There are many challenges associated with supplier evaluation and internal auditing, but compliance with QSR and ISO 13485 and diligence are the antidote to these.
In any organization, continuous and scientific evaluation is a must. This is all the more important for an FDA-regulated industry. Supplier evaluation and internal auditing are done to ensure that the intended quality standards are met on a consistent and continuous basis.
Features of supplier evaluation and internal auditing
- Both supplier evaluation and internal auditing are necessary and critical for almost any organization
- Supplier evaluation and internal auditing complement and supplement each other as separate, but deeply related programs
- The ways in which these two elements work are different, since they deal with different aspects of the quality process, but both supplier evaluation and internal auditing are intertwined.
Supplier evaluation is a very critical aspect of almost every industry, since a majority of organizations -be they in pharmaceuticals, medical devices, software or any other – rely on external suppliers for many of their needs. Most raw materials are sourced from external parties. Since it is these raw materials that determine the quality of the final output; it is imperative for an organization to ensure that the raw material is of the required quality and up to industry standards.
Major challenges associated with supplier evaluation
Solutions for problems associated with supplier evaluation
Complying with QSR and ISO 13485 requirements for supplier selection and assessment is the answer to challenges associated with supplier evaluation. These standards have guidelines on:
Internal auditing follows supplier evaluation. While supplier evaluation is about assessing the quality of raw material from an external party; internal auditing is a process in which:
- The material sourced from outside is audited from within the organization
- The internal auditing is also done for raw materials or other related materials not sourced from outside, but produced within the organization
- Products made out of raw materials procured from external sources are also audited internally
This consists of a series of stringent quality checks, since internal auditing is about how well the risks are mitigated.
Challenges in internal auditing
Way by which to address challenges of internal auditing
Unlike resort for CFR and ISO 13485, which act as effective safeguards against supplier evaluation issues; there are no such regulatory remedies for addressing challenges associated with internal auditing. It is left to managements to intuitively look for solutions to issues relating to internal auditing. Some of these can be looked into:
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