Two major elements in Quality Risk Management (QRM) areas follows:
The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient
The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk
It appears from both the points above that ALL RISK is therefore, associated with PEOPLE. working in a Pharmaceutical manufacturing and testing environment. Scientific knowledge, level of effort and documentation are all person-related activities.
Risk is defined as a situation involving exposure to danger.
What danger are we referring to? Danger to the quality of the product which translates as danger to the patient consuming the product. Before we look a the danger to the quality, let us consider danger to the patient.
A poor quality product may not produce the desired result, which means it is not efficacious. It may be unsafe, harmful. The harm can be as severe as death.
Efficacy and safety of the product can be affected by several factors and all these factors are contributed by the action or inaction of people involved from Product Development to product sale, distribution, diagnosis and administration.
Some of those factors are:
1. Material: Right from selection of material at Product Development stage, risk has been activated. Scientific knowledge is the limitation of the scientist involved in research and formulation development. Material selection begins with material specification and vendor finalization. While specifying parameters and acceptance criteria, it is possible to miss out on tests that should have been in place. Sometimes lack of analytical ability can lead to absence of a test from an official protocol. Then there is the mundane activity of material storage and handling which being mundane, increases the risk. We can trail the material and find several risk points along the way and all will be associated with people and their action or inaction.
2. Machines: Again, machines are selected, installed, operated and maintained by people and it is their level of knowledge and skill in doing each of the above, that determines the risk to the quality of the product.
3. Method: All methods, from development, execution and documentation are the handiwork of people and if tried and tested methods are not followed due to lack of understanding, training, skill, discipline and supervision, the risk will increase.
4. Metres (manufacturing and testing environment) Spaces are conceived, designed, used and maintained by people. The concept and design is done by a different set of people and the user of space is a different individual and many a times there is a mismatch in what was conceived and what was adopted in operations. We therefore have situations like "as designed" and "as built".
5. Minutes: Time of manufacturing is crucial. Factories operate in shifts and human efficiency is questionable at different times of the day. Afternoons and nights are not the most conducive times for human alertness. Moreover, all people involved with activities are driven by the commercial aspect of the enterprise. And time is money! So there is always a pressure on operating staff to deliver results within the specified time. Haste makes waste and performing under time crunch situations multiplies the risk.
6. Maintenance: is a culture. Maintaining premises and equipment is commonly understood. Maintaining documents is also considered normal. The difficult thing to maintain is discipline and here again we are talking of people. It i lack of discipline that allows infrastructure and equipment to malfunction and degenerate.
7. Monitoring: Though advancement in technology has given us gadgets like camera and recording devices, it still takes people to monitor the data collected to derive meaningful information from the same. Monitoring means observing and reporting and here again the reliance is on people. No wonder we have failures despite the best of installations of hardware and software.
8. Measurement: The route to accuracy is measurement because it is objective. Accuracy depends on the availability of measuring devices and the ability to use those devices. But importantly, people have to "look at" measurements. We see instances of measurements being recorded (quite a few by automatic devices), but nobody sees those measurements or tracks the trends or derives any information out of those measurements. The measurements are piled up as raw data without any practical application. Another "people" issue!
9. Modification: The urge to modify is inherent in humans. If it is a controlled modification then we are within the ambit of change control but when it comes to an impulsive modification then we enter the realm of deviation. We are witnessing the amount of strictures regulators apply when it addresses deviations.
10. Manipulation: One thing leads to another and in the mode of defense, to hide the origin "sin" people resort to manipulating. Doctoring of documents has been a malaise that the regulators are coming down heavily upon and is reflected in their strict stance against some companies. While we are using diplomatic language, the simple word in English for manipulation is "cheating".
11. Mistakes: Being what human beings are, it is in natural progression that mistakes are bound to happen. It is "how" those mistakes are dealt with that reduces or enhances the risk to quality. When mistakes happen the immediate human response is denial. Usually it is out of fear of consequences. The play of people is quite 'unmistakable'.
12. Management: It is the top management that sets the tone. If the top is commercially oriented, almost every time there is a conflict between quality and commerce (and this conflict exits on nd off), invariably the commerce wins.
13. Motivation: Strictly a people's subject, it is a double-edged sword. If people are not self-motivated by the fact that their work causes healing in the world, and if they have to depend on external motivating factors such as incentives, then it is a given that in the absence of those factors, the people will not be motivated enough to give of their best.
14. Market: If my product quality is based on the market to which I am catering, I am acknowledging that I have multiple standards of quality. This is again a matter of attitude and organizational culture which in turn is a "people" subject.
15. Money: has always fascinated people and it is the singular most powerful driving force visible in humanity. Why are more and more companies gearing up to raise their quality standards? Simple! The markets that demand the higher levels of quality standards pay premium prices for drug products. So if money is a motivator, then while actually improving quality and thereby reducing risks, people are also running the risk of "showing" that their quality is improved. That is riskier!
16. Mapping: This is generally about audit trail. If you can map the route through which a product has traveled from its development stage till its final consumption in the market or its expiry, then you have charted a good map. A map can be used for gap analysis and enhancing reliability by bridging the gaps. This is where flow-charting becomes an important Process Control tool. When a Process is brought under stricter control the risk is minimized. Good mapping is also dependent on the knowledge, skills, diligence and perseverance of people.
17. Mastery: QRM tools are available to all. But tools require skills to be used. A screw driver is a tool, which in the hands of a skillful carpenter can fix a piece of furniture. The same screw driver in the hands of a skillful electrician can illumine a room. If the respective departments in an organization can use the tools offered under QRM effectively, then there will be a meaningful reduction in risks. Knowledge of the tool and the skill to use it is entirely up to the people. This is the realm of personnel selection, education and training. Unfortunately training is being treated as a regulatory obligation to be fulfilled and not as an essential aspect of risk-free manufacturing and testing.
18. Mission: Most organizations have mission statements. Only few take the effort to have the mission percolate down to all levels of people in the organization. A very tiny percentage ensures that the Mission is revisited, revised and kept alive in all strata of the organization.
If one has to go into details of each factor, it becomes a big exercise in HR management. But if one does invest in such an activity, the QRM becomes child's play. Risk Management exists because risks exist. Risks exist because of people's inadequacies. Inadequacies in knowledge, skills, management, monitoring and control exist in the best of organizations. Risk identification, risk analysis and risk mitigation becomes easier with enhanced knowledge and improved skill sets. Investing in educating and training people is as vital as investing in infrastructure and equipment.
Hopefully the industry will see the savings (money again) in this investment and take concrete steps in this direction.