QC Laboratory at a Glance: Part 3

As a Quality Control "QC" professional responsible for an important part of the "conform-non conform" cycle for all production inputs and outputs you can predict a huge working stress!

Speaking about the QC role? Why QC is so important? How does the QC laboratory perform and fit into the manufacturing facility system? Finally, how to manage the total view of QC and avoid mistakes in the laboratory affecting instruments, performance or accuracy? Those points and interesting details are covered in this concise series of 3 articles entitled: "QC Laboratory at a Glance". We discussed in the last 2 articles (part 1 and part 2) the role of QC, general categories of tests, the integrated roles of QA and QC and specific tests for a specific dosage form. In part 3 we will focus on the whole picture of the QC laboratory to highlight the management, preserving resources and avoiding mistakes.

GOOD LABORATORY PRACTICE UMBRELLA

As a basic knowledge, any manufacturing facility for drug products should follow good manufacturing practices guidelines. One of the relevant topics is good laboratory practice which is the cornerstone of laboratory work. Far from the technical details, the GLP umbrella can be understood as a triangle of honesty, accuracy and diligence supported by documentation (see Fig. 1)

Fig. 1 GLP philosophy

Of course, attitude of honesty is the base for choosing QC personnel, accuracy also should be a critical and important side of the QC personality, diligence provides the caring attitude of the QC personnel which covers his work and finally the documentation keeps all right and available for any investigator.

QC LABORATORY RESOURCES 

As a QC manager, you should care for your laboratory resources. Not only to keep them but also to improve!

Human power

The top important resources are personnel. Your team members are your eyes and hands, moreover, they can be minds added to your mind if you invest in them. How to invest with your team? Spend some dedicated time for training, listen carefully to their opinions and discover their needs. One of the most important skills for the manager is to DIRECT others in a manner suitable for them! Worthy to mention, is the known theory of SITUATIONAL LEADERSHIP which supports the manager with the right role according to the degree of maturity reached by his team. 

Instruments and tools

QC instruments have a special care program starting from qualification (design qualification "DQ", installation qualification "IQ", operational qualification "OQ" and performance qualification "PQ") and not ending with a good plan for preventive maintenance.

Moreover, the right selection of instrument brands, tools and good distribution of both in the laboratory to avoid zigzag motions during routine analysis are very important notes, which also support a very unique resource: the TIME. 

Time

As a QC unit, you are always under pressure of time to meet deadlines for giving results to support quick release of products which is a very stressful environment which needs special care for time. Time is a resource which cannot be purchased! Spending time with the team to assure lean processes with the cancellation of extra steps and training team members on time management are 2 key points helping time-saving. 

Chemicals 

The methodology section which is responsible for developing methods of analysis, if guided, can design efficient methods with a cost-reduction approach to save consumable chemicals. Also, following storage conditions and expiry dates with a simple efficient system is important to avoid missing chemicals. 

BALANCING BETWEEN TOP VIEW AND DETAILS

Usually, managers need to avoid being overwhelmed with details. They should delegate some of their tasks and they should follow missions via other people. Although, when they are solving problems they need to dive deeply! Some famous tools such as the fishbone diagram help efficiently trace detailed predicted causes of problems. So, we can say to the manager: "Manage routine work from the top view and troubleshoot by diving into details!" 

AVOIDING REPEATED MISTAKES

One important rule I learnt from one of my managers, we can accept ten different mistakes but not the same mistake twice! This can be achieved through good follow-up and continuous training and improvement. Conducting corrective action/ preventive action (CAPA) after detecting mistakes is a good shield versus repeated mistakes. Normally, a corrective action can be conducted quickly after a mistake, even by the team member who made the mistake, but the preventive action normally needs the manager’s decision.