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What is Your Signature on the Risk Radar?

April 12, 2019

What is Your Signature on the Risk Radar?

Notwithstanding the benefits and goodness of Life Sciences products, regulators will worry about the risk posed by these. It is part of their role and obligation in the larger scheme of things. For the organization, it is a delicate balancing act. The force field is multi-dimensional and dynamic – going from pressures to launch, to tradeoffs between Cost of Risk Management vs. Cost of Remediation, and more.

Therefore, it behooves us to understand the myths that create a false sense of security among organizations and lead them to conclude we are in good shape. Let us look at five of the many that exist.

Myth 1

We are ISO 9001, or 13485, or 22001 Certified. A certificate on the wall indicates that the company’s systems met the requirements of the standard. There is a temporal, and a human dimension to this; the former is linked to the observations at the time of the audit, the latter to the effectiveness of the auditor and the audit process.

Myth 2

We have a history of “zero” recalls. Well, that was in the past, and is enough said.

Myth 3

The last audit did not surface anything; no findings, major or minor. And, we have not changed anything. The underlying assumption is that all regulators / inspectors function identically and are created equal; not so. Person to person variability, and differences between regulatory agencies exist; and they matter.

Myth 4

We are only a contract manufacturer – so we don’t have to worry. Wrong. If you produce “Finished Medical Device” you can be audited / inspected by the FDA. An adjunct to this is the belief that spec developers are not accountable to ensure QSR and GMP requirements are met by their contract manufacturer.

Myth 5

We have done extensive validations for processes and products both. So, nothing to worry about. Not so fast – the next level of investigation will be equipment calibration, PMs, and training records.

Contributed by: Rai Chowdhary, Chair: Regulatory Compliance and Quality Committee at BioUtah