Not having Training Records for Documentation Changes - ISO 13485 Clause 4.2.3

bio_subbu

Super Moderator
#11
Re: Not having training documentation for documentation changes - ISO 13485 Clause 4

Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
Set of policies, procedures or requirements are defined as audit criteria as per the standard ISO 19011- 2004: Guidelines for quality and/or environmental management systems auditing. Since you are a medical devices industry, procedure for change control and training are mandatory requirement as required by ISO 13485:2003. The auditor can write non conformity, if your internal procedures (audit criteria) either training or change control called for the information stating that “Training required if there any revision changes in the documents”. But I don’t know what your procedure says.

In our organization, we described our internal training procedure that “procedural training for affected personnel is completed prior to employees using a new or revised procedure.” and also described in our document and change control procedure “Training records must be submitted when there is revision changes in the existing procedures. If training is not required, provide justification why not required”. (i.e.) as stated above by arios, if there is any administrative changes such as minor typographical errors, page alignment and etc.

Some organizations are maintaining integrated procedure (ISO 13485 & FDA QSR) and follow their requirements (e.g) 21 CFR 820.40 “Approved changes shall be communicated to the appropriate personnel in a timely manner”.
 
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Phil Fields

#12
Re: Not having training documentation for documentation changes - ISO 13485 Clause 4

Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
ISO tired,
Could you please provide the exact nonconformance as written by the auditor. This would help to focus the conversation on the facts.

Phil
 
A

arios

#13
Re: Not having training documentation for documentation changes - ISO 13485 Clause 4

Some organizations are maintaining integrated procedure (ISO 13485 & FDA QSR) and follow their requirements (e.g) 21 CFR 820.40 “Approved changes shall be communicated to the appropriate personnel in a timely manner”.
Adding to Bio_Subbu's comments.

Per ISO 13485:2003 section 6.1

"The organization shall determine and provide the resources needed
b) to meet regulatory and customer requirements."

If this issue relates to a US marketed product then consideration needs to be given to the relevant or particular regulatory requirements applicable for that market. That implies 21 CFR 820.40

Please comment.
 
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D

DesiQE

#14
Re: Not having training documentation for documentation changes - ISO 13485 Clause 4

My :2cents: is that a simple checkpoint in your change request form, where the requester and.or the approvers note whether the particular change warrants a training and/or notification.

DesiQE
 

jkuil

Quite Involved in Discussions
#16
Re: Not having Training Documentation for Documentation Changes - ISO 13485 Clause 4

How can a change in a procedure be effective if you do not inform the personnel that has to execute the procedure on the changed requirements.

Sure, it depends on the impact of the change.
  • Textual changes do not require training.
  • Significant changes in validated procedures may require qualification of personnel (ISO 13485 7.5.2.1b).
  • Other changes with product impact may be communicated e.g. during departmental meetings. Attendance should be recorded (ISO 13485 7.3.7) Also a read-and-understood statement by all employees that execute the changed procedure may sufice. If an annotaded copy identifying the changes is provided, the reading may take limited time.
  • Procedures document specific quality objectives. Management should ensure that changes to quality objectives are communicated (ISO 13485 5.4.1 and 5.4.2)
If any of the above mentioned changes introduces a personnel competence gap training should be part of the change implementation plan (ISO 13485 6.2). If not, it is adviceable to record in the implementation plan (especially where it potentially concers product safety and efficacy) that training was considered, but was deemed not applicable.
 
I

ISO tired

#17
Re: Not having Training Documentation for Documentation Changes - ISO 13485 Clause 4

I want to thank everyone for thier involvement in this post. I have decided to challenge the nonconformance. I do not see anywhere the specific requirement for training on documents. The FDA clause states "made aware"
not "trained" as stated in some of the reply's to my original post. There is nothing in any of my SOP'S that expressly state that I will train after each change to documents either.

To fully comply with the FDA requiremnent, I use a system (home grown) that is sent to all department personnel that requires them to click a box that they have been made aware of the document changes. This record is stored in the changed documents folder as objective evidence. I do not send this email for clerical changes, and I only sent it to the personnel that is impacted by any changes.

I tend to read ISO and FDA documents literally and not read into them hidden meanings. I also do not follow guides as regulatory law, since they are not auditable as well.
 
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claire_b

#18
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

I have to say that I've always believed that when documents change, unless it is to correct typos etc, whoever uses them must get trained to the new revision. The whole procedure may have changed. Otherwise, what is the point of having documented procedures when you may not be trained to the latest revision and you may be doing things, for example, in the wrong order.

This would be covered in the regs in the effectiveness of training would it not?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#19
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

I have to say that I've always believed that when documents change, unless it is to correct typos etc, whoever uses them must get trained to the new revision. The whole procedure may have changed. Otherwise, what is the point of having documented procedures when you may not be trained to the latest revision and you may be doing things, for example, in the wrong order.

This would be covered in the regs in the effectiveness of training would it not?
It should be noted that changes in the process and supporting documentation can range from inconsequential to critical and everything in between. If a procedure was revised to effect a minor change, where the people affected can easily comprehend the change by READING the revised document, why create a non value added training? The KISS approach still applies. Certainly, if the change is non trivial, it does make sense for a (formal?) training.
 
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claire_b

#20
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

It should be noted that changes in the process and supporting documentation can range from inconsequential to critical and everything in between. If a procedure was revised to effect a minor change, where the people affected can easily comprehend the change by READING the revised document, why create a non value added training? The KISS approach still applies. Certainly, if the change is non trivial, it does make sense for a (formal?) training.

PS to moderator of this forum. The thread title would read better Not have training records for documentation changes - ISO 13485 Clause 4.2; I tried editing it, but it looks like I don't have moderator rights in this forum.
You know I'm starting to realise the problem here. We need to define what we all mean by training. I mean everything from formal training to a quick self study by reading a document.
 
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