Where's the weakest link in your compliance mechanism? While you may be well aware of the most problematic areas in the facilities you're personally responsible for, supply chain compliance deficiencies have a way of sneaking up on firms.
GxP-regulated organizations can't afford to lose sight of what occurs within their supply chains. Unfortunately, today’s distributed manufacturing processes and the need to minimize expenditures can make it extremely hard to implement effective supply chain management strategies without assistance.
Conducting supplier audits is a highly effective way to tighten the reins on your production processes and regain control.
Leveraging the Audit
Supplier audits are similar to the mock FDA audits many firms already conduct. These exercises focus on the evaluation of manufacturing processes with regards to a predetermined set of regulatory guidelines or recommendations. By comparing your processes to the standard and quantifying deviations, you can get a better handle on how far out of compliance your firm is and devise a suitable corrective plan.
Of course, self audits aren't simply about performing generic mock inspections. Because these practice runs can be customized to account for your organizational needs and history, they also facilitate improved comprehension of your business operations. For instance, you may decide to track or audit certain critical process parameters to gain a better understanding of your manufacturing process as a whole.
Why Audits Need to Extend Beyond Your Firm or Facility
Similar compliance auditing techniques should be applied to suppliers. Your firm lacks the time and direct oversight capability to check up on every one of your freight teams, shippers and vendors whenever they make a move. Instead, you must use regular audits to gauge their performance over time.
Why not simply rely on your suppliers and vendors to self report? While there's nothing wrong with trustworthy supply chain services that provide their own compliance information, your ultimate goal is to pass inspections and keep your products marketable. As such, you'll need to maintain uniform records of your conformity efforts and ensure they include all information required by the standards you're targeting.
In short, your next FDA inspector isn't going to hunt down random compliance documents and verify your supply chain's conformity on your behalf. It's your responsibility to provide the correct information in an organized format that facilitates easy access.
Implementing an Effective Supplier Audit System
Of course, we've simplified the typical supplier audit process quite a bit for the purposes of the previous examples. Still, the basic principles and motivating factors remain the same as you expand into foreign markets, open new facilities or forge business partnerships.
It's critical that you devise a supplier audit system which facilitates effective scaling and keeps your bases covered. Regardless whether you're simply trying to verify ingredient handling procedures or ensure your stock tracking applications adhere to FDA software validation principles, a good framework is a must for maintaining a healthy supply chain.
GxP-CC consultants possess real-world expertise and tested theoretical knowledge of a range of compliance fields. With an exhaustive command of diverse compliance methodologies and international regulations, these consultants understand how to help firms implement effective audit strategies for all relevant aspects of their operations. Contact them soon to discover more.