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Digg It - ISO9001:2000 QMS - How to Interpret the Eight Quality Management Principles
During my early days of employment in the late 80's, the company I worked with engaged a consultant to get the company certified in ISO9002 QMS. I was one of the working committee then. Training was provided, followed by documentation of all our processes. A simple guideline was given to us to "document what we do" and "do what we documented". During that time, this guideline was quite straight forward. So we did and the com
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
pany obtained its ISO 9002 certification.
In late 90's there was a rush into converting our ISO9002 QMS to meet the new ISO9001:2000 revision. I was told that this new revision is more align to business needs as well as less emphasis on documentation. On the business needs aspect, there is the "Eight Quality Management Principles" in the new revision. They are as follows:-
1) Customer Focus
2) Leadership
3) Inv
In late 90's there was a rush into converting our ISO9002 QMS to meet the new ISO9001:2000 revision. I was told that this new revision is more align to business needs as well as less emphasis on documentation. On the business needs aspect, there is the "Eight Quality Management Principles" in the new revision. They are as follows:-
1) Customer Focus
2) Leadership
3) Inv
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
olvement of People
4) Process Approach
5) System approach to management
6) Continual improvement
7) Factual approach to decision making
8) Mutually beneficial supplier relationship
Here is the interesting part of this article. The author like to share with readers how some of the companies he worked with interpret these principles and applied them. By no means these companies are wrongly applied
4) Process Approach
5) System approach to management
6) Continual improvement
7) Factual approach to decision making
8) Mutually beneficial supplier relationship
Here is the interesting part of this article. The author like to share with readers how some of the companies he worked with interpret these principles and applied them. By no means these companies are wrongly applied
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the Eight Quality Management Principles. As a matter of fact, these companies has their valid reasons for doing so. This articulation of the principles is written in 3 parts, namely; principles supposed to meant; how it is applied as a case; and author's view to expand its application
Principle 1) Customer Focus "Organizations depend on their customers and therefore should understand current and future customer nee
Principle 1) Customer Focus "Organizations depend on their customers and therefore should understand current and future customer nee
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ds, should meet customer requirements and strive to exceed customer expectations".
Case 1) Many companies viewed customer needs are obtained from a survey. And as ISO auditor come around to conduct surveillance audit once or twice a year, they get the survey done right before the auditor come around.
Author's view 1) Conducting a survey is a form of documentation. In fact, customer needs can be obtained in ma
Case 1) Many companies viewed customer needs are obtained from a survey. And as ISO auditor come around to conduct surveillance audit once or twice a year, they get the survey done right before the auditor come around.
Author's view 1) Conducting a survey is a form of documentation. In fact, customer needs can be obtained in ma
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ny forms (most company knows that). Other than a formal survey, customer needs obtained in other forms such as during customer visits, customers complaints, customer feedback etc. These data should be taken officially as an input into the ISO system
Principle 2) Leadership "Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people
Principle 2) Leadership "Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
can become fully involved in achieving the organization's objectives".
Case 2) Most leaders set direction in the Quality Policy and Quality Objectives. Management reviews were conducted to ensure its fulfillment. However, most leaders are not involved in creating an internal environment in achieving the organization's objectives. Most often than not, they delicate to the Quality manager.
Author's view 2) Del
Case 2) Most leaders set direction in the Quality Policy and Quality Objectives. Management reviews were conducted to ensure its fulfillment. However, most leaders are not involved in creating an internal environment in achieving the organization's objectives. Most often than not, they delicate to the Quality manager.
Author's view 2) Del
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
egating to the Quality manager seems to be the most logical role to a Quality Manager. However, in some smaller company, Quality manager does not have enough influencing power to his/her peers hence cannot command radical improvement to the Quality System.
Principle 3) Involvement of People : "People at all levels are the essence of an organization and their full involvement enables their abilities to be used for t
Principle 3) Involvement of People : "People at all levels are the essence of an organization and their full involvement enables their abilities to be used for t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he organization's benefit".
Case 3) While most company involve their employee in the ISO compliance effort, some involves them in other aspect of the business especially in production and process improvements as well.
Author's view 3) This is the principle which is well implemented by most companies I came across. While it is perfect to involve employee in ISO compliance aspect. Some involve too much with the
Case 3) While most company involve their employee in the ISO compliance effort, some involves them in other aspect of the business especially in production and process improvements as well.
Author's view 3) This is the principle which is well implemented by most companies I came across. While it is perfect to involve employee in ISO compliance aspect. Some involve too much with the
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
employee in selecting improvement projects. It is only logical that employee select projects that they are familiar and easy to do. But this selection often miss the key alignment to the company critical issues.
Principle 4) Process Approach "A desired result is achieved more efficiently when activities and related resources are managed as a process".
Case 4) All if not most ISO certified companies are v
Principle 4) Process Approach "A desired result is achieved more efficiently when activities and related resources are managed as a process".
Case 4) All if not most ISO certified companies are v
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ery good in production processes. Their ISO documentation for these process are well kept. However, their process approach seem to limit within the production and related supporting departments.
Author's view 4) In the aspect of business process such as decision making, there is lack usage of a process approach in decision making. Often than not, quick decision are expected hence attention is not given to go through
Author's view 4) In the aspect of business process such as decision making, there is lack usage of a process approach in decision making. Often than not, quick decision are expected hence attention is not given to go through
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
a logical steps.
Principle 5) System Approach to Management "Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives".
Case 5) This area seem to show a loose link between production and the rest of the departments especially the supporting group. In some case, Key Performance Indicators (KPI) are e
Principle 5) System Approach to Management "Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives".
Case 5) This area seem to show a loose link between production and the rest of the departments especially the supporting group. In some case, Key Performance Indicators (KPI) are e
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
stablished for each department but they are not interdependent.
Principle 6) Continual Improvement "Continual improvement of the organization's overall performance should be a permanent objective of the organization".
Case 6) In general, most companies work on continuous improvement as oppose to continual Improvement. some of the companies take "fire-fighting" as a way to continual improvement. VEry few rea
Principle 6) Continual Improvement "Continual improvement of the organization's overall performance should be a permanent objective of the organization".
Case 6) In general, most companies work on continuous improvement as oppose to continual Improvement. some of the companies take "fire-fighting" as a way to continual improvement. VEry few rea
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
lize the objective of this principle.
Author's view 6) it is my opinion companies need to understand that source of information to trigger a continual improvement effort. And to establish it in order to clearly identify whether it is a "fire Fighting" or continual improvement.
Principle 7) Factual approach to decision making "Effective decisions are based on the analysis of data and information".
Case 7
Author's view 6) it is my opinion companies need to understand that source of information to trigger a continual improvement effort. And to establish it in order to clearly identify whether it is a "fire Fighting" or continual improvement.
Principle 7) Factual approach to decision making "Effective decisions are based on the analysis of data and information".
Case 7
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
) This is probably the weakness principle in terms of its application. To a large extent, Management make decision based on past experience, statement past around and so on. Often minimum data are sough after when a decision is made. Perhaps it is due to time factor. However, this phenomenon is so in the Quality Department.
Author's View 7) This is an important principle management staffs need to develop. Past
Author's View 7) This is an important principle management staffs need to develop. Past
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
right decision made may not be repeated due to changes in the business environment.
Principle 8) Mutually beneficial supplier relationship "An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value"
Case 8) Most smaller company practice to some extent this principle quite well. perhaps it is due to smaller outfit that cannot comm
Principle 8) Mutually beneficial supplier relationship "An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value"
Case 8) Most smaller company practice to some extent this principle quite well. perhaps it is due to smaller outfit that cannot comm
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
and better service from the supplier, person in charge seems to have close relationship with supplier. On the other hand, bigger companies are bound by internal policies that requires 2-3 quotes from different supplier for the same items. Relation ship with supplier does not help to some extent.
Author's View 8) This principle is difficult to master due to the fact that integrity is involved. Unless the company has b
Author's View 8) This principle is difficult to master due to the fact that integrity is involved. Unless the company has b
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ig volume of purchase and strong vendor development program, it is understandable company pay less attention to this principle.
In summary, while ISO certified companies tried to comply to ISO requirements, they should extent the objectives of these Eight Quality Management Principles to enhance their business such that it become part of their business system.
As a side note, these quality management principles has ma
In summary, while ISO certified companies tried to comply to ISO requirements, they should extent the objectives of these Eight Quality Management Principles to enhance their business such that it become part of their business system.
As a side note, these quality management principles has ma
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ny similarity to the TQM principles. So, it is of the interest of leaders in ISO certified companies understand it and put an effort to extent the objective of ISO certification beyond certification purpose.
Disclaimer The "Author's View" section provided are merely the author's personal point of view and has no binding to any implication thereof. The author take no responsibility to the use of this article by anyone
Disclaimer The "Author's View" section provided are merely the author's personal point of view and has no binding to any implication thereof. The author take no responsibility to the use of this article by anyone
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
in any way.
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All rights reserved. You are free to reprint or re-publish this article as long as you include my resource box at the end of this article. And ensure that the URL in the resource box remain intact and it is linked to the author's website.
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tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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