Quality Management


The Expert’s Management Tool

Quality Management is about understanding and communicating the organization’s strategic direction.

General Knowledge & Insights

Quality Management core focus is to implement strategy by introducing structure and harmonization to achieve a common goal. It is about knowing and predicting stakeholder-expectations and fulfilling these expectations by making the necessary resources available.  Lastly, it is ensuring that the personnel has the right skill set to keep improving the business processes. In short – Quality Management is about running an effective business. 

The objective of Quality Management is to ensure that products and services are delivered in the expected level of quality as promised to the customers – this applies n Life Science as well as all other industries. In Life Science, the rules and regulations are set in place to protect the patients. In non-regulated industries, the standards are put in place to indicate the company has focused on customer satisfaction – and what company wouldn’t want to have focus on customer quality?

Quality is first and foremost a mindset. The concept of Quality in the company needs to be incorporated thoroughly into the organizational culture. By setting high expectations for all divisions, defining a strong set of common values, and making sure that the required resources are available, makes it natural to integrate Quality into daily habits.

In 2018 the word “Quality” is unfortunately associated with words such as old-fashioned, ineffective, time-consuming, and expensive within companies – and to some extent, these associations are true. Many companies are experiencing that Quality activities are running inefficiently on their current established IT systems and at least the younger generation does not have the patience to work with counterintuitive solutions– and therefore it is difficult to motivate people to do the quality activities. 

To implement Quality as a mindset it is vital to incorporate the correct Quality Management tool. Setting up ONE SYSTEM is for the greater good of the company. If the company does not state a clear strategic direction, employees are likely to set up their own individual systems to make sense of their daily routines. Everyone likes to work in a special manner and even though a side-invented system might work well, one thing is for sure – when people are not working in a harmonized way it cost the company a lot of money and time as NO ONE is speaking the same language.

If you have chosen the Quality Management path and you are not getting the right guidance, the first steps of the way can seem rough. The implementation may appear to generate none to little value because the immediate huge focus on Quality Management takes the focus away from the core business. When selecting the right system, the journey is guided, and the Quality Management processes are something you can use immediately instead of inventing them from scratch.  The fact is that the core business is being supported and complemented by Quality Management.

You must make sure that the Quality Management processes are as effective as they can be in relation to time, budget, and quality. It is essential that you keep track of trends to understand the current situation and at the same time monitor processes to discover whether there are areas of improvement.

Top Management must ensure that best practices are shared, and scalability of top-performers is used as guidance throughout the organization. Everyone is responsible for an effective business. Everyone is responsible for quality!

Tools & Strategies

Before looking into strategic tools and theories ask yourself or your team members the following simple questions – the answers can often clarify the entire situation. Where are the requirements are coming from? What is the input? How should this information be handled? What does the expected output look like? Who is the receiver of the output?

The first tool is SIPOC (Supplier, Input, Processes, Output, Customer), which is mostly known from Six Sigma and Lean Manufacturing, but the origin of SIPOC derives from early Quality Management programs of the 1980s. The ISO standard in 2015 goes through the same process (Source, Input, Activity, Output, Receivers).

SIPOC should be used to understand and document the business process and communicate the expected end-to-end solution to the implementation team.  While assessing the process flow, data should be traced through the different processes and eventually the supporting system landscape.  When the process and data flow is mapped the risk must be assessed.  This helps the team to identify where the efforts should be focused in delivering a fit-for-intended-use solution – documenting the business process, data and the associated risks is also a quality management expectation. 

The second tool PDCA (Plan, Do, Check, Act) has the objective of improving processes. Clearly define the requirements, the objectives, and the scope before starting any solution-activities. When these elements are incorporated and verified, the results must be assessed. If the outcome is unsatisfactory or can be improved, the implementation must be corrected and/or improved in relation to the requirements.

While SIPOC is used and established during initial implementation, the documented information should not be seen as a static document.  During implementation, and while verifying the solution, new opportunities might arise, which may require updates to the existing documentation and solution.   It might be that the associated risk in one place needs to be adapted due to new learnings during verification but also during the operational phase where the product or service is used by the customers. Plan, Do, Check, Act is another way to describe constant improvement, optimized processes, and business efficiency. The documented information is called system life cycle documentation, since the documentation is expected to be ’living’ or ’current’ during the life cycle of the product or service.

Assessing Opportunities

When it comes to inspections and audits it is my experience that familiarity is a winning partner– if you find methodologies that are unknown, and you raise suspicion, then you better be in control of your methods! I recommend starting your quality management journey by using the international standardized processes i.e. ISO-9001.

ISO 9001 is recognized in the world as a Quality Management System, which aims at customer focus and business efficiency.  The standard is used by over one million companies and organizations in more than 170 countries.  The ISO standard can be used by companies of all sizes. It is a great tool for global collaboration and trading partners, and its baseline the market expectations and requirements.

The international standardized process will also help you when you are increasing (right-sizing) your workforce. Working with qualified personnel is a must and ramping up new employees in a homegrown methodology cost unnecessary time and money – and a homegrown system is not fit for an external partner or customer collaboration.

Business & Leadership

Quality Management starts with the top management’s commitment to Quality. To run an effective business at a professional level of quality your company should author and communicate a company Quality Policy. The policy must include the strategic direction of the company, a statement of the framework and importance of quality within the business, a commitment to make the resources available, and continuously improve the processes. See an example of Quality Policy of MyBlueLabel.

Even though it seems bureaucratic and old-fashioned, the direction must be set and supported at the top. This is the way to introduce one standard and a new normal in the company.  When employees in an organization are encouraged to work with one set of harmonized and standardized processes the efforts of collaboration will improve.

Today in a constantly fast-paced changing environment, people seldom celebrate 5-year-company-anniversaries and more companies are working with external contractors. It must be satisfying to know that information is documented correctly, and company knowledge is recorded and shared amongst the right people, and that Quality Management ensures confidentiality, integrity, and availability of all company data.

A final side note, the implementation of a Quality Management tool can only be 100% successful when the top management and the entire company is aware of the Quality Policy and everyone is working to achieve a common goal.

Industry Specific

The expected requirements for Quality Management vary depending on the industry your company operates in. ISO 9001 is an international standard that functions well as a company quality scope and a process baseline across industries. The requirements for Quality Management are getting firmer in regulated industries such as Food, Tobacco, Life Science, Aerospace, and Defense. In non-regulated industries Quality Management is a choice, in regulated industries, it is a requirement.

Regulated agencies are added requirements necessary to protect the patients – the people we care about. An extra precaution is expected in these agencies, but the main principles of Quality Management are not different.

In Life Science, data integrity is of the essence.  Data integrity is the assurance that data is complete, consistent and accurate throughout the entire data lifecycle. Documentation must be time-stamped, reviewed by multiple people and documents are approved and signed electronically in compliance with regulatory expectations. Regulated Compliance aims to Protect the Patent where Quality Management is Customer Focused.  

Life Science is by definition a branch of science that involves the scientific study of life and organisms.  But in the context of this article Life Science is meant by pharmaceutical, medical device, and biotech companies that discover, develop, produce, and markets drugs products used as medications or medical devices i.e. pacemakers, insulin pumps.

FDA (Food and Drug Administration) is the United States federal agency of Health and Human Services.  MHRA (Medicines and Healthcare products Regulatory Agency) is the agency of Health and Social Care in the United Kingdom.  EMA (European Medicines Agency) is a European Union agency.  These agencies have the responsibility for ensuring that medicines and medical devices work and are acceptably safe and that patients can trust the products which are supplied by the companies. 
Most countries around the world have their own government health agencies, for safeguarding the general public when companies want to introduce new products into the market.

Quality Management Today

Up until recently, Quality Management activities have been paper-based to avoid IT systems causing damage and to ensure company Data Integrity. Lately, IT systems have become more appropriate for regulated industries – processes are done faster and less error-prone. It is required that the IT systems are validated and deemed fit-for-intended use – documented objective evidence must exist to ensure that the IT system is performing correctly. Electronic documentation is becoming an absolute necessity for a multi-international corporation when sharing information and approving documents across countries, time zones, and continents.

Early on when IT systems were made available, corporations spent millions of dollars implementing solutions that often did not match the requirements of an effective Quality Management System.

If we fast forward to 2018, large corporations manage complex IT landscapes with an IT strategy that is neither business-effective nor cost-effective. Instead of improving systems internally, large corporations seek external suppliers and small and midsized companies with opportunities of working smarter and helping them develop and deliver new and innovative products and services.

With the option to work smarter with Quality Management Systems, smaller companies can live up to the documented expectations of large corporations far more effectively.

Future prospects of Quality Management

Machine Learning is going to support repetition-work such as reviewing documentation against Good Documentation Practice expectations. System failures should be reported digitally by the IT systems themselves and not wait for the end-user to identify the issues. Automated Testing is already here, mostly in the IT industry, but it must be implemented more widely in the regulatory environments.

Hopefully, this insight has opened your eyes to the advantages of Quality Management and you can become the expert yourself.

I hope that you will associate the word “quality” within your company with words like optimized processes, business efficiency, and a state of control and transparency.   Using a Quality Management System that is developed for Quality Management will bring you one step closer to running an effective business in the expected level of quality by the company stakeholders. 

My recommendation is to take one project at a time – and soon you will be able to see the efficiency and the advantage of thinking quality and make it natural to integrate quality into your daily habits.