Staab White Paper (download)
Regulations & Purchasing Controls
FDA regulation, 21 CFR Part 820, says, “Each manufacturer shall establish and maintain procedures to ensure suppliers can meet the requirements.” As manufacturers, we need to have procedures to make sure that the suppliers can meet what we’re asking them to do. The next part is we need to evaluate and select those suppliers based off their ability to meet those requirements.
ISO 13485 Evaluating Data Trends
Staab: ISO 13485:2016, Section 7.4 goes into purchasing and the purchasing process. It is very similar to QSR 820 in that you need a procedure that conforms to specified purchasing information. You need to document what you are going to do, communicate with the relevant supplier on what is needed and establish a criteria for the evaluation and selection of suppliers. The criteria should be based off the supplier’s ability to provide the product relevant to your requirements, supplier performance, the effect on the purchased produce relevant to the finished product and then monitor and re-evaluate your suppliers.
Darwin: Communicating back to your suppliers, setting up what SCAR will look like, solve the problem, and then remediate it for improvement to make the issues go away.
Staab: Absolutely, it is all about the trending data, how you manage it, looking at the data. Most importantly, if you are collecting the data, use the data because it will guide you.
Staab: Quoting the regulation, “the nonfulfillment of purchasing requirements shall be addressed with this power proportionate to the risks”. This is a risk-based decision on NCR and how you manage it; define that NCR and grade it. Set up your action plan, proceduralize your action plan on what you’re going to do with those types of nonconformances.
Make sure you don’t miss the regulatory piece; if the supplier changed material or manufacturing location, there can be regulatory implications even if the NCR process is fully functional and compliant.
Once you get that data, start tracking it and you’ll start to see trends and challenges in certain areas. There’s all different ways of classifying these failures: dimensional concerns, corrosion concerns, short circuits, tool marks, etc., but getting the data is only half the talks. Using the data and then taking action with your suppliers to fix challenges is the other half.
Supplier performance in meeting requirements for the purchase goods shall be monitored and the results of the monitoring shall be an input to the revaluation process.
Performance Factors to consider:
- Non-Conformance/ Non-Conformance rate (NC/Receipts)
- Supplier CAPAs
- Timeliness of those SCAPAs. Were they late? Were the responses adequate? Did they go effective or ineffective?
- Supplier Fault Product Hold or Field Actions- Did they cause challenges for you in your finished good?
- Organizational- Internal audits, external audits, and then third-party results. Did they have any 483 for other matters?
- Fill Rate
- On-Time Delivery
Initial Supplier Evaluation
Staab: You need to evaluate every supplier, what they are providing and understand their QMS.
Shurig: When you are picking a supplier, what does that timeframe look like to pick a supplier?
Staab: The Earlier the better. You need to get in with your advanced sourcing team or NPD team and understand who they are selecting and work with them early in the process; early understanding of the supplier’s capabilities is critical to success.
Supplier Evaluations Post COVID
Staab: We see all the time now, “Due to COVID-19 we will not be allowing any visitors at this facility”. How are you supposed to do a quality management system audit or an onsite audit where you can’t get onsite?
Shurig: I have witnessed some scenarios of a clients moving to video auditing or creating a combination of remote and onsite.
Staab: Yes, you must understand the challenges and then put work arounds in place to manage them. Many suppliers are open to uploading files in advance. You need to work with your manufacturing sites and what supplier challenges they are having up front, so you know where to focus.
You must be knowledgeable of the suppliers process up front so you can build efficiency to your process up front and then use electronic tools, such as Box, WebEx, Video Chat, and Zoom. For Example, many suppliers are open to taking the computer around the manufacturing facility for an audit.
Supplier Surveillance Evaluations
Staab: Surveillance Evaluations: this is the piece of monitoring and leveraging our scorecard to determine which suppliers need to get out to because they are high risk. This allows you to see what challenges they are having and work with them to make sure they have the proper controls in place.
Create a schedule for your suppliers based on risk and then stick to it while leveraging your time per supplier based on your performance monitoring.
Shurig: How many different sets of eyes do you have looking at that data that you are obtaining for your suppliers?
Staab: From a performance monitoring standpoint, we review the data as a cross-functional team for all sites with all of our sourcing counterparts so everyone is aware of how that supplier is performing. Additionally, you want to make sure NPD understands how relevant sustaining suppliers are doing for future projects. The team is looking at data, understanding it even if it is just escalating up key data points to those outside of the cross-functional teams, it is important.
Getting Suppliers to Manage Their Suppliers
Shurig: Chris, how do you get your suppliers to effectively monitor and manage their suppliers?
Staab: Great question! In Medtech, we are often telling our suppliers who to use which adds an entirely different dynamic. It comes down to communication; you need to partner with your suppliers, make sure they know their responsibilities and set up appropriate supplier controls for whatever is coming in their door.
Shurig: I think the successful implementation comes down to proactivity versus reactivity, right? Do you have success examples relevant to giving more business to supplier that you are not having issues with?
Staab: Absolutely and we leverage those performance criteria with like suppliers. They are all competing for the same business so make sure you leverage performance monitoring and leverage the data in any way possible to make sure your suppliers are continually reaching for “best practices”.