Conducting a Gap Analysis: A key first step to ensure your shop floor digitalization effort is successful

At ComplianceQuest, we recently published a whitepaper titled “Gearing up to restart shop floor operations? Here’s a checklist for manufacturing leaders”. In this paper, we suggested a 4-step approach to drive digital transformation of your factory operations.

The steps include the following:

1. Conducting a gap analysis
2. Identifying specific workflow improvements that are needed
3. Shop floor data integrated with the entire ERP, EQMS and EHS system that’ll drive connected automation across operations, quality and health & safety requirements
4. Continuous Improvement, taking advantage of predictive analytics and proactive measures

In this blog, we share a checklist that’ll come in handy during the gap analysis process. This first step in shop floor digital transformation will help you design a clear set of requirements and expected impact from your transformation project.

Checklist to conduct the “gap analysis” – even before you start your shop floor digitalization effort

A key first step is to run a collaborative process involving a few key stakeholders who are involved in shop floor operations. It is important to start with understanding the guidelines offered by CDC, OSHA, EPA, WHO and other governmental agencies. In addition to adherence to regulatory compliance, it is essential that there is a broad set of rules for your own organization around workplace safety and employee health. Both these factors are extremely critical to manufacturing operations.

The next step is to get the supply chain ready, upgrade workflows for new quality (inspections, audits, risk management, supplier qualification) and safety (incident reporting, incident management, training, proactive approach to taking corrective and preventive action, etc.) processes.

One essential aspect to consider during the gap analysis phase is to plan for new regulatory requirements. For medical device manufacturers, for example, this means a careful understanding of old and new EU-MDR regulations, MDSAP audits, and other regulatory needs. The medical device ecosystem is playing a crucial role in tackling the challenges posed by the current pandemic. These regulatory changes have been designed to ensure medical device manufacturers and their suppliers are keeping abreast with the latest quality and safety requirements.

The gap analysis must result in a collection of checklists, each related to specific processes. You’ll have a workplace safety checklist, supplier readiness checklist and so on.

Here’s a sample checklist from the gap analysis phase:

• New processes needed for quality and safety management
• Changes to old processes
• Additional digital tools needed to enhance efficiency and automation
• Understand specifics of new regulatory requirements (the below list – if you are a medical device manufacturer)

• EU-MDR
• MDSAP
• 21 CFR Part 11
• GDPR
• HIPPA

• Workforce training
• Safety checklist
• Supplier Readiness Process
• Daily routine management

The next step in the process is to design workflows and processes that are custom designed for your enterprise. It is critical to note that automation solution or SaaS software must be flexible and customization to suit your organization’s requirements.

Read this whitepaper to find out more.