Observation or non-conformance

Quick question for all you quality enthusiasts.

Mother A wished to donate her blood product, she shares her name with Mother B. Mothers B donation information unintentionally was pulled from the hospital records for Mothers A donation. A member of staff discovered this after the donation.

Is this a staff observation or an internal non-conformance? And why?

 

Does it not also depend if the system defines it or not?

Assume the current state is Last/First name on the donation. This allows the situation of different people with the same names to have their donations swapped. If the organization did not consider this during their PFMEA and does not detail this in their work instructions and it is then discovered "during production," to me, the is a non-conformance ONLY if it does not engender the appropriate responses. (Update the PFMEA, update the work instructions, improve, improve, improve).

But that's me being logical. I don't answer these questions much because I'm not very involved or experienced with ISO/TS or the audits.

 

That then explains why when I give blood I get a cookie. If it were TS, I would get a punch in the gut.

But I still think my comment is valid. That being:

At some point, they have to come up with some list of steps to perform a task (A PFD in automotive). Whatever form that takes, there is some more or less formal evaluation as to the order and necessity of each task, hopefully driven by both careful consideration and past experiences (A PFMEA in automotive).

If this blood mixup is because a violation of established procedures - someone went outside the correct way of working - then to me it would be a non-conformance. But if it was a new failure mode that just was not considered when the procedures and steps were developed, that would be a staff discovery.

 

For me this would be an internal non-conformance and a major one at that for the following reasons:

• if there is a procedure for pulling names and reference data which are unique to the donor then it would have been a breach of the procedure and therefore a non-conformance (assumption being that there is a Unique Patient Identifier that should have allowed the user to pick up the issue).
• it would be a major non-conformance because of the potential consequences of the mixed bloods. e.g. if mother A was O- and Mother B was O+ then the consequences could be dire for someone with an A- or B- blood group due to the mislabelled blood. This also elevates the seriouness of the gap idenitified so it can be addressed properly.

Though it could also be argued that it is an obersevation, this is not a minor issue and with the potential consequences the status needs elevating to at least a minor non-conformity.

Ultimately though it depends on how your business defines its obervations and non-conformities pulling guidance from regulations and standards.
Definitions usually applied are:

• Major non-conformity - safety issue, lack of compliance to regulatory requirement, total breakdown of the QMS (example repeat gaps or multiple issues in the same area).
• Minor non-conformity - is a single identified failure in the QMS, mainly deviations from the business's own procedures.
• Oberservation - is where potential/concerned exists for failures where a 1st or 2nd level structure or process fails or is missed.

Please note the response above is within the context of ISO 13485.

I hope this helps.

 

Andy, both ISO 13485 [(2003 clause 8.5.2)(2016 clause 8.7 and 10.2)] and 21 CFR 820 (subpart J) reference noncomformities but do not define levels within that. The levels of non-confirmity are really trully only required within the context of Notified Bodies in the EU.
And my answer was not what I THINK but what is both practice and guidance for notified bodies in the EU and in QMSes generally. One's notified body will always apply the definitions I provided in my previous post.

And there is no point in regurgitating on here what the standards say with no interpretation: the interpretation is what we all bring, from our years of experience and knowledge afterall

 

Lets take a step back and look at what a non conformance IS.....it is a situation that does not conform to an official standard (often made official by the company itself in approved procedures).

I can't tell from any of the above whether or not a standard exists. As such, I can't tell if the situation conforms or not. Therefore there is no known basis (in this thread so far) for a non conformance.

Something happened that was not wanted...that much is clear.
Is there a recognized and documented process that SHOULD have happened (sure, there was a process that should have happened...but is it documented?)

If this info was shared to Mother B, there may be statutes from outside the company requiring conformance (HIPPA?).
If it was internal...what would the error not conform TO?

Without something to conform to, there cannot be a non conformance.

 

Without knowing all the circumstances, the processes and procedures in place, and assuming ISO 13485; then I would start by looking at 7.5.8 (Identification) and/or 7.5.9 (Traceability).

Whether its an observation, minor or major non-conformance is a matter for the individual organisation's procedures. In practice, its not the name of that process that is important, it's actions the process generates (correction, CA, regulatory notification, Field action, etc) that the organisation will be measured on; and we need a lot more information to discuss that.

 

Andy,
Please note I had made assumptions that (clear in my response), much in the same way that you assume that none exists for the issue at hand.
In any case this is all theoritcal as George Ferguson has not shed any more light on it.

It certainy has allowed for some debate. And it would be awesome if you offered up a view even if it is hypothetical