Lead auditor scenario (Need help) is this non conforming to ISO13485

[Rob Donohue]

In the final inspection and despatch area you are examining the inspection and despatch records for order number 1234. This relates to product XYZ that is due to be sent out to a customer.

You note that in the final inspection section of the records the word ‘OK’ is written with the initials JW alongside it. The Despatch Supervisor tells you that JW is one of the junior inspectors.

You ask the supervisor: ‘Who has authorised the release of the product?’ The supervisor replies that authorisation is not necessary for this type of routine product and it is clear from the records that the inspection was satisfactory. He says: ‘If there has been any problem, we get a signature from David Manvers, the Chief Inspector, but only if they had to do some rework to the product.’

You check the organisation’s procedure for the product release process and find it states that the Chief Inspector is responsible for authorising final release of all products.

 

[Jean_B]

Authority can be delegated, and often is for normal/routine matters, as else you would be wasting a lot of specialist knowledge and skill because there is no call for it being applied.
When special conditions occur (e.g. unusual or non-conforming input/output) or specific criteria are met escalation to either specialists by knowledge or management due to responsibility/authority occurs. See Management by exception - Wikipedia.

In your case it is important to distinguish between two types: unmonitored and monitored.
Unmonitored relies fully on the delegate actor to escalate to the original authority.
Monitored means that a lot of information is gathered, possibly aggregated, and monitored by the specialist. We can often process information a lot quicker than we can perform the motions that lead to or from that information. Though I don't recall the specific term, the navy operates in this manner: key functions send notifications up, and command has the discretion to intervene if they have knowledge that means that action is not beneficial.

In either case it would be expected that the delegation of the subset of authority (normal/routine) is documented. This could be in process, or for example through job/role description (when a person is qualified or designated to that position).
In the unmonitored case you would audit to see whether they can make appropriate calls on good, bad and ambiguous (see the wording in 21 CFR 820.25 (b)); in the monitored case you would see whether they are entering/passing on all needed information in a workable manner, and it is being processed by the authority/specialist.

 

[Rob Donohue]

thank you so much Jean for your helpful reply