Supplier Selection - The valuable CSV tool
Did you hear about the supplier selection
Again, I bet, that in 80% of your projects, the supplier selection is missing, or it is only some kind of " Nobody will make this machine, only this company" scrap paper, which is automatically checked.
Selection of the supplier of an Automated Control System is based primarily on the ability of the supplier to satisfy the purchaser's requirements.
Medical Devices, Pharmaceuticals, or any other regulated company require a high level of confidence that the Automated Control System will meet their requirements and the supplier is capable to perform deliver their Automated Control System, which will meet the purchaser's requirements. Therefore, the Supplier audit
But what kind of audits can be performed?
Each audit should be based on the criticality of the Automated Control System being provided. The documented justification should be in place when the regulated company is not auditing the supplier of the Automated Control System. In the case of the highly critical GxP Automated Control Systems, the audit will have multiple phases and the audit will be more deeply.
There are multiple types of audits, which should be taken into mind :
1. Basic Assessment
The supplier of the Automated Control System will be based on the public access files, market reputation, knowledge, and experience of prior implementation of the Automated Control Systems, or in discussion with other regulated companies.
This assessment will provide input, on whether the audit of the company is necessary needed, or not and how deeply it will be. In the case of common applications, such as Microsoft Office applications, or other commonly used applications, the documented decision not to perform any assessment/audit may be appropriate.
2. Postal Audit,
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As the audit itself is time-consuming for both participating companies ( Regulated Company and Suppliers Company), the postal pre-audit form is in place. A postal audit will provide a good peek into the supplier's quality management, which may be confirmed during the on-site audit
The postal audit will provide valuable information, about where the auditing team from the regulated company should focus their on-site audits. This input will shorten the time-consuming on-site audit to a minimum, and focus more deeply on the found non-conformances.
3. On-Site audit,
The onsite audit, with the input from the postal audit, will be a less time-consumable audit, than without the postal audit. Of course, the regulated company can assess points from the postal audit in person on-site, if the supplier has everything as stated in the postal audit questionnaire.
The detailed audit usually covers all aspects relating to the product or service under consideration. If the regulated company is ordering the Automation Control System, the on-site audit can be focused on the training of the programmers, its software development tools, Quality Management Systems, Change Control, Review and Approval Processes, and many other aspects.
4. Follow-up audit
These check on issues raised during the on-site audit, where the non-conformances were found.
5. In-Contract audit.
These audits are periodic audits planned to verify, that the supplier is maintaining the required standards as agreed in the contract or as seen during the previous audits. They should be focused on general issues or on critical project-related issues.
Did you have some supplier selection experience, did you perform these audits, or did some kind of shortened audits? Let me know!
The next chapter will be about the points, which should be focused on during the supplier selection audit, where you will find more valuable information, so do not forget to subscribe!
OT Expert / MES, IIoT, SCADA, Aveva PI & LIMS Specialist/ Data Analytics & Cybersecurity Architect in Industry 4.0 | CISSP, PMP, Scrum
2 年Lifescience companies are in the business of making medicines wether drug products, medical devices or therapy products or healthcare services. They're not in the business of building software. They're in the business of partnering and collaborating with external vendors either EPCM, System Integrators or Tech companies to bring in the best software that can ultimately support their business processes. They're responsible "legally" for the quality of the software they use that has impact on data integrity, product quality and patient safety. They're in one of the most competitive and regulated fields on Earth. They need to focus on their own competences, thus delegate and rely on partners for the products and services they use in their value "supply chain". I have seen innumerable times companies pay attention to financial, timing criteria when selecting a vendor but forgetting that a piece of equipment of computer system without the right standard of quality, although cheap and one-time is still worthless. Supplier assessment and audit are crucial to leverage your own suppliers strengths and look into their QMS vs yours for gaps and improvement opportunities altogether.
CSV / CSA Quality | Life Sciences Consulting | MBE Entrepreneur
2 年Very insightful article Erik!