When we talk about manufacturing execution systems (MES), we often imagine a heavy tool, requiring long and laborious deployment timescales and not necessarily adapted to the flexibility and reactivity required by small to medium size enterprises (SME).
What if you were told that the MES contributes to the flexibility of SMEs and that it is an important tool to achieve operational performance and efficiency ?

The missing link in the digital continuity between the supply chain and manufacturing, the MES has become the structuring solution for the industrial ecosystem – industry 4.0.

However, let us be realistic, as with any subject of this scope, its implementation requires a project organization including the analysis of the real needs, definition of a cross-functional team, identification of KPIs, budgeting, etc. In short, a process that will have the inevitable result of frightening SMEs and raising two key questions:

• 
Is this the right tool for us?
• Are we able to easily manage it?

 

Is this the right tool for us?

To the first question, we believe the MES is the real conductor of the workshop, and thus the only guarantor of the availability of the right information at the right time in the right place.

Defined through the ISA95 standard, an MES must contain defined functional solutions which aim to bring benefits according to quality, delivery, costs.

Thanks to the MES, communication between people, machines and software will be more dynamic, faster and more reliable thus allowing real-time reactions.

A process that drifts, a bottleneck, a cycle time penalized by an operation, a machine more frequently broken down than others, a stop due to a component shortage.

All these hazards will be logged, quantified, analysed and monitored over time. The agility so often talked about will be possible: load transfer, priority change, reassignment of machines.

But short-term reactivity will not be the only benefit. Indeed, longer term analysis will be possible thanks to the centralization and standardization of data: design review, analysis of downtimes, scrap, etc.

 

Are we able to easily manage it?

To the second question we believe that the implementation of an MES is accessible to all, even small companies that do not necessarily have the means to commit a large team for months at a time.

To do this, it is necessary to proceed in stages, targeting a precise scope and deliverable at each phase in order to achieve a well-defined goal that is understood by all. Progressing according to real added value of the functionalities deployed will make it possible to observe their returns immediately and to confirm the project ROI.

Setting up an MES should not be a forced or suffered decision, but a decision voluntary and desired. In this context, the project can be carried out by an SME as well as large companies and the benefits obtained will be very rapid.

As you will have understood, the benefits are so important that the only question that you have to ask yourself is «When do we start?»

Frédéric Henrionnet
CT Infodream

What are the benefits of managing shopfloor skills & competencies?

Clearly there are regulatory requirements for specific job roles are but there are also other benefits for the operations team. This article will explore what these benefits are and how they can be achieved using Qual@xy MES.

Skills, authorisations and certifications

Let us now define what skills, authorisations and certification are.

Skills Competence

Competence is the ability to transpose acquired knowledge for the accomplishment of one or more tasks in a particular field.
It is a « business » concept, specific to each plant or department. It is often supplemented by a level of competence such as: beginner, intermediate or expert.

 

For each operation, the skills matrix displays the number of operators with expert, intermediate or beginner levels.

 

In industry, skills can be developed through training and mentoring (transfer of know-how).

Authorisation

The authorisation indicates an aptitude and a legal authorisation to carry out an activity in complete safety.
The aptitude is validated by following a training course, both theoretical and practical, and by an individual assessment of the knowledge acquired.
Following an individual assessment, a jury grants legal authorisation – in accordance with the legal texts – to carry out an activity.
The authorisation is often valid for a period of time.

Example of authorisation: Certificate of Operator Safety Competency.

Certification

Certification is a title or diploma awarded by a competent authority (a high authority, an institution or a school).
A vocational certification attests that the holder has acquired, through training and/or work experience, the competences, skills and knowledge necessary for the exercise of a profession.

Certification provides greater professional recognition to the holder.

Examples of qualifications: Youth Training, BTEC, etc.

 

What are the benefits of skills management?

For the operator

Competence monitoring motivates and values production workers.
As a sign of recognition, a certain loyalty to their employer can be expected. This tends to reduce turnover.

For the manager

In times of crisis, holidays or ramp-up, staff absences are less noticeable because they have less impact on production.
The replacement of absent operators is facilitated by anticipating the necessary operator skills.

For industry

In a highly competitive industrial world, the more competence is developed, the less the industry is threatened.
This is particularly true of new technologies that lead to new behaviours and changes in production processes.
Thus, with the increase in skills, the capacity to adapt also increases.

 

What are the benefits of managing authorisations and certifications?

For the operator

The management of authorisations and certifications validates skills, both internally and externally. It enhances the value of operators, increases their intrinsic value and therefore their employability.

For the manager

Since the personnel are qualified for the tasks to be performed, the autonomy to carry out the operations increases, and accidents at work decrease.

For industry

The customer is reassured by the certifications held by a supplier. This is a guarantee of the seriousness and quality of the future product delivered.
The supplier, for his part, obtains recognition from his customer. And this generates a climate of mutual respect and trust.

In general, maintaining a high level of competence can be a way of developing mentoring in the company.
It is about an experienced operator sharing their knowledge and experience with a colleague who is new to the job.

Whether we are talking about competences, skills or certifications, they all tend to give more visibility to the human resources department.
For example, when it comes to managing a continuous training plan.

All of these benefits should boost team morale and ultimately improve productivity.
In addition, multi-skilling gives a positive impression of decompartmentalisation of workshops and production areas.

 

Fears and concerns about multi-skilling

We have just seen that there are many benefits. However, the misuse of skills and competences can lead to disappointmentt.
Indeed, the costs of learning to become more competent can be high in relation to the intended purpose and its actual day-to-day use in the workshop.
The operators present may be called upon to intervene on levels lower than their now recognised level, which may lead to disorganisation and frustration.

 

Conclusion

Good management of skills, certifications and authorisations therefore has several advantages:

For production operators, it means better visibility on their career. They know their place, their strengths and weaknesses, and what training they need to do to progress. They are also more competitive.

For the HRD and managers, targeting areas for improvement is made easier. Everything is centralised in the same database. They can both modify it according to the departures and arrivals of employees, or their increase in competence.

For the company, it leads to greater efficiency in production management. There are fewer line stoppages, better anticipation, etc.
The company is more serene. The quality of production improves, costs fall and this offers more prospects for everyone.

 

At a glance, you can see whether an operator is competent to perform an operation, and at what level (beginner, intermediate or expert in this example).

 

Which tool to use for multi-skilling?

Do you want to digitise your skills processing but don’t know which tool to use?

In the age of Industry 4.0, we can agree that the solution is digital. But will you be satisfied with an Excel file? Will you invest in a dedicated HR solution?

At Infodream, we believe that this is a matter for the production tool, as close as possible to the operators. This is why we have included all the necessary functionalities in our MES solution: the Qualaxy Suite.

This title is deliberately provocative.

The aim is to put an end once and for all to the old idea that operators are resistant to change.
In particular, with regard to the use of digital tools in the workshops.

 

Today’s operators

Definitions of ‘operator’ may vary slightly between sources.
But the general idea is that the operator is the one who makes things work, who is productive, who is closest to the finished product. He is also referred to as a journeyman, or a worker.

From an organisational point of view, this means that he or she follows, or rather is subject to, the decisions of top management.
The latter imposes ways of doing things, tools and software in a quest for productivity.

If his role is to produce with new means and new technologies, his job is evolving to become more specialized. The complexity of the software solutions imposed on him (ERP, MES, PLM) goes hand in hand.

 

 

Fat Fingers syndrome

It has often been claimed that operators have fat fingers ¹.

That is, they could not type accurately on a keyboard or clearly select an item from a drop-down menu. This would make them impervious and therefore resistant to the digital evolution of production tools on the shop floor.

The persistence of this syndrome could therefore be directly attributed to management’s lack of conviction. Not believing in the capacity of operators to perform well in the use of IT, they would therefore consider them to be a time-consuming job with no added value, which would be a brake on the performance so much sought after.

This may have been the case a few years ago, but today the computer has invaded our spaces, our homes, our lives, to become as common as a fridge or a TV.

 

81.1% of French households have at least one computer
and 93.6% have at least one mobile phone

Source: Insee study ² of 2016

 

Not to mention the new generations for whom digital has become everyday life, and who know no other way to :

• book a train or plane ticket
• consult its accounts
• pay taxes
• find your soul mate.

It is therefore logical to think that the problem does not come from the computer medium…

 

 

So whose fault is it?

First of all, therefore, we must logically turn to the software used and its complexity, which makes us doubt its usefulness. And which also means that we still hear phrases such as « before we didn’t have computers in the workshops and we still produced. »

If we accept that technicality and simplicity are not antinomic, the cause of this dislike for IT can be found in a poor choice of solutions that would not take enough account of the operator.

This is the major difference between everyday and industrial applications.

Many industrial solutions seek to be attractive through the functional coverage they offer by addressing a range of complex technical needs. Consumer applications, on the other hand, seek to meet a single, specific need by focusing their appeal on the user experience.

The second point, which is certainly more insidious, is attributable to the very nature of digital technology, which means that the data collected becomes accessible to everyone, everywhere, instantly. This state of affairs gives rise to the fear of a loss of partial responsibility on the part of middle management.

Besides, isn’t it said that knowledge is power?

 

Win/win

The digital tool cannot be ignored: it is efficient, indispensable and win/win for the operators and their management.

For the operator:

• Removal of non-value added transactions
• Reduced risk of errors
• Focus on high value-added business operations

For management :

• Real-time view of the workshops
• Time dedicated to data analysis instead of data collection
• Workshop optimisation

If ‘IT’ is not massively deployed for operators in the field, it is not a question of finger size but of the choice of software solution which has often been made in spheres disconnected from the field with underlying fears.

 

Fat fingers ¹ Very physical medical syndrome « at the beginning », later hijacked for people who are adept at typing mistakes

Insee study ² on French households’ equipment in durable goods

 

Benoît Redler
Director, CT Infodream

You may also be interested in this article…

It is well known that companies can afford to spend their time without counting.

Abundance of resources, absence of unforeseen events, extremely simple IT environment, immediate understanding of your needs by your service provider…

You will of course recognise your company through these few classic success factors.
Perhaps you are tired of seeing every project around you succeed at first sight?
What if for once you were to try your hand at the unspeakable pleasure of doing, undoing and redoing?

This article is for you!

So here are 10 tips to help you avoid missing out:

 

1. Don’t provide details of your IT environment

A good service provider will be sufficiently knowledgeable to interpret without error your operating mode, your imperatives and your final objectives. Moreover, if they don’t ask any questions, it will be proof that they understood everything at first glance, and certainly not that they are afraid to ask.

 

2. Neglect the PQOQCCP*

These academic precepts from another time are perfectly inapplicable in companies. They are only the result of empirical research on common methods of analysis and understanding between individuals with different experiences.

This is why, if you want to miss your specifications, you should not even think about these elements.

* What? Where? When? How? Who? How much? Why?

 

3. Use internal vocabulary…

…and don’t explain it, with a lexicon for example. What an idea! This way, you are certain that your supplier will be able to misinterpret your requests, and therefore misrespond to them.
On the other hand, the use of acronyms, shortcuts, or references to documents not supplied is highly recommended to destabilise your supplier and undermine the relevance of your specifications.

 

4. Prohibit the possibility of clarification

Indeed, some service providers have developed the unfortunate habit of reading the specifications sent to them and, above all, of asking questions to the client in order to clarify the needs expressed. By not leaving this possibility open, your potential suppliers will remain in the dark, and you will obviously limit any risk of a relevant answer.

 

5. Ignore any illustration

Making mock-ups of the desired screens, even summary ones, or diagrams clearly explaining your expectations, may help us to understand your needs. No, if you want to miss your specifications, plan instead to use text (preferably not in a formatted form) in order to reduce the clarity of your message.

 

6. Make comparisons impossible…

…between the different offers received. To do this, avoid asking for quantifiable elements (cost, lead time, support service coverage, etc.), and any opportunity to explain the figures announced in addition. This way, you can be sure that you will be able to compare elements without knowing what they cover, and therefore select the offer that is least suited to your needs.

 

7. Stay vague on performance measurement

A truly ineffective specification should not reflect the level of importance of the project to your company.
In fact, clearly indicating how the chosen services will be measured against clear, pre-defined indicators could suggest that the project is of interest to your company; it is therefore better to avoid them.

If you have inadvertently defined a relevant key indicator, do not measure its value before the start of the project. There is no risk of being able to assess the impact of the chosen solution.

 

8. Do not specify a budget envelope

The offers of potential suppliers may prove to be very different, in terms of the technologies used, the time spent on the associated intellectual service, and the levels of post-project support.
Thus, the budget envelopes can have a large amplitude.

Failure to specify the budget envisaged for your project will mean that you will waste time analysing offers which, in any case, will not be successful.

 

9. Send without internal verification…

…your specifications to all the identified service providers. Indeed, the other teams in your company could have a complementary view of the reality on the ground to be taken into account.

 

 

Drawing up a set of specifications with the other teams in the company could help the project to succeed.
Another obvious risk would also be to create a company dynamic around your project, and thus promote its success.
It is therefore better to send your document without proofreading or validation.

 

10. Do not take customer references into account

Don’t do it! Respondents, thinking they are doing the right thing, can sometimes give you customer references with whom similar projects have been carried out.

It is very important that you do not take an interest in these examples and do not contact the references mentioned. You might get advice, feedback or good ideas, and thus risk moving in the right direction.

 

In conclusion

And there you have it, you have all the elements to write a really unusable specification.
No risk of seeing your project progress serenely, and guarantee that the desired objectives will be achieved.

Unless, of course, you make the final mistake of choosing an experienced service provider who is available, who has mastered the development of his product and who has a real sense of anticipating production needs.
With his production- and efficiency-oriented vision, he could still bring your project to a successful conclusion… The trap.

Florian Cassin
Sales Engineer at CT Infodream

21 CFR Part 11 is a regulation concerning the use of electronic documents and signatures.

Its respect has become essential for the pharmaceutical, cosmetics or food-processing industries wishing to market their products not only in the United States, but also internationally.

Standards to secure data.

In several industrial sectors, the digitalisation and digitisation of processes is multiplying the number of data exchanged. This is especially true in the health sector.

So how can all this data be secured against multiple threats (hacking, technical failure, handling errors, etc.)? How can the reliability and integrity of this data be guaranteed? It is essential for manufacturers to set up standards and technical methods to guarantee the best possible protection and durability of data.

 

21 CFR Part 11

One of the most important regulations governing the manufacture of pharmaceutical products is 21 CFR Part 11.

The first draft text was released in its basic version in 1997. This reference framework is constantly evolving and is modified over the years. This makes it the most influential regulation in the field of electronic records and signature management (ERES*).

 

The 21 CFR Part 11 standard is issued by the American FDA (Food and Drug Administration).

 

 

It lists all the regulatory provisions to which an organisation must adhere in order to comply with the retention of electronic records and signatures.

Whether electronic or paper-based records are used, a number of data management rules must be followed. This is in order to offer equivalent guarantees of durability, authenticity, confidentiality and traceability. And to avoid any sale of non-compliant products that could have serious health consequences..

The standard clearly sets out the list of controls and good practices to be followed for electronic records and signatures.

This ensures data accuracy and reduces the potential for human error.

The repository also aims to ensure that all changes made to an electronic document are effectively tracked.

Companies in the pharmaceutical, cosmetics or food-processing industry that wish to market their product(s) in the United States must comply with this standard.

 

What is an electronic registration?

According to the definition of the repository, it is any information in digital form that is created, modified, preserved, archived, withdrawn or transmitted by a computer system. This information consists of a combination of text, graphics, data, audio, images, etc., in digital form.

Any paper document scanned into a computer is also considered an electronic record.

 

What is meant by compliance with 21 CFR Part 11?

There are many solutions for digitising industrial manufacturing processes that comply with 21 CFR Part 11. This is in order to exchange data electronically and to ensure traceability, security and durability over time.

However, it is not only the computer system that has to be compliant. It is also the whole of the processes to be digitised and the application that is made of them in the company.

This is why it is always advisable, before investing in data management software, to think about standardising exchanges and information flows in order to bring them into line with the reference system.

*ERES : Electronic Records and Electronic Signatures
*MES : Manufacturing Execution System
*FDA Compliant : meets the requirements subject to appropriate software parameterisation.

Infodream, FDA compliant publisher and integrator…

Infodream is a publisher and integrator of an MES (software package dedicated to quality and productivity).

Installed for more than 30 years in manufacturers in all sectors, our software helps you to set up and optimise your digitalisation and continuous improvement process.

Infodream’s clients in the pharmaceutical sector include Biomeyrieux, Molnkycke, Bayer Healthcare, Novasep and others.

The fruit of this expertise, the Qual@xy Suite, our innovative MES* for the factory of the future, is an « FDA compliant* » solution. It combines ease of use, rapid deployment and immediate economic gains.

It is designed for all types of company: SMEs, ETIs or large groups.

Industry 4.0 is a buzzword: technical publications, research projects, real deployments are multiplying throughout the industrial world, but sometimes we hear about Factory/Industry of the Future or called Smart Manufacturing.

What do these terms mean? Can we give them a precise meaning? Should we even give them a precise meaning?

Industry 4.0

This concept was first highlighted at the Hannover Fair in 2011. It defined all the new digital technologies that were emerging as well as their interconnections and their possibilities to communicate with each other.

The term 4.0 obviously refers to the 4th industrial revolution.

 

The term “new technologies” is often considered as a catch-all in which we find cobots (1), additive manufacturing (2), IoT (3), Big-Data, digital simulation, virtual and augmented reality.
This list cannot be exhaustive as it continuously enriches new concepts with the certainty that the next few years will see new tools and concepts being introduced!

Industry of the future

Our definition of the Industry of the Future is more general and does not focus on the tools but on their utility and integration within the production plant in which the human remains the central element.
So of course this industry will use the “new technologies”, but we detach ourselves from the tool to study its relevance to be integrated with already existing means, thus creating a global and relevant digital chain that will be referred to as an integrated value chain.
An integrated chain is the interconnection of communicating means and software to obtain the relevant and necessary information at the right time to act (operator) or to decide (manager).

Automation and digitization will indeed have an impact on the place of the Human in the industry, but it will certainly not eliminate it: it will just refocus on the high value-added tasks requiring know-how and localized decision making.
Any technique or tool to guarantee or improve this digital continuity may (in our view) fall under the term ‘Industry 4.0’.

So, Industry 4.0 or Industry of the Future?

As you will have understood, it is not easy (if not impossible), to separate these two notions which are intimately linked and destined to evolve together according to ongoing research and technological developments.

This link is also physically represented by MES (Manufacturing Execution System), a link between Industry 4.0 and factory of the future which enables an IoT means of production by allowing machines to communicate in an industrial environment (Industry 4.0).

The key point in this digital environment where endless data is available is to firstly clearly understand what information is needed to add value to the global process. Then, the ‘how’ (IoT) and ‘when’ (MES) this information is made available can be established, and utilized in the shared industrial environment (Factory of the future).

 

Frédéric Henrionnet
CT Infodream

 

(1) cobot or collaborative robot: robot or automated cell in production in a human environment among operators
(2) additive manufacturing or 3D printing
(3) IoT: Internet of Things (with the rise of RFID technology for example) or IIoT: Industrial Internet of Things