The three questions an auditor asks about a sterile services department, the qualification work that answers the first one, and the daily evidence and traceability records that answer the other two.
An auditor standing in a sterile services department asks three questions, in this order. Was this machine ever shown to work for the loads you put in it? Was this particular cycle correct on the day it ran? And if a problem were found today, could you name the patients who received instruments from that load? A department can pass the first and fail the third, and the third is the one that matters when something goes wrong.
Validation of moist heat sterilisation follows ISO 17665, with EN 285 covering large steam sterilisers and EN 13060 covering small ones. Washer disinfectors upstream have their own standard in ISO 15883, and a sterile load that started with an inadequately cleaned instrument is not sterile whatever the cycle chart says.
Qualification comes in three parts and all three have to exist on paper.
Requalify at a defined interval, after any repair that could affect performance, and after any change to a load configuration. Also keep the calibration certificates for the instruments used to do the validation. A validation carried out with an uncalibrated data logger proves nothing at all, and it is the omission an experienced auditor looks for first.
Daily, before production: an automatic control test, a vacuum leak test on machines that use vacuum, and an air removal test such as the Bowie Dick on porous load sterilisers. For hollow instruments, a process challenge device or helix test, because a cycle that passes on a textile pack does not prove steam penetration into a lumen.
On every load: an external chemical indicator on each pack, which shows the pack has been through a process, and an internal indicator inside the pack, which is what the person opening it in theatre actually relies on. The two are not interchangeable, and a department using only external tape has no evidence about the inside of any pack.
Biological indicators go in at the frequency your policy sets, and always with an implant load, which is quarantined until the result is read. Then somebody named checks the cycle record against the specified parameters and signs to release the load. Release is a decision made by a person, not an event that happens when the door opens.
Traceability is a chain, and it breaks at whichever link is not written down.
Set a retention period in policy, keep it longer for implants, and store the records somewhere that survives a monsoon. A CSSD keeping thermal printer rolls in a cardboard box under a bench has records that will be blank in two years, because thermal paper fades. Scan them, or specify a machine that logs electronically to a server.
One test of whether the system is real: pick a pack off the theatre shelf at random and try to produce, within ten minutes, the cycle record it came from and the name of the person who released it. Departments that can do that pass audits. Departments that cannot have a filing system rather than a traceability system, and they usually discover the difference at the worst possible time.