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Cover Story

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.

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