Quality Control - TQM, Six Sigma, ISO 9000/What is a validated product



I work for a manufacturing facility that produces filters for the Food & Beverage and Pharmaceutical Industry. My background and practices have me well versed in TQM and cGMP.  This specific industry has me challenged in new ways. Output in both sales and production is very slow, time consuming and apparently strict. I don't fall into FDA testing or audits. Nor am I required or ISO certified.The black and white rules I am being informed of are from my staff, who were trained by others before them. Are these so called do's and do not's from the way we always have done it, or a rule within the industry?
Presently my biggest challenge is the feeling of being held hostage if you will by the phrase "validation". The entire cycle from vendor, raw material, inspection, QA/QC, testing, documentation, logistics, etc.
We seem to come close to the FDA reg QSR21 CFR820, we don't make a drug or a machine, we supply a filter that is part of a process.
Recently I have been hit from several suppliers on price increases, I feel like a hostage as I cant go anywhere else or shop them.  To revalidate a raw material in our process I am told takes years and money.
If the end product performs the same or close, why can't I change, why must I notify?
Are the rules in this subjective or not, in my product specific.

ANSWER: This is a great question and one which many individuals may not quite understand.  I have extensive experience in quality control principles and I have done a number of audits.  The situation you described in not uncommon.  The validation process not just the process of validating material content to ensure the qualities and properties meet contractual standards but each phase of the manufacturing process involves validating in terms of meeting the requirements when going to the next phase.  Requirements exist at each level of manufacturing it is necessary and almost a routine action to ensure a product is ready for the next step.  This constitutes a validation activity.

Validation does not require years or large sums of money for your specific product.  Many companies have been recognized for their quality in terms of the materials you receive to produce your product.  Evaluations must be done and companies must perform some type of verification/validation.  I would suggest contacting your customers to determine their validation process and if they have some level of quality verification performed by those they recognize as a company who produces a quality product or process.  In terms of your industry the same process is usually in place and this information may well be available which would reduce your level of validation to some extent.   

To answer your question more specifically a validated product is one that the product and/or the materials which comprise it have been verified to meet contractual and process requirements.  Each process in a manufacturing cycle has certain requirements.  Ensuring process requirements are being met is a validation of the product being produced at that point in time.  In terms of your beginning and end product once you have some level of confidence as to the quality of the product you are producing and the quality of the material you are receiving validation can be reduced to a sample.  The quality function in and of itself is a validation activity and not only involves the quality department but each individual within the manufacturing process.  

Each individual should understand the benefits of meeting the quality requirements for their specific area and how it relates to the next phase in the manufacturing cycle.  In terms of notification it would only be required if critical elements of your product have been found to be defective.  There can be deficiencies in any product but only when it impacts the functionality of a product or in your situation a health risk, notification would be required.  There can be minor deficiencies and these do not in most cases require notification.  This requirement can be and often is dictated by contractual requirements.

I hope this helps.

---------- FOLLOW-UP ----------

QUESTION: This is a big help, let me then ask a final question that I do not want you to feel like I am looking for a yes or no to, but more of your opinion and or suggestion.  Lets say that I do not have any contracts in writing regarding my product between our customer and I.  We have audits that are done to show proper control and check points are being done to maintain quality and performance and corrections are done when applicable. If I have a raw material that I purchase from one vendor, and I can purchase it from a new supplier for reasons such as cheaper, logistics, or even a backup if needed.  Do I need to inform that customer if the end product performs the same or better. We produce a manufactured product, it is note regulated or approved by FDA or other agencies,as long as it meets the specs we claim, may I outsource to other vendors. These so called validated vendors are killing me in holding me hostage.

Great follow-up question.  

Customers care about one thing and that is that the product meets their requirements for function and quality.  It is not necessary unless required to notify your customer when you change or add new sources for such things as raw material.  If customers have questions it is however important to have the records as to the changes in your supplier and the reasons for them.  In addition it is always a good idea to have backup resources to ensure a supply of the material you need.  Sometimes suppliers have problems and if you only have one resource it would hamper your contractual commitment to your customer.

The key to adding an additional resource is the quality of the product being purchased from additional resources.  If the quality matches or exceeds the quality of a present supplier it makes sense from a business standpoint to protect the relationship with a customer.  In this example having an additional resource.  Additionally another benefit is the creation of competition between two resources.  This sometimes can lead to lower prices if they know they are in competition with another business.  It is not appropriate to identify the additional resource to your present supplier only that you have a second source.  

Hope this helps

Quality Control - TQM, Six Sigma, ISO 9000

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Dennis AuBuchon


I cannot answer questions on Six Sigma. I cannot answer questions as they relate to software programs. I can answer questions related to TQM principles. I can answer question on ISO 9000 quality system principles and requirements as they relate to quality system procedures and instructions. I can answer questions as they relate to integrity principles and quality system/control requirements. I can answer questions related to quality control procedures and instructions. I can answer questions related to quality auditing, procedures and instructions.


I am a certified quality auditor with the American Society for Quality in Milwaulkee, Wisconsin and have been since 1992. I have over 25 years experience in quality control/system responsibilities. I have written a book titled Integrity: Do You Have It? 2nd edition. I have written over 40 articles on integrity regarding various issues and concerns in society. I have taught quality auditing classes for my work. I have experience as a quality program manager. This involved knowing the requirements, analyzing the procedures/instructions and assuring they conform to contractual requirements. I have written position descriptions for various job functions. I organized and managed a seminar related to ISO 9000 quality system requirements in the 1990's. I am also familiar with the current issue of the documents.

I belong to the American Society for Quality and have since 1989.

My writing has appeared in the Education Division, Management Division and Quality Auditing Division of the American Society for Quality. The title of the articles was Integrity in Education, Integrity in Management and Integrity in Auditing. Other articles are published on line through ideamarketers.com and helium.com. I also have a blog on blogger.com where several articles are posted.

I am a certified quality auditor with the American Society for Quality since 1992. I have created and taught classes related to ISO 9000 quality system requirements. I have training in leadership and facilitation. I held the position of Education Chairman for 6 years for my local branch of the American Society for Quality. I am also self taught in many cases. I have learned much about quality systems through my own initiatives such as reading books, magazines and information available on the Internet. I belong to the American Society for Quality (ASQ) and read the monthly magazine which keeps me abreast of current issues and trends. My local section of ASQ has monthly meetings for which speakers present various topics of interest to quality.

Awards and Honors
I was nominated twice for excellence in my work and ranked in the top 10 in my area both times.

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