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Maintaining quality in all aspects of a business is a vital part of any company’s operations, and the cornerstone of its success. Quality management enables effective planning, control and continuous improvement, all with the aim of providing customers with products and services that meet or exceed their expectations. A quality management system (QMS) is a valuable tool that equips businesses with a robust framework for good practice, helping them to reduce errors, control risk, increase productivity, and deliver fit for purpose products and services, as well as comply with relevant industry regulations.
In this blog I will detail the inspiring path Ingenza has taken to implement, improve and maintain the rigorous QMS it has in place today, and how this contributes to its mission to be the partner of choice in industrial biotechnology and synthetic biology, embodying a culture of innovation and workplace excellence.
The start of the journey
Ingenza was founded in 2002 and has since evolved into a world leading engineering biology company specialising in the design, development and manufacture of diverse, high value industrial and therapeutic protein products. Ingenza moved to new premises in 2007 and this prompted the team to implement a QMS, using ISO 9001 as the framework.
I started my career with Ingenza over 17 years ago in 2005. I completed my Ph.D. in Germany, my country of origin, and then moved to the UK to carry out a postdoc at the University of Edinburgh. Following this, I became one of the first employees at Ingenza, starting out as a Senior Scientist. Over the years, I naturally progressed from this role, accumulating additional leadership responsibilities in areas such as training and development and project management where I am PRINCE2® qualified.
In 2021 I took on additional responsibilities in the area of Quality Assurance and Compliance.
I spent a lot of time researching and speaking to knowledgeable people in the field. I gradually built up a good picture of the system we had in place at the time, and performed a gap analysis to identify the steps that we needed to implement – as well as the new infrastructure we required – to strengthen our existing QMS.
Reaching the finish line
I have been building on the foundations of Ingenza’s initial QMS, updating it to fit the company’s objectives and ever-changing business and regulatory needs. As a result, the QMS is now a comprehensive toolbox, tailored to fit the organisation’s unique aims and activities, as well as compliance requirements. The system includes both standardisation measures – to produce consistent results – and flexibility, to allow for continuous improvement.
Ingenza has an in-house quality management team with 15+ years collective experience in quality assurance and compliance, responsible for ensuring that quality is maintained throughout the business. To continuously fulfil Ingenza’s objectives, industry and compliance requirements, our QMS has evolved and is now based on ISO 9001, ISO 13485 and ICH Q10, which guarantees regulatory compliance during biomanufacturing. In addition, the company develops all its in-house processes and manufacturing steps according to the principles of GMP, and thoroughly reviews and approves its outsourced activities, with all processes being meticulously documented to allow full traceability and rapid scale-up with third party CDMOs. Ingenza uses a cutting-edge data management system that includesafully time-stamped audit trail, with daily back-up of all organisation data. On top of this, the company provides ongoing staff training and has long-established qualified person support to ensure up-to-date regulatory compliance during product & process development and biomanufacturing.
Highlighting workplace culture
The quality-focussed attitude has always been there at Ingenza, and the recent QMS revamp has brought this to the forefront of daily practice, embedding it in every aspect of the company’s operations. Establishing a new QMS has enabled Ingenza to define what quality means within the organisation, and showcase this to its customers to positively influence how it is perceived.
Quality ultimately depends on people, so personnel buy-in is incredibly important. This is why Ingenza has prioritised transparency and regular QMS training, with the aim of encouraging and aiding the implementation of quality control measures right across the firm. Colleagues are now more aware of the benefits of the company’s underlying quality culture and the QMS, and the strengthened and formalised quality focus has motivated and empowered employees to maintain stringent standards within their specific projects and tasks.
I invested quite a bit of time in providing training to everybody at Ingenza, to help staff understand the purpose and scope of our QMS, and the benefits it provides. I think everyone now realises that quality involves more than just production, and plays into all the activities we perform on a daily basis.
My training programs have also gone a long way in breaking through previous stigmas surrounding quality systems, standardisation and compliance. In the past, there was a tendency to think that standardisation was a contradiction and hindrance to the creative scientific process. However, Ingenza has proven that the QMS actually helps employees to work more effectively and productively and, ultimately, promotes innovation.
Standing out from the crowd
Customers expect a high level of quality across the board from their partners, and rightly so. Meeting or even surpassing consumer expectations will make a company stand out and stay ahead of their competitors in the market. My recent efforts on extending and updating Ingenza’s quality management toolbox have undoubtedly created a key asset that enables the company to showcase its spectacular work in the best light possible, and to gain the recognition it truly deserves.
One of the main reasons we are so passionate about our QMS is that we prioritise customer satisfaction. Our clients are hugely important to us, so we go above and beyond what they would expect in order to guarantee the highest levels of consistency and quality in everything we do from start to finish.