On July 27, 2010 at approximately 14:45 hours one of my direct supervisors asked me to correct a sewer document entry that I had previously made on both July 12th and July 19th of 2010. The entry I made was for sewering “MB-10, a cleaning chemical used in building __ as a disinfectant. I entered on the sewering document that I sewered 3 and ¾ gallons of this product.

This entry was questioned by fellow technicians upon document review. The review technicians referred this entry to __________ for consideration of accuracy. Upon returning from my flex flow assignment in LAR, the review technicians asked me to speak to ___ about the entry. I did.

I told Stacy that the manufacturer came to department 210 when the MB-10 Tablets were rolled out and explained to the technicians the proper way to mix these tablets with water to make the desired solution for application. As stated through Quip Laboratories web page (attached), “Individual foil envelopes, each containing 1 (one) 1.5 gram MB-10 Tablet for quart bottles of activated product.”
or: Individual foil envelopes, each containing 1 (one) 6.0 gram MB-10 Tablet for gallon bottles or larger quantities of activated product.”

_______ remarked that our SOP # 210- refers to liters. I said I am not incorrect and for her to change the SOP. I also suggested that all measurements used in the department should be either metric (liters) or english (gallons). _____ said I was making her angry and left her cube. I returned to the break room.

_____ entered the break room and asked to continue our conversation. I agreed. We went into the conference room along with __________. In the conference room, _____ threatened me with insubordination if I continued to document document on the sewering log in fractions of gallons instead of liters.

I or any other technician in department _____ cannot function in a business manor operating under the impossible, ambiguous and contradicting SOP guidelines or managements lack of ability to understand facts.

Fact is that a quart is less than a liter, that a gallon equals four quarts. Six grams of MB-10 makes one gallon of solution. One and one half grams of MB-10 makes one quart of solution. Fact is to document liters instead of quarts is to falsify documentation. Fact is to document quarts is to not follow the SOP. The technicians in department 210 are placed in a “dammed if I do and dammed if I don't” situation.

I recall the incident that initiated sewer logs be used. An employee was asked by his supervisor to dump a solution down the drain. This caused a fish kill and Philadelphia to close the cities drinking water intake. Both supervisor and employee were fired. The PA EPA fined Merck. Merck was the front page story. Dammed if I do and Dammed if I don't!

ALWAYS follow the SOP regardless of what the supervision says. In the event the supervisor is giving you a hard time, get the Quality/GMP, and upper management involved. That way the supervision doesnt mess with you. You are paid to ONLY do what is in the SOP. Period. If you deviate from it, it is your ass on the line.