SIL Analysis for Manufacturers of SIF Components

PresentationSafety systems comprising of electric, electronic, and/or programmable components have been used in various industries over the years. A typical safety instrumented function (SIF) consists of a sensor to detect a process upset, a logic solver to compute the required action, and a final element to affect a change in the system to bring it back to safe state. IEC 61508, “Functional safety of electrical/electronic/programmable electronic safety related systems”, was first released in 1998 and provides a robust framework for the development and implementation of such functional safety systems. Since the integrity of the overall safety instrumented system (SIS) is dependent on the integrity of the components that comprise it, manufacturers of these components have a critical role to play in the functional safety lifecycle of a SIF. Increased focus on safety and reliability has led a lot of end-users to request functional safety analyses, so many manufacturers of sensors, logic solvers, and final elements for safety systems are now being asked by their customers to provide components suitable for safety integrity level (SIL) systems, along with the necessary documentation to prove their components’ reliability. To meet the technical requirements set by their customers, many manufacturers choose to rely on third party functional safety experts to provide SIL analysis and certification services. This presentation discusses the benefits and drawbacks of certifying components with respect to SIL, and also some common challenges that manufacturers face in meeting the requirements set by IEC 61508. The presentation also provides recommendations for manufacturers seeking to perform a SIL analysis and/or certification for their products. Finally, it presents the overall utility of a functional safety analysis, which goes beyond meeting SIL requirements. A robust SIL analysis can help manufacturers analyze their product design and manufacturing processes from a reliability perspective, help limit failures in the field, and facilitate better understanding of the overall safety system

Data integrity within the biopharmaceutical sector in the era of Industry 4.0

Data Integrity (DI) in the highly regulated biopharmaceutical sector is of paramount importance to ensure decisions on meeting product specifications are accurate and hence assure patient safety and product quality. The challenge of ensuring DI within this sector is becoming more complex with the growing amount of data generated given increasing adoption of process analytical technology (PAT), advanced automation, high throughput microscale studies, and managing data models created by machine learning (ML) tools. This paper aims to identify DI risks and mitigation strategies in biopharmaceutical manufacturing facilities as the sector moves towards Industry 4.0. To achieve this, the paper examines common DI violations and links them to the ALCOA+ principles used across the FDA, EMA, and MHRA. The relevant DI guidelines from the ISPE's GAMP5 and ISA-95 standards are also discussed with a focus on the role of validated computerised and automated manufacturing systems to avoid DI risks and generate compliant data. The paper also highlights the importance of DI whilst using data analytics to ensure the developed models meet the required regulatory standards for process monitoring and control. This includes a discussion on possible mitigation strategies and methodologies to ensure data integrity is maintained for smart manufacturing operations such as the use of cloud platforms to facilitate the storage and transfer of manufacturing data, and migrate away from paper-based records

Food supply chain stakeholders' perspectives on sharing information to detect and prevent food integrity issues

One of the biggest challenges facing the food industry is assuring food integrity. Dealing with complex food integrity issues requires a multi-dimensional approach. Preventive actions and early reactive responses are key for the food supply chain. Information sharing could facilitate the detection and prevention of food integrity issues. This study investigates attitudes towards a food integrity information sharing system (FI-ISS) among stakeholders in the European food supply chain. Insights into stakeholders' interest in participating and their conditions for joining an FI-ISS are assessed. The stakeholder consultation consisted of three rounds. During the first round, a total of 143 food industry stakeholders-covering all major food sectors susceptible to food integrity issues-participated in an online quantitative survey between November 2017 and February 2018. The second round, an online qualitative feedback survey in which the findings were presented, received feedback from 61 stakeholders from the food industry, food safety authorities and the science community. Finally, 37 stakeholders discussed the results in further detail during an interactive workshop in May 2018. Three distinct groups of industry stakeholders were identified based on reported frequency of occurrence and likelihood of detecting food integrity issues. Food industry stakeholders strongly support the concept of an FI-ISS, with an attitude score of 4.49 (standard deviation (S. D.) = 0.57) on a 5-point scale, and their willingness to participate is accordingly high (81%). Consensus exists regarding the advantages an FI-ISS can yield towards detection and prevention. A stakeholder's perception of the advantages was identified as a predictor of their intention to join an FI-ISS, while their perception of the disadvantages and the perceived risk of food integrity issues were not. Medium-sized companies perceive the current detection of food integrity issues as less likely compared to smaller and large companies. Interestingly, medium-sized companies also have lower intentions to join an FI-ISS. Four key success factors for an FI-ISS are defined, more specifically with regards to (1) the actors to be involved in a system, (2) the information to be shared, (3) the third party to manage the FI-ISS and (4) the role of food safety authorities. Reactions diverged concerning the required level of transparency, the type of data that stakeholders might be willing to share in an FI-ISS and the role authorities can have within an FI-ISS

HACCP based quality assurance systems for organic food production systems

HACCP provides an effective, logical and structured means of assuring food safety. Although first used in food manufacturing operations, HACCP can be – and, increasingly is – applied to food production and handling operations at all stages in the food chain. This includes the primary production sector. The purpose of this paper is to illustrate how the principles of HACCP can be applied to organic production with special reference to the primary sector

Characterisation framework of key policy, regulatory and governance dynamics and impacts upon European food value chains: Fairer trading practices, food integrity, and sustainability collaborations. : VALUMICS project “Understanding Food Value Chains and Network Dynamics” funded by EU Horizon 2020 G.A. No 727243. Deliverable D3.3

The report provides a framework that categorises the different European Union (EU) policies, laws and governance actions identified as impacting upon food value chains in the defined areas of: fairer trading practices, food integrity (food safety and authenticity), and sustainability collaborations along food value chains. A four-stage framework is presented and illustrated with examples. The evidence shows that European Union policy activity impacting upon food value chain dynamics is increasing, both in terms of the impacts of policies upon the chains, and, in terms of addressing some of the more contentious outcomes of these dynamics. A number of policy priorities are at play in addressing the outcomes of food value chain dynamics. unevenness of the distribution of profit within food value chains, notably to farmers. Regulation of food safety and aspects of authenticity has been a key focus for two decades to ensure a functioning single market while ensuring consumer health and wellbeing. A food chain length perspective has been attempted, notably through regulations such as the General Food Law, and the rationalisation of the Official Controls on food and feed safety. However, there are still gaps in the effective monitoring and transparency of food safety and of food integrity along value chains, as exemplified by misleading claims and criminal fraud. This has led to renewed policy actions over food fraud, in particular. EU regulations, policies and related governance initiatives provide an important framework for national-level actions for EU member states and for EEA members. The more tightly EU-regulated areas, such as food safety, see fewer extra initiatives, but where there is a more general strategic policy and governance push, such as food waste reduction or food fraud, there is greater independent state-level activity. Likewise, there is much more variation in the application of both national and European (Competition) law to govern unfair trading practices impacting upon food value chains. This report presents the findings of a survey of members from the VALUMICS stakeholder platform, that were policy facing food value chain stakeholders across selected European countries, including both EU and EEA Member States. The survey was conducted to check the significance of the main policies identified in the mapping exercise at EU and national levels and so to incorporate the views of stakeholders in the research. The responses suggest the policy concerns identified in EU and national-level research resonate with food value chain stakeholders in participating nations. The report concludes by exploring in more detail how the themes of fairness and of transparency are being handled in the policy activities presented. Highlighted are the ways that both fairness and transparency can be extended within the existing frameworks of EU policy activity. The findings in this report provide an important context for further and detailed research analysis of the workings and dynamics of European food value chains under the VALUMICS project

Consumer attitudes and preference exploration towards fresh-cut salads using best–worst scaling and latent class analysis

This research explored the preferences and buying habits of a sample of 620 consumers of fresh-cut, ready-to-eat salads. A best–worst scaling approach was used to measure the level of preference stated by individuals regarding 12 attributes for quality (intrinsic, extrinsic and credence) of fresh-cut salads. The experiment was carried out through direct interviews at several large-scale retail outlets in the Turin metropolitan area (north-west of Italy). Out of the total number of questioned consumers, 35% said they did not consume fresh-cut salads. On the contrary, the rest of the involved sample expressed the highest degree of preference towards the freshness/appearance attribute, followed by the expiration date and the brand. On the contrary, attributes such as price, organic certification and food safety did not emerge as discriminating factors in consumer choices. Additionally, five clusters of consumers were identified, whose preferences are related both to purchasing styles and socio-demographic variables. In conclusion, this research has highlighted the positive attitude of consumers towards quality products backed by a brand, providing ideas for companies to improve within this sector and implement strategies to answer the needs of a new segment of consumers, by determining market opportunities that aim to strengthen local brands

Code of Practice for Organic Food Processing. With contributions from Ursula Kretzschmar, Angelika Ploeger and Otto Schmid.

The consumers of “low input” and organic foods have specific expectations with respect to quality parameters of processed food. These may relate to the degree of processing, concern about specific additives, nutritional composition, integrity or whole food concepts, the degree of convenience, the level of energy use and transportation distances, but also to food safety. For many processors, fulfilling all of these expectations represents a tremendous challenge in understanding and implementing the standards requirements in daily practise. Therefore, it is necessary to have in this field a guidance document for processors as well as standard setting institutions and certification/inspection bodies. In the EU project on “Quality of low input food” (QLIF, No. 50635), which deals with food safety and quality issues related to food from low-input and organic food systems, it was possible to elaborate a specific code of practise for food processing as part of the Subproject 5 on processing. The starting point for this publication was a literature survey about underlying principles of organic and low-input food processing (Schmid, Beck, Kretzschmar, 2004) and a broad European-wide consultation in 2 rounds, which was also undertaken in the QLIF-project. The results of these studies showed that many companies have serious questions related to the implementation practice of the complex requirements for organic food. Some recent scandals in this sector have made clear that in several areas an improvement of the current practises are necessary, e.g. the separation practises between organic and conventional foods. The aim of this “Code of good practice for organic food processing” (COPOF) is to give companies a comprehensive introduction to the most important requirements of the organic food sector applicable for the daily practice. Additionally, the COPOF offers a number of tools that make it possible to: a) improve the production skills effectively, b) improve and maintain the quality of organic foods and c) guarantee the safety of organic products. The basic idea of this publication was that the responsible persons in companies producing and handling the products have a strongest influence on the final products characteristics themselves. Therefore, their knowledge, abilities and the structural conditions for their work are most important factors to ensure a high quality and safety of the produced food

Focus groups of value concepts of producers: National Report Italy

The Organic Revision project was funded by the EU with the aim of supporting the further development of the EU Regulation 2092/91 on organic production. As part of the project focus groups were run in five European countries on value concepts of organic producers and other stakeholders, during 2004-2005. The project aims to provide an overview of values held among organic stakeholders, and of similarities and differences among the various national and private organic standards. In Italy four focus groups were held, a pre-test with AIAB staff, a group of policy makers, a group of established organic producers and a group of newly converted producers. The following conclusions were reached: The general impression is that there are three main values or areas which were considered important by all participants: • food quality and health (safety) • environment health and care • livelihood. Within the first issue, many detailed implications are included, starting from own health, consumers’ health, and so on, arriving to food safety, avoiding residues and link to regional or local territory. In this area, there were no significant differences between groups, perhaps only some personal point of view which could differ from one person to another; but generally speaking, this point was considered fundamental by all participants. It is important to mention that many discussions and ideas were raised by the term “quality” which seems very meaningful depending also on who is related to. Interesting was the idea about the possibility of finding measurable parameters of food quality in order to make it more comprehensible for consumers. More or less the same kind of considerations could be attributed to the value of environment health/care (which sometimes overlaps). In this case, we could say that virtually there was no real difference amongst participants, also in terms of personal values or points of view. The concept that organic farming is fundamental for preserving the environment and land it’s clear for all, and all of them agreed that this value should be strongly communicated to consumers. Regarding the third value, ‘livelihood’, it is possible to affirm that it is a fundamental aspect either in farmers and policy makers. But to say if this has to be considered as a value, rather than a mere practical problem, it is difficult to assess. In our opinion, farmers did not expressed their financial concern as directly linked to organic farming; they were more likely complaining about an actual situation, that could also change in the future. They were not expecting livelihood to be included in the organic farming values. Additional thinking over could be done on other minor areas, for their differences and peculiarities amongst participants. The issues of soil and animal welfare were discussed only by very few participants. The first one, was mentioned only by two cattle farmers in the experienced farmers group, having opposite ideas. The second one was cited only by two persons in two different groups. It seems that these matters are of secondary importance for Italian farmers and stakeholders. Or maybe, they are somehow included in other bigger areas. Also, the area of professional pride was considered quite important by many participants, especially by the experienced group, which mentioned it from the beginning, including it in the associations and in the motives for their conversion to the organic sector. Another aspect that was shared by all of them was the disappointment in finding out that consumers do not recognize their role and their value, so their efforts for doing “the right thing” seem worthless sometimes. Values under the ecological integrity area were yet discussed, but for sure were not considered relevant as others. Somebody focused on biodiversity, someone on energy consumption, but it was more a personal conviction moving these ideas than a typical characteristic. This is also demonstrated by the fact that there was not a clear connection between value importance and group category. Last, but not least, the moral implications in organic farming were indicated by two women from two different producers groups, indicating perhaps that women could be more interested in ethical values also in their professional life

Risk Perception and Drug Safety Evaluation

The authors present a Risk communication framework based on a survey of empirical research concerning public Risk perceptions. They also apply it to the area of pharmaceutical regulation to suggest more effective regulatory strategies