The role of quality assurance in quality inspection

What is the role of QA in quality inspection? Let's take a look at the position and role of QA in the quality management system!

First, the position and role of QA in the quality management system

The role of 1 and QA

The quality management of the whole process of drug production involves both inside and outside the enterprise. Is it necessary to implement it in the whole process of quality management? Prevention first? Principles, the focus of quality management, check the design and manufacturing process before and after, strengthen the quality management of all links in the whole process, eliminate all kinds of hidden dangers of unqualified products in the process of quality formation, and achieve? Nip in the bud? At the same time, gradually form a quality management system including the whole process of market research, R&D design and sales use.

Therefore, in the process of drug production, there should be enough well-trained production operators and managers who are competent for their own jobs, make use of factories, facilities and equipment that meet the conditions of drug production, use qualified raw materials and packaging materials, and adopt verified and approved production methods to strengthen the strict management of process hygiene and safety production. Under the control of documented quality management system, the quality of products produced is credible through reliable inspection and monitoring means.

In the whole production process, QA is responsible for the quality monitoring of the whole production process, ensuring the safety, effectiveness and stability of drugs and ensuring that all products meet the quality requirements, which plays an important role.

2. The position of quality assurance in pharmaceutical enterprises.

It is the focus of all departments of the whole enterprise to strengthen quality management and ensure product quality by implementing GMP. Therefore, it is very necessary to establish and improve the quality management system of a pharmaceutical enterprise, and at the same time, an independent and authoritative quality management department is responsible for coordinating and implementing this system.

China's GMP stipulates that a quality management department must be established independently of other departments, and its person in charge shall not concurrently be the person in charge of the production management department.

Through it, it is responsible for coordinating and implementing the quality management system, and conducting command and control activities in quality management, including formulating quality policies and objectives, and carrying out quality planning, quality control, quality assurance and quality improvement.

Therefore, the quality management department must be responsible for reviewing all aspects that may have an impact on product quality. All materials and procedures related to products and their quality should be submitted to the Quality Department for approval, and the Quality Management Department has veto power over the quality of materials, semi-finished products and finished products.

Second, how to reflect the value of QA?

Let's look at a story first:

Once upon a time, there was a mountain road that left many traps.

The first pipeline inspection every few days can always rescue people who fall into the trap. People are grateful to him and occasionally get some grateful money. The second plumber carefully inspected the road and set up a sign where there was a trap, so people remembered him; It took the third plumber a long time to fill all the traps, and no one has known since.

In the end, people appreciate the first person, remember the second person and forget the third person.

A lot of work of a qualified QA is preventive, which is essentially similar to the third person in the above story.

They often take preventive measures before the accident or take corrective measures in time after the problem occurs to prevent the problem from happening or happening again.

The nature of QA's work has also caused most people to forget him and think that QA is worthless.

Therefore, QA should pay attention to revealing the hidden work results in order to gain the approval of stakeholders.

There are two main ways: qualitative and quantitative.

Qualitative is to strive for opportunities to introduce yourself to people in daily communication and reports? Work? ; Quantization is to present the improved results through measurement.

Third, the relationship between enterprise quality objectives and QA

As we mentioned earlier, QA should work from the perspective of patients.

In fact, the depth and breadth of QA work are different because of the different cultures of enterprises.

After all, QA is also an employee of the enterprise and should work according to the company's quality concept.

Crosby's four basic principles of quality management also mentioned: quality meets the requirements, not good! The definition of ISO quality management system is that the requirements of customers are the standards of quality.

For drugs, everyone abides by the same standard, but the focus is different in the specific implementation process.

A good QA is not mechanically copying standards, but appreciating the company's quality culture and grasping the key points.

Fourth, quality assurance and quality culture.

For QA, talking about quality culture is like being in front of you.

Just like the air around you, you can't catch it, but you still need it.

Why? As an ordinary employee, QA cannot change the company's quality culture, but it is deeply influenced by it.

When we talk about quality culture, most of them revolve around one point: whether leaders attach importance to it.

I believe this captures the source of corporate culture.

Enterprises can be regarded as social people by their way of thinking and behavior.

Fundamentally speaking, it is determined by its culture, and someone in an enterprise (especially an entrepreneur) plays a decisive role in the precipitation of corporate culture.

We can imagine that it is difficult for a boss with theory X to have a manager with theory Y. In this way, the boss's idea affects the manager, the manager's thought affects the employees, and the behavior of all employees constitutes the behavior of the enterprise.

In fact, there are far-reaching regional culture and national culture on the periphery of corporate culture.

If you can't change the big environment, you can change the small environment; If you can't change the small environment, sit down and plant sweet potatoes.

Wait until one day, learn from a painful experience, and the top management realizes that the middle management has improved its quality? Sweet potatoes can also be harvested, and everything is getting better.

Verb (abbreviation of verb) QA's career development

It is said that pharmaceutical company QA is the most hopeless position.

Why?

First, at present, the quality concept of pharmaceutical manufacturers in China is generally not high, so it is difficult to attach importance to QA;

Secondly, a good QA needs a lot of knowledge and high literacy, which is difficult for ordinary people to achieve;

Thirdly, under the background of emphasizing practical experience in the talent market at this stage, the career prospect of a person who has been engaged in QA for a long time is only a QA supervisor, and then he will be a quality department manager, and both positions in a pharmaceutical factory need strong ability. Without special learning opportunities or special efforts, it is difficult for a QA supervisor to accumulate enough knowledge background without five years of practical experience, and he must have strong communication and coordination skills to be a QA supervisor.

Therefore, an undergraduate may not be able to be a QA supervisor after five years of QA. If an undergraduate has not been a workshop director after five years of production, it is also very bad! Of course, the above is true, so where is the career prospect of QA? Everything has two sides. Let's look at the other side of the above three points.

First, the quality concept of domestic pharmaceutical companies is generally not high at this stage, which is a good opportunity for QA to play its own level. Imagine if everything is perfect and you are only allowed to do some very daily work, will your ability be greatly improved? Obviously not! It is impossible to improve quickly without challenges.

On the other hand, QA has a high status in foreign companies and good income.

With the strengthening of domestic drug supervision and the improvement of people's quality concept, the status of QA will be gradually strengthened.

To take a step back, even if the quality level of domestic pharmaceutical companies can't be improved, as long as you have a real level, go to a foreign company, which is a paradise for quality workers.

But: not everyone can go to heaven.

Second: it is difficult for ordinary people to do it, but since you have chosen to do QA, are you still an ordinary person? ! Huh? If you can't accept this challenge, change careers as soon as possible, because you can't be a QA.

Thirdly, steady promotion is the career ideal of most people, but in fact, we have many choices besides steady promotion.

For example, at present, many large pharmaceutical wholesale companies will conduct comprehensive quality audits on production enterprises, including on-site audits. Excellent QA is also an excellent customer auditor. At present, the country is implementing resident supervisor, which is also an external QA from the perspective of responsibility. If we continue to implement this system, there will definitely be many vacancies. You can take the civil service exam and then go back to your original company to be the resident supervisor. The taste should be hard to imagine If you don't want these things, you can also take the exam as a quality engineer and then become a senior QA, which can realize your own value; Or, do quality for a while and then switch to production. Rich experience in quality management will surely make you nip in the bud from time to time in the production process?

QA is sometimes a bit difficult to do, but as long as you put your heart into it, you can certainly do it well.

The company still attaches great importance to our opinions, and share with you several small ways to gain trust and respect.

1, we can make a report on the monitoring data we often do, explain the reasons, and it is best to design it in tabular form (many leaders are not engaged in drugs and should be more popular).

Say it when you do it, and let them know that your work is valuable.

2. Be kind to workers, establish prestige, use all your abilities to solve some practical problems of workers and let them know, so that the next work will be much easier.

In fact, workers are very simple, so we should consider the problem from the same angle, and don't make it into a relatively hostile situation.

We should seriously deal with individual unconscious workers and establish prestige.

3. Communicate frequently. There are many QA personnel in our company. Every time we hold a regular meeting, we should actively communicate with each other the problems we encounter and listen to your thoughts. There will always be omissions in one's thoughts, but the more people participate, the fewer omissions will naturally be. We are not required to consider some difficult problems carefully, but try to reduce other problems caused by insufficient thinking.

4, self-protection, I don't know if you play games, in a classic game sold around the world, the most mentioned sentence by players around the world is that only survival can contribute and progress can be made.