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  • Useful Advices - Problem Solving / Corrective Action

    Introduction

    This article introduces the problem-solving model as a technique for managing performance issues that are more controversial, or that are not effectively addressed through coaching or feedback. Issues such as tardiness, being out of uniform, continual poor performance, and others are best handled by a direct, objective approach. By following the Pr
    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
    oblem Solving Dialogue Model taught in this article, you can feel confident in addressing these thorny issues with employees.

    Problem solving sounds so simple. However, we know it isn’t as simple as it seems. Employees don’t behave as we hope they would. Problem solving conversations are the ones we all tend to — or want to — avoid. Why? Because we fear — or
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    are concerned about — how the employees may react. In a minute we will find ways to overcome these challenging situations.

    What you must remember is that it is important NOT to avoid these conversations as a result of feeling uncomfortable about having them. If you were the coach of a baseball team, you would want your players to give it their all. What they
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hould be able to expect of you in return, is that other players on the team are performing as they need to. Why should the shortstop play his heart out if you let the pitcher or first baseman not play at the same level?

    Key Points

    Guiding questions are a significant tool when in a problem solving dialogue. Regardless of the emotional response of the employee,
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    we must always focus on the problem behavior not the problem employee. It is not personal.

    Two key things to keep in mind are:

    • Always treat the employee with professionalism, dignity, and respect.

    • You are responsible for the performance of your entire team. If you let the lack of performance of any one person go unaddressed because you are uncomfortable
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    dealing with it, you are being unfair to everyone else on the team. As a result, you would not be fulfilling your job responsibilities as a team leader. It is your responsibility to address any individual issues that are affecting the team’s performance or morale.

    The Problem Solving Model

    It is valuable to allow the employee to solve as much of the problem as
    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
    possible. The more employees can solve their own problems, the more likely they are to carry through with the solution, AND the more independent they become. In problem solving, the chances are fairly likely that the person will not be able to solve the problem without help from you. It is important that you recognize the performance problem and the reasons fo
    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
    the problem.

    It is also important that you plan solutions to the problem’s resolution before you meet with the individual. If the employee engages in inappropriate problem solving — blaming, excusing, defending, looking to others for the solution — you need to be able to redirect the problem solving to a more productive vein. You may find that you have to TELL
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the employee what the acceptable solution is. Thoughtful planning and practice increase the chance of success as you manage performance.

    1. Open the conversation/clarify the purpose of the conversation. It is important to focus the problem solving conversation early. It you want to discuss other things, save them for another conversation. Mixing other topics
    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
    into a problem solving/corrective action conversation diffuses the impact of the conversation and reduces the likelihood of performance change.

    Be up front and specific. “I want to discuss the missed deadline.” “I want to talk about your production numbers.” At the same time, express your confidence that we together can resolve this problem.

    2. Clarify the pr
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    oblem. This is where you clearly define the problem. Use specific outcomes or observable behaviors. Avoid absolutes, generalizations, hearsay, or opinions. Be specific. Instead of saying, “you’re always late,” say, “you were at least 10 minutes late three times last week.”

    Further clarify the problem by identifying the impact of the person’s behavior on:

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

    Following aspects would a
    The group (i.e., “others have to cover for you when you’re not on time.”)

    b) The department or team (i.e., “our coverage numbers suffer”)

    c) You (i.e., “I have to take time to conduct meetings like this when I could be coaching or doing other management activities.”)

    d) The employee (i.e., “Your chances for growth or even continued employment may be jeopardize
    dd to the challenges in developing combination products:

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

    3. Make sure that you ask if the person understands the problem and the impact of the problem. Look for a verbal or non-verbal agreement. Getting agreement that there is a problem and that the problem has significant impact is half the battle!

    4. Create solutions that are acceptable to you. It is better to ask for involvement and ideas from the employee a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t this stage since doing so increases the likelihood that they will implement the solution. However, the solution must meet YOUR requirements and standards! You may also find that the employee is not willing or able to come up with solutions. For these reasons, it is important that you have several solutions in mind before the meeting.

    Solutions must include:
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    a) Specific steps: what will the employee do to correct or alleviate the problem.

    b) Timeframe: corrective action discussions need to include some type of timeframe to mark the successful end of this intervention. “Okay, let’s start this tomorrow and try this for 30 days.”

    c) Consequences: consequences must be clear and appropriate. Moreover, consequences mus
    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
    t be present or behavior will very likely not change. “If you are late again within the next 30 days, I will need to issue a written warning which may lead to termination.”

    d) Follow-up date and expectations: set a specific date and time to meet to review the progress and either act on the appropriate consequences or celebrate success.

    5. As you and the employe
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    are creating acceptable solutions, you will want to direct the conversation. If the employee is generating acceptable solutions, you will want to support and build on those ideas. If the employee is exhibiting inappropriate problem solving by blaming others, coming up with excuses, accusing you of being unfair, etc., defer or redirect the conversation by saying
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    , “I would like to talk about that more later; right now, I’d like to stay focused on what you can do.” In some cases, you will simply have to tell the employee what you think the best solution is. Again, be prepared!

    6. At the conclusion of the meeting, summarize the solution and express confidence in the employee to implement the solution. Then document the
    .

    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
    eeting and follow up accordingly.

    Summary

    We, as managers, supervisors, and team leaders, realize that it is our responsibility to ensure that EVERYONE on the team performs to their potential — and to the expectations of the job. Poor performers not only affect themselves and their specific jobs, their effect negatively impacts the performance of other team mem
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    bers.

    While it is challenging, conducting an effective problem-solving meeting is made easier when applying the Problem Solving Dialogue Model.

    (This information comes from Coaching for Performance, a module in Entelechy’s High Performance Management program. Check out this module as well as our 40 other modules, training tools, and eGuides at www.unlockit.com.


    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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