The floor of the loading dock was cold and the air smelled of wet concrete. Radu pushed the cart and the wheels squeaked on the grit. He stopped at the entrance of the cleanroom and he looked at the three units on the bottom shelf. They were stainless steel and they were heavy.
Yara stood by the control panel and she watched the screen. The numbers on the screen were green and they were steady. Radu pointed at the units and he asked why they were always in the same three positions. The protocol said the worst-case scenario required an annual re-evaluation. Yara did not look up from the green numbers and she said the placement was per SOP.
The Silence of Compliance
There was a silence in the room and the silence lasted for five seconds. Radu looked at the units and he looked at the logbook. He knew the annual re-evaluation had not happened since and Yara knew it too. The conversation was over and the green numbers continued to move.
Radu nodded and he said right. He moved the cart into the room and he placed the units in the same three spots. The procedure was a shield and the shield was thick. It stopped the questions and it protected the schedule. Yara was relieved and Radu was quiet. They both knew the truth but the truth was not in the SOP.
The Engineering Reality
I was once an engineer in a plant that made heart valves and I believed in the paper. I thought the binder was the reality and the reality was the binder. We had a checklist for the sterilization cycle and I signed the checklist every morning.
I saw a small flicker in the pressure gauge one Tuesday but the checklist did not have a box for flickers. I checked the box for pressure and I signed my name. I was wrong and I learned that I was wrong when the batch failed the test. I had followed the procedure and the procedure had failed the physics.
The paper was perfect but the valve was not. I learned that day that a documented process is a map but the map is not the territory.
The phrase “per SOP” is a social contract and the contract is meant to keep the peace. It allows a senior manager to stop a junior engineer from being curious. Curiosity is often seen as insubordination and insubordination is dangerous in a regulated environment. People want the safety of the documented word and they want the comfort of the routine.
When a person says the words they are telling the room that the thinking has already been done. They are saying that the thinking happened a long time ago and we do not need to do it again. This is how a company becomes a museum of old ideas and the ideas are preserved in plastic sleeves.
A standard operating procedure is meant to be a floor and it is meant to be the minimum level of quality. It often becomes a ceiling and it stops the growth of the process. In the pharmaceutical industry the ceiling is low and the weight of the compliance is heavy.
People fear the auditor and they fear the deviation report. They use the SOP to hide their fear and they use it to justify their stagnation. The units stay in the same three positions because the positions were validated in and the validation was expensive. To move the units is to ask for work and to ask for work is to invite scrutiny.
When a measurement is lost the batch is lost and the money is gone. The stainless steel housing is hermetically sealed and it is helium leak tested to 1e-8 mbar*l/s. This is a number and the number represents a high level of precision. The battery is high-temperature and it is rechargeable.
The system is designed for the person who has to stand in the room and explain the data. If the data is wrong the SOP will not save the batch. The auditor will look at the electronic record and the auditor will look for the evidence. The evidence is in the sensor and the evidence is in the record.
“The gaskets were checked per SOP.”
– Validation Manager, regarding a leaking process
I watched a validation manager once who had a binder that was four inches thick. He carried the binder like a shield and he spoke in the language of the procedure. He told me the sensors were placed according to the map and the map was approved by the committee.
I asked him if he had checked the gaskets on the door and he said the gaskets were checked per SOP. The gaskets were leaking and the steam was escaping and the binder did not mention the steam. The manager was protected by his words but the process was failing. He was a man who loved the rule more than the result.
Swiss Engineering & Endurance
The Swiss Alps are high and the air is clear. The engineering in the mountains is focused on the endurance of the machine. A datalogger must work in the steam and it must work in the cold. It must hold the data and it must tell the truth. Valimetric builds the instrument to be rugged and it builds the instrument to be exact.
The ISO 9001 certification is a mark of the system and the system is designed to produce a reliable tool. The person who uses the tool is often a validation engineer and the engineer is under pressure. The engineer needs the data to be right and the engineer needs the hardware to be tough.
We use procedural language to avoid the uncomfortable questions and we use it to avoid the work of thinking. It is a social mechanism and it is a control mechanism. The most senior person in the room is usually the most relieved when the conversation ends with the SOP. They do not have to explain the lack of re-evaluation and they do not have to justify the old methods. They can look at the clock and they can move to the next meeting. The meeting will have its own procedures and its own shields.
A lost measurement is a gap in the history of the product. The gap cannot be filled with words and it cannot be filled with protocols. The gap is a failure of the measurement and it is a failure of the instrument.
To prevent the gap you must have an instrument that is designed for the environment. You must have a sensor that is calibrated and a housing that is sealed. You must have a battery that lasts and software that keeps the record. The hardware must be better than the procedure and the data must be better than the shield.
Radu walked back to the office and he sat at his desk. He opened the file for the re-evaluation and he saw the empty signature lines. He saw the notes about the budget and he saw the notes about the time constraints.
He knew the units should be moved and he knew the worst-case scenario had changed. He looked at the manual and he looked at the SOP. He closed the file and he started his next task. The protocol was safe and the units were in their places. The green numbers were steady and the world was quiet.
The Physical Act of Truth
The measurement of temperature is a physical act and it is a technical challenge. It requires a platinum sensor and a calibrated bridge. It requires a high-temperature rechargeable battery and a glass-to-metal seal. These are the components of the instrument and they are the components of the truth.
THE METAL
- • 121°C Steam Resistance
- • Platinum Sensor Data
- • Glass-to-Metal Seals
THE PAPER
- • Committee Approvals
- • Ink Signatures
- • Institutional Peace
When the steam is the sensor knows it and the record shows it. The paper can say whatever the committee wants it to say but the sensor only says what is real. The real world is made of metal and heat and the SOP is made of ink and paper.
The procedure documents the world but it ignores the metal.
The engineering of a thermal validation system is the engineering of trust. The trust is not in the person and the trust is not in the phrase. The trust is in the traceability of the calibration and the trust is in the history of the failure.
A rugged datalogger is a witness and the witness must be reliable. It must survive the water and it must survive the pressure. It must provide the electronic record that stands up to the scrutiny of the regulator. This is the goal of the design and it is the result of the Swiss engineering.
Radu saw Yara in the cafeteria and they did not talk about the units. They talked about the weather and they talked about the weekend. They were polite and they were professional. They had used the shield and the shield had worked.
The conversation had ended and the peace had been kept. The re-evaluation was still missing but the SOP was still there. It was a perfect institutional moment and it was a quiet technical failure.
The metal was in the room and the heat was in the steam and the paper was in the binder. Everything was in its place.