2. z
Identify Supplier
§ Criteria to assess and evaluate the supplier
§ Identify the criteria to evaluate the supplier based on the
material supplied
§ Also identify the level of risk involved for your product
§ Scrutinize based on the high risk
§ Maintain the supplier risk with the detail of the component/
material supplied
www.regulatory1.in regulatory.one@yahoo.com. info@regulatory1.in
3. z
Identify Supplier
§ Identify potential supplier
§ Define your requirement from the supplier (Cost, full functions,
engineering capabilities)
§ Identify list of suppliers from B2B directories
§ Share your requirement with well defined product specification
and expect a positive response or questions
§ A random answer is not a good sign
§ Scrutinize based on the feasibility, quality and cost. (remember:
Cost is the last aspect, lower than the average cost may end in
low quality.
4. z
Manage risk with supplier
§ Need to have objective evidence to make sure supplier meet the standard
requirement
§ Onsite audit or certification or supplier form to understand your supplier
better
§ Service level agreement or contract is mandatory
§ Need to have controls if the supplier are classified critical through process
of 100% inspection, contract agreement with defined roles and
responsibilities
www.regulatory1.in regulatory.one@yahoo.com. info@regulatory1.in
5. z
Manage Supplier
§ Regularly conducting audit to ensure proper documentation at supplier site
and in-house with acceptance criteria set and stringent monitoring activities
in place will help in easy outcomes for your medical device.
§ Manage supplier with regular interaction and co-ordinate your production
schedule on time
§ Discuss ways to reduce overall costs through size /timing of orders/contracts.
§ Consider additional products or services that your supplier could provide.
www.regulatory1.in regulatory.one@yahoo.com. info@regulatory1.in
6. z
Manage Supplier
§ Update them on changes or new products early on - this helps them adapt to meet
those changes.
§ Analyse how well you forecast sales and plan to meet your supply needs. Sharing
the results of this analysis with your suppliers will allow you to develop accurate
sales plans and sales forecasts and schedules.
§ Use a purchase order system to control and monitor the buying of goods and
services from suppliers - this facilitates internal financial controls and prevents
specification misunderstandings at the supplier's end.
§ Pay bills promptly. Paying late will strain your relationship with the supplier and
could lead to less favorable terms in future.
www.regulatory1.in regulatory.one@yahoo.com. info@regulatory1.in