systems whereby production operators, laboratory technicians and management were aware of contamination issues, without taking steps to control production.

To ensure high yield and exceptional quality [17], quality systems in any food industry must be established from raw materials right through to finished product [18], with sampling inspection plans [19]. This is achieved through analytical testing and sampling strategies [20] which are governed by legislative and regulatory guidelines and standards. Generally, within the Irish dairy industry inspection is based on EU Directives and Regulations. The EU Regulation (EC) No. 178/2002, states that it is necessary to consider all aspects of the food chain as a continuum to ensure food safety, furthermore, it states scientific risk assessment alone cannot guarantee food

safety along the production chain and societal factors, environmental factors and '*feasibility of controls*' should also be considered [21]. Guidelines on sampling can be product or process based [22] and are routinely carried out from milk intake to finished product.
