Supplier Quality Management For Medical Device
Manufacturers: A Critical Step Towards Global Regulatory
Compliance
Preeti Vani
Plant Head (Medical Division)
Sahajanand Laser Technology Ltd. |
The quality of supplier’s
product or service plays a vital role for the quality
of final product manufactured by Medical Device
Manufacturer. Hence, supplier quality management
is a critical part of the quality management system.
Supplier Quality Management is a confidence in
supplier’s ability to deliver a good product or
service that will satisfy the customer’s needs. It can
be achieved through interactive relationship between
the customer and the supplier; it aims to ensure that
product is ‘fit’ to the customer’s requirements with
little or no adjustment or inspection.
Every manufacturer in the
healthcare industry is required to document the
qualification of suppliers and the on going evaluation
of those suppliers. Supplier qualification and
evaluation activities should be strategic. There
are no specific rules and regulations on how supplier
qualification and evaluation is done. The only
requirement is that company shall have a procedure, do
it and keep records. Now the recently updated quality
management standard ISO 13485:2016 has enhance
supplier qualification requirement. The standard
suggested to use risk based approach for it. |
Thus, risk based approach for supplier management includes
following phases and activities.
1. Planning
Planning phase includes various activities like
Identification of Product or services to be obtained from
the supplier, Technical and process information of the
product or service to be purchased, Identification of
potential suppliers, Identification of risk and
Identification of controls to reduce the associated risk.
Identify what type of service or product need to be
purchased from the external source. It can be critical raw
material, consumables used into the manufacturing process,
packaging material. Services to be obtained from supplier
include sterilization, calibration, validation, design,
manufacture, transport, external quality testing of
product or consultant etc. Finished medical device may
also become supplier’s product for own brand labelers.
After identification, define the technical requirement of
to be purchased product. Technical requirement can be
product specifications, part requirements, some detail
about its manufacturing process or work instructions. This
can be comparable to your existing supplier or other
potential suppliers. Later, prepare a list of potential
supplier who can provide you the product or service you
want. Collect and make a list of name and contact
information of all potential supplier. Now identify the
risk associated with it. Also, identify the controls
associated with the product for both of manufacturer and
supplier. Controls can be auditing the supplier facility,
supplier’s quality management system certificate and other
required regulatory certificate, certificate of analysis
with each supplied batch, batch size and lot size required
at each order time, Inventory control, traceability,
change control and quality system records. These are the
important controls; require following for the supplier.
Assess the supplier based on this controls. These controls
can address and control the identified risks associated
with product.
2. Supplier Evaluation And Qualification
Potential suppliers for proposed product or service shall
be selected. Their contact details are saved into
database. Selection of supplier from the database is done
based upon its business capability and operational
capability. A potential supplier’s business conduct,
practices, reputation and financial viability may provide
useful information about the business capabilities of that
supplier. A potential supplier’s business capability could
have an important effect on a manufacturer’s ability to
deliver safe and effective devices. The financial
viability of the potential supplier is particularly
important especially when a manufacturer intends to enter
into a long-term partnership. Investigation of the
supplier’s technological capability should include the
assessment of the supplier’s ability to meet the
manufacturer’s product and/or service specifications.
Things to consider may include the adequacy of
manufacturing processes or equipment, information
technology, system infrastructure, engineering resources,
etc.
The scope of the investigation may include the supplier’s
past performance, experience, expertise, and human
resources. Based on that, supplier evaluation criteria are
fixed and all potential suppliers are evaluated based on
that. Communicate with supplier and evaluate its ability
to fulfill the requirements for manufacturers. Thus,
evaluate and qualify the supplier.
It Should Be Supported By Following Documents.
• The manufacturer’s assessment of the supplier’s
resources (e.g. facilities, personnel, infrastructure),
current product/service portfolio
• Documentation and records provided by the supplier, such
as environmental control records, equipment maintenance
programs, calibration records, qualification records of
appropriate personnel, process validation records,
capacity planning, certificates, etc.
Based on the evaluation and acceptance criteria, supplier
qualification should be done and shall be supported by
necessary documentation.
On selection of supplier for particular product or
process, manufacturer and supplier should sign a quality
agreement with agreed terms and conditions. It should
mention the time period of the contract, other business
and quality requirements. It should be thorough enough to
be used as a reference for any violation that
may occur in future.
Page
1 :
2 :
3
|