Summary - Business

For seventy-five years, American organizations have used a fairly standardized procedure to handle familiar personnel problems such as absenteeism, poor performance, and other misconduct. This approach, usually called “progressive discipline,” provides for an increasingly serious series of penalties — reprimands, warnings, suspensions without

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

pay — when employees fall out of step with the organization’s expectations. When problems arise, the job of the manager is to find the punishment that fits the crime.

But today, a growing number of companies are moving away from using a criminal-justice mentality for employee performance improvement through corrective action. They are aband

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

Examples of combination products may in

ning traditional approaches that focus exclusively on punishment. Instead, they are adopting an approach of accountability - employees with unfavorable performance, conduct or attendance issues are required to take personal responsibility for their choice of behavior.

Discipline and Recognition

One immediate difference is that tradit

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

ional, punishment-based discipline systems ignore the great majority of people who never create disciplinary problems. In a non-punitive, “Discipline Without Punishment” approach, there’s a new step added to the process — a positive contact. Just as the policy is expected to resolve employee problems when they arise, it also makes clear that

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

upervisors are expected to recognize employees when they perform well.

Recognizing good performance is no longer just good advice handed out in a management training class. Now it’s a formal policy requirement, a step of the organization’s overall discipline procedure.

Diffusing Problems

Supervisors continue to be responsible for be

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ginning the correction process by employee coaching prior to formal disciplinary action. The exception is when the magnitude of the behavior warrants serious disciplinary action or even termination for a first offense.

In the early stages of disciplinary action, the Discipline Without Punishment approach replaces the familiar responses of ve

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

bal reprimands and written warnings with two comparable steps toward employee performance improvement: Reminder 1 and Reminder 2. Yes, they seem similar, but there’s more than mere semantic sleight-of-hand at work here.

Instead of being reprimanded for his mischief or warned about what will happen the next time he misbehaves, the employee is

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

formally reminded of two important things. First, he’s reminded of the organization’s exact expectations of high-quality work, on-time performance, or whatever else has triggered the need for the discussion. And second, he is reminded that he has a responsibility for meeting the organization’s standards – he must do what he’s being paid to d

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

and he must do it well.

The Last Chance

The biggest change from the traditional, punishment-based approach comes at the final step of disciplinary action. When the employee is one step away from termination, a dramatic gesture is needed to forcefully drive home the message that the end is at hand — one more time and you’re fired. Bu

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

t merely giving the employee a “final written warning,” or placing her on probation for some period of time, or creating a employee performance improvement plan aren’t powerful enough to clearly communicate the message “Once more and you’re out!” That’s why a disciplinary suspension from work is the best final step for a corrective action sys

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

em.

Withholding Pay Does Not Work

traditionally, this disciplinary suspension has been without pay. The intent is that by depriving the employee of pay, he will come to his senses and return to work determined to do whatever is necessary to keep his job.

But the theory rarely works in practice. Employees who are placed on a three-da

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

disciplinary suspension without pay don’t often return having seen the error of their ways and a commitment to excellent performance. They usually come back angry, all the organization has accomplished is creating a bitter employee.

There are other problems with using punishment as the basis for disciplinary action. Supervisors, many of who

dd to the challenges in developing combination products:

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

m are in the tricky position of being both on-the-job boss as well as off-the-job friend, often hesitate to place friends on an unpaid disciplinary suspension. Because they know the family is also getting punished by the loss of pay, they may cut their people more slack and open themselves to charges of favoritism. And suspensions without pay

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

just aren’t appropriate for exempt, knowledge-worker individuals.

A Paid Disciplinary Suspension

A “Decision Making Leave,” the final step of the responsibility-based Discipline Without Punishment process, provides all of the advantages of a disciplinary suspension as a final step and eliminates the drawbacks. This disciplinary suspe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

nsion with a twist suspends the individual for one day and one day only. On this day, the employee is required to make one of two choices: correct whatever problem brought him to this final step of the discipline process and make a commitment to fully acceptable performance in every area of his job in the future, or decide to quit and find

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

reener employment pastures elsewhere.

Paying the employee for the day he’s away on “decision day” changes the supervisor’s role from adversary to coach. It demonstrates the organization’s good faith in wanting to see him change and return to fully acceptable performance, and is consistent with the values of almost every organization. By elim

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

inating money as an issue, it doesn’t impact the family’s grocery budget and thus reduces the possibility of anger, hostility and even workplace violence.

Agreed Accountability

If the employee decides to remain with the organization and commits to fully acceptable performance in every area of the job (as almost all people placed on d

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

cision making leave do) and then doesn’t live up to his commitment, termination turns out to be much easier and guilt-free.

And should the employee challenge the termination in an EEOC complaint, unemployment hearing, or any other venue, the fact that the organization gave the person a day at its expense to decide whether he was willing to d

.

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

o then job he was being paid to do and the employee didn’t live up to his own commitment assures legal defensibility.

Traditional discipline approaches may indeed convince some problem employees to shape up, others to ship out. But punitive tactics can’t produce employees who are genuinely committed to the goals of the organization and the p

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

Companies that provide selfless information through particip

licies and rules by which they operate. We may be able to punish people into compliance, but we can not punish them into a commitment to employee performance improvement. And a culture of commitment is what today’s organizations really need

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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If you live or own a business in the Dallas area, there is a good chance that you have access to a Dallas phone book. You can use you Dallas phone book to find a number of Dallas carpet cleaning companies in or around the area. In the back of your phone book there is a section that is referred to as the yellow pages or the business directory.

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