Requirements for Product Related Emails - ISO 9001 Clauses 7.3.4 and 4.2.1

R

rowley711

Registered
i am in the middle of a certification audit
the auditor is informing us that all emails sent and recieved related to a product need to be archive, preferably in a central folder

i could use some guidence from the group ASAP - we have RFQ, PO, Prints, COC, etc. but not all emails
 
D

db

Specifically where is this requirement coming from? Quote the exact "shall". Although it might be a good idea, I am not sure you will find a mandate for that.
 
WCHorn

WCHorn

Rubber, Too Glamorous?
Trusted Information Resource
Regarding 7.3.4, it is relevant only to Design & Development review, not all e-mails. If the e-mails are part of the review, they must be identified as quality records and those records must be retained as defined in your record retention procedure.

The part about a "central folder" is not a requirement but would make it easier to retrieve results for the organization's purpose as well as making it easier for the auditor. If the e-mails are scattered about, it will take a long time to aggregate them for any purpose.
 
R

rowley711

Registered
great points - thank you

i pushed back- origninally the auditor stated that all emails from customers needed to be archived

he called back to the office and got direction. any emails that pertain to the design process need to be archived, suggested one folder for each project. in additional any notes, sketches, etc. need to be saved-again best practice is a project folder. i am not sre how this will be policed - will talk to the IT dept

thank you for your input
 
G

Golfman25

Trusted Information Resource
I certainly wouldn't make it so that ALL related emails need to be archived. Way too easy to miss one. I would look at your procedures. How do you handle reviews and associated documentation. Typically email suggestions, comments, revisions, changes, etc. could be compiled on the final prints. You could use forms for specific things that need to have documentation. If needed, the emails could be used as attached backup and reference material.
 
W

Wilderness Woody

rowley711 said:
great points - thank you

i pushed back- origninally the auditor stated that all emails from customers needed to be archived

he called back to the office and got direction. any emails that pertain to the design process need to be archived, suggested one folder for each project. in additional any notes, sketches, etc. need to be saved-again best practice is a project folder. i am not sre how this will be policed - will talk to the IT dept

thank you for your input
Click to expand...

Hopefully you have some decent IT support. Keep in mind that ISO is flexible in terms of how you retain and retrieve records, so make sure the system works for you! Leveraging Outlook or SharePoint can make sense depending upon the volume and diversity of the records.

If you or your customer is using email to communicate product specifications, contract details etc., organization and control will need to be considered as well! :2cents:
 
J

JaneB

rowley711 said:
great points - thank you

i pushed back- origninally the auditor stated that all emails from customers needed to be archived

he called back to the office and got direction. any emails that pertain to the design process need to be archived, suggested one folder for each project. in additional any notes, sketches, etc. need to be saved-again best practice is a project folder. i am not sre how this will be policed - will talk to the IT dept

thank you for your input
Click to expand...
Depends on what they are and why they're important.

IF the emails are records that are relevant to the design process, then yes, you would need to include them in your records management (identifiable, retrievable, etc). As someone already said, if you are using them as evidence of reviews of design. (Although if you also had a formal design review with evidence, then you could skip the emails usually).

But IF they are simply part of a discussion/ephemeral use only, not.

As for 'must be saved in a central folder', tchah! That's not in any ISO 9001 and is an auditor stepping beyond the requirements. Up to you how you meet the requirements (never an auditor).
 
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