Risk/Impact assessment is key in simplifying your qualification/validation strategy and also in defining the extent of the qualification processes you need to use. It also plays a pivotal role in defining the extent of qualification processes. A risk/impact assessment of the proposed changes should be done to assess the impact of modification/upgrade activity on various aspects such as quality, efficacy, and safety of the manufactured products. When it comes to 21 CFR Part 11 compliance, making sure you use platforms that are pre-validated will save you precious time. Take eLeaP’s 30-day free trial and get started ensuring you and your team have the tools to stay compliant with life science industry regulations.

The Key to Fixing Your Qualification or Validation Strategy

An impact assessment is a procedure by which the effects of the system and the critical components within those systems on product quality are assessed. The risk/impact assessment is to be performed before the qualification of the respective equipment/utility/system. Also, the identified risk mitigation must be verified during the qualification stages. Connect with our GxP, validation, and advisory solutions specialist today.

The stepwise risk-management process empowers concurrent remediation of errors and non-conformities with follow-up verification as an integrated part of the qualification and validation activities.

The level of determination, correctness, and documentation of the quality risk management process must be commensurate with the level of risk.

How is system risk assessment measured?

System risk assessment is measured in three categories:

  • Direct product impact
  • Indirect product impact
  • No impact

The scope of the systems and components subject to qualification can be reduced by performing design impact assessments. An appropriate focus should be placed on the quality-impacting systems and components that may present a potential risk to the product.

What is the difference between Qualification and Validation?

“Qualification” is generally used for equipment, utilities, instruments, and facilities, whereas “Validation” is used for systems and processes. Qualification is a part of validation. Processes must be validated on qualified equipment.

Benefits of Risk/Impact assessment in Deciding/Assessing the following:

  • Which equipment, system, or instrument must be qualified/validated?
  • What is the level of qualification/validation required?
  • What aspects of equipment, system, instrument, product, and process are critical and essential to be qualified/validated?
  • How to decide on the criteria and equipment specifications versus process requirements?
  • What is the qualification strategy for like-to-like major equipment?
  • The facilities, systems, and equipment must be classified as having either ‘Direct,’ ‘Indirect,’ or ‘No Impact’ based on the criticality/impact made by the same on the product/process.

Impact assessment is a formal process used to identify systems and the components of those systems that directly or indirectly impact product quality.

  • ‘Direct Impact’: Such a system is expected to have a focused and immediate impact on product quality.
  • ‘Indirect Impact’: Such a system is not expected to impact product quality.
  • ‘No Impact’: Such a system must have neither a direct nor indirect impact on product quality.

The assessment is initially performed by evaluating the system’s impact on the product’s quality. After conducting the system-level assessment, the components of the system must be evaluated to determine if they are critical to establishing or maintaining the product’s quality.

The appropriate qualification levels can then be applied to the ‘Direct Impact’ system and the critical components. However, some ‘Indirect Impact’ systems must be assessed for appropriate qualification levels. The ‘No Impact’ system and its components are subject to less stringent tests. Inspection Procedures must be designed, installed, and commissioned based on business risk and typical good engineering practices.

Impact assessments must be performed on the ‘System level’ and ‘Component level.’

System Level Impact Assessment:

System-level impact assessments are generally performed to differentiate those systems that have a direct impact on product quality from those having an indirect or no impact on product quality. The system impact assessments are considered primary until the completion of subsequent component impact assessments for each system.

Only direct impact and some of the indirect impact systems that are based on risk assessment require qualification.

A system is generally determined to be of direct impact if it:

  • Affects the products SISPQ (Safety, Integrity, Strength, Purity, and Quality).
  • Produces/delivers a gas or liquid that has direct contact with the product or is used as an ingredient in the product.
  • Is used in cleaning, sanitizing, and sterilizing direct product contact surfaces of process equipment (e.g., clean steam).
  • Preserves product status (e.g., environmental control systems, nitrogen purge for oxygen-sensitive products).
  • Produces data, which is used to make quality decisions (accept/reject) regarding product status (e.g., electronic batch record system, critical process parameter chart recorder).
  • Is a process control system (PLC, SCADA, DCS, etc.) that may affect product SISPQ, which has no independent verification of control system performance?
  • If the system has direct contact with the product (e.g., air quality) or a product contact surface (e.g., Clean in Place solution).
  • Is a system expected not to directly impact product quality, but it supports a direct impact system?

Component Criticality Assessments:

After the system impact assessment is completed, component criticality assessments are performed to identify those components within a system that have either direct, indirect, or no impact on product quality. The results of the component criticality assessments have a direct bearing on the validation of the system in that Installation Qualification (IQ) and Operation Qualification (OQ) testing of the system can be used to focus on those components that have been identified as having a direct impact on product quality.

A component is usually determined to be critical if it:

  • Contacts the product or product component.
  • Presents information that becomes a part of a GMP record; is recorded on a GMP document or is entered as GMP data into a computer system.
  • Controls critical process elements that will affect product quality, where there is no independent verification of control system performance.
  • Provides an alarm for a condition that has a direct effect on product quality or its efficacy.
  • Creates or preserves a critical status of a system.
  • It has a direct effect on product quality if it fails.
  • Is accustomed to demonstrating compliance with the registered process.
  • Those components identified as critical components must be verified during IQ and OQ testing, and those components identified as non-critical components of the system do not require any verification during IQ and OQ testing.
  • Assessment of the criticality of the equipment, discrete instrument, and utility are considered important in view of defining the periodic requalification and calibration frequency.
  • Assessment for the requirement of qualification stages must be performed in cases of the addition of new types of equipment, discrete instruments,s and utility.

The assessment process for qualification/validation is to be carried out for:

New equipment, system qualification, and validation requirements for new equipment, instruments,  machinery, and systems must be established. User requirement specifications must be prepared, followed by design qualification, installation qualification, operational qualification, and performance qualification (as applicable) before the release of the equipment/system for routine purposes.

Qualification/validation requirements for legacy equipment must be established. Special considerations must be made while analyzing the legacy equipment.  Since some documents may not be available, the need for the required document must be evaluated in terms of impact on operation and maintenance. Documents, such as ‘drawings’ and ‘specifications,’ should be developed either ‘as-is’ or ‘as-built.’ The data that is required for risk assessment could be taken from historical data, for example, product failures or complaints, rather than from designs. Operational requirements must be similar to new systems or equipment. One needs to identify the qualification requirement for the equipment in accordance with the impact and complexity analysis.


The essential elements of quality need to be built in initially, and any GMP risks (GAMP and 21 CFR Part 11) must be mitigated to an acceptable level during the initial phase itself. Indeed, a systematic approach to confirming that manufacturing systems acting singly or in combination are suitable for intended use with regard to patient safety. The product’s quality is, after all, determined through an in-depth risk/impact assessment procedure. Risk/Impact assessment provides predictable, clear, and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity, and detectability of the risk.

An effective quality risk management approach can further ensure the quality of Qualification by providing proactive means to identify and resolve potential issues. Integrating risk assessment with the existing operation can extend solutions to several problems. Protecting the patient by managing the risk to quality must be considered of prime importance. An effective risk assessment is key to the validation lifecycle approach for any pharma, which assures a company’s ability to deal with any potential risk. The suitable use of risk assessment can facilitate but doesn’t necessarily preclude the industry’s obligation to comply with regulatory requirements. To build mutual confidence and promote more consistent decisions among regulators practicing risk assessment/impact assessments is seen as the best practice. Implementing effective risk strategies and practices will help us conquer and fix the elements of qualification and validation. The cost of preventing risks by better assessment can navigate us to new milestones.