For every task, you have a choice of tools that you can use. For qualifying your suppliers, are you using the correct tools?
This blog reviews how to utilize statistical process control, process validation, and supplier auditing to qualify suppliers effectively.
If you could afford to audition suppliers for a few months against hundreds of other competitors, then only the qualified suppliers would be approved. Unfortunately, you don’t have the same budget that American Idol has. So what should you do instead?
Most companies use the same three, tired tools to qualify suppliers: ISO Certification, Quality Manuals, and questionnaires. ISO certification is a weak tool because certification is only as good as the registrar’s worst client. Quality Manuals are intended to define the intent of your supplier’s Quality Management System, while most of the details are located in procedures. You only need a copy of your supplier’s Quality Manual to help you plan audits. Supplier questionnaires seem to be the most popular tool, but most of the questions require a “Yes/No” response that suppliers rarely answer negatively. To assess the qualifications of potential suppliers more effectively, try using the following tools instead:
Tool # 1: Statistical Process Control
Most companies require a Certificate of Compliance (CoC) with every shipment. A CoC is useless. Just like the “Yes/No” responses to questionnaires, you will never see a CoC that indicates something is wrong. A Certificate of Analysis (CoA) is much more useful, because the CoA has actual data, and the tolerance range is typically indicated for each test or measurement that was performed by the supplier. The best report you can get from a supplier is a statistical analysis of each specification during the prototype production lot. When you have a Statistical Process Control (SPC) run chart, you know quantitatively if the supplier is capable of making an acceptable product. The run chart can also be used to develop an appropriate sampling plan for incoming inspection.
Tool # 2: Process Validation
Process validation is much more than determining if a process is capable of producing a consistent product. An SPC run chart can do that. Process validation tells you what range of operating parameters will produce a consistent product. Therefore, when you have process deviations or measurement devices are slightly out-of-calibration, you will know if your supplier’s process will still make an acceptable product. The validation of a process should also identify which variables are critical indicators of the process. This information can be used to reduce the number of variables and specifications that are monitored for a production process, and focus both your supplier’s resources and your own.
Tool # 3: Supplier Auditing
A multi-disciplinary team audit of a potential supplier is an effective tool for assessing a supplier’s qualifications and will help build a stronger relationship between your team and the supplier’s team. Before you conduct an audit, it is important to plan the audit to ensure you get the greatest possible value. The following recommendations are important to supplier auditing:
- Use a risk-based approach to auditing suppliers (this goes beyond just critical and non-critical)
- Strategically select auditors and train them well
- Plan the auditing goals and objectives for the team in advance
- Create a formal audit agenda that defines which processes each auditor will be focusing on
Auditing 100% of your critical suppliers may seem impossible, due to limited resources, but have you ever seen a cost/benefit analysis?
What’s the cost of rejects, rework, and product redesign?
Supplier Quality Management Webinars Available
Are your Suppliers Qualified? Prove It!
http://robertpackard.wpengine.com/suppliers-qualified-prove/
Supplier Auditing and Remote Auditing: Tips to Save You Time and Money
http://robertpackard.wpengine.com/supplier-auditing-and-remote-auditing-tips-save-time-money/
What a great article, however I have a question. I have recently joined an R&D company and I am in the process of setting up an ISO 13845 QMS in what is a fairly young company (2 1/2 yrs old) and the next element we plan to implement is Supplier Management including Supplier Approval. We already have a list if unapproved suppliers that we buy from and we do intend to approve all these suppliers in stages and assign them categories based on their criticality to our business and processes. We are committed to auditing our most critical suppliers however for less critical suppliers we were intending to use their ISO Certs and supplier surveys. I do think the SPC method is a good way of approving suppliers however we don’t have the luxury of reviewing historical CoA’s as after discussion with my colleague in charge of receiving goods they informed me that we have never requested, received or kept this kind of information. We do plan on implementing quality control specifications in which the CoA’s will be a required piece of documentation that needs retained. After that brief explanation the question I have is ‘what is a more effective way of approving our less critical suppliers if the survey and certification are not effective way?’. Any help would be greatly appreciated. Thanks, Hugh Edwards.
Thank you for the question Hugh. Suppliers can be qualified by verifying certificates and surveys, but you might be interested watching our recorded webinar (http://bit.ly/Supplier-Qualification-Webinar) on qualifying suppliers. The “antique” tools for supplier qualification can be modified slightly to improve the value you get from reviewing certificates and surveys.
You can also have a policy of provisionally qualifying suppliers based upon the certificates and surveys, and then you can change the status after you have received one or more lots that pass incoming inspection. Therefore, you could move 100% of your suppliers to provisional status and convert each one to “approved” status once you develop the data you need to show that the supplier is capable based upon SPC of CoAs.
Supplier audits are another choice, and finally–if a supplier is making an off-the-shelf item you may not need to do anything to approve them other than to review and approve the purchasing information for the product(s) you intend to buy from the new supplier.
Hugh mentioned the use of ISO certifications for Supplier Qualifications. You might mention to him that FDA has taken the position (and many Notified Bodies as well today) that ISO Certificates are not, by themselves, acceptable methods of Supplier Qualification. The methods you suggest are suitable for this purpose, and I think you should take a more definite position on this matter. The medical device manufacturer’s product risk analysis should be used as one method to identify essential design outputs (EDO’s are required in 21 CFR 820.30 (d)). Essential Design Outputs that are in a supplied item identify those items that are subject to heightened supplier oversight such as Process Validation and detailed Supplier Audit.
Pingback: Supplier Qualification: How to Get the Best Results Medical Device Academy