Before going into detail, let’s look at what the acronym SPC stands for. And what is SPC software?

Some theory on SPC

SPC stands for Statistical Process Control. It is the statistical control of processes (or Maîtrise Statistique des Procédés (MSP) in French).

Okay, but in concrete terms, what is the SPC?

This technique became very popular in the mid-1980s in the American car industry.

The main objective of the SPC is to reduce scrap or rework rates by anticipating non-quality through continuous production quality control and sampling.

For a given industrial production, producing parts on which measurements are made, the SPC will consist in carrying out, at regular intervals, the following steps:

1. Take a sample of parts from the production (e.g. 5 parts)
2. Measure the characteristics of this sample (e.g. height, width and length of my part)
3. Calculate the average and range (max-min) over my 5 pieces for each of my characteristics
4. Plot these values on time charts called control charts
5. Apply statistical laws that allow me to know the behaviour of the total population of my parts, even if I only process samples
6. In the event of an alert, investigate the causes and take corrective action if necessary
7. Start again at step 1

Among the alerts, we will notably detect the exceeding of control limits (which are tighter than the tolerance limits) and the drifts that show that a process is deteriorating.

For more information, read our article on SPC alarms (or alerts).

Anticipating non-quality

We can see that we can then react to the manufacturing process before manufacturing non-conforming parts.
Non-quality is then anticipated, and not suffered a posteriori.

This technique can be applied to any manufacturing process, whether you manufacture small or large series, whether you do 100% inspection or sampling.

It can be seen that the potential gains from applying this methodology are enormous.

Initially initiated by the automotive industry, for which it was vital not to measure all the parts (because of the very large production runs), the technique gradually spread to other sectors such as the medical and aeronautical industries, and more generally to the manufacture of parts with very high added value.

In the latter case, all parts continue to be measured, but thanks to the SPC technique, control can be lightened, and reducing the rate of non-conformity means reducing the number of reworkings, concessions etc.

Qual@xy SPC, Infodream’s SPC software, has been developed with this in mind, i.e. SPC software should be accessible and of interest to all.

Qualaxy SPC, the reference SPC software

Thus, the advanced functions of Qual@xy SPC make it possible to control the activities of:

• Large series
• Small series
• Serialized and non-serialized parts
• Multi-cavity process
• Control by attributes
• Assembly with traceability according to EN9100
• Automatic management of control reliefs
• For medical: FDA 21 CFR Part 11 compliance

As new professions, new practices and new standards emerge, Qual@xy SPC software evolves to follow users in their continuous improvement efforts.

Learn more about Qual@xy SPC

Do you have any idea what Non-Quality costs your company?

If so, you are now certainly convinced of the need to monitor this indicator within your quality approach, as it represents a significant source of savings.

If not, this article aims to summarise some of the main methodological concepts for initiating this approach within your company.

Non-Quality: what are we talking about?

Let’s start at the beginning: here are three ways to define Non-Quality:

1/ For H. J. Harrington, Non-Quality includes :

• Direct » non-quality costs, i.e. those borne directly by the company: control procedures, human resource skills training, product rejects/removals, etc. These types of costs, which are concrete and easily identifiable, are the most easily monitored.
• Indirect » non-quality costs, which are more difficult to measure because they are borne by the customer (damage to image, complaints, etc.)

2/ The AFNOR, through a dedicated study, distinguishes between Non-Quality and Non-Performance: the first refers to product non-conformities, while the second refers to shortcomings linked to the organisation’s management.

3/ Finally, at Infodream, we offer three components of Non-Quality :

• Product non-conformity: characteristics out of tolerance (scratching, tightening torque, etc.)
• Application non-compliance: non-compliance with procedures, unforeseen and damaging workshop events (obsolete tracking form, lack of qualification, etc.)
• Regulatory non-compliance: failure to meet a legal, normative or customer requirement (poorly positioned marking, non-existent traceability field, etc.)

How to measure Non-Quality, and why it is so difficult?

According to AFNOR, while 92% of companies consider it necessary to measure non-quality, 20% of them do not know how to measure it. Beyond the figure itself, the reasons for this obstacle are just as interesting :

• technical difficulties related to the definition of the scope and the choice of indicators
• lack of time to add these new tasks to the existing tasks of the actors concerned
• difficulties in uniting employees around this subject, or even in legitimising it within the company.

The NFX 50-126 standard

Despite these difficulties, the NFX-50-126 standard proposes a methodology for detecting and calculating the costs linked to non-quality. Although a little old, its guidelines are still relevant today for identifying cost items :

• Costs of internal anomalies, linked to product quality defects during the manufacturing process (scrap, rework, defective raw material, absenteeism, etc.)
• Costs of external anomalies, linked to product quality defects as a result of the manufacturing process (complaints, penalties, refunds, etc.)
• Detection costs, linked to the verification of product conformity (payroll dedicated to controls, depreciation of equipment, dedicated subcontracting, etc.)
• Prevention costs, linked to the continuous improvement process (supplier evaluation, audits, dedicated administrative workload, etc.)

Finally, how much does it cost me?

The question of the cost of this non-quality is essential, especially for companies that have not yet initiated this evaluation process.

Obviously, the results can be very different from one company to another.

Nevertheless, here are three key ideas to keep in mind on this aspect:

1/ Estimated order of magnitude:

• The first studies on the subject (dating from 1986) indicate a minimum cost of 2,500 euros per year per employee.
• Then, in 1991, the Mouvement Français pour la Qualité (French Movement for Quality) estimated the costs of Non-Quality to be around 15% of companies’ turnover.
• Nowadays, the AFNOR study reveals that for 53% of companies, the cost of non-quality is between 1 and 5% of turnover (for 34% of them, this cost amounts to more than 5% or even more than 10%).

2/ Costs according to the phase of detection: another method of evaluation consists in dividing them according to the phase during which the anomalies are detected. According to Guy Couturier, the cost is:

• 1 € if the defect is detected during the design phase
• 100 € if the defect is detected during the manufacturing phase
• 1000 € if the anomaly is detected by the customer
• And how much in case of an accident?

3/ Finally, it is wise to seek to prioritise improvement actions rather than to eradicate defects completely. Indeed, the human, organisational and financial efforts required are probably too high in relation to the additional benefits obtained by a prioritisation approach.

To get started

If you are now convinced that it is in your company’s interest to initiate a Non-Quality assessment process, here are some ideas for identifying the information required:

• look in the general or analytical accounts (purchases of raw materials, supplies, payroll, etc.)
• check administrative, technical or commercial documents (non-conformity reports, rejected quantities, follow-up of customer complaints, etc.)
• ask, through the organisation of surveys or direct questioning of knowledgeable staff.

But also and above all, rather than suffering the costs of this non-quality, have you ever thought of looking upstream in order to avoid its appearance? Indeed, solutions exist to monitor, manage and control your industrial process:

• MES (Manufacturing Execution System): it allows, among other things, the digitisation of tracking sheets;
• SPC (Statistical Process Control), ensures the control of your production for real-time detection of drifts (anticipation of manufacturing defects);
• Dashboards, to help you visually manage the performance of your workshops.

Sources

• AFNOR survey, The costs of non-quality in industry (October 2017)
• Blog of Guy COUTURIER MC Management
• H. J. Harrington, Le cout de la non-qualité Ed. Eyrolles (January 1990)

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.

Non-conformity, defect, rejection, anomaly… whatever the name, it’s always a production nightmare.

Whether it is critical, major or minor, non-conformity must be dealt with before it impacts the production. And the M.E.S. is a formidable tool for this.

No, anomalies, YOU WILL NOT!!!!

Qualaxy software suite: the saviour of ano(malies).

Or how to control your industrial processes.

Do you recognise yourself in this heroic posture, calliper in one hand, waste bin in the other, fighting relentlessly to avoid delivering non-compliant products?

If so, it means that you are part of the anomaly community.

Let’s speak frankly. Don’t you think your time would be better spent if you could concentrate on the essentials? If so, you might be interested in discovering 5 benefits of our Qual@xy Suite, Infodream’s MES for Industry 4.0:

Control your batches with statistics

You are guided in the control of the batches received from your suppliers. The software helps you to decide whether it is in your statistical interest to accept or reject them. But you also have the possibility of automatically increasing or decreasing the level of control per characteristic as the controls are carried out. In accordance with official and/or in-house standards…

Digitise your work instructions

Your work instructions are digitised. No more paper sheets stored in a binder at the foot of the machine, never consulted or updated. The software shows your operators, guided step by step, the work instructions. They are illustrated by a clear and precise medium (text, image, video or pdf). This way, your operators are not likely to miss any steps or interpret the procedure to be carried out. This guarantees a constant level of quality in the workshop. And you can be sure that your process, always up-to-date, is understood and respected.

Follow the capability of your machines

You monitor the capability of your machines through a module for acquiring manually or automatically controlled measurements. You can thus anticipate the progressive drifts of your process and make the necessary adjustments before producing non-conformities.

Set up alarms for corrective actions

If a non-conforming value is entered or statistical deviation is detected, the software generates an alarm and notifies a group of users. Causes and corrective actions can be assigned to these alarms. In this way, you can carry out a detailed analysis and implement good practices as part of a continuous improvement process within the workshop. In addition, the handling of non-conformities can be organised through a simple and efficient decision-making workflow*: acceptance as is, quarantine, retouching… These are examples of decisions, traced out, which you can take according to the rights specific to your profile.

Display your key performance indicators

To efficiently manage your workshop, the software displays your workshop’s performance indicators in a dashboard. It is a clear and customisable « quality weather ». All the statistical indicators necessary to monitor your process in the medium / long term are provided: Cp/Cpk, Pp/Ppk, TNC, GCP, Normality, % HT, stability…

In short, the Qualaxy Suite is a ready-to-use software package that ensures that your industrial process is carried out correctly. But also to anticipate and treat the causes of non-conformities before impacting your production. Finally, you can share all this reliable information in real time with the users concerned.

Do not hesitate to contact our teams if you would like to see a video demonstration.

CT Infodream

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.

Setting up an MES project requires essential preparatory work that should not be neglected.

Implementation of an MES solution : key questions to answer.

The implementation of an MES solution is a wise investment for any company wishing to strengthen the structure of its organization and optimize its production. However, managing  the implementation of an MES can be complex if the key questions have not been asked in advance. Here is a non-exhaustive list of the key points which must be considered:
Voici une liste non exhaustive des points à passer en revue par l’équipe de travail :

What is the purpose of the MES project?

Above all, it is important to consider the objective sought through data collection, reliability and sharing. How will the consolidated data be used? What today generates inconsistency and inefficiency within my organization, and what can be corrected through an MES approach?

What is the scope of the proposed project?

Then, it is necessary to determine precisely the most relevant workshops, productions and processes to be included in the project. Is it better for your organization to start the project on the most critical parts, or is it better to start the reorganization phase with a less risky scope?
The question of the operators’ motivation and their willingness to optimise their working methods must also be raised in order to give the pilot project every chance of success.

Functional division between the MES and other (existing) IT environment?

Digital continuity from ERP to the workshop is a recurrent performance factor targeted by any company, as data must flow in a structured, shared and reliable way. Nevertheless, the project team must clearly define which operations fall within the ERP domain, and which are supported by the MES, in order to avoid creating duplication or omitting information: indeed, the MES is not intended to manage all the resources of a company.

Read the article : How is MES complementary to ERP?

Likewise, all the company’s IT components (EDM, CMMS, database, etc.) must be considered in order to create a coherent and efficient environment. The MES must bridge the gap towards efficient business tools and ensure the digital continuity of all actions carried out in the workshop or on the line.

Are the actors well identified and involved?

As in any project team, a set of actors with complementary visions must be brought together in order to consider all the technical and functional issues: the main actors concerned (method and production teams) can be accompanied by « facilitators » (IT team, quality department), while the support of the Management, shown by the sponsorship of one of the members of the Management Committee, allows to maintain the motivation of the actors, because of the strategic nature of the project.

Finally, it may be important to inform all the other actors in the workshop (logistics, maintenance, management, etc.), who are also affected by the implementation of an MES, in order to guarantee the success of the launch during the kick-off.

What level of service quality is expected?

The success of an MES project comes as much from the quality of the IT solution chosen as from the project management. It is also interesting to plan the human, technical and financial resources required to manage the implementation of the solution, as well as its operational maintenance once in production. If the client does not have sufficient resources, what support is required? Training? Configuration assistance? Start-up assistance? Maintenance? Support?

What are my external constraints?

In some sectors of activity, such as aeronautics or pharmaceuticals, many specific standards are present to ensure the quality of production (EN 9100,…). These are in addition to all the standards on the market, which cover all sectors (ISO 2859/3951/9001).

Outside the normative and regulatory framework, customer requests, particularly from major principals, can become a « must have » that my organization must take into account to remain competitive on the market. Is this aspect consistent with the MES that my team is considering? At the heart of the manufacturing process, the MES connects to all the components of the connected workshop, to the management systems as well as to the machine equipment.

How to separate MES from the market?

If all the above points have been covered and the MES requirement is verified, it is easy to see that there are many software providers. So how do we decide between them? Again, several questions may be asked to guide us: do I need a lot of customization, a source of often cumbersome integration phases, or a standard packaged offer, lighter to implement? What is the desired commissioning time? Is the software fixed, or are the short, medium and long-term development points known?

And now what?

To conclude, an effective method for obtaining an objective opinion on the relevance of an MES approach consists in setting up a pilot project in real conditions, in order to confront real problems that have not been considered before, and thus eliminate any remaining doubts. The first conclusions resulting from this pilot project also make it possible to review the overall scope envisaged, the processes to be digitized, and the changes to be made in the level of service associated with the software offer.

Florian Cassin
Sales Engineer at CT Infodream