Risk assessment, then risk reduction by design, then safeguarding, then information for use, then validation, then the file, then the declaration and the mark. Every step depends on the one before it. The mark is the last thing that happens and it is evidence that the rest was done, not a task in itself.Risk assessment, then risk reduction by design, then safeguarding, then information for use, then validation, then the file, then the declaration and the mark. Every step depends on the one before it. The mark is the last thing that happens and it is evidence that the rest was done, not a task in itself.

Because the mark is the deliverable somebody is asking for, and the assessment is not. So a cell gets built, and then somebody is asked to make it compliant. At that point every option in the hierarchy above safeguarding has already been spent: the layout is fixed, the access points are where they are, and the only remaining lever is to bolt on guarding, which is the most expensive and least effective end of the hierarchy.Because the mark is the deliverable somebody is asking for, and the assessment is not. So a cell gets built, and then somebody is asked to make it compliant. At that point every option in the hierarchy above safeguarding has already been spent: the layout is fixed, the access points are where they are, and the only remaining lever is to bolt on guarding, which is the most expensive and least effective end of the hierarchy.

The one we see most: a cell where the operator has to reach in every few cycles for a task nobody assessed. Guarded properly, the cell cannot hit its rate. Assessed at design stage, the same task would have been engineered out for the cost of a different infeed. We have watched a plant spend more on retro-fitted guarding and the lost rate that came with it than the entire original cell cost.The one we see most: a cell where the operator has to reach in every few cycles for a task nobody assessed. Guarded properly, the cell cannot hit its rate. Assessed at design stage, the same task would have been engineered out for the cost of a different infeed. We have watched a plant spend more on retro-fitted guarding and the lost rate that came with it than the entire original cell cost.

Every task, including maintenance, cleaning and clearing a jam, because those are where people get hurt and they are the ones left out. Every reasonably foreseeable misuse, which means watching how the job is actually done rather than how the procedure says. Then a performance level derived from severity, frequency and avoidability, and a safety circuit designed to meet it, with the calculation kept.Every task, including maintenance, cleaning and clearing a jam, because those are where people get hurt and they are the ones left out. Every reasonably foreseeable misuse, which means watching how the job is actually done rather than how the procedure says. Then a performance level derived from severity, frequency and avoidability, and a safety circuit designed to meet it, with the calculation kept.

Worth stating plainly because it catches people out: three CE marked machines linked into a line usually make a new assembly, and the assembly needs its own assessment and its own declaration. The individual marks do not add up to one. If you have linked machines and nobody has produced an assembly-level file, that gap is yours.Worth stating plainly because it catches people out: three CE marked machines linked into a line usually make a new assembly, and the assembly needs its own assessment and its own declaration. The individual marks do not add up to one. If you have linked machines and nobody has produced an assembly-level file, that gap is yours.

The technical file is not paperwork you produce at the end. It is the assessment, the drawings, the calculations, the validation records and the instructions, collected as you go. Assembled properly it takes days. Reconstructed two years later from people's memories it takes weeks and it is worse.The technical file is not paperwork you produce at the end. It is the assessment, the drawings, the calculations, the validation records and the instructions, collected as you go. Assembled properly it takes days. Reconstructed two years later from people's memories it takes weeks and it is worse.