Following the acquisition of Israeli Medical Device company by global corporation, a gap assessment was performed, resulting in identifying gaps followed by a demand to raise the standard of work in various departments to the global company standards and level of an international company.
This case study describes our 5 steps process to meet this challenging goal.
Challenge
Following the gap assessment, it became clear that the procurement processes were at an insufficient level compared to the current regulatory requirements. In addition, MDSAP audit was scheduled for a couple of months later, in which the procurement processes occupied a considerable volume of the audit. The estimated number of suppliers was somewhere in the range of 450.
Solution
For aligning the procurement processes as well as supplier evaluation and approval process, with the high-quality standard of the global company, and complying with the MDSAP requirements within a 2 months timeframe, a work plan was created and included the following steps:
Step 1: Strategy establishment
Strategy establishment for all procurement processes according to the requirements of the global company & MDSAP.
- Strategize the supplier’s evaluation & qualification process in accordance with the company’s matureness (early stages = simple and efficient process). The strategy shall support internal processes and regulatory requirements.
- The knowledge of regulatory requirements and internal processes is necessary.
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Step 2: Documents
Writing (creating or updating) documents that support the strategy which include all the purchasing aspects:
Purchasing process; Supplier Evaluation; Supplier Risk Classification; Service Supplier Approval Requirements; Supplier Approval process; Supplier Audits process; Supplier reevaluation process and metrics.
- When planning your BOM, i.e. components, always think of certified materials and manufacturers.
- Intercompany collaboration between engineers and QA will decrease future headaches.
Step 3: Raw Material Risk assessment
At this stage, all raw materials were mapped, classified, and characterized according to the risks they pose to the final product, to the end customer, and to regulatory requirements (sterilization, UDI and etc.). The suppliers were classified accordingly.
- Raw Materials mapping and classification requires the final product performance understanding and manufacturing process knowledge.
Step 4: Build plan
Build a supplier evaluation and approval plan according to the new strategy.
- Until company stabilization – outsourcing supplier quality can make your life much easier
Step 5: Remediation – a plan implementation.
At this stage, a team of purchasing and quality personnel was established, training was provided to raise awareness of the importance of the procurement process and to achieve cooperation between both departments. Evaluation and approval of suppliers, Supplier audit performance as required, and supplier files updating are started.
- For successful implementation, the engagement of all sides shall be achieved.
Result
Approximately two months after the project initiated, the Israeli company was the first company in the country to successfully pass the MDSAP audit, in which the evaluation and approval of suppliers plays a significant part.
A supplier appraisal process has been implemented according to the high standards of the global enterprise and to the strict regulatory requirements.
During the period of one and a half-year, approximately 450 supplier files are approved and maintained.
RS-NESS supports Life Science companies in rapid scale-up and meeting GMP compliance requirements; proving the experience you need when you need it.
Our services include but are not limited to Regulatory, Clinical, QA, Validation, and Engineering processes.
If you are planning a Supplier Evaluation and Approval process, contact us to discuss how we can support your goals.
