Own Procedure was not effectively implemented

#1
Good day.

Can I ask input about this Nonconformity?

"Own Procedure was not effectively implemented"

Root Cause and Corrective Action please..

Thanks in advance.
 
Elsmar Forum Sponsor

AMIT BALLAL

Trusted Information Resource
#2
You should ask further, why it was not implemented? You'll get to further cause, whether it was awareness / accessibility of the procedure problem. Then further root cause analysis can be done.

We can't suggest a root cause and corrective action directly without knowing the causes as mentioned above. Once you've analyzed primary causes, I can suggest further steps/actions.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
umaayhie,

That's like telling us you didn't make it to work on time today and asking us to give you a root cause and corrective action. What do we know? Nothing.

As Amit said, ask "why" as many times as it takes to get to a root cause, then go from there.

Sounds like you need some formal training in RCCA.
 
Thread starter Similar threads Forum Replies Date
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6
V One procedure to have 3 sites own procedure no. Document Control Systems, Procedures, Forms and Templates 8
H Training myself on my own SOP (Standard Operating Procedure) ISO 13485:2016 - Medical Device Quality Management Systems 13
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
J Create your own symbol? Other Medical Device Related Standards 7
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
C Can You Internally Audit a Process You Own? Internal Auditing 25
S Calibrating our own equipment, can we? Micrometers to calibrate vernier calipers General Measurement Device and Calibration Topics 13
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
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
C Can we be our own EU authorised representative? EU Medical Device Regulations 31
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
N How to obtain Own Brand Label (OBL) CE Marking? EU Medical Device Regulations 18
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
V Own foreign manufacturing facilities declared as sub-contractors ISO 13485:2016 - Medical Device Quality Management Systems 5
A 3D Printing concept in airline to manufacture its own aircraft cabin parts EASA and JAA Aviation Standards and Requirements 3
F AEMPS (Spain) Registration - Medical Devices - We do not own the products we make EU Medical Device Regulations 2
S OBL (Own Brand Labeling) - Full Quality to Production Quality EU Medical Device Regulations 5
B Submit a Special 510(k) or "Documentation by our own" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
L ISO 13485 and OBL (Own Brand Label) Agreement EU Medical Device Regulations 20
S Internal Auditors shall not audit their own work? Internal Auditing 21
L Build own Power Magnetic Field Test Equipment for IEC 61000-4-8 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
P OBL (Own Brand Labelling) - Technical Files/Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 3
L Building your own Leakage Current Tester IEC60990 Other US Medical Device Regulations 4
P OBL (Own Brand Label) - Annex III ? EC Type Examination EU Medical Device Regulations 2
A EC Certification Process and Time Frame for Own Brand Labeling Medical Devices EU Medical Device Regulations 4
E "Internal" CAPA (Audit Nonconformance) Issuance to your own Department Nonconformance and Corrective Action 4
R Auditors can NOT audit their own work audit finding Internal Auditing 17
V Own Brand Labeling Agreement/Contract Review ISO 13485:2016 - Medical Device Quality Management Systems 5
M IEC 60601-1 testing for device with its own 2V battery power supply necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D State Past Due on its own Meter Inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Richard Regalado BYOD (Bring Your Own Device) Policy by UK Information Commissioner's Office IEC 27001 - Information Security Management Systems (ISMS) 0
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Own Brand Labeling NB (Notified Body) requirements EU Medical Device Regulations 3
D Recommendations for Own Brand Labeling Notified Bodies for Medical Devices EU Medical Device Regulations 6
R Customer using their own version of the AIAG PPAP Forms APQP and PPAP 5
B Production signing off on their own work General Auditing Discussions 6
M Corporate Procedures and their effects on Companies they Own Quality Manager and Management Related Issues 6
J Document my own training? Training - Internal, External, Online and Distance Learning 5
S Piggybacking on OEM to become OBL (Own Brand Label) CE Marking (Conformité Européene) / CB Scheme 5
K New to Minitab but figuring it out on my own.........HELP Using Minitab Software 2
S Do you assign your own part numbers to customer's parts? Manufacturing and Related Processes 10
C Own Brand and Trademark Labeling Question EU Medical Device Regulations 10
J Requirements for Own Branding Class I Non-Sterile Device? ISO 13485:2016 - Medical Device Quality Management Systems 1
Similar threads


















































Top Bottom