The Changing Role of Quality Assurance in the Pharmaceutical Industry

beiwei5du

该文是PDA前主席ROBERT G. KIEFFER于2014年12月发表于PDA Journal上的评论文章，非常的好，极力推荐！！


The Changing Role of Quality Assurance in the Pharmaceutical Industry
制药行业QA的角色转换
ROBERT G. KIEFFER*


ABSTRACT: ICH Q10. Pharmaceutical Quality System emphasizes that senior management is responsible for the quality system. Thus, it is not the quality assurance organization that has the primary responsibility for the quality system. With this shift of responsibilities, what can quality assurance do to help senior management fulfill their responsibility? How can quality assurance be more proactive, add more value? What new skills does quality assurance need to have in order to perform its new role? This article attempts to answer these questions.
KEYWORDS: ICH Q10, Senior management, Quality assurance, QA, Quality system.

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Excerpts form the commentary:
1、It is well known that quality practices in the pharmaceutical industry have lagged behind best practices in other industries.
2、ICH Q10 emphasizes the role of top management, the responsibility of senior management for the ownership of the QS including its development, implementation, control, and improvement.
3、I see the need for QA to perform a much more proactive role in improving the QS, focusing much more on prevention and continuous improvement
rather than appraisal.
4、Functions that are properly those of the engineering department or other specialized units because of their unique training and expertise
should not be duplicated or usurped by the quality control unit. Where expertise is in other units, the responsibility of the quality control unit is to assure that such expertise has been utilized.
5、The Commissioner intends to make the quality control unit responsible for ensuring that controls are implemented during manufacturing
operations which assure drug product quality, not that the quality control unit actually perform each one of the duties.
6、To clarify that the quality control unit could not and should not perform duties duplicative of other parts of the organization, the Commissioner has modified the definition of quality control unit in 210.3 (b).（be responsible for duties relating to quality control,not perfom duties relating to quality control）.
7、In my experience, over the years the quality unit has taken over more and more of the quality-related tasks that correctly should be performed by other departments, especially by production and engineering. We learn from best practice in other industries that production has to take responsibility for the quality of their work, for the quality of their process, and for the quality of the output of that process, the product.
8、In the past QA has periodically been described as the policeman, the controller, or even the enemy. Today, we like to think of QA as the promoter of improvement of processes, the promoter of best quality practices, and a valued ally and helper.
9、Much of this traditional responsibility, however, can be done by periodic, effective audits. If other departments are doing their work properly, then QA should be able to significantly reduce its checking and oversight activities. QA also needs to stop doing the work of other departments. This should free up QA personnel to perform more proactive and preventive type of activities, which would be more value-added to the organization.
10、ICH Q10 assigns the primary responsibility for the QS to senior management. “Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives.”
11、What can QA do to help senior management fulfill its responsibilities? ICH Q10 discusses the need to use quality risk management and performance indicators, as well as to determine the root cause of problems and to do quality planning. These are all areas where QA can play a leading role.
12、Most of these QS processes can be measured in a quantitative way. QA, in conjunction with the process owner, can determine the appropriate metrics, the best way to collect the data, analyze the data using risk analysis for prioritization and root cause analysis for focus on the real problem.Finally QA can present this data to senior management for action as part of their periodic review of the QS. If possible QA, with the help of all departments, can suggest corrective and preventive actions to senior management. Note that generally only senior management has the capability to fix root causes. Root causes are senior management problems.
13、there are two other aspects of the QS that are very important, the quality culture (or the culture of the company) and the qualification of people. It is necessary and possible to measure these factors also. Culture, which is the responsibility of senior management, is frequently a root cause of problems.
14、Quality is achieved through the work of others. QA does not produce the quality product. QA, however, can influence the work of others who are more directly involved in the production process.QA also achieves the desired quality results by the promotion and selling of quality.
15、We need to sell quality at all levels and to everyone in all departments. To do that we need to be clear on what we want to sell and why it is important. I believe telling people you must do it because it is a regulation or because the procedure says so is not very effective.
Explaining the logical and scientific reason for doing a task in a specific way is more effective.All quality activities in a pharmaceutical plant should find their ultimate meaning in a benefit to the patient. Also, important to the doer is, how does doing the task this way make my life easier? The most important part of the selling process is the preparation.
16、The best way to promote quality is by recognizing and rewarding good practice. Good quality practices can be promoted in a variety of ways. The only limitation is our imagination.Another way to look at the QA department is as a team of experts: experts who can help others to achieve
their quality goals and to fulfill their responsibility for the quality of their work.
17、I have made two assumptions so far in this article: (1) the QA department is competent in fulfilling its traditional role, and (2) senior management is willing to take ownership of the QS.
18、QA needs to sell quality. QA needs to convince senior management to take responsibility for the development, implementation and continuous improvement of the QS.three steps:
(a) The QA department must have credibility.(QA needs to be seen as a department that can help and even train senior management.)
(b) Given QA credibility, the best way to sell management on a more proactive and preventive approach to quality is by using quality metrics especially by measuring quality costs.（the role of QA in obtaining and reporting to senior management quality metrics or data. Determining the costs of quality is a powerful way to get management’s attention.）
(c）The third recommended step is to get outside help. As W. Edwards Deming said, a system cannot understand itself without help from outside the system.

vincentchampion

需要非常全面的知识，基本上都是做主导和管理层的管理体系的守卫者

beiwei5du

vincentchampion 发表于 2016-10-7 19:42
需要非常全面的知识，基本上都是做主导和管理层的管理体系的守卫者

主要是QA理念和定位的差异呢！

北重楼

理念和意识是一方面，

一沙一叶

这个要收藏着看一下

syhorchid

学习一下

globle002

thanks for sharing

福娃

谢谢分享。。。

bjlidi

很有道理！

hongyu

收藏

chenjiao501

好好学习一下，谢谢分享

scslk0045

谢谢分享！

至德堂zhq

感谢！您的资料很好！

asd30456891

好好学习一下，谢谢分享

小金库

楼主辛苦了，感谢分享