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Why life science industry should invest in digital inspections

5 good reasons why investing in digital inspection execution is good idea for pharma production.

09.02.2021 | Peter Verstraeten
 

STORY HIGHLIGHTS

  • Inspecting equipment thoroughly, correctly and to compliance requires a digital workflow and not a form.
  • Reduce Inspection administration and coordination efforts by 50% or more.
  • Two-way communication embeds continuous improvement in inspection processes.
  • The value of inspection execution analytics extends far beyond cost and compliance.

 

Imagine you’re performing a regular 5S audit of a lab or a manufacturing facility. While you’re checking the various aspects of the 5S inspection, you need to record the each element’s status. You can encounter many different issues. A measuring instrument can be out of its calibration window and requires inspection and if needed recalibration. A chemical substance might not be properly stored. A freezer lock might be broken.

For each of these problems you need to document the issue. You might have to take pictures or videos with your phone to clarify the problem. You need to fill follow-up forms and send out mails to people authorized to deal with the problem. Forms could be archived on a server. Email notifications could be used to inform and remind. Excel logs could be used to follow up open actions. There might be a need to record a non-conformity in the QMS (Quality Management System) and start a CAPA (corrective and preventive action plan) for some of these issues. And before starting a new 5S inspection in the same area next month, you will have to check your mails, the previous report and all issue forms, the excel logs and the QMS to be fully aware of the situation.

This is why paper or pdf-based inspections trigger much more administrative efforts and coordination than one would expect at first sight.

At Proceedix, we’ve partnered with leaders in the life sciences industry on their digital transformation journey and have seen the benefits of implementing a digital inspection workflow execution platform. Organizations taking a step-change approach towards implementing innovative solutions tools have received a faster return on investment than those looking for incremental improvements.

While “nothing is easy” in the Life Sciences Industry because of the heavy regulations and highest standards in terms of compliance and control, the investment in digital inspection execution delivers a positive return that goes far beyond cost savings. More specifically, empowering inspectors with mobile or wearable digital workflow guidance like Proceedix, assures management that inspections are executed in full and correctly and unlocks additional potential:

1. Inspecting it in full and correctly

An inspection protocol in a pharma or biotech plant can be quite detailed and complex to execute. Some elements only need to be controlled depending on the observations or control results of upstream inspection tasks. When performing a 5S Audit in hundreds of labs, one needs to be aware of situational differences between them. Some have freezers, some don’t. Some store hazardous chemicals and some don’t. Depending on the research activities performed in a particular lab, different safety products need to be present.

Inspecting the performance of measuring equipment can be pretty technical and complex. Rather than an inspection form, a digital workflow guides the inspector in a step-by-step approach. Depending on upstream result recordings, the person is automatically routed into the correct path. Enriching inspection tasks with technical equipment specifications or with explanatory videos provide comfort to the inspector in case of doubt. By scanning the lab door, the 5S workflow is automatically tailored to the particular lab’s characteristics and needs. Replacing a form with a digital workflow platform assures inspectors know exactly what to check where and how.

2. Securing 100% execution compliance

Health and safety is on everyone’s mind in this industry. Hundreds of line cleanness and line clearance inspections, 5S audits in labs and in operations and many different controls are performed every month. Product recalls, or patient health issues are a pharmaceutical manufacturer’s nightmare. For compliance reasons, operators and inspectors are often requested to sign off the inspection document systematically archived. Nothing inhibits a person from quickly ticking boxes and signing off a form hours after the facts just to “be compliant on paper”. A workflow execution platform automatically logs all the inspection execution details with both the time and location stamps given by the device and with all the inspectors’s comments and acknowledgments. It provides indisputable proof that inspections were followed for each control element by the right person at the right time and place, guaranteeing 100% execution compliance.

3. Reduce inspection administration by 50%

A digital workflow platform automatically records all inspection findings and acknowledgments in an execution log. Inspection reports can be produced and sent by the system to each of the stakeholders and archived on an internal server. Each type of action represents a specific follow-up workflow in itself and is automatically managed by the same mechanism. Configurable notification mechanisms eliminate labor-intensive manual email communication. Taking out manual report writing, manual information sharing via emails, excel based issue tracking and individual reminder management, easily reduces the administrative workload of inspections by 50%.

Moreover, standardizing the inspection process in a step-by-step workflow guides inspectors in doing both the preparation and the actual inspection right, the first time. The execution logs are also a valuable source to analyze and initiate further LEAN inspection improvements, reducing the actual time and effort to execute the inspection itself.

4. Embed continuous improvement with a digital feedback mechanism

The traditional inspection document is a “form”. It specifies which elements to check and allows for issue reporting. But it typically does not allow to enrich the execution with situational photos and videos at inspection task level. It has no room, nor a channel for the inspector to communicate back how things went. Neither does it provide action management features like facilitating action context recording and automatic escalation follow-up. Did the person encounter inspection execution challenges? Could some complex inspection tasks be explained or illustrated in a better way? As there is no room for feedback on the form, the probability is high that the inspector does not report back to the supervisor and as a consequence a colleague will face the same issue in the next inspection round.

A digital workflow solution allows the operator to initiate follow-up actions in case of issues or directly formulate suggestions for improvement. This way, a digital inspection execution platform empowers the connected inspector and embeds continuous improvement in the operations DNA.

5. Leverage the value of the automatic inspection executions far beyond cost and compliance

Companies in the life sciences industry are open to massive investments in sensors, IoT technology and predictive analytics. These initiatives aim for better product and process quality and safety, perfect compliance and all of this in a cost-effective way. This might reduce some of the human inspection activity but it will never eliminate the need for physical controls by process and product experts. If the algorithms determine a high risk of equipment failure, experts will be requested to verify on-site and make the call for action.

If all of these human inspection execution results are “buried in pdf reports” on a server, they remain basically invisible to the organization. We miss the opportunity to enrich IoT data with human-centric inspection and evaluation recordings. Hence the algorithms can only rely on sensor data and miss the valuable human observation and evaluation of similar cases in the past. Minor issues might be reported regularly throughout the plant during various audits. By archiving the observations in pdf reports, we miss the opportunity to detect the systemic problems and hence the structural improvement opportunities.

Read more about our solution for the pharma industry.

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