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What are the common challenges and pitfalls of QRM implementation and how to avoid them?

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Quality risk management (QRM) is a systematic process of identifying, assessing, and controlling potential hazards and uncertainties in the pharmaceutical industry. It is based on the principles and guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9 document. QRM can help improve the quality, safety, and efficiency of products and processes, as well as comply with regulatory requirements and standards. However, implementing QRM is not without challenges and pitfalls. In this article, we will discuss some of the common difficulties and mistakes that can hinder the success of QRM and how to avoid them.

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1 Lack of QRM culture

One of the main challenges of QRM implementation is the lack of a QRM culture within the organization. A QRM culture is a shared mindset and attitude that values and supports the use of QRM tools and methods throughout the product lifecycle. Without a QRM culture, QRM activities may be seen as a burden, a formality, or a deviation from the established practices. To foster a QRM culture, the senior management should demonstrate leadership and commitment to QRM, communicate the benefits and expectations of QRM, provide adequate resources and training, and encourage feedback and continuous improvement.

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Alex Ramirez

Director, ConTech at PCL Construction
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It is easy to see risks from a financial perspective because cost is a common denominator for improperly managed risk. However, I would propose that quality is the most adequate perspective when trying to address risks. Teams should aim to understand what is specified, how to achieve it and how to confirm and prove it was achieved. Only when these three aspects are taken care of can we ensure that we will deliver a product that meets expectations. Deviations from these is what causes risk. It is important to align the culture to understand this as a priority.

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2 Inadequate QRM planning

Another common pitfall of QRM implementation is the inadequate QRM planning. QRM planning is the process of defining the scope, objectives, roles, responsibilities, and methods of QRM for a specific product or process. Without a clear and comprehensive QRM plan, QRM activities may be inconsistent, incomplete, or ineffective. To avoid this, the QRM team should follow a structured approach, such as the QRM process model described in the ICH Q9 document, and document the QRM plan in a QRM protocol or report. The QRM plan should also be aligned with the quality objectives and the risk appetite of the organization.

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Alex Ramirez

Director, ConTech at PCL Construction
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Project planning should formally include resources and timelines to carry out quality risk management. It is helpful to describe the process in a flowchart manner so that everyone knows what is expected and in what order. Typically, when the process is laid out clearly and as a formal part of the project planning process, teams are able to benefit from the output of this process and minimize risks to the project execution.

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3 Improper QRM tools and methods

A third common mistake of QRM implementation is the improper use of QRM tools and methods. QRM tools and methods are the techniques and procedures that help identify, analyze, evaluate, and control risks. There are various QRM tools and methods available, such as failure mode and effects analysis (FMEA), hazard analysis and critical control points (HACCP), and risk ranking and filtering. However, not all QRM tools and methods are suitable for every situation. To avoid this, the QRM team should select the QRM tools and methods that are appropriate for the complexity, uncertainty, and data availability of the risk scenario. The QRM team should also apply the QRM tools and methods correctly and consistently, and document the assumptions, data sources, and results.

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4 Insufficient QRM communication and review

A fourth common difficulty of QRM implementation is the insufficient QRM communication and review. QRM communication and review are the processes of sharing, verifying, and updating the QRM information and outcomes with the relevant stakeholders. Without effective QRM communication and review, QRM activities may be isolated, misunderstood, or outdated. To avoid this, the QRM team should establish a QRM communication and review plan that specifies the frequency, format, and content of the QRM information and outcomes, as well as the roles and responsibilities of the QRM stakeholders. The QRM team should also ensure that the QRM communication and review are timely, transparent, and traceable.

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Alex Ramirez

Director, ConTech at PCL Construction
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A great practice to start on the right foot is to what a kick off meeting where the process is clearly outlined for everyone with a formal agenda and minutes distributed to everyone attending.

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5 Inflexible QRM approach

A fifth common error of QRM implementation is the inflexible QRM approach. QRM approach is the way of applying QRM principles and guidelines to a specific product or process. An inflexible QRM approach is one that does not adapt to the changing needs, conditions, and expectations of the product or process. An inflexible QRM approach may result in over- or under-estimating the risks, missing or ignoring the new or emerging risks, or wasting or misallocating the resources. To avoid this, the QRM team should adopt a flexible QRM approach that allows for adjustments, modifications, and revisions of the QRM activities and outcomes based on the feedback, data, and experience. The QRM team should also monitor and measure the performance and effectiveness of the QRM approach and implement corrective and preventive actions as needed.

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What are the common challenges and pitfalls of QRM implementation and how to avoid them?

1

2

3

4

5

1 Lack of QRM culture

2 Inadequate QRM planning

3 Improper QRM tools and methods

4 Insufficient QRM communication and review

5 Inflexible QRM approach

Quality Management

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What are the common challenges and pitfalls of QRM implementation and how to avoid them?

1

2

3

4

5

1 Lack of QRM culture

2 Inadequate QRM planning

3 Improper QRM tools and methods

4 Insufficient QRM communication and review

5 Inflexible QRM approach

Quality Management

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