Yield Calculations in Validations

Hi all,

Can anyone explain the importance of determining the yield in a validation process? I understand that you need to determine yield to ensure profitability and plan for materials for production, however, it does not seem to affect the quality of the final product (especially in my case where this is a low risk, disposable, non-sterile, non-implantable medical device). Furthermore, I believe that some of our more savvy customers may use this yield information to calculate material costs and give them leverage in pricing negotiations. Since we are required to share validations with customers, I would not like to include this information in validations and would not like to create 2 versions of the validations (internal only/external).

The validation SOP for my company includes a section that demands that a process must be determined to have an 80% yield in a PQ study. Will auditors find fault if this provision were removed from the SOP and replaced with something like “yield calculations may be made during OQ or PQ studies when deemed necessary”?

If yield calculations are necessary, can they be documented in engineering reports separate from the validation?

Please let me know what your thoughts are on this subject. Thanks in advance!

Yield is a over all summary of a production planning.
If you have a yield of 80%, the rejection rate would be higher.

If you do not want to include the yield in validation- what is the authenthicity of the validation process.
Any process as per a manufacturing record after validation study must show a percentage of yield that is traceable and near the calculation attained by Master record.
If you have higher rejections and lower yield, that shows the manufacturing and validation process is not robust and infact not to be reccomended into production.

Every manufacturing plant is moving towards LEAN process.
If your plant considers LEAN approach it is most advisable to calculate Yield properly, rectify the rejection rates, Re-validate and place the master validated process into Medical Device production floor.

Quality-Yield-Manufacturing time are essence of a LEAN methodology.