SOURCE: marcus evans

marcus evans

August 18, 2016 10:07 ET

Supplement Supplier Audit Programs Based on Product Risk Analysis and FMEAs

Interview With Indu Lakshman, Vice President of Quality, Scanadu

CHICAGO, IL--(Marketwired - August 18, 2016) - In the medical device industry, the complexity of supplier-manufacturer relationships poses quality and compliance related risks that could be very costly and have a high operational and reputational impact. Global supply chain operations have become increasingly intricate and selecting the suitable vendors as well as managing them effectively can significantly influence the bottom line and overall competitive advantage.

Indu Lakshman, Vice President of Quality at Scanadu, recently spoke with marcus evans about topics to be discussed at the Medical Device Supplier Quality & Risk Management Conference:

Beyond ISO certifications, how do you pre-qualify suppliers?

IL: ISO quality management systems and certification programs have shown significant quality improvements in a typical supply chain over the last couple of decades. Additionally, the ISO standards provide more transparency between supplier-manufacturer operations.

Knowing supplier's technical and quality capabilities in process quality, state of the art equipment, new product introduction, developing pFMEAs, collaborating for complaint investigations, systems to track traceability etc. beyond ISO certifications will help towards pre-qualifying suppliers. This includes supplier's familiarity and ability to transfer products from design to manufacturing and executing successful process validations.

What do most companies fail to include in their QMS evaluation audit checklists?

IL: There are several QMS audit checklists available on market and in-house developed. Mostly, the audit checklists are designed to center around QMS requirements. These checklists must be supplemented with items pertaining to supplier responsible specific key processes which may contribute towards potential product risks, failure modes and defects.

How can FMEA documents help mitigate potential risks?

IL: FMEA and risk analysis documents are typically designed to assess potential risks and failure modes with quantitative values for Severity, Probability of Occurrence and Detection. A calculated value called risk priority value is obtained based on the quantitative values assigned to S, PO and D. This calculated value is compared to a pre-established acceptable risk value. When potential risk priority values exceed acceptable levels, process of risk mitigation is triggered.

During this risk mitigation process, risk priority values which exceed the acceptable risk values are further assessed to identify appropriate mitigations via additional controls, verification & validations, warning/precautions, labeling, alarm/alerts etc. By applying any or a combination of appropriate mitigations, potential risk priority values may be reduced. FMEA documents are designed to support the potential risk mitigation process.

Join Indu at the Medical Device Supplier Quality & Risk Management Conference, October 12-13, 2016 in Chicago, IL. For more information, please visit the conference website or contact Tyler Kelch, Digital Marketing Manager, marcus evans at 312.894.6310 or

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