info@easymedicaldevice.

com
Author: Monir El Azzouzi EasyMedicalDevice.com

ODIAC METHOD
Area Final cleaning
Date 22-Jan-19
Person 1
Participants Person 2
Person 3

OBSERVATION
Topic Question
Do you know where to find the Quality Policy?
Is there any Good Document Practices that are not respected (DHR,
Wrong data format...)?
MAN
Is there any Data Integrity problem? (Non-Controlled documents
used as post-its, document with critical information...)
...
Is there any gage that paste the calibration date?
Are all the inspection sheet legible?
MEASUREMENT
Are all the KPIs up-to-date
...
Is the maintenance done at the right time?
Are the documents to setup the machine up-to-date?
MACHINES Are the procedure used to manufacture the products mentioned on
the DHR?
...
Is the line-clearance procedure respected (only one product at the
place of work)?
METHODS
Is there any mix-up on storage area?
...
... ...

DISCOVERY
Issue # Description of the issue
1 The document is signed but impossible to identify this person.
A gage was find with the calibration due date of December 2018 - Immediately removed from the a
2 Non-Conformity opened
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Monir El Azzouzi https://easymedicaldevice.com info@easymedicaldevice.com

 info@easymedicaldevice.com
Author: Monir El Azzouzi EasyMedicalDevice.com

IDEA
Issue # Root cause
Human Error - Didn´t understood the importance of a legible
1 signature
2 One employee in charge of collecting gages is on sick leave
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ACTION
Issue # Action
Invite employees to a formal training about Good Document
1 Practices
2 Identify a backup persons for gage collection and train them

CONFIRMATION
Issue # Description of the action implemented to solve the issue
1 Training record seen. Check documentation on the area - All OK

Monir El Azzouzi https://easymedicaldevice.com info@easymedicaldevice.com

 info@easymedicaldevice.com
Author: Monir El Azzouzi EasyMedicalDevice.com

METHOD

Status Issue # Location

ok n.a. n.a.
Cleaning machine
Issue 1 10

ok n.a. n.a.
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Issue 2 Work Table 5
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of the issue Pictures/Videos

possible to identify this person. Yes
mber 2018 - Immediately removed from the area and a Yes
mity opened
.. ...
.. ...
.. ...
.. ...

Monir El Azzouzi https://easymedicaldevice.com info@easymedicaldevice.com

 info@easymedicaldevice.com
Author: Monir El Azzouzi EasyMedicalDevice.com

Solution
Information to all the employees about Good Document
Practices
Identify a backup person for recurring tasks
...
...
...
...
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Responsible person Due Date Status

Person 1 25-Jan-19 Done
John Doe 30-Jan-19 On-going

Approver Date Status

Person 2 25-Jan-19 Closed

Monir El Azzouzi https://easymedicaldevice.com info@easymedicaldevice.com