Audit All of your Vendor’s Validation Related Documentation before Purchase
Overview
This post is the result of a number of complaints from my clients who purchased systems from vendors and validation related documents, templates, protocol, etc for these systems. These validation documents (and validation services) were sold either separately as line items, or as part of the system (with the appropriate discount incentives added). The bottom line is that a complete quality audit was never done on these documents by the clients prior to the purchase. In the case of the particular vendor in question, (I won’t name in this post) the documentation was not shown to the clients prior to purchase with the excuse being that if the documents were audited they could be reproduced without purchase. The vendor assured the clients that all documents were developed by Quality Professionals with years of experience within the industry. Having seen these documents, my opinion is that they belong in the shredder.
Vendor Audits
A Vendor Audit should always be done prior to purchase of any system. In this case, all validation related documents should be audited prior to purchase. There is no threat to the vendor of a client using their validation documentation without payment if the client performs the audit in person at the vendor location (or the vendor representative can provide these documents in person at the client site). Validation related documentation can offer a window into the Quality System utilized by the vendor (if any).
Vendor Quality Process
This is a vital part of the selection process for any vendor. The overall audit of the vendor should include how validation documents were developed and what procedures are in place which governs the development of the documents. This should be part of the overall vendor/supplier audit. Even if it is simply an audit of the validation documentation and services, it is important to confirm the quality of the deliverables before purchase. Smaller companies and organizations may rely upon the vendor for advice and guidance. In this case, it may be well worth the expense to hire a quality professional or utilize a contractor with validation experience. Ignorance is not an excuse that one can give during an audit or inspection.
Qualified Service Delivery
In the case where a vendor offers validation related services, make sure the people performing the service are qualified from a technical and quality perspective. A technical person lacking quality experience is acceptable if the client wishes to oversee the quality requirements and has a strong quality system. Keep in mind that this may increase the risk of an observation if close attention isn’t paid to the work performed or tempaltes/protocols utilized.
Flexibility
A Vendor offering validation templates, documents, protocols, etc. should always be willing to adapt their methods to the client’s Quality System. This is CRITICAL! A vendor isn’t responsible for the validation documentation and services during an audit/inspection. The responsibility lies solely with the client (responsibility can never be outsourced). In some cases the vendor may be the expert from a technical standpoint, but the client should have full control of their quality system and regulations/requirements that they must adhere to. In addition, there may be existing policies and procedure already in place that may conflict with the vendor provided documentation or services. If the vendor isn’t willing to adapt their services and deliverables to the client, there will most likely be more work ahead to correct the issues encountered. More work equals more time and money. A vendor should be more than willing to expose their Quality Systems and practices to clients as a method of reassurance. Any vendor who hesitates to expose their Quality System is most likely trying to hide significant issues.
Audit versus Time, Effort, Money, and Risk
Will the cost of performing an audit up front be more than the time, effort, money, and potential risk if the quality of the validation documents and services does not meet expectations? What happens if the audit of a vendor determines their quality systems are substandard before or after purchase? Does substandard quality in their validation related documentation reflect on their product, equipment, or system?
These are all questions that should be in the back of your mind.
I welcome any and all feedback on my posts.
If you are interested in how my expertise can contribute to your validation project or company, please contact me at greggsalomon @ yahoo dot com.
