Manufacturer of Natural Products That Empower People to Live Healthier Lives
Nutrition for Optimal Wellness
How Vendor Audits Help Assure Quality
Having a good working relationship with our raw material suppliers (vendors) is an important goal at NOW Foods.  This is because building trust through these professional relationships can benefit both NOW Foods and our vendors, with quality assurance cost savings that can be passed on to our customers with no reduction in quality. 
 
One part of this process is developing and reviewing historical data on the raw material supplied by that vendor.  Another part is conducting a vendor audit, which is where we visit and inspect the supplier’s facilities.
 
Someone in the Quality Control Department at NOW Foods will schedule the audit.  Sometimes there is an audit survey form that we will send to the vendor in advance, asking them to complete and return it as a kind of a preliminary “self audit”.  This will give us a snapshot of what kind of processes and control systems they utilize.
 
During the audit, NOW Foods’ Quality technicians will inspect/review documents and walk through the supplier’s facility.  We use the extensive NNFA GMP (Good Manufacturing Practices) procedures as a guidance to conduct the audit.   Most of this is verified by reviewing documentation, so it is crucial that the documentation be legible, complete, and accompanied by the appropriate approval signatures.  The reason for the audit is two-fold:
 
1.  We get to verify in person what we assume from reviewing the product history – that the vendor is trustworthy and makes a quality product.
 
2.  Once this is verified, we may be able to further reduce testing and rely more strongly on the vendor’s COA (Certificate of Analysis) as evidence of quality and identity, to more quickly release the raw material to Production and thus minimize out-of-stock situations.  
 
THE AUDIT
 
Personnel
·  Does the employee have adequate training to perform the assigned job?  This includes training on Standard Operating Procedures.
·  Are the employees wearing protective attire appropriate to the job– hairnets, beard covers, safety glasses, lab coats?
 
Plant and Grounds/Sanitation
·  Is the inside and outside of the plant kept clean to prevent contamination?  Are the air vents clean?  Is there paint falling of the walls, etc.?
·  Are there pest control procedures in place to prevent contamination?
 
Equipment
·  Is equipment properly maintained and in good repair?
·  Is equipment calibrated regularly and properly documented?
 
Quality Control
·  How is the quality department set up and do they have control of the final disposition of the product? (In other words, can they stop production or sale of a product that fails their Quality Control testing?)
·  What is the process for approving/rejecting a batch/raw material? 
·  What kinds of testing can they do on site?  Do they send materials to an independent lab, as appropriate? Do they have an industry-leading lab that develops widely accepted testing methods?
 
Production and Process Controls
·  Are there batch records for each batch?  A batch record is a complete history of the batch and is kind of like a recipe.  It includes a list of ingredients with the quantities needed, directions on how to make it, signatures of who made it and the date when it was made. 
·  Are all activities done in a way that protects against contamination, mix-ups, and errors?
 
Warehousing, Distribution, and Post-distribution Procedures
·  Is a sample retained from every batch produced? 
·  Is there a procedure in place for handling customer complaints?
 
Procedures and Records
·  Are there Standard Operating Procedures for each process?  These exist so that everyone does the same thing every time.  It limits variation in the process that can lead to errors. 
 
In addition, we verify
·  Regulatory inspections – has the company been inspected by the FDA, health department, etc and what was the outcome?
·  Certifications – GMP, organic, kosher, etc.  – This helps us know what standards to use during the inspection.  
 
After the audit, there is a closure meeting with the vendor.  Any compliance issues are discussed along with any corrective actions that are required. Typically, three things could happen:
 
1.  For a significant non-compliance issue - e.g. the plant is exceptionally dirty - the vendor may be disqualified until the corrective action has been taken and verified by someone in the NOW Foods quality departments. 
2.  For a less significant issue - we may just perform additional testing to ensure the product meets specifications.
3.  Also for a less significant issue – we remain with the current testing schedule and elect to not further reduce testing.
 
The historical data, vendor audit report, and how well the vendor responds to problems are reviewed together to complete our evaluation of the vendor.  If we can rely more on the vendor’s COA, then we can reduce our raw material testing to a minimum, which reduces the cost of our testing without sacrificing quality.  Also, the vendor can then be rewarded with more business, because they are not just a vendor, but a trusted partner. We prefer using that current supplier - which has already proven itself a worthy partner - over a completely new supplier that has not yet been so strictly qualified. A new supplier will necessitate us doing audits and testing before we can reach the same level of confidence in their raw material versus a proven, audited partner.
 
NOW Foods uses this system to reduce unnecessary testing that could inflate our costs, using the time-tested technique of applying more of our testing resources to qualify ingredients from newer vendors, who have not yet proven their integrity.