Advice You - Business

In my previous article entitled: Information and Analysis - Baldrige Assessment Case Studies for Category 4, I shared about common assessment findings of several companies being assessed by a group of trained and experienc

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

ed assessors. In this article, I will provide similar findings but on Human Resource Focus of the Baldrige Criteria. It is provided in the form of case studies which include Criteria summary as described in year 2

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

001 Baldrige Criteria, assessment findings in terms of Strengths and Area for Improvements.

There are seven categories in the Baldrige Criteria. In this article, I will deal with the bold categories listed below:

Leader

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ship | Strategic Planning | Customer and Market Focus | Information and Analysis | Human Resource Focus | Process Management | Business Results

Criteria Summary Category 5 - Human Resource Focus
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
>

The Human Resource Focus Category examines how your organization motivates and enables employees to develop and utilize their full potential in alignment with your organization’s overall objectives and action pla
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
ns. Also examined are your organization’s efforts to build and maintain a work environment and an employee support climate conducive to performance excellence and to personal and organizational growth.

5.1) Work Systems
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
Describe how your organization’s work and jobs, compensation, career progression, and related workforce practices motivate and enable employees and the organization to achieve high performance.

5.2) Employee Education,
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
Training, and Development Describe how your organization’s education and training support the achievement of your overall objectives, including building employee knowledge, skills, and capabilities and contributing to hig
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
h performance.

5.3) Employee Well-Being and Satisfaction Describe how your organization maintains a work environment and an employee support climate that contribute to the well-being, satisfaction, and motivation of al
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
l employees.

Common Strengths

A long term Strategic HR is established and put into practiced especially for succession planning, oversea postings, R&D capabilities and Engineering Improvement resources
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
li>
There is systematic approach to improving the work system to cope with the business needs taking consideration of skill personnel are lesser in the employment market

A structured manpower training progra
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
m to inculcate corporate culture is in placed to disciminate corporate values. Global manager development program is in placed to develop more future leaders to support business expansion.

Common Area for
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
Improvement

while corporate training program is in placed, balancing between corporate and company level needs is lacking as a result many employee still not aware of corporate culture

Although Emp
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
loyee well-being and satisfaction survey is carried out periodically, there is lack of analysis of the survey result and action plan to close the gap
Motivational program to encourage employee to higher performan
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e level is ad-hoc and non systematic. Without such motivational program, it is difficult to engage more employee drive the company toward a greater height

In summary, having understood the core value and conce
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
pts of Malcolm Baldrige, leaders of company would have a better idea TQM success may be represented by Malcolm Baldrige Assessment. Its assessment report both Strengths and Area for Improvement is a value-added feedback m
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
oving forward. My next article will share some case studies on assessment of several companies in Process Management - Category 6

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Disclaimer:

All
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rights reserved. This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it has no intention to conflict with exp
.

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
erts in similar topic. The author holds no responsibility for the use of this article in any way.

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elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ed. 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 remained intact and it is linked to the author's website

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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Advice You - Human Resource Focus - Baldrige Assessment Case Study for Category 5 to Measure TQM Success

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