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
 
Elsmar Forum Sponsor

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

Leader
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
 
Thread starter Similar threads Forum Replies Date
H At what level (harm, hazardous situation, seq. of events, etc) is "risk" estimated? ISO 14971 - Medical Device Risk Management 12
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
T When is a hazardous situation? ISO 14971 - Medical Device Risk Management 34
R Power Failure or Cold Start Situation in PFMEA FMEA and Control Plans 6
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
S Who needs a 510(k) in this situation? Class II medical device for a US Orthodontist Other US Medical Device Regulations 4
M Is PPAP required in this situation? APQP and PPAP 5
O Unique situation regarding a Veterinary Medical Device and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
K Effectiveness of CAPA in this Safety Situation Nonconformance and Corrective Action 8
F Is this situation against ISO 19011? Internal Auditing 2
C Example of Hazardous Situation Report Funny Stuff - Jokes and Humour 1
O Hazards vs. Hazardous Situation Confusion ISO 14971 - Medical Device Risk Management 11
C AS9100C Implementation in a Complex Situation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J NCM (Nonconforming Material) Situation.. Then What? Nonconformance and Corrective Action 1
optomist1 CMM Shortcomings - GD&T - Inability of CMMs to verify the MMC situation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K What is the most embarrassing audit situation you have seen or experienced? Internal Auditing 4
D Women in Employment - the Indian Situation Imported Legacy Blogs 10
ScottK The situation in Japan and your Supply Chain Quality Manager and Management Related Issues 5
Q Employees perceive CAPA as Bad - How to cope with the situation Nonconformance and Corrective Action 15
Marco Bernardi Concentricity Tolerance: A Unilateral Boundary Situation (Minitab) Using Minitab Software 22
somashekar Shared Services - What must be done in a situation like this ... Miscellaneous Environmental Standards and EMS Related Discussions 10
A The Best Way to Quickly Review the Quality Situation Quality Manager and Management Related Issues 40
Chennaiite "Unusual Situation" in Gemba? Just Food for thought Quality Manager and Management Related Issues 0
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q CONTAINMENT of affected product - What situation mandates PRODUCT HOLD ISO 13485:2016 - Medical Device Quality Management Systems 4
ScottK As an ISO9001 auditor what would you say about this of this (open SCAR situation): ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Which ISO9000 Registrar would you pick? (Hypothetical Situation) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Changing Lead to Lead-Free - What is the situation with PPAP? APQP and PPAP 8
S QMS Implementation - Weird Situation - Need Suggstions Quality Management System (QMS) Manuals 2
J Does any black belt meet this situation? The problem is the process Six Sigma 6
D Interviewing for a Job - What's your experience or situation? Career and Occupation Discussions 101
K Unique Situation - Preventive or Corrective Action? Preventive Action and Continuous Improvement 13
L Non Applicability of Clauses in ISO13485 for Medical Devices Medical Device and FDA Regulations and Standards News 4
B Transport Validation For Non-sterile Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
W Posting Non-Quality System instructions on the Production Floor Manufacturing and Related Processes 13
T Justification of use of non-harmonized standards for MDR conformity Other Medical Device Related Standards 12
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
D Is a lost calibrated tool an non-conformance for an audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 58
B Leadership non-conformity, Top Management's involvement in Problem Solving IATF 16949 - Automotive Quality Systems Standard 10
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
S Non-approved supplier? Supplier Quality Assurance and other Supplier Issues 3
R FMEA's for non-manufacturing sites FMEA and Control Plans 4
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
C Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
N Non-dairy Creamer US Food and Drug Administration (FDA) 3
G Shipping Validation of Non-Sterile Parts? Other Medical Device and Orthopedic Related Topics 9
Edward Reesor Class I non-sterile "Shelf Life" labeling (EU/UK) CE Marking (Conformité Européene) / CB Scheme 4
E Comparing process parameters on non-normal batches Capability, Accuracy and Stability - Processes, Machines, etc. 11

Similar threads

Top Bottom