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FDA Compliance

The Value of Risk-Based Supplier Inspections in Pharma Quality Management

An effective strategy requires recruiting qualified personnel familiar with the process and technology

Published: Monday, June 27, 2022 - 12:03

Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.

Pharmaceutical manufacturers must ensure that the ingredients and packaging materials they use comply with regulatory requirements and meet the standards their markets expect. Risk-based, incoming supplier-product inspections help optimize supplier compliance, improve quality, and boost company profitability.

How risk-based supplier inspections work

Conducting a risk-based inspection (RBI) program requires companies to implement a system that includes three primary components: a sampling plan, a skip lot schedule, and inspection state switching rules.

Sampling plan: The sampling plan identifies a specific number of items to select for inspection from each raw material batch. Manufacturers can use ANSI/ASQ Z1.4-2003—“Sampling Procedures and Tables” to determine a robust baseline for the acceptable defect ratio or acceptance quality level (AQL). This can be set at zero percent for the components of critical products, ensuring a 100-percent inspection ratio, or it could be less stringent for materials used in noncritical products. This sampling method also defines the maximum number of defective components acceptable for the lot to pass inspection.

Skip lot schedule: A skip lot schedule determines how many lots or batches of raw materials must be inspected out of the total received from suppliers. When possible, pharmaceutical manufacturers avoid inspecting every single lot because it’s time-consuming and expensive. Skip lot sampling is effective when dealing with suppliers who have previously demonstrated high-quality products. Some materials require a higher inspection ratio than others to mitigate risk.

Switching rules: The final component of a risk-based, incoming supplier-product inspection strategy comprises switching rules, which determine when and how to adjust the sample size and skip lot schedules. In sampling methodologies such as ANSI/ASQ Z1.4, these rules apply to changes between a normal, reduced, or tightened status. Normal status refers to the typical baseline criteria, while reduced status indicates fewer lots and fewer samples, based on previous positive results. If a tightened status is implemented, more samples per lot and more lots are inspected, based on poor former supplier inspections.

Because switching rules depend on statistical evidence to ensure quality remains high when modifying the inspection schedule, organizations benefit from following an established plan instead of devising their own skip lot schedules. 

Challenges facing risk-based incoming supplier product inspections

Implementing a risk-based, incoming supplier-product inspection strategy offers pharmaceutical organizations multiple advantages, with the main benefit of being able to produce quality products for their customers. When this key benefit is met, additional benefits, such as differentiation from competitors, improved profitability, and better brand trust and loyalty will follow.

However, the process isn’t free from challenges. Some prime concerns facing the implementation of risk-based supplier inspections include:
Deploying the right technology to record and guide the process
Getting full management support and buy-in for the strategy
Recruiting and training qualified personnel to conduct risk-based supplier inspections and interpret the data
Developing effective, documented procedures for implementation
Gathering the data necessary to determine the criteria for inspections

In addition, the fundamental risks found in complex supply chains, continuously changing regulatory requirements, and manual inspection processes all affect the strategy’s success. Technology can ensure that testing is adequate and appropriate for the product and supplier. The resulting data are then passed into the company’s technology ecosystem to help guide decision-making and insights across the supplier ecosystem.

Best practices for implementing an RBI strategy

Developing an effective RBI strategy requires identifying and recruiting qualified personnel familiar with both the process and the technology. Begin by clearly defining the goals and objectives.

Determine the probability of failure (PoF) and consequence of failure (CoF) associated with each product, and assess past inspection effectiveness and results. Document all potential defective states and product failures, their causes and solutions, and identify the ingredients and packaging components that lead to such failures.

Deploy an inspection management technology solution with the capability to automate the RBI process completely. Appropriate systems combine industry-standard sampling systems with supplier performance data. This will enable the system to trigger notifications when an inspection is required and switching rules need attention.

Maximizing RBIs’ value and benefits

The value and benefit of risk-based supplier inspections depend on the solution’s power to improve the reliability, safety, and performance of the products. These enhancements promote customer loyalty and trust, increase profitability, and optimize quality while avoiding adverse events. Deploying the right technology enables companies to reap these benefits without the administrative and statistical headaches of a manual quality management system.


About The Author

Kari Miller’s picture

Kari Miller

As regulatory and product management leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction and delivering industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated life sciences market. She also is responsible for the quality compliance product road map, product partner relationships, and overall product direction. Miller earned bachelor’s degrees in business administration and psychology from Marian College, Fond du Lac, Wisconsin.