Summary
- ICHQ12 Opportunities & Limits
- Understanding the mechanisms of liquid leak and bacterial penetration to build integrity control strategy in Single Use systems
- Comparison of WFI production by membrane based method and distillation based method, according to the Revised EP Monograph for WFI Production
- Why assessing a bioburden and what to do with the results?
- Regulatory changes impacting the medical device sector since the start of 2018
- The place of Man in the management of risk systems: feedback from the nuclear industry
- Digital, digital, digital, DI.GI.TAL !!
The nuclear industry, as well as most of the so-called “risky” industries, are subject to regulatory obligations in terms of safety of people and the environment, but also to constraints of reliability of their factories / workshops, which aim both improving their performance but also increasing the quality of their final product.
In order to respond to this, these industries design technical systems and technologies that lead to “moving” people away from their work. Although beneficial because it favors the protection of workers, this “distance” must be accompanied by specific studies in the humanities and social sciences, in order to ensure that women and men can always play their role in driving and control of these risk systems. This role remains essential, since Man alone is capable of recovering from a failure in the socio-technical system.
1. A little history The desire to keep workers away from “risky” work situations is historic: for about 30 years, the concept of 3D (for Dull, Dirty and Dangerous) has grown rapidly, particularly in the American military industry, leading to justifying the arrival of robotic and / or remotely operated (or even completely autonomous today) devices making it possible to “protect” the soldiers, who remained far from sources at risk.
2. The 3-D concept applied This principle is still applied in the high-risk industries of today. Generally, the implementation approach is the same independently of the field of application and the reason for the separation:
- In the assembly line industries (such as the automobile), workers are replaced by automated systems, because the work is repetitive, monotonous and painful, and the workers do not have a real added value. to these systems;
- In industries that are high-risk or have contained atmospheres, workers are distanced from their work in order to avoid being exposed to dirty, contaminating and perhaps dangerous materials or substances…
So, the problems intrinsic to work situations that require resolution are identified, then a choice – generally technical – of protective solution is introduced, in accordance with the magnitude of the problem identified, but also in accordance with resources, constraints and project/ field of application issues. In this context, for some industries as is the case in the nuclear industry, the materials or substances handled are identified and characterized according to the level of danger posed to workers (factory, workshop, laboratory operators…), the environment and also the population. This in the first instance leads to the application of regulations appropriate to each of the materials/substances identified, then to the determination of the solutions to be put in place. These may be solutions to be implemented:
- In design, such as for example: workstations adapted to the characteristics and constraints of the materials, automated systems for all or part of the human operations, collective protective measures which imply the design of appropriate premises;
- In the operational/production phase, small or large scale, such as for example: a specific policy of using personal protective measures, appropriate organizational arrangements, special training and/or instructional resources, operational documentation precisely defining a modus operandi or a procedure be applied.
3. Adapting work to humans One of the fundamental principles of worker protection consists in designing work situations well, in order to avoid protective actions being the exclusive responsibility of workers(1). When the risks intrinsic to a given situation are correctly evaluated in the design phase, their causes can be eliminated and their consequences limited as far as possible.
Further, the approach of adapting work situations and their components to the capacities, constraints and specificities of the individuals in whom these elements are found, not only contributes to the control of industrial risks – improvement of the reliability and safety of installations – but also to increased human performance in a significant manner(2): production quality can be confirmed, and on the other hand the women and men occupying well thought out workstations are more satisfied(3).
4. Trap to be avoided When technical teams are mobilized for the design of a factory or laboratory, for example, they define the “best” solutions for human and / or environmental protection. The criteria determining the choice of a protection solution rather than another are generally based on technical / technological aspects, but also budgetary and temporal. However, the observation made by the nuclear industry – and also shared by other risky industries – is that depending on the solution chosen, this can have a negative impact on the role and place of Man as a ” actor ”in the operation / production of the factory or laboratory.
It is essential, when human and / or environmental protection solutions are studied and designed, to set up a multidisciplinary approach complementary to “classic” design engineering approaches, based on the application of methodologies from Cognitive Sciences, Human and Social. The association of different disciplines from different backgrounds allows, among other things, to meet the growing need to adapt work situations and their components to the capacities, constraints and specificities of “future users”(4). In fact, the deployment, as early as possible in the design process, of ergonomic knowledge, models and methodologies aims to comprehend the functioning of sociotechnical systems in their entirety.
5. Application to a project (image 1) In the context of the design of a new factory dedicated to the manufacture of combustible nuclear elements, based on an existing factory currently in production, one workstation in particular posed different problems. During one of the production steps, the operator had to (and will have to) transform different materials presented in powder form into a final solid, compact product. This is performed at a workstation which requires the wearing of a respiratory protective device: there is a work table, above which is arranged equipment for sorting/organization, mixing/blending and compacting of powders (a die), surmounted by a transparent partial hood coupled to a ventilation system which restricts the dissemination of radioactive substances (contamination of the operator and the room in particular), and a ventilation system for the room where this workstation is located.
The preliminary study of the existing work situation had shown that the workstation in question was not satisfactory for the following reasons:
- Constraining gestures and postures: powdery materials being extremely dispersible, operators can only mix (or knead) the different substances summarily, in order to minimize their dissemination. This does not contribute to the homogeneous distribution of the powders in the compacting matrix, requiring operators to apply successive “scraping” gestures of the powder, in order to carefully and gradually fill the matrix with layers of powder and thus guarantee the final quality of the product.
- Environmental protection: despite the particular attention to operations during the mixing of powdery materials, a part “lost” during the process can be sucked up by a powerful ventilation system (extractor hoods). These materials must be sorted and further processed, which generates additional (and expensive) work steps.
- Protection of workers: indeed, the people assigned to this workstation must wear specific protective clothing and gloves (several superimposed layers), as well as a mask of the “filtering device” type (the mask has a filter which retains dangerous dust and thus purifies the air breathed by the operator). These individual protections, costly for installation (sorting, cleaning, replacement, etc.), are also bulky and sources of discomfort for operators: in fact, we observe particular efforts to breathe, a reduction in visibility and dexterity required to the successful completion of this activity, which requires precision and thoroughness.
The preliminary analysis led to the setting up of an ergonomic study of the future workstation. This study had to meet the following objectives:
- Improvement in the quality of the final product;
- Reinforcement of the protections vis-à-vis the operators, in order to be able to envisage the suppression of the mask, as well as the environment;
- Reduction of the operational costs associated with this station.
6. Iterative and participatory design The study responding to the needs identified was constructed on the principles of the ISO standard cited in (4). It was carried out from a detailed analysis of the existing situation, followed by multidisciplinary design meetings punctuated by sessions to evaluate the solutions under consideration, in an iterative manner. So, the appointment of a UWG during project start-up promoted the principles of a participatory approach and of co-design: the steps defining the new protective solution were therefore monitored taking into account all project requirements and constraints: regulatory but also those intrinsic to the technical roles and to the installation, and to the future user.
7. Analysis of the current workstation A detailed study of the current workstation was set up, mainly in order to understand the overall production environment, and the particular constraints associated with the manufacturing process.
As a result, a meticulous analysis of the gestures and postures of the operators, assisted by video means and the realization of chronologies of operations was carried out. This analysis made it possible to show that, depending on the stage of the manufacturing process, the operators are forced to adopt very different positions from one another in order to do their work. This makes it difficult to put in place waterproof protection, which would favor the containment of materials. Indeed, the solutions of type “glove box” or “isolator” conventional require that the operator adopts a static posture because of the position of the circles of gloves, tiring in the long term and not allowing him to easily carry out all operations in the isolator.
The observations performed in the existing installation highlighted the fact that to carry out the different tasks ofthe modus operandi, the operators must adopt the 3 following different positions in the space of a few minutes:
- Position 1 : manipulating the knobs located in front of and in the middle of the work table -operators with arms bent, elbows at waist level and hands positioned in front of the stomach;
- Position 2 : adjusting the levers placed at the back, to the right and left of the work table. These areas are difficult to access and the operator cannot move from the central position – operators with their arms completely extended and positioned either outstretched, or to the left or the right, but still below the shoulder line;
- Position 3 : retrieving the tools positioned at a height, in the part in front of the work table – operators with arms bent and rotated upwards, with the palms of the hands directed towards their face, elbows almost aligned with the shoulders but a little below this line.
8. Thorough review of project input data (image 2)Beyond compliance with the regulatory requirements to which the factory is subject, as well as with the norms andstandards of the technical roles involved in the project (resistance of materials, mechanical constraints, particularlyof electricity and ventilation), analysis of the current workstation supplemented the functional specifications of theproject with:
- A list of existing equipment and tools, which had proved their worth, to be reused in the future factory;
- A list of “wishes” for the future user, notably concerning the problems of lack of visibility and dexterity linked to the wearing of personal protective equipment;
- A list of recommendations associated with the operational constraints (accessibility) posed by the need for containment of the workspace.
Image 2
This set of input data was the subject of a presentation within the project, so that all the actors participating in the design (MOE, MOA and future users) are “on the same level” with each other. of others. In the context of working groups, knowing the constraints of others promotes the establishment of a collective work of co-construction of a “common” solution, which responds as much as possible to the constraints of the project.
In addition, if one of the identified requirements cannot be taken into account, the wearer is more inclined to find compromises that satisfy the largest number of participants. This approach also guarantees the fidelity of the “wishes” expressed by future users, linked to their tasks and constraints encountered on a daily basis.
9. Proposal for solution -> Assessment -> Proposal for solution -> Assessment -> … The technical professions, assisted by the project’s ergonomists, started a process of defining “probable future” solutions, going from sketches to a detailed solution, to which all of the project’s stakeholders were able to contribute. At each stage of the process (from the most “rough” solution to the one chosen), a stopping point was made with the participants of the GTU, in order to collect their point of view and thus consolidate the design choices made..
When a successful version of the envisaged solution was available, the GTU evaluation work was carried out in virtual reality: on the basis of the 3D model of the new workstation, the participants, equipped with helmets or 3D glasses , were able to “use” the solution virtually. This allowed in particular future users to visualize the arrangement of equipment and tools in the new workspace, their accssibility for both operatieons and maintenance operations, and finally to better understand the new sequences of operations and constraints. associated space-time.
The working group participants were able to virtually visualize the planned design features, and to test them in a setting very close to reality. They were able for example to observe that in certain postures, operators had to insert one of their shoulders into the glove port provided for this purpose almost completely, to be able to perform their work correctly. Further, the passing of tools from one hand to the other was observed, with one arm in position 1 and the other in position 3 (cf. figure 2).
Also, it was possible to validate the addition of a weighing operation on the right of the workstation, in an area difficult to access (if the operator has to stay in position in the central area of the station, as is the case today) and which requires the operator to move to the side.
Thus, the solution adopted at the end of this iterative process includes a containment system that allows a less restrictive and strict positioning of the arms of the operators, while allowing them to no longer wear a mask with filtering device, or layers additional clothing / gloves. In addition, the layout of certain equipment and tools has been revised, in order to better match them with the logical sequences of operations to be performed on the work table.
This solution is currently being implemented. It has all the features necessary to meet the initial issues of the workstation ergonomics study:
- The final quality of the product must be improved, insofar as the containment and leak tightness of the solution which covers the work table, associated with a more effective ventilation system, must facilitate the manipulation of hazardous substances;
- Operator and environmental protection are enhanced and are no longer based on the wearing of personal protective equipment. Moreover, this also helps to improve product quality (increased operator visibility and dexterity).
- And finally, this will also allow reduction of the operational costs associated with this station: fewer suits and masks to maintain, more effective working time for operators, less substance loss (the new design of the work table eliminates areas where materials are deposited / accumulates and optimizes the circulation of air).
10.Humans at the center of production The protective solution envisaged for this new workstation is in the final validation phase within the project in a more cross-functional manner. It should be deployed in the new factory that is under construction. This solution makes many improvements to this workstation, and puts operators back at the center of production.
During the analysis phases of the existing and evaluation of the solutions envisaged through the GTU, it appeared that the women and men currently working on this workstation, consider that their contribution to the “good progress” of the production is not up to their capacities and knowledge. For some, they mentioned “undergoing” working conditions, as they could not be real actors in the production results of their factory. Difficulties in carrying out tasks, associated with a workstation that can be largely optimized, beyond operators’ fears about the risks involved, constitute as many obstacles to the implementation of efficient work and quality.
Support must be put in place especially in this regard in the future factory, in order to measure the impact (positive and negative) of the new protective solution on the actual work and feelings of operators.
11.Conclusions and prospects The implementation of a multidisciplinary, participatory and iterative approach when designing solutions (technical, technological, organizational or other), is applicable to any work situation that needs to be optimized. This approach helps to take into account all the aspects and constraints that make up this work situation, including from the point of view of socio-organizational and human factors. Our experience feedback shows that when this approach is integrated sufficiently early with specialists in the Human Factors field, the gains are considerable, both in terms of reliability but also performance, safety, production quality and operator satisfaction at their workstation.
The role and place of humans are considered in work situations in their entirety, and the resources and tools which they need are adapted to their activities. Moreover, their operations are defined so as to limit, indeed prevent any action that can potentially be a source of faults, while leaving them enough room to maneuver where needed especially to correct a sociotechnical system failure.
This design methodology can be applied to all sectors of activity, especially the pharmaceutical industry. In addition to the classic design engineering approaches, the pharmaceutical industry can benefit from the input of Cognitive, Human and Social Sciences whatever the production volume.
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Angélica LEAL – ORANO PROJETS
angelica.leal@orano.group
Édouard MOUILLÈRE – ORANO PROJETS
edouard.mouillere@orano.group
Bruno DUMONT – ORANO PROJETS
bruno.dumont@orano.group
Glossary
3D concept: Dull, Dirty and Dangerous
Dull: Monotome, boring, uninteresting
Dirty: Messy, contaminating, painful
Dangerous: Dangerous
HF : Human factors
UWG: Users Working Group
PM: Subject mastery
CO: Contracting Authority
Definitions
Human Factors : set of socio-technical factors having an influence on performance and more broadly on human work, such as skills, environment and work tools, characteristics of tasks and organization (in particular). (notamment).
Ergonomics : Scientific discipline that studies the relationship between Man and the socio-technical factors that make up work, in order to contribute to their definition / design and thus ensure that they are used with maximum comfort, safety and efficiency by the most large number of people.
Bibliography
(1) Guérin F., Laville A., Daniellou F., Duraffourg J. and Kerguelen A. (2007). “Understanding work to transform it: the practice of ergonomics”, ANACT, Lyon-Montrouge, 5th edition.
(2) Daniellou, F. (2013). “Consideration of human and organizational factors in the design of a risk system.”Issue 2013-05 of the Industrial Security Notebooks, Foundation for a Culture of Industrial Security, Toulouse, France (ISSN 2100-3874).
(3) Cambon Julien. “Towards a new methodology for measuring the performance of occupational health and safety management systems.”Doctoral thesis in Sociology. École Nationale Supérieure des Mines de Paris, 2007. French.
(4) ISO 9241-210: 2010. Ergonomics of human-system interaction – Part 210: “Human-centered design for interactive systems.“