QCD in Purchasing Management

QCD in Purchasing Management

Purchasing management is important in the design and manufacturing process of medical devices.
In MDSAP, process The purchasing management process is to be audited, linked from audits of design management, manufacturing management, etc., through a technique called linkage.

Pre-evaluation and periodic re-evaluation (e.g., once/year) of suppliers is very important.
In the case of suppliers who have already delivered, the quality and the performance of the supplier in question (e.g., on-time delivery, number of products manufactured, etc.) can be evaluated based on the results of acceptance tests.
On the other hand, for new suppliers, a supplier evaluation based on the survey form must be conducted.
Many medical device industries are likely to investigate Q (Quality), C (Cost), D (Delivery) and other items in supplier evaluations.
The important point here is that QCD should not be summed up.
The first and most important aspect of medical device regulation is quality.
Therefore, only the evaluation of quality must be footnoted.
This is because the sum of QCD may lead to the adoption of a product even if its quality is poor.
Summing QCD is equivalent to summing height, weight, and blood pressure, so to speak.
Just as height, weight, and blood pressure must be evaluated against their respective standards.

Risk-based supplier assessment

On the other hand, a company’s resources are finite. It is also impractical to conduct rigorous evaluations of all suppliers.
In supplier management, it is essential to manage according to the risk of the supplied products and suppliers.
The following classifications are needed, and the footnote (acceptance criteria) points in each class need to be varied.
Class A: Critical process contractors – design, main manufacturing, OEM supply, sterilization, etc.
Class B: Critical parts and materials (for items that have a significant impact on the final product)
Class C: Non-major assembly/finished product storage
Class D: Parts and materials (including units and general purchases)
Class S: Services with significant impact on product quality (calibration / analysis and testing / transportation and packaging / consultancy)

For example, for Class A,

• Mandatory pre-contract supplier audits.
• Document communication rules among QAs, and promptly handle problems as they arise in accordance with these rules.
• In principle, a supplier audit shall be conducted once a year.
• Conduct supplier evaluation once a year.

The level of supplier management must be defined in the QMS, such as
Other factors that must be determined for each supplier’s supplies include whether an inspection of all products is required or whether spot checks (sampling) are acceptable.

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