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Advice You - Implementing Total Productive Management (TPM)
Total Quality Management (TQM) and Total Productive Management (TPM) can be effective management tool
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
s when applied correctly; however, when implemented haphazardly, they can be counterproductive. Pleas
; 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
e read some books by Deming, Juran, or Crosby before implementing either of these process improvement
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
strategies.
In my experience, Total Productive Management (TPM) is more effective than TQM in a man
In my experience, Total Productive Management (TPM) is more effective than TQM in a man
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ufacturing environment, and while they can operate side-by-side, implementing both at the same time m
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ay overwhelm employees and create substantial resistance to change.
The basic concept of TPM is to i
The basic concept of TPM is to i
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
ncrease productivity and overall equipment effectiveness through reduction of maintenance downtime of
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
critical manufacturing or service equipment by empowering non-maintenance personnel to perform routin
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e and preventative maintenance, within their respective capabilities. Based on current research, impl
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
ementation of a TPM program is beneficial to overall equipment effectiveness and presents positive co
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
st/benefit results, when properly implemented and monitored.
However, as in similar quality and empl
However, as in similar quality and empl
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
oyee empowerment initiatives, TPM can blur the lines between job definitions, distract workers from c
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
ritical task areas, create hostility among employees who may perceive TPM as a job enlargement scheme
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
, and may pose potential collective bargaining unit contract violations where specific job assignment
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
and scope have been delineated.
The risk of costly maintenance complications resulting from low-ski
The risk of costly maintenance complications resulting from low-ski
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
lled personnel attempting on-the-spot fixes can also prove cost prohibitive, and may violate warranty
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
agreements on covered equipment. Safety is an additional concern, and any authorization for non-main
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tenance personnel to perform maintenance functions should be cleared through the employer's worker co
.
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
mpensation underwriter prior to TPM implementation.
As a Project Manager assigned the implementation
As a Project Manager assigned the implementation
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
of TPM, you will need to iron out all these details long before proceeding with this management tool
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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