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MEDICAL DEVICE INDUSTRY
SUPPLIER QUALITY MANAGEMENT & REGULATORY EXPECTATIONS
Outsourcing of raw
materials, components, sub-assembly, processes etc can
significantly improve operational efficiency and fill gaps for
the medical device manufacturers when they are struggling with
in-house. However, failing to properly manage suppliers and
vendors presents huge risks for product safety and compliance.
Although a viable supplier
business model demands high quality products and services, the
responsibility for maintaining regulatory compliance
ultimately rests on the Medical Product manufacturers.
Monitoring and managing
quality is extremely important when outsourcing that could
potentially impact the product including outsourced products /
services like components, contract manufacturing, consulting
etc.
Good Quality Management
System require manufacturers to develop and maintain
procedures that ensure all purchased / outsourced products /
services adhere to defined set of requirements.
This starts with evaluating
suppliers, contractors and consultants on the basis of their
ability to meet specified requirements including quality
requirements. The evaluation needs to be documented.
Once identified and
shortlisted, a thorough audit should be planned and executed
either on – or – off site, depending on the nature of the
product or service provided.
Purchasing document would
include , among other documents, an agreement for the supplier
to agree to notify the manufacturer of changes in the product
or service so that manufacturers may determine whether the
changes may affect the quality of a finished device.
Key attributes of a good
supplier
On and above the basic
qualification of a supplier there are certain qualities the
supplier should exhibit like :
- A reasonable customer
response time when responding to a quote or a query.
- To communicate about any problems quickly so that the
manufacturer do not face unnecessary delays to production.
- Most economical and with fastest lead time.
- If possible, highly recommended by someone known or trusted.
It’s much better to
discover that a supplier might not be a good fit before added
to the approved supplier list. The forms and process for
adding a supplier can be lengthy and difficult to complete,
costing time for the manufacturer.
Companies have often a
tendency to want to minimize the numbers on the approved
supplier list. It is therefore important to :
a) Choose the right
supplier in the first place and
b) Immediately remove suppliers from the approved list who
don’t turn out to be a good fit.
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