Is this situation Non-Conformity???

#1
You ask the Business Controls manager for this year’s schedule for internal audits.
This shows that the ten departments in the organization are each audited once every twelve months and that this year’s programme has been completed.
You ask the Business Controls manager how the frequency of audits was decided.
She says that when the system was implemented three years ago, internal audits were scheduled at intervals of twelve months.
The organization has kept to the same schedule ever since.
You confirm that all of the scheduled audits for the last three years have been completed and fully reported.
Over the three-year period, a total of forty-five (45) nonconformity reports (NCRs) were raised. Of these, twenty-five (25) NCRs were in the Purchasing department and (15) fifteen were in the Inspection department.
The remaining (5) five NCRs were shared between five other departments.
Three departments had no NCRs
 
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Jean_B

Trusted Information Resource
#2
The situation is not.
But absence of evidence of trend evaluation or (renewed) risk assessment of (changed) conditions might be, as these are considerations underlying the programme. However, statements of fact by persons can be evidence. What did they have to say about the two clusters? Did that story make sense? How were those NC's distributed, are they mostly from the first year, or from the last, or still evenly distributed?
 

Ron Rompen

Trusted Information Resource
#4
I agree with Jean B that there is no nonconformance noted in the information provided. I am presuming you are auditing to ISO 9001 or IATF 16949. The requirements are pretty straightforward - you must audit all processes of the QMS within a given timeframe (ISO does not specify the frequency of the audit cycle, IATF specifies a MAXIMUM 3 year cycle). I would, however, look harder at the nonconformances raised against the Purchasing and Inspection processes - this could suggest that your Corrective Action process is ineffective (this would be a nonconformance) especially if they are repeat nonconformances.
IATF also requires (9.2.2.1) that the frequency of audits shall be reviewed and adjusted based on occurrence of internal and external nonconformities. This could also result in a nonconformance, unless you can demonstrate that the nonconformances raised were fully assessed (risk analysis) and determined not to be significant enough to warrant an increase in the audit frequency.
Another area to look at is Management Review - one of the required inputs (from ISO 9.3.2 6) is audit results. If the findings were reviewed, what actions were planned/taken?
 

BradM

Staff member
Admin
#5
Ron and Jean provided some excellent feedback about your question regarding the establishment of the interval schedule.

I would be more interested... in all the non-conformances (NC) raised. I'm not sure about the size and scope of the organization, but that sounds like a lot of write-ups. Or worded differently....

Whether 2 or 200, are all them looked at, effective Root Cause analyses (RCA) performed, addressed, and close in a timely manner? Are these NC's repeats from year to year to indicate RCA is not robust? Are the individuals performing the internal audits trained and know how to write-up observations? Is management involved and engaged in the internal audit findings and the program, or does it appear the organization is going through the motions? Are the NC's slam dunk clear as a bell and without question; or should some be observations/ recommendations?

I would think an external auditor would be more concerned with the effectiveness of the internal audit program, more than how the audit schedule/ interval is established. Just my two cents. :)
 

malasuerte

Involved In Discussions
#7
Like Jim says, not enough information. On the surface no...but if I start making assumptions, then sure...there are plenty of NCs I could write.

  1. The audit has to cover the QMS & processes, not departments - I see no evidence in the OP that says all elements of the QMS were audited.
  2. The frequency of audits should be based on more than "that's the way it's always been".
  3. Where are the corrective actions? You don't say. Were CAPAs validated/verified? Was anything done?
  4. Was there a management review?
  5. Other
 
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