4. Have On-Site Quality Audits Performed by an Objective Auditor
On-site audits are the most reliable source of information about a supplier's operations. For an on-site audit program to
function properly, the audits must be thoroughly objective and conducted by a qualified auditor. That means an auditor from
your compliance function, or a third-party auditor, is usually preferable to an in-house team member, such as the supplier
quality engineer who works with (and tends to identify with) the specific supplier.
Audits must be performed regularly to ensure quality. The logistics and costs of site audits have increased significantly
with the rise in outsourcing to foreign countries, especially for Western companies with suppliers in Asia. All too often,
audits are postponed or limited to being carried out "for cause," or follow-up audits are not performed simply because it's
such a nuisance to get them done. Unfortunately, saving money by skipping audits is never a good trade-off.
Instead, you can minimize costs by bundling audits of suppliers in the same geographic region. It's simply a matter of planning
ahead, so your auditors can schedule multiple visits on a single trip.
Use a risk-based model for planning your audit program. Not every supplier requires on-site audits; for less critical ones,
third party laboratory testing, certificates of analysis, and supplier surveys may be acceptable substitutes for some on-site
audits.
5. Include Suppliers in Your CAPA System
Supplier defects become your responsibility by default, so you have to initiate corrective actions associated with supplier
operations just as diligently as you would with in-house products.
That means supplier quality problems should be input into your corrective and preventive action (CAPA)/deviation system and
followed up with whatever corrective action is needed to prevent recurrence of the problem.
CONCLUSION: BENEFITS THAT GO BEYOND REGULATORY COMPLIANCE
Regulators require you to manage supplier quality as if it were your own. In reality, supplier quality management is far more
complex than internal quality management, because of factors of both distance and incomplete control.
A systematic risk-based approach to supplier quality management, as outlined above, can make the process manageable even if
you are dealing with hundreds of suppliers worldwide. In fact, we believe it is the only feasible approach. When you treat
every supplier as a top priority, you have no way to systematically gauge how much attention (and investment) each one realistically
deserves.
Establishing a risk-based system is well worth the effort. In addition to ensuring compliance and avoiding recalls, regulatory
and quality problems and liability, a well-managed supplier quality management system enables you to establish sustainable
processes that improve operational efficiency and make your product more competitive in the global marketplace.
The bottom line is that it's too important to risk not doing.
Bob Rhoades is the senior director of quality systems in the regulatory and quality practice at Quintiles, Durham, NC, 678.896.8026,
Bob.Rhoades@quintiles.com
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