Risk acceptance for missing DHR info and saving records

Quality_Goblin

Involved In Discussions
We cant ship the product until QA has signed off on the batch record. In your shipping SOP, you can add this so your warehouse team will need to see your signature to ship products. Your company can make all the errors it wants to but nothing leaves until you say so.

Do you report to the CEO or executive management? If not this is a you need management help. If management refuses to give QA that level of control thats a red flag.
We sign off on the shipping documents, but that doesn't include the items that are in the traveler packet. Those are sent to me after the product has shipped. We have started to implement in-process production audits where we check travelers throughout the shop and see if they are following their process. So far it's been working.
 

d_addams

Involved In Discussions
We sign off on the shipping documents, but that doesn't include the items that are in the traveler packet. Those are sent to me after the product has shipped. We have started to implement in-process production audits where we check travelers throughout the shop and see if they are following their process. So far it's been working.
To summarize a lot of great discussion here:
a) the org needs to determine if these 'errors' are really errors that need to be addressed or not.
b) based on a) set what the new expectations going forward are. If the missing information isn't needed, remove the requirement/space on the forms. If it is required, it seems there is some serious retraining or redesign of the documentation flow to limit the error creation.
c) If the managers want to stop having to sign off on these 'exception' documents, get their teams to start filling out the paperwork completely up front. Address the source of the errors rather than make the error correction less burdensome.
d) based on a and b, that final QA sign off (to allow shipping) needs to be reconsidered. If these DHR errors are actually important that final QA check signature shouldn't be getting applied. If final QA sign off was appropriate, it seems a lot of this stuff was superfluous.

Good luck
 
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