The success of products depends on the quality, user experience, and safety among other aspects. We have seen a myriad of innovative products over the years; however, not all of them have found success. These failures occur due to the lack of proper codes and standards to ensure the safety and quality of the products. Compliance to regulatory standards not only drives better quality but it is also key to safe and environment friendly operations. Organizations have to demonstrate compliance with regulatory requirements in the form of internal and external audits to prove that they follow all the necessary guidelines mandatory for successful product development.

However, development processes may not be the same everywhere, and as a result, there may be faults or gaps in the process that may not adhere to the defined standards of the regulatory bodies. They have to be checked from time to time and resolved or not may result in non-compliance and failures.  There needs to be a procedure in place to check for gaps and fix them from time to time. Gap Analysis is a procedure that can help in identifying non-conformities in a process and helps in rectifying or addressing them.

What is Gap Analysis?

Before understanding gap analysis as a process, we need to first define what compliance management is. Compliance Management is a complex process that is centered around identifying gaps, along with standards, design specifications, verification and validation, and auditing. To add more perspective, we can state that compliance management consists of 3 steps namely-

Check– where gaps are identified,

Act– gaps are assessed and resolved during this stage,

Report– where the gap elimination process is documented and reported.

Gap Analysis is an integral part of compliance management, which includes different processes like gap identification, risk assessment, gap elimination plan, followed by reporting. It can only be carried out when you have your Standard Operating Procedures (SOPs) in place. SOPs are prepared based on regulatory standards and product development is carried out based on the procedures mentioned in the document. It is based on these SOPs that your gaps are identified. This process is predominantly the same everywhere despite the product. Therefore, if we have to piece a gap analysis process, it will be as follows:

Performing Gap Analysis

First of all, there has to be a clear understanding of the standards that apply to your product. Once you have that understanding, then you will be able to successfully execute the process.

• The first step in gap analysis is always preparing a plan. There are certain questions we need to ask ourselves like when do you want to execute the plan, and who will be executing the plan. Internal regulatory audit teams carry this out.
• The second step is to identify the gaps. Prepare a list of requirements, in the form of questions. Then review all your current processes for adequacy, suitability, effectiveness, and compliance. You also need to explain why it has been identified as a gap and provide needed evidence to justify it.
• Once the gaps are identified, they have to be documented and a risk assessment needs to be conducted. Different gaps may have a different level of risks and a severity score will have to be given to it.
• Creating an action plan would be the next logical step to eliminate these gaps.
• Implement the action plan and track the actions that you are performing to close the gaps.
• The last part is preparing a report detailing the entire procedure.

How it Yields Benefits to Product Development?

Though gap analysis could be a time consuming process initially, it yields greater benefits in the long run. Since there are SOPs in place, each team is held accountable to follow due procedure. This will aid in building a product that will be worthy of the global market and disciplined execution.

Documentation is also another key element here. As every step of the development process is documented and the entire process can be tracked, you will have all the necessary pieces in place for future reference and audits. All the corrective actions are also recorded along with the process. These documents can also be referred to for new product development projects. This contributes towards improving the quality of the workforce along with their performance.

In this way, the entire process can be mapped for further streamlining and optimization, ensuring smooth product delivery. Evaluation is carried out for tools and technologies used during the development, to validate them. All of these steps indirectly play an important role in delivering better quality and customer experience. Better customer experience will lead to more profits and brand loyalty.

Conclusion

Hiring a development partner who already has experience in developing products that require regulatory clearance is also a formidable choice. eInfochips with over 25 years of experience in silicon to device design and development, can deliver superior products with exceptional customer experience with compliance to global standards. eInfochips has a Quality Excellence Group (QEG) team that enable product quality. A proprietary platform called ‘eQuip’ – eInfochips Unified and Integrated Quality Platform has also been developed to address the dynamic and stringent quality requirements from clients. To know more about our Quality Process Consulting services, get in touch with us.