Internal Audits - Categories of non conformances

qualprod

Trusted Information Resource
#1
Hi everybody

In the practice of internal audits, I have seen that nonconformances detected would cause different impacts in the system,
in that case , I think it would depend of the negative impact of the non conformance to decide to write up or not the non conformity.
In detail, according to 19011 " nonconformity = non-fulfilment of a requirement".
Auditing the manufacturing process, and the documents of this process.

In this case if into a procedure there is the next line " the supervisor sends an email to quality inspector to release the product."
" the quality inspector sign off the form xxxx and release the product"

In this case, if the supervisor didn´t show the email (forgot to send it) to inspector, but inspector , without receiving the email, anyway he released the product.

Should the absence of the email the need to write up the nonconformity (email sending) or would be sufficient the inspector signature in the form XXX? and nothing to do, or to write up the nonconformity only for the absence of email as a nonconformity (non-fulfilment of a requirement)?

If we consider non-fulfilments , this is a non-fulfilment (email) , but is it a good practice to do it?

How do auditors consider this situation?

Thanks you so much
 
Elsmar Forum Sponsor

John Predmore

Quite Involved in Discussions
#2
the supervisor sends an email to quality inspector to release the product
What is the purpose of the email? Does the email serve as a record? Or is it merely a reminder or a prioritization of tasks on the inspector's schedule? Who has the authority to release the parts? Whose signature on the Certificate of Conformity? If the authority lies solely with the supervisor, then in the scenario I describe, the inspector released parts without proper authority. That conscious decision to proceed without authority would be the more serious violation than not sending a message.

"8.6 The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. The organization shall retain documented information on the release of products and services [to] include: ... b. traceability to the person(s) authorizing the release. "

Your procedures should clearly define personnel who have authority to release product.
 
Last edited:

qualprod

Trusted Information Resource
#3
What is the purpose of the email? Does the email serve as a record? Or is it merely a reminder or a prioritization of tasks on the inspector's schedule? Who has the authority to release the parts? Whose signature on the Certificate of Conformity? If the authority lies solely with the supervisor, then in the scenario I describe, the inspector released parts without proper authority. That conscious decision to proceed without authority would be the more serious violation than not sending a message.

"8.6 The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. The organization shall retain documented information on the release of products and services [to] include: ... b. traceability to the person(s) authorizing the release. "

Your procedures should clearly define personnel who have authority to release product.
Thanks John
The email is just a reminder that product is ready to be inspected, the authority to release is granted to inspector.
From here, what is the difference between reminder or record?
In Other case:
Procedure says the inspector sends the approval into the email to shipping and addition, shipping responsible write down in the form xxx with a cross check.
but if inspector, didn't send email ( no evidence) because he informed by phone to shipping.
But anyway the approval is in the form xxx.
Should I write down the non-conformity? because there is not email, although it exist in the form xxx.
Thanks
 

indubioush

Quite Involved in Discussions
#4
I would write this up as a nonconformity or observation. It seems like a low risk item, but it indicates to me that whoever wrote this does not have a good grasp of quality systems. It makes me wonder if there are other instructions in other documents that they only follow some of the time. If they are forced to correct this, it will be a good learning opportunity. The lessons are as follows:
- all procedures need to be followed exactly
- shall, must, should, and may are very important words in procedures
- all process outputs need to be recorded in a way that shows compliance to the procedure
- not every little activity needs to have a record (For example, the procedure can instruct the supervisor to "communicate" to the quality inspector regarding product status with no documented evidence of this. It would be implied that this communication took place if the product got released.)
 

qualprod

Trusted Information Resource
#5
I would write this up as a nonconformity or observation. It seems like a low risk item, but it indicates to me that whoever wrote this does not have a good grasp of quality systems. It makes me wonder if there are other instructions in other documents that they only follow some of the time. If they are forced to correct this, it will be a good learning opportunity. The lessons are as follows:
- all procedures need to be followed exactly
- shall, must, should, and may are very important words in procedures
- all process outputs need to be recorded in a way that shows compliance to the procedure
- not every little activity needs to have a record (For example, the procedure can instruct the supervisor to "communicate" to the quality inspector regarding product status with no documented evidence of this. It would be implied that this communication took place if the product got released.)
Thanks indubioush

In the next:
- not every little activity needs to have a record (For example, the procedure can instruct the supervisor to "communicate" to the quality inspector regarding product status with no documented evidence of this. It would be implied that this communication took place if the product got released.)

According to your comments what is in bold:
if a nonconformity is a non-fulfilment, then in this case, the communication have to be done, but if it didnt happend (no evidence) so, is a non-fulfilment, why not to raise the nc?, in which cases such "statements"apply and when do not?
Maybe in cases where there is a more important issues?
In the other item (in bold), I think it could be a good criteria, if finally what is needed is the product released, then why to worry about the missing email, is it like this?

Thanks
 
#6
In the next:
- not every little activity needs to have a record (For example, the procedure can instruct the supervisor to "communicate" to the quality inspector regarding product status with no documented evidence of this. It would be implied that this communication took place if the product got released.)

8.6 is mandatory records an organization must have. The form signed by inspector i believe this include evidence of conformity and acceptance criteria however traceability to person authorizing release of product is missing here. NC is justified for this breakdown
 

indubioush

Quite Involved in Discussions
#7
Another example: "Submit training records to Document Control." Does Doc Control need to have a receiving stamp to show they received the training record? No because the fact that the training record is filed away means Doc Control received it.

Guna, as the OP said before, the inspector authorizes the release of product and this is indicated on the record.

Qualprod, I would strongly suggest that all quality system procedures be reviewed and all instructions for sending an email be removed. All evidence of activities should be recorded on approved, controlled quality system forms.
 

qualprod

Trusted Information Resource
#8
Another example: "Submit training records to Document Control." Does Doc Control need to have a receiving stamp to show they received the training record? No because the fact that the training record is filed away means Doc Control received it.

Guna, as the OP said before, the inspector authorizes the release of product and this is indicated on the record.

Qualprod, I would strongly suggest that all quality system procedures be reviewed and all instructions for sending an email be removed. All evidence of activities should be recorded on approved, controlled quality system forms.
Thanks to all
To finish this issue, then, in which cases apply the non-fulfilment? To send an email (was not sent) yes or not?.
Or ....
Should write up NC only if such issues "Email sent" "inspection records" are included in the ISO obligated records or internal required records, which are included in the master list of records in the qms?
Please clarifying this point.
Thanks
 

indubioush

Quite Involved in Discussions
#9
Hi Qualprod. I don't understand your question fully, but hope this helps.

If there is no objective evidence for a specific requirement called out in the SOP, that is an audit finding. In this case, an email is required. A printout of the email would provide objective evidence. A statement by the auditee that they always send the email would provide objective evidence. You instead have a statement by the auditee that they did not send the email. Therefore, this is a finding.

If there is no objective evidence that the requirements of ISO 13485 are fulfilled, that is an audit finding. But I don't know enough about the objective evidence you have gathered to make a determination on whether they are meeting the requirements of ISO 13485.
 

John Predmore

Quite Involved in Discussions
#10
The email is just a reminder that product is ready to be inspected... what is the difference between reminder or record?
You told us the email is just a reminder, and in this case, the work was done without the reminder, so was the reminder necessary? Logically, from what you told us, I conclude no. If your procedures mandate a communication which is not necessary, then in my opinion your procedures are unnecessarily restrictive. But since an auditor wrote a finding, I don't know what he saw or heard that made him think a finding was appropriate.

You told us the product was released to ship and that decision was within the authority of the inspector. Perhaps, your organization's procedures state an email must be sent. What if the supervisor made a phone call to the inspector instead of an email? What if the supervisor spoke to the inspector standing in the aisle, instead of an email? In my opinion, the form of the reminder or whether a reminder occurred is secondary to the fact who had the authority to decide and was the correct decision made. I think your customer does not care about reminders between employees, unless the email serves as a record (I meant the only record of the decision).

ISO-9001 requires retain certain documented information be retained (I use the word record here to mean certain documented information). I am not telling you you have to retain emails, the ISO standard is not telling you the organization must retain emails, your organization must decide what records must be retained and in what form and for how long. The ISO standard does require the decision that a product is released-to-ship must be retained as a record, but the format (email or some other form) is the decision of your organization.

I personally would not write a finding based on what you have told us, but I am not saying the auditor was wrong. Maybe he knows something about your situation I do not know. You have to understand what the auditor saw and what he was thinking when the finding was generated. I can't clarify for you what someone else saw or was thinking.
 
Thread starter Similar threads Forum Replies Date
C Internal Audits in a tiny Dx Company Internal Auditing 33
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
O Informational Scaling back internal audits due to corona virus while avoiding a NC Internal Auditing 7
G Internal Audits and Employee engagement Internal Auditing 16
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
K A way to monitor our Internal Audits as a KPI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
A External Auditor issue with Internal Audits Internal Auditing 7
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 144
Gman2 Quality Record Retention (Internal Audits, CA's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Informational What is the purpose of Internal Audits? Internal Auditing 27
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 23
Pmarszal ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits Internal Auditing 8
R ISO 13485:2016 Registration - NC on full cycle of internal audits ISO 13485:2016 - Medical Device Quality Management Systems 7
J Internal Audit clarification - How to perform the audits IATF 16949 - Automotive Quality Systems Standard 6
S Corrective Action from Internal Audits not performed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
W FAA Advisory Circular (AC) Requirements (FAA AC 00-56) - Internal Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Going into IATF 16949 transition without Internal Audits IATF 16949 - Automotive Quality Systems Standard 4
S Internal Audits performed by another local business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K No Internal Audits For Upcoming IATF Trans Audit IATF 16949 - Automotive Quality Systems Standard 5
J Supporting Processes - Internal Audits - Need help settling a debate IATF 16949 - Automotive Quality Systems Standard 4
K AS9100 Rev. D Transition - Internal Audits & Gap Analysis Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
J Internal Audits - Closing Audit Deficiency Reports (ISO 13485) Internal Auditing 4
S Is Audit Plan / Agenda required for Internal Audits? Internal Auditing 2
J ISO 9001:2008 - Can I still conduct Internal Audits in my company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F What is your favorite software for ISO 9001:2015 Internal Audits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2008 Surveillance Audit - No Internal Audits Internal Auditing 9
J Dinged on Internal Audits for supervising an auditor I was training Internal Auditing 10
Marc ISO 9001:2015 vs. 2008 - Internal Audits - What changes are you making? Internal Auditing 44
M Are auditing checklists required for Internal Audits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
dubrizo Internal Audit Value - What is the point of conducting internal audits to a checklist Internal Auditing 40
D Using consultants for Internal Audits Internal Auditing 24
O New Job 1 Month from Recertification Audit - Missing Documents, no Internal Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
R How do I conduct my API Q1, ISO compliant internal audits? Internal Auditing 1
F Is it good to outsource the Internal Audits? Quality Manager and Management Related Issues 16
S Advice for ISO17025 First Round of Internal Audits ISO 17025 related Discussions 10
S Engineering Audits - Internal Audits IATF 16949 - Automotive Quality Systems Standard 7
L Time Allocation for Internal Audits Internal Auditing 5
A A Guide to Effective Internal Management System Audits Book, Video, Blog and Web Site Reviews and Recommendations 2
M Utilizing ISO and Customer Audits for Internal Audits Internal Auditing 14
N Internal Process Audits - 7.1 Planning - How do YOU audit it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G Scope of External & Internal Audits General Auditing Discussions 10
S Internal Audits of QMS Corporate Basics at the Local Plant Level ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Internal Audits: Rabbit Holes or Marked Roads? Internal Auditing 13
Gman2 Frequency of Internal Audits per TS 16949 Requirements IATF 16949 - Automotive Quality Systems Standard 12
K Can anyone share an Note to File for justifying postponement of Internal Audits ? Quality Manager and Management Related Issues 5

Similar threads

Top Bottom