Who is responsible for the quality of the product?
Xin Qiaojuan
The problems related to the quality of steel drums between steel drum manufacturers and steel drum users, as well as between steel drum users and steel drum users, are endless. In recent years, due to the increasing use of steel drums, domestic production has become larger and larger, and steel drums have accompanied the goods to all parts of the world. However, the quality of domestic steel drum enterprises is uneven, and quality disputes have occurred. The responsibility for some quality problems is difficult to identify, causing many misunderstandings and injuries to both the supply and demand sides. Below we use a more typical case to analyze this problem.
[Case] ​​A pharmaceutical company found in the factory inspection of tablets that "red spots" appeared in white tablets. The test results show that these red spots are "rust". Why is it rusty? Investigators continued to look for reasons, and as a result, rust was found in steel drums containing mixed accessories. They breathed a sigh of relief because the problem was not on their own side, but at the excipient supplier. The pharmaceutical factory officially sent a letter asking the supplier to take corrective and preventive actions to prevent the rust problem from recurring. However, the supplier's reply made the pharmaceutical factory stunned: "The inside of the lid is rusty. If the operator closes the lid too hard, the rust will fall into the mixture. We attribute this problem to 'human problem'. We The corrective action to be taken is to retrain those employees – telling employees not to cover them so hard.â€
From this case, the steel drums used for mixing accessories will rust even during normal use. The most practical corrective action should be to take corrective action against the rust of the steel drum itself, not the operators who open the lid. Why can't I choose a steel drum that does not rust to hold the material? In this way, no matter how much effort is used to cover the lid, there will be no rust falling into the mixture. This really found the cause and prevented the formation of rust in the first place.
This problem is easy to say, but it can be done. Everyone is afraid of taking responsibility, so push and push, simple problems are complicated. Don't you understand where the problem is? It is afraid of bearing the consequences and responsibilities.
In many cases, no effective action is taken not because of the lack of ability and method to analyze the problem, but to consider more realities. In terms of the problem of rusting steel drums, in fact, rust removal will not be a matter for material factories. He can trace the steel drum manufacturers. Steel drum production plants can analyze according to the quality problems that arise. The selection of steel drums will give a satisfactory result, and fundamentally eliminate the recurrence of such problems. Excipient suppliers only need to spend more time to re-verify and confirm the materials produced.
In China, most pharmaceutical companies have passed the US Food and Drug Administration Certification. This organization is very rigorous, and the companies that pass the certification are in the supervision and management. Any move by the company may alarm the US Food and Drug Administration, who will send someone to the site to see if the program has changed or not, and to see if other parts of the program or other procedures are affected by the rusting of the steel drum. If the program has a major change, you will need to re-apply for the new drug approval process. This is a big deal for many Chinese pharmaceutical companies. To complete this series of certifications, in addition to the considerable manpower, material resources and financial resources, it is not always possible to pass the certification, and may Need to stop production. And if you position the problem as a 'human problem', retraining the operator and taking adaptive action is much simpler, saving money and risking – at least in the short term.
As can be seen from the above cases, a qualified quality engineer must not only have strong professional knowledge, but also the quality of senior management personnel. Dealing with the problem properly, can not make the company have too much loss, but also let the same kind of problems can not happen again. Taking rusted steel drums as an example, it should be the product quality problem of steel drum production plants. The reasons for quality problems and responsibility analysis are as follows:
1. The steel plate of the raw material of the steel drum itself is rusted, and there is no rust removal during the production process. Therefore, the auxiliary material factory has rust on the front cover of the material. A quality accident involving a steel drum production plant will cause unqualified products to leave the factory.
2. The steel drum is not qualified for rust when it leaves the factory. It is not well preserved before and after the auxiliary material is stored, and it reacts with water and rusts.
3. The barrel factory said: “The operator has too much force to open the lid, and the rust that has already rusted has been shaken into the raw materials of the medicineâ€. Then, how much force is used to operate, is it qualified, is there any regulation, is there any quantitative indicator, can it be effectively controlled and tested?
4. The steel drum selection is not correct.
The problems for the above analysis are resolved by the responsible entity.
Steel drum producers: Firstly, the quality of steel drums is strictly controlled. According to the ISO9001 procedure, qualified products are produced. Unqualified raw materials are not put into production. Unqualified products do not flow into the next process, and unqualified products are not shipped. The second is to use the instructions for the use of steel drums, to inform users of loading and unloading, storage conditions, the size of the force when the lid is used and to what extent the lid is tightened. The third guide and training customers use the steel drum user manual to understand the purchase, use and maintenance of steel drums.
Excipient supplier: The purchased steel drum should be inspected first, and then put into storage after passing the test. Filling and using according to the process flow, the package should be first checked and operated, stored and transported according to the package instructions.
Pharmaceutical factory: Firstly, the raw and auxiliary materials entering the factory will be inspected at the factory, and the qualified products can be put into storage. When leaving the warehouse, the warehouse manager and the borrower should inspect the materials and packaging respectively, and then pass the next process after passing the qualification. The unqualified materials and materials are never put into production.
If every link is strictly in accordance with the management system procedures, it is impossible to find the problem until the final inspection of the drug. Therefore, this quality accident cannot be said to have no one's problems, but it cannot be attributed to "human problems." It shows that although several production enterprises have management systems and quality assurance systems, the execution power is not in place, and the details determine success or failure.
At present, stainless steel drums are generally available for metal steel drums for food and medicine turnover. When used to store accessories or other raw materials for sale, in order to reduce costs, galvanized steel drums, inner coated steel drums, etc. are used. If there are other requirements, the steel drum factory can help users to select the type. However, there must be a serious and responsible attitude towards the quality accidents that have already occurred. Regardless of whether the user requires it or not, as a manufacturer, it is necessary to rework and verify the products already produced. According to the food and medicine safety management procedures for re-inspection, if they are afraid of taking responsibility and not touching the problem, similar problems will happen again, and the enforcement of the system will be weakened, and other problems will follow.
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