Quality Assurance Philosophy

Paul Palmer and Yan Kugel talked about the quality assurance (QA) and Quality Control (QC) philosophy in organizations. Many companies don’t get it right, and it costs them in compliance, time, and money. But it is not too late for any company to change that.

In the podcast/article, you will learn:

• What QA philosophy is
• What benefits QA philosophy holds
• How to implement the QA Philosophy across the organization
• What mistakes to avoid when looking at trend analysis
• Why and how to choose consultants to support you

Watch the whole talk :

What is QA Philosophy

Manufacturers must understand the core differences and the responsibilities of the QC and QA departments. Here is the simplified model – QA is responsible for the activities before the process (e.g., equipment qualification and process validation). QC would have here only supporting functions. QC is primarily accountable for the actions at the end of the process, within live manufacturing runs. It is there to confirm that results meet the requirements of the validated plan.

A good example is the aseptic manufacturing process, where you must rely mainly on controls that you have in place. You cannot rely exclusively on the sterility test in the end, because you test only a small number of samples.

A company with a proper QA philosophy cannot rely only on QC test results. Instead, they must have full control over the process life cycle. It is not enough to release a product that seems to be in-spec while ignoring the fluctuations in test results that get closer and closer to the action-limit with each day that passes. In order not to lose control over the process, QA must review trend analysis at least every month, always taking the last 12-months into account.

QA Philosophy Across the Organization

However, there is more to the QA philosophy than the QA department alone. A company must spread the QA philosophy across the organization! Each person must feel the responsibility for the quality of the product and not rely on QC and QA departments to detect problems at the end of the process. Each team, from validation to purchasing, should have its appropriate controls and ways to measure the quality of their part in the process.

For example, the purchasing team must be tightly involved in quality issues. They must understand that they cannot switch production material on a whim, only to save costs. Even if the raw-material has the same name and CAS number, it still may have different properties due to its manufacturing process. Besides, there may be additional parameters which the company didn’t list on the spec sheet, like particle size, for example. Such slight changes in the material specification may cause a tablet to fall apart after a few months.

Therefore, a team of experts must evaluate every material change in-depth and perform test runs, before using it in full-scale manufacturing. A process revalidation may even be required, depending on the critically of the changed material. By avoiding such mistakes, a company won’t waste precious APIs on failed batches, which otherwise may lead to significant capital losses, which could take years to recoup.

Establishing QA Philosophy Across the Organisation

To ensure a high-quality product, with minimal losses, a company must implement a Total Quality Management concept throughout the whole organization. It means that every member of staff must be committed to maintaining high standards of work in every aspect of a company’s operations. To implement the concept, a company must first evaluate its current state by mapping their whole business process- from purchasing of raw materials to the finished product, while identifying all the critical control points, and performing robustness tests. Process capability index (Cpk) is an excellent tool to start with for measuring that.

It shouldn’t be extremely difficult for companies that already manufacture a product for years, as they can look at the data they already have – especially the failures (deviations, non-conformances, and complaints). It’s always a good idea to start with the problems, and only then to expend to other sections which you can improve. As soon as you have identified the issues, conduct a proper root cause analysis, and be careful with human-error conclusions.

If you do the job properly, you do it once. If you do it half-hearted, you’re going to do it again next month.

– Paul Palmer

Steps for Process Life Cycle Improvement:

1. Process mapping
2. Stress tests
3. Problem identification
4. Root cause analysis
5. Testing of the solutions
6. Implementation in full-scale production
7. Monthly review of trend analysis

The time it would take companies to implement a total quality management concept would depend on their current state. A company with thousands of deviations a year would have a more challenging journey than a company with only 500. The hardship is, of course, identifying the most critical ones for the process.

Tips For Effective Implementation of the QA Philosophy Across the Organisation

1. Electronic Quality Management System (QMS)- if you don’t have one, consider investing in one. It eQMS would make everything magically quicker and more reliable. The costs of the system would pay for themselves by saving hours on labor time.
2. Start with the “Retraining” CAPAs. If you see that an operator had to be retrained five times for the same issue, you might have a bigger problem on your hand!
3. Be suspicious of data that shows problems after an implemented change. e.g., new, more sensitive equipment that captures additional information.

Rewards for Reporting Deviations & Mistakes

As you can see, the whole concept rotates around finding weak points in the system and analyzing deviations or mistakes done by employees. Therefore, for a company to succeed with the transformation to a Total Quality Management concept, it must encourage and reward employees for reporting deviations. Blame is not the answer, especially not in the pharmaceutical industry. Scared employees would prefer to hide mistakes than to report them, which would cause tremendous setbacks in the future. Management should punish those who hide mistakes severely while commending those who document them, especially if it was their own mistakes.

Getting Outside Help

Companies that lack the internal resources to perform a process mapping should consider hiring a consultant to support them with the activities. It is essential to let a party look under the hood because they:

1. provide a fresh point of view on your systems
2. are not biased nor have any conflict of interest
3. bring with them knowledge from many companies, where they worked before

Choosing the Right Consultant for Your Company

So you decided to bring in external support. How to choose the right one for your needs? This part is tricky, as you someone who would understand the business as a whole. Look someone with a relevant depth of knowledge and training. A graduate won’t cut it. To map the business process, you need someone who has done and seen it all. A qualified person would have an advantage here, or at least someone with a lot of auditing experience. Even if you think that you found the perfect person for the job, implement his work on trial runs to test the results. Additionally, the advisors must work with representatives from each department. That way, you minimize conflicts, make sure that everybody is on board, and, most importantly, keep the knowledge inside the company when the advisor leaves.

In conclusion, take it slowly and step by step. To achieve the best results, you must make sure that everybody is on board. Otherwise, the friction would doom the whole process. Then, start by looking at your past data and map the process to find the weak points. Afterward, look at the cost of the failures and use them to justify the investment. And remember – it ALWAYS pays off!

Some of the questions that I asked:

• What don’t companies understand about QA/QC philosophy? (1:08)
• What should companies do to change their quality concept? (10:24)
• How long should it take for a company to implement the QA philosophy? (20:07)
• How to choose the right consultant? (42:14)