There’s a lot of uncertainty in quality audits. Which documents will they ask for? Who will they want to speak to? What questions will they ask about your processes or training?
But there’s one thing you can absolutely count on: you will be asked to show your vendor list. Compliant vendor management is a requirement for GxP standards, ISO standards – the list goes on. You must prove your vendors are controlled and that you have a thorough understanding of what they do, their level of risk, and their ability to meet your requirements.
The problem? If your supplier and vendor management is overly complex, proving this is really hard. Here are two key strategies to help simplify supplier and vendor management without sacrificing compliance:
1. Set realistic risk categories for your vendors
One of the most common ways Quality teams add more complexity to their vendor management is by categorizing all vendors under the same level of risk.
Quality folks are a risk-adverse bunch (for good reason!), but often, organizations fall into the trap of categorizing every vendor as “critical,” just to be safe. This “critical” rating means more frequent vendor/supplier audits, more in-depth requalification requirements, and more intense scrutiny overall – for each and every vendor.
It might be easier to just categorize all vendors as critical to ensure you don't take on any risk, but in the long run it's definitely not simpler. Here’s why:
Why Realistic Vendor Risk Assessment Matters:
- Not all vendors are created equal: Not every vendor plays a pivotal role in your organization’s GxP activities, so not every vendor needs the same level of scrutiny. By assigning risk categories – such as high, medium, or low – you can focus resources where they’re truly needed. As an example, here’s how we categorize vendors at ZenQMS:
- Critical: Any vendor that could directly impact our GxP software, operations, data, etc. These vendors are audited most frequently and face significant scrutiny during qualification/requalification.
- Non-Critical: Vendors that do not impact operations but still carry a moderate amount of risk and a need for vendor control. These vendors are audited and requalified on a slightly longer schedule.
- Exempt: Vendors that have no impact on operations, carry little-to-no risk, and do not have the need for vendor control. These vendors either do not require auditing or can be audited on an extended schedule.
- Overly complex = an overburdened team: When you treat every vendor as high-risk, you create unnecessary workloads for your Quality team. Auditing and requalifying vendors is a time-consuming, resource-heavy process, and if every vendor requires the same frequency of audits and checks, it’s easy to fall behind.
- Unrealistic expectations might mean unsuccessful audits: An auditor won’t penalize you for categorizing a vendor as Critical even when it’s not, but they will care if you fail to follow through on your processes. If all of your vendors are marked critical out of extreme caution, but it’s not feasible for your Quality team to perform rigorous audits on them all, you’re setting your team up for failure. Instead, categorize vendors realistically and allocate resources efficiently.
In short: Prioritize audits and requalification efforts based on risk, making vendor management simpler and allowing your team to focus on what truly matters.
2. Leverage Vendor Management Software with Automation and Configurability
It’s tempting to stick with spreadsheets or paper for vendor management because they’re inexpensive and familiar. Unfortunately, “inexpensive” and “familiar” aren’t synonymous with “simple.” As your vendor list grows, manual tracking grows more complicated, difficult to manage, and prone to mistakes.
Instead, find a vendor and supplier management software that incorporates automation and configurability.
How Automation & Configurability Can Simplify Vendor Management:
- Automate audit schedules and notifications: Imagine you have a list of 100 vendors used across your organization. With tools like Excel or Google Sheets, the Quality leader has to manually input and track audit dates, remember to check the sheet, and send reminders to the right people. That’s a lot of tedious work – and room for human error.
This is where an eQMS with automated vendor and supplier management tools can make a world of difference. For example, with ZenQMS, it’s possible to set a repeating schedule for your vendor audits and assign an owner to each audit. The system will then automatically send reminders to the appropriate person when the audit is approaching, rather than relying on the Quality leader to remember dozens of different dates and send manual notifications. Simply record it once and the system takes over. - Ensure compliance with custom fields: Excel and Google Sheets pose a lot of compliance issues, but they do have one big benefit: they’re incredibly flexible. You can create and input whatever fields you need. Thankfully, you don’t have to sacrifice that flexibility when you switch to an eQMS… if you pick one that’s configurable.
Let’s say all of your vendors need to be GDPR compliant. A nonconfigurable system may not have a “GDPR Compliant” field within the vendor Qsheet, and so you'll have to find a workaround or track that information elsewhere. A configurable system, on the other hand, allows you to add the fields you need so all of the vendor information stays in one controlled and compliant spot.
Vendor management is critical, but it doesn’t have to be complicated. If you’re on the hunt for quality management tools that can improve your process, watch a quick 3-minute preview of vendor management software here.