Solution Insights

Technology investments improve quality outcomes

The most significant impact is improved quality driven by process automation which reduces human error.

Technology helps us get closer to the idea of ‘100% inspection automatic product release.’ You could call it ‘automatic quality everywhere.’ This entails testing all the products without human intervention. Starting with controlled inputs means you can trust your processes to deliver controlled outputs. We're removing the human touches. Every touch is a loss, which we are trying to get away from. We’re using data to get to the next frontier.

– Consumer Goods, Quality Assurance

Everybody comes from a different background, from different industries, and they have no understanding of GMPs. Instilling best practices is a big culture shift. A QMS platform allows that. It's not one person saying, ‘we're doing it this way.’ It becomes a culture in the company.

– Consumer Goods, Quality Management

Technology investments have a major impact on quality management practices.

All in-depth interview participants agree that technology is having a major impact on quality management practices.

There are quality requirements to ensure transparency. Products are labeled properly, we have the appropriate claims, and so forth. It's also important for anybody internally that's interested in understanding how are we releasing a product or the testing requirement for something. Veeva QuailtyOne provides data transparency and allows easy access by all teams. They can find it right in Veeva.

– Consumer Goods, Quality & Compiance

"Technology plays a role in making things better... The better you can get at the system to support your business, that’s the best thing ever. [It] just makes your work life easier."

– Consumer Goods, Quality Assurance

Other technology impacts on quality management practices include:

Making better decisions related to product quality and consumer expectations
Help predict failures and avoid rework
Economically and efficiently capture and collect more quality data for analysis
Makes everyone’s work life better / easier
Managing risk
Automating non-value added tasks
Get closer to realizing Quality 4.0
Process validation
Transparency of products and processes (internally and externally)
Unifying organizational quality culture

KEY TAKEAWAY:

Technology investments improve quality outcomes and have a major impact on quality management practices.

KEY TAKEAWAY:

Technology investments improve quality outcomes and have a major impact on quality management practices.

A supplier portal is the most important requirement of a QMS.

This is yet another indication of just how difficult supplier management is. Concerns around supplier management rise to or near the top of questions about challenges, investments, and solution requirements.

Additionally, a QMS needs to integrate with other solutions, be cloud-based, and enhance collaboration between related departments. We found that QMS is used more often on a desktop or laptop and only sometimes on a mobile device, so it is not surprising the mobile accessibility is not the most important QMS requirement for many.

Although artificial intelligence (AI) and automation capabilities is not the first or second requirement for as many companies as other solution requirements, this does not mean it is unimportant. Rather, companies acknowledge the benefits AI and automation provide to better quality and to greater efficiency.

A supplier portal must include several critical capabilities.

Ability to upload and view documents from the entire supply chain, audit suppliers remotely, support a circular economy model and score suppliers are equally critical supplier management capabilities.
Ability to view inspection test results from the entire supply chain is not much less important, while CoA management is of lesser importance.

^{If there was a solution to centralize your quality system globally, which of the following requirements would be critical to meet current and future objectives? Rank up to three, in order of importance, with 1 being most important. Base: Total (n=260)

Which of the following supplier management capabilities would be critical to meet current and future objectives? Select all that apply. Base: Supplier Portal Selected as a Solution Requirement (n=142)}

KEY TAKEAWAY:

Companies struggle to manage suppliers and supplier data. A supplier portal is the most important requirement of a QMS.

KEY TAKEAWAY:

Companies struggle to manage suppliers and supplier data. A supplier portal is the most important requirement of a QMS.

Is this key takeaway something you are able to apply in your business?

Yes, absolutely
We'll try, but might need support
I don't think so

AI and automation capabilities must provide data analytics.

Those who require AI and automation in a QMS expect that first and foremost it will provide data analytics.

Watch How AI and Automation Can Support Product Compliance Across Your Supply Chain and hear more about how Unilever, AWS and Veeva worked together to address the Certificate of Analysis use case to immediately save significant resources, improve data accuracy, and more!

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^{If there was a solution to centralize your quality system globally, which of the following requirements would be critical to meet current and future objectives? Rank up to three, in order of importance, with 1 being most important. Base: Total (n=260)

What do you expect AI and automation capabilities to provide? Select all that apply. Base: AI and Automation Capabilities Selected as a Solution Requirement (n=96)}

Automation makes processes better, especially document review & approval, tracking, and reporting.

Supplier management follows in improvement potential, along with change control and recall prevention. The bottom tier of processes most improved by automation comprises risk management, managing recalls, training compliance, and audit notification.

"We have moved toward an electronic document management system, but our sites still rely 90% of the time on paper because our production is not much automated... You spend a lot of time checking what somebody else has entered... This time would be saved by a computerized system."

– Specialty Chemicals, Quality Management

"With QMS, you would be able to have communication – there’s maybe minor changes – and then move through to the final approval. And not having that paper copy in a filing cabinet."

– Consumer Goods, Quality Management

^{In the context of quality management, which processes do you think can be most improved by automation via software tools? Please rank up to three in the order of improvement possibility, with 1 having the most room for improvement. Base: Total (n=260)}

Resources and resistance to change are the leading barriers to adopting new technology.

Organizationally the leading barriers are cost and IT resources for implementation and migration. Almost all in-depth interview participants cited resistance to change among users as the leading barrier to adopting new technology.

To switch to existing, known ways of managing quality processes that are not internally-approved takes a bit of massaging. It requires saying to the organization, ‘we had a way of doing things in the past that was very specific, fit our business needs, and we were the best in the world at doing, but given we want to do in the future, we need to adjust. Others have already gone through the pain of getting better processes and better approaches. Why don't we just copy and paste versus trying to customize, to replicate what we used to do, but which is no longer applicable in our new environment?’

– Consumer Goods, Quality Management

Culture is a challenge. People have a hard time with change. People freak out at even the mention of SharePoint. Training and getting people comfortable with the cloud is a challenge, especially people who don't use a lot of technology and don't understand relationships between objects.

– Consumer Goods, Quality Management

Other barriers to technology adoption include:

Concerns about cloud security
Adequate user training
Customized legacy systems tailored to the business
Justifying return on investment
User engagement (concern the company is watching the employees)

Organizations are in the early stages of Quality 4.0 adoption.

Almost all in-depth interview participants indicated they are moving in the direction of Quality 4.0 but are still early in the process. Some organizations are trying to understand what Quality 4.0 really means and how to best implement it across their business.

I don't think there's a crystal-clear definition of Quality 4.0. We are relatively well-advanced in the abundance of data we collect online from our production lines. However, I still don't think we fully understand how to best do it and what the real challenges are.

– Consumer Goods, Quality Management

We've gotten a little better at analytics. We have a project we call the IMS 4.0, which is an allusion to Industry 4.0, that relates directly to our integrated management system. We're trying to strategize exactly what we want to do and why we want to do it that way and struggling with internal or external vendors and just how much money we're willing to spend.

– Specialty Chemicals, QHSE

Resources and resistance to change are the leading barriers to adopting new technology.

We're moving towards Quality 4.0, but it's going to be a while before we fully get there. We'll have pockets of our company that are really getting there and others lagging because they're worried about other things, or it's not a priority to invest time and money in.

– Consumer Goods, Quality Assurance

We’re building a large IT infrastructure. We have a large footprint moving in the direction of full automation. This spans nuts and bolts across the company: finance, marketing, etc. It's a field that's expanding so quickly that while we are applying pieces of Quality 4.0 where they make sense, there's still a large opportunity to expand what we're doing.

– Consumer Goods, Quality Management

Other considerations and barriers to adopting Quality 4.0 mentioned included:

Lower priority than other initiatives
Funding / return of investment
Executive buy-in
Lack of human resources and necessary skill sets
Ability to be agile, especially among large organizations
Managing internal and external vendors
Legacy systems
Culture and change management
Organizational alignment of goals, values and needs across all business units