Live Audit disasters

rubbimeister

Starting to get Involved
Recently concluded an AS9100 and 145 Regulatory Audit of a 145 component maintenance facility.

Whilst conducting the Audit a portion of ceiling collapsed into the workshop area onto some maintenance equipment.
I'm currently writing up the Audit report but am in a quandary as to how to best categorize/capture.

The operations team completed the correct actions - Stop work, cover WIP, flag a report (online system) and tidy/clean however.
Facilities team (third party) and Director were un-responsive to several calls/contacts. When the Audit concluded 3 hours later there had still been no response/visit from anyone to assess the severity of incident.

The impression I gained during the Audit was that staff knew what they should do, however the system in place did not appear to be reactive or sufficient to
Has this happened to anyone else? If it did, how would you capture....
Regulatory wise this falls within 145.A.25(c) however AS9100 Rev D im undecided...

8.1.3 Product Safety - Appears to be more around the entire product life cycle, not operational areas or incidents.​
7.1.3 Infrastructure The organization shall determine, provide, and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE: Infrastructure can include: a. buildings and associated utilities; b. equipment, including hardware and software; c. transportation resources; d. information and communication technology.​
7.1.4 Environment for the Operation of Processes The organization shall determine, provide, and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE: A suitable environment can be a combination of human and physical factors, such as: a. social (e.g., non-discriminatory, calm, non-confrontational); b. psychological (e.g., stress-reducing, burnout prevention, emotionally protective); c. physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ substantially depending on the products and services provide​
The lack of action by the facilities team indicates either a breakdown in their process or a lack of promotion/awareness within the organisation.

Discuss! :)
How would YOU document this type of instance?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
By "portion of ceiling" is that a ceiling tile or are we talking about steel support and concrete?
 

rubbimeister

Starting to get Involved
Fortunately, not!
Suspended ceiling panel due to moisture ingress from a leak above - further review indicated paint blistering on wall paint indicating a leak was tracking - however, several further tiles were noted with staining/bowing.
The collapse was directly onto maintenance equipment.

Its a Northern based facility near the coast so subject to poor weather.
 

Randy

Super Moderator
Interesting, it'll be fun to see what you get back on this one, pretty unusual.
 

Sidney Vianna

Post Responsibly
Leader
Admin
How would YOU document this type of instance?
From an AS9100 (assuming 3rd party) audit perspective, I would report this as a comment/observation in the audit report including the apparent slow reaction from facilities management. As you mentioned, the workers seem to have dealt with the potentially affected product and process equipment in a reasonable manner.

If you are a diligent CB auditor, you would even try to convince this registrant to adopt ISO 41001 ISO 41001:2018 - System Standard for Facility Management :sarcasm:
 

Mike S.

Happy to be Alive
Trusted Information Resource
I kinda agree with Sidney. If you have a hard time finding a suitable shall that is violated, sometimes that means no shall was violated. Don;t torture the standard to find one. A 3 hour lack of response from the outside supplier is not a terrible thing, its not like a gas leak was taking place.
 
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