Unique Situation - Preventive or Corrective Action?

K
#1
Unique Situation, Preventive or Corrective

I know this has question has been visited in a number of threads, but I ran into one today....:confused:

On 10/8 Manufacturing drafted a work instruction on assembly of a PBN (a magic device in the product we produce). This was viewed as a Preventive action, it was not in response to a nonconformance but was drafted to document "tribal knowledge".

On 10/16 we get an e-mail from a customer that a PBN they received some 6 or 7 months ago was assembled wrong. The 10/8 draft of the WI was approved by the appropriate people today, and as a matter of fact was utilized (in part) to answer the customer's CAR.:)

SO, is the WI a preventive or corrective action?:rolleyes:
 
Elsmar Forum Sponsor

Mike S.

Happy to be Alive
Trusted Information Resource
#3
I wouldn't argue if you chose either one, it seems mainly an exercise in semantics. But if I had to vote I'd say corrective. The defect was already produced and you had not yet formally approved and instituted your new WI, but you did finalize it as part of the customer's CAR, which I'm guessing sped the approval and implementation process along.
 
M

M Greenaway

#4
OK here we go !

What about this.........

Its both PA and CA (ahem).

If you have a QS or TS approval, or if you are a very good company otherwise, you may well perform an APQP process. During this process you would go through an FMEA cycle on the manufacturing process itself, at which point you may well identify the need for a Work Instruction to control your process. The whole APQP process may rightly be considered as preventive action, and you would retain records to demonstrate this. Alternatively if you are a 'bare bones' ISO9001 company you probably dont have such a formal process, relying more on instinct and intuition, nevertheless you would have taken preventive action by creating this document.

Then, simply because you quote this action in response to a complaint, and perhaps the complaint forced the issue to finalise the document, it is also a corrective action.

So its both IMHO.
 
#5
Mike said:
it seems mainly an exercise in semantics
I agree, but I would call it a PA because they seem to be much harder to come by, and this allows us to show the system works. But, I even think that is crazy because we are doing (listing) things for the benefit of the registrar (an action I firmly disagree with).

The bottom line is the system is improved. I would worry more about the outcome of the action, rather that what list it should be categorized as.
 
B

Bruce Wade

#6
How about:

The situation that led to the documentation of the work instruction is Preventive Action.

Application of the work instruction and testing to see if it addresses the nonconformance is Corrective Action. Corrective Action does not require you redouble efforts, only to take action commensurate with the significance of the nonconformance. If the nonconformance took several months to record, and effort was already in place to address the conditions that caused the nonconformance, you are not required to take additional action.

I would agree with Martin. The action answers, and should be recorded as both PA and CA...
 
B

Bruce Wade

#7
Jim,

I was responding to the assertion found in the first post that:

On 10/8 Manufacturing drafted a work instruction on assembly of a PBN (a magic device in the product we produce). This was viewed as a Preventive action, it was not in response to a nonconformance but was drafted to document "tribal knowledge".
Ergo, my response the action addressed PA. Documenting "tribal knowledge" would be preventive, addressing the "Mack Truck" theory of succession planning...
 

gpainter

Quite Involved in Discussions
#9
WI's by nature are PA. However, since it was approved on 10/16 and presumably no one had been trained on it. I would vote that is a CA
 

Ninja

Looking for Reality
Trusted Information Resource
#10
What is the difference between an orange?

Call it either one...doesn't matter...that's my vote...
 
Thread starter Similar threads Forum Replies Date
O Unique situation regarding a Veterinary Medical Device and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
John Broomfield Interesting Discussion Regionally unique food and drink Coffee Break and Water Cooler Discussions 4
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
K Unique Device Identifier for updates to legacy standalone software Other US Medical Device Regulations 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Unique Device Identifier Advice Other US Medical Device Regulations 1
S Unique ID Required for Thread Gage Replacements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 31
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
B Class II Medical Device UDI (Unique Device Identification) Question(s) Other US Medical Device Regulations 8
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
D attribute gage RR in a unique way Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
M UDI (Unique Device Identification) for Convenience Kits with several options Other US Medical Device Regulations 3
M UDI (Unique Device Identifier) ISO/IEC 15459 (Unique Identifiers) Requirements Other US Medical Device Regulations 4
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
J UDI (Unique Device Identification) and Reprocessing Medical Devices Other Medical Device Regulations World-Wide 10
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
M UDI (Unique Device Identification) Verification Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
C UDI (Unique Device Identifier) Definition of Labeler Other US Medical Device Regulations 1
M Official EU Unique Device Identifier (UDI) Requirements EU Medical Device Regulations 3
E Unique Device Identifier for Small Dental Screws ISO 13485:2016 - Medical Device Quality Management Systems 3
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
C Looking for 3rd party audit firm for unique contract, have RFP General Auditing Discussions 1
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
W Class II Medical Device Unique Device Identifier (UDI) Requirements US Food and Drug Administration (FDA) 8
R Unique Device Identifier for Software Medical Device Other US Medical Device Regulations 3
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
suildur Sterilization Validation of a Unique Medical Device Other Medical Device Related Standards 5
K Why Quality Assurance is Unique Misc. Quality Assurance and Business Systems Related Topics 8
M Calibration Unique Device Naming Calibration and Metrology Software and Hardware 3
Ron Rompen Very Unique Prototype Requirement - Cutting Holes in Tubing Manufacturing and Related Processes 2
N Unique Document Identification Numbering System Document Control Systems, Procedures, Forms and Templates 69
Q FDA's Unique Device Identification, New Regulations - Pending March of 2010 ISO 13485:2016 - Medical Device Quality Management Systems 3
C Control of Documents - Is a unique format required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M FDA Unique Device Identifiers on the labeling of devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Acronyms/Unique terms in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Unique Opportunity for QM - 'Chief Quality Officer' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S Correct Document Control - Does each Document need its own Unique Numbering? Document Control Systems, Procedures, Forms and Templates 13
J Where traceability is required, the unique identification of the product is recorded ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Unique automobile on Ebay Coffee Break and Water Cooler Discussions 3
S Looking for Unique forum for Design and Development Design and Development of Products and Processes 6
M UID - Unique identification Labels - 2D Data Matrix - Next Generation Barcode Misc. Quality Assurance and Business Systems Related Topics 5
D Unique user ID under ISO 27001 - ID can never ever be reissued to another user? Other ISO and International Standards and European Regulations 7

Similar threads

Top Bottom