During an internal audit, I found a lot of gaps and some of them did not meet QMS requirements and some of them require implementing new procedures from process owner. All findings not critically and I completed audit with 1-NC, 17-OBS (observations), and few OFI. The report was prepared with recommendations for each OBS and OFI. Also, I gave a time period for reply to OBS and inform them OBS can become NC.
Can I use this practice and write OBS and OBS can become to NC or not?
I do not follow that practice. What is an OBS for you? A best practice that you believe the organization should follow? If it is so, then you are acting as a consultant not as an auditor. The problem is that ISO 19011:2018 does not use or define “observation” as a classification for findings.
If you raised a finding that is not according to the audit criteria it is a NC, major or minor, and the organization has to close the NC.
If you raised a finding and considered it an OFI it is an invitation for the audited organization to think about it. They can decide that they will not accept the invitation.
Then, again the question: What is an OBS for you?
How to determine what is NC refers to standard?
When you write a NC you should include a reference to the clause you believe is not being followed.
Thank you for your promt response. Unfortunately, QMS did not fully implement in my company. Also employee not fully aware about QMS and ISO 9001 req's. Now i am in hard road and try to help company to understand and implement QMS system. For this case i do not want raise a lot of NC's and try to give them chance to eliminate issues during some period (4 week). Therefore i planned raised as OBS not NC.
if i will used this practice have any chance to get NC during 3rd part audit?
if you have other recommendation please advise me.
First, find a way of incorporating your own QMS’s definition of OBS in your internal audit procedure and how to handle them, to avoid an NC during the 3rd part audit.
Second, with findings raised in your internal audit, you identified several “fruits” that you want to improve, but in your second question I believe you identified two important root causes that can help improve your QMS situation (I use the term root cause here as important NC):
QMS did not fully implement
Employees not fully aware of QMS and ISO 9001 req's
You could have raised these two NCs making the 18 findings as evidence that support their existence.
While your organization has to close those 18 findings, what can also be done to improve implementation and employee’s awareness about QMS and ISO 9001 req's? Employees don’t need to know everything about QMS and ISO 9001 req's, try to make a matrix about the relationship of employees, or groups of employees, or departments and QMS and ISO 9001 req's. Who can influence them? Whom they trust? What can be the benefits for them with certification? Please check if you can find any ideas here: