Why did your corporate quality department not understand anything!

I understand, I understand...

You often think that the Corporate Quality Department is isolated in its ivory tower, completely ignoring your reality on the ground.

They seem to just impose unenforceable procedures on you, and you are lucky if you manage to grasp their content. As for your real problems, who takes care of them seriously?

Then, three years later, things change and you join Corporate! Congratulations on your promotion!

However, this time, you're complaining because the sites don't understand the issues, don't respect group standards, and act as they please.

Today, in this article, we are going to help you better understand the ambivalent relationship between corporate quality and site quality.

Recently, at one of our customers, we were called upon to support both the corporate quality department and several sites.

As a result, we were dealing with several decision-makers.

However, for our part, we are only one company.

Thus, we observe the power relationships that are established between the two hierarchical levels and how these relationships can hinder projects and even put the business at risk.

It's not an easy situation to deal with.

But you already knew that.

The difficulties encountered by Corporate quality

At the corporate level, there are several difficulties to take into account.

The first: the heterogeneity of sites.

Indeed, each site has its own history, industrial culture, manufactured products and size. In other words, each site is unique. However, the corporate must establish rules common to all these sites, which represents a major challenge.

The second: the lack of maturity of a process-oriented vision in the field of life sciences and, in particular, of the pharmaceutical industry.

When you structure a business around processes, you can identify three types of processes:

• centralized processes (where all sites must work in the same way while respecting operating procedures, as in the case of deviation or change control processes, for example).
• decentralized processes (where each site has the freedom to work as it wants but respecting macro rules, which is the typical case of the manufacturing process).
• articulated processes, where part of the process must be common to all sites and another part specific to each site (as in the case of the customer complaints process, for example).

The third: the lack of vision focused on the final operator, Michel, who is involved in the processes.

Corporate staff give the impression of not knowing the reality on the ground well, because the rules they establish are organized by theme and regulatory chapter, and not by profile. This may sound complex, but let's take a moment to explain. At the corporate level, for example, in the same procedure, the rules for determining the sampling points for the environmental control of rooms, as well as the procedure for taking air or water samples to carry out these checks, are defined. All this in a single procedure, as the expert must write the procedure corresponding to his area of expertise.

However, at the end of the chain, there are two different “Michels”: one must define the sampling points for each room, and the other must take the samples. However, with a single procedure, everyone has to read information that they do not need, which unnecessarily increases their mental load.

Now that we've explained that corporate quality is missing the point, let's look at the situation at the sites.

You will see that it is not much more brilliant.

The difficulties encountered by the quality of the Site.

Site quality is caught between a rock and a hard place at all times.

On the one hand, there are global rules and local regulations that may be specific, and on the other hand, the requirements related to the establishment of global quality systems and the urgency of field operations.

In other words, when a local quality manager has to choose between closing a deviation to clear a lot and working on compliance with a corporate procedure, what do you think they will choose?

As a result, the corporate is extremely frustrated, as their concerns always come first.

Site quality is always disrupted by customer audits, corporate audits and inspections.

When an audit is announced, it's a frenzy: cleaning documents, premises and data becomes the top priority. Everything else is in brackets. In this context, corporate quality is relegated to the background, which leads to even more frustration.

Site quality is confronted with grains of sand on the ground that the corporate can't even imagine.

This can include gaps in training, careless mistakes made by staff, unexpected computer problems, WiFi connection issues, cramped workspaces, or outdated equipment.

In short, the vagaries of daily life!

These obstacles can sometimes turn into real trials, which the corporate does not perceive.

In short, corporate quality and site quality represent two worlds, two atmospheres.

The question now is how to bring these two worlds together and harmonize them.

Here are three actions you can take in your business to achieve this.

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Action 1: develop a “business process management” culture.

The processes allow us to focus on the activities of operators, like Michel (e), and thus to speak a common language, regardless of our position.

This requires courage at the corporate level, because business process owners must be appointed and empowered.

This power can sometimes conflict with that of department heads, raising the debate between the search for local optima and the global optimum.

One day, maybe I could offer you a course on this subject, but if you really want to understand the difference, I recommend that you read the writings of Goldratt, the author of the theory of constraints, in particular his book “The Goal.”

A good process owner will be able to find a consensus on what can be centralized or decentralized and will establish the appropriate compromises between global and local quality.

If you want to take this approach, don't hesitate to contact us. The gains in documentation and training are significant, and I invite you to assess the benefits for operations for yourself.

Action 2: separate project resources from operations.

I know, like you, that I have read articles criticizing project management in businesses and the problems of balancing power and goals that it creates.

However, in our experience, customers who implement changes on sites, managed by the corporate and by allocating specific resources to the project, obtain better results than those who do not. Why? As I mentioned earlier, when it comes to choosing between releasing a lot, preparing for an audit, or participating in a global project, the choice of local quality will be quickly made, and this is generally not in favor of the global project.

Therefore, it is advisable to set up dedicated local resources, including quality resources. In this way, the global level can expect a much more effective implementation of its projects.

Action 3: go bottom-up, innovate on sites, and then transform into a global one.

The main mistake of projects initiated by global quality is to start from a regulation, directive or any other idea or concept and decide to implement it from the top without consulting the field. Yes, it does happen, and it usually leads to failure.

The most successful global quality projects are those that are born thanks to local innovation, on sites. A site takes risks by deliberately choosing to operate differently from what the corporate imposes or requires, and proves that it is more efficient and effective than other sites.

Of course, the visionary on the site who promotes such innovation must be confident, because otherwise, there is a big risk! However, when this works, the corporate can then examine how to adapt the solution to other sites by centralizing what can be centralized and leaving what should be decentralized. This is the case, for example, of our innovation projects in the field of documentary simplification or training. Projects that have always been successful have started from local initiatives that have transgressed, or rather reinterpreted, global rules. Or rather, they have broken beliefs and habits. Then they proved that it works, and the corporate appreciated and launched a global project to support such a transformation on the other sites.

So, on the overall quality side, please let the sites innovate, even in the field of quality. And on the site side, be innovative, because the corporate sector needs your experiences in the field. Dare! Without you, they're blind and not user-centered. Help them.

The final word.

Share this video with your global and local quality teams.

Get them to think about what is centralized, decentralized, and how much room for innovation the global team leaves to local teams and take appropriate actions.

On our website you can also access a portion of our DOC&training simplification training.

So see you on the other side!

See you soon!