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Digg It - This Thing Called Quality- Getting It Right the First Time
The late Phil Crosby of the Zero Defects fame tells of how as quality manager he once spent time explaining to his boss in sophisticated statistical terms how the defects they found i
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
n the shipments to a customer (which had resulted in complaints by the customer, and the need for field repairs) were inevitable and indeed much lower than their competitors could man
; 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
age. As the story goes, the boss had patiently listened to his excuses and explanations and when he had finished replied, "Philip, somewhere in this world there is a quality manager w
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
o can get me products and services with no problems in them. I sure would like that person to be you."
Crosby, suddenly realising that the matter had moved from a merely academic deb
Crosby, suddenly realising that the matter had moved from a merely academic deb
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ate to one of professional survival for him - his job was on the line - achieved one of the swiftest shifts in paradigm ever! Mulling over the matter, he came to the conclusion that t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e only acceptable goal for quality was Zero Defects. He reasoned that all errors and defects resulted either from a lack of knowledge or a lack of attention. The first cause could be
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
remedied through proper training and education. The second required that management consistently show its determination not to allow the delivery of any defective goods or services to
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
customers.
Zero Defects - How Possible?
Is zero defects possible? To answer that question, consider how many times you have picked the wrong kid when you went
Zero Defects - How Possible?
Is zero defects possible? To answer that question, consider how many times you have picked the wrong kid when you went
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o collect your child from school, or driven home to the wrong house after work, or had the wrong salary paid to your employees.
The tasks we have outlined are routinely performed wit
The tasks we have outlined are routinely performed wit
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
h precision. Why? Because those involved know what to do, and more relevant, find the outcomes important enough to command full attention.
What Management Must Do
Crosby defines quality as "conformance to requirements". Management must set the requirements and make sure they are known by all concerned. And then management must refrain from sa
What Management Must Do
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Crosby defines quality as "conformance to requirements". Management must set the requirements and make sure they are known by all concerned. And then management must refrain from sa
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
botaging its own efforts through inconsistency.
For example the company that professes quality and then under pressure to meet profit projections at year end, allows defective produc
For example the company that professes quality and then under pressure to meet profit projections at year end, allows defective produc
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
ts to get to the customer, only shows to the workforce that its commitment is only for show. Employees know that management will cave in when push comes to shove.
On the other hand,
On the other hand,
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
he company that orders a product recall on discovering defects shows its people that management is serious and that there are no exceptions to the rule.
Quantifying Non-Confo
Quantifying Non-Confo
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
rmance
On the whole, the damage from poor quality is unquantifiable. Loss of customer loyalty, loss of market share, loss of good-will. Even some of the effects can and
On the whole, the damage from poor quality is unquantifiable. Loss of customer loyalty, loss of market share, loss of good-will. Even some of the effects can and
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
ust be captured in monetary terms, since money is a language that grabs the attention of management.
The cost of non-conformance involves all the additional costs incurred because th
The cost of non-conformance involves all the additional costs incurred because th
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
ings were not done right the first time. These might include overtime, scrap, rework, warranty claims, recalls, processing of customer complaints etc.
Error Prevention
Error Prevention
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ng>
As Deming (and Crosby himself) often said, quality cannot be inspected into a product or service. It must be built in right from the start. This means preventing the errors t
As Deming (and Crosby himself) often said, quality cannot be inspected into a product or service. It must be built in right from the start. This means preventing the errors t
.
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
at produce defects from occurring in the first place.
Thus for identified defects/errors, the first step is to determine the source or root cause. The next step is then to eliminate
Thus for identified defects/errors, the first step is to determine the source or root cause. The next step is then to eliminate
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
the cause so that the problem is gone forever.
The journey to Zero Defects is an eternal cycle of observing defects, determining their causes and permanently eliminating these causes
The journey to Zero Defects is an eternal cycle of observing defects, determining their causes and permanently eliminating these causes
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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