The concept of “Quality” has been emphasized more than ever. However, it is a subjective term. Every person, Industry, and business may have their own version of definition for quality. But it generally has two standard criteria, i.e., It shall perform the intended function, and it shall be free from flaws.
The real challenge that arises with the concept of quality is achieving compliance with the applicable regulatory requirements. It implies the need for a robust quality management software that can help enterprises bring quality and compliance together. The right EQMS solution will not only help meet the company’s’ and customers’ requirements, but it will also help leverage multiple benefits, including:
- Streamlined and controlled processes.
- Reduced wastage of resources.
- Lesser mistakes and product recalls.
- Lowered costs of quality.
- Quick and easy identification of training opportunities.
- Improved employee engagement.
- Smooth supplier communication and strengthened relationships.
- Consistent results and timely product delivery.
- Increased possibilities of growth and profits.
Bringing quality and compliance together is not easy unless you have the right tools and strategy. Let’s first look at a step-by-step guide to create a successful quality management strategy, and then we will look at the technology and tools you can utilize. The stepwise guide requires you to:
1. Define the quality objectives or requirements you want to fulfill
Having clear quality objectives and goals helps make the right strategy and align your critical processes in a more streamlined and standardized manner. It may take your time initially but will save you from many expensive failures towards the end. So, make a list of your requirements – internal, external, or compliance-related to set realistic goals for yourself as well as your quality team.
Also, if your team will have transparency through the organizational goals, they will make efforts in the right direction without wasting time on repetitive tasks. Wouldn’t it be a productivity bliss for the organization?
2. Identify the actionable steps to achieve compliance quickly.
Achieving quality gets more meaningful when your product or process meets compliance, as well. It opens up wider opportunities for business expansion in the global market. Building and maintaining a culture of quality and compliance is a long-term success strategy for any business or Industry. It also instills more confidence in customers, stakeholders, and even your employees.
The winning rule is quite simple here. Identify the actionable steps to achieve compliance while attaining quality, such as aligning processes with the industry best-practices specified in the standard requirements.
3. Keep the process cycles simple and straightforward.
When your process cycles are more spartan and straightforward, your organization’s productivity will be all time high. Your employees will not be following individual routes to make it all chaotic. Instead, they will follow a standardized workflow. It will save administrative time and efforts, helping them achieve quality goals efficiently. You can also review and refine your processes regularly when they are not complicated enough.
Processes being modified regularly, ensure continuous improvements in the organization, allowing you to gain operational excellence and a competitive edge. There are cloud-based EQMS available that comes with configurable workflows so you can align your processes in the most simplified manner possible.
4. Keep all the processes, policies, and SOPs documented
Keeping all the essential information regarding quality processes and policies such as SOPs documented is critical to achieving compliance with FDA 21 CFR Part 11. You can easily find reliable electronic document management software to keep your documents safely stored on a centralized platform that your team can instantly access. However, security is still the topmost concern. Make sure to choose the document management software with advanced security controls since you cannot risk your customers’ information.
The document management software provides you more control over critical information through features like version controls, electronic signatures, watermark, audit trail, and much more.
5. Ensure that your workforce understands their responsibilities
It is imperative to ensure that your employees have a clear understanding of their responsibilities to deliver the best quality results. You have aligned processes, documented them step-by-step, then only one step is remaining – i.e., educating and training your employees about the responsibilities they are expected to fulfill. You can utilize integrated training management system to keep your workforce trained and competent for the tasks assigned.
Training management done right; your employees feel encouraged and motivated to engage more and take ownership of the assigned tasks.
6. Define the key performance indicators clearly
It is crucial to understand what you are trying to achieve with all the processes you have set in, the resource requirement, and the expected results. Document the critical drivers so you can easily measure the performance and efficiency later. It will also help you evaluate the effectiveness of the changes implemented over time. If anything, not performing as expected, you can identify new areas of improvement and strategically move ahead to your quality goals.
The key performance indicators can help you take a holistic approach to improvements that can take product quality to new heights.
7. Evaluate the results against the key performance indicators
Defining the key performance indicators will alone not work; you must consistently evaluate the process’s results to determine the corrections required. It will further help in process optimization. You can also perform an analysis of results and outcomes to understand the core pattern of how things are working – whether there are significant improvements in overall quality, efficiency, and productivity. It also fosters smarter decision making among quality teams.
You can set and evaluate key performance indicators in the context of suppliers. You will experience a world of difference in your business relationships, wherein both parties can grow and improve mutually.
8. Take care of accountability.
Assigning accountability is also significant for the consistent review of the KPIs you have defined. You can make process owners accountable for the quality goals. The process owners will also feel motivated with such sort of ownership. When you put many people accountable, everyone will take care of quality at their end rather than believing it as one person’s responsibility.
9. Automate the regular activities with the right tools
With the advent of next-generation technology products and tools, you can automate many day-to-day tasks and achieve operational excellence. All you need to do is research for the right kind of tools for the processes running in your organization. If you are going to implement software, you must ensure that it is easy-to-use so your quality teams can quickly learn to operate it without any hassles or delays. It will reduce the training needs as well, and you will notice a significant growth in efficiency and productivity. So, have you identified the set of tools your quality team will appreciate?
10. Leverage the support of your team members
Segregate and spread the word to your team members, utilizing their bandwidth to productive use. With the tasks distributed so well and automated tools, you can achieve your quality and compliance goals quickly.
11. Measure the improvement opportunities
You must develop a process to evaluate the applicable quality standards regularly to determine the need for changes and identify significant opportunities for improvement. Once you start understanding and acting appropriately on the patterns and trends, you will stay ahead of the competition in terms of innovation—continuous improvement results in optimization of the organization.
Now that you have a step-by-step guide, you can quickly bring quality and compliance closer without any additional efforts.
One of the best EQMS software that can make it easier to achieve quality and compliance goals is Qualityze EQMS Suite. It helps meet your quality, compliance, and regulatory requirements by leveraging Industry best practices with standardized, repeatable processes through easy-to-configure predefined workflow templates.
Qualityze integrated design connects all the QMS processes for a complete solution. Want to know how?
Get in touch with our customer success team on 1-877-207-8616 or write to us at firstname.lastname@example.org, and we will be right there for you.