NC and Deviation approach - please help

#1
Hello,

Does this process comply ISO and CFR? This is my first time “working backward” from Deviation to NC

My new company has our new division (Validation, Quality, F&E) for Contract Manufacturing Services and we’re in the stage of developing documents. My team wants to use same documents from existing product for CMS Car-T with these two docs (A) and (B)
(A) Deviation SOP applies to “validation process/execution”
Then it splits into Non-Critical and Critical. Critical deviation will proceed NC

(B) Non-Conformance SOP defines “NC process including recognition, notification, investigation, assessment of impact, determination of root cause, immediate corrections, identification of CAPA, and documentation”
NC also splits into Major, Minor, Critical
NC also determines if CAPA is needed
 
Elsmar Forum Sponsor

John Predmore

Trusted Information Resource
#2
Does this process comply ISO and CFR? This is my first time “working backward” from Deviation to NC
I am lost. Your mention of CFR and CAPA leads me to think you are in the Medical Device industry, so that indicates ISO 13485. Many people in general forums are from different industries and jargon does not help us communicate. For example, the word Deviation is sometimes used to describe a non-conformance in the product, but also a NC in the process, but also as a shorthand for the Deviation Waiver Request, which is a document. I can't tell which meaning you intend from context in your posting. Even the word critical can reflect different meanings in different contexts.

Your general question is about a process. A couple statements is not enough to describe a process adequately to judge compliance with any quality management standard. Typically, a process has inputs and outputs and resources and persons responsible and some sequence and boundaries for achieving the intended purpose.

Is your question whether having two SOPs for Deviation and Non-Conformance allowable? I think it is allowable, but that does not equate to compliance. Compliance with an identified requirement (such as 8.7) would be judged based on whether your implementation is suitable, adequate, and effective in meeting that requirement.

I suggest you ask a more narrow question.
 
#3
I am lost. Your mention of CFR and CAPA leads me to think you are in the Medical Device industry, so that indicates ISO 13485. Many people in general forums are from different industries and jargon does not help us communicate. For example, the word Deviation is sometimes used to describe a non-conformance in the product, but also a NC in the process, but also as a shorthand for the Deviation Waiver Request, which is a document. I can't tell which meaning you intend from context in your posting. Even the word critical can reflect different meanings in different contexts.

Your general question is about a process. A couple statements is not enough to describe a process adequately to judge compliance with any quality management standard. Typically, a process has inputs and outputs and resources and persons responsible and some sequence and boundaries for achieving the intended purpose.

Is your question whether having two SOPs for Deviation and Non-Conformance allowable? I think it is allowable, but that does not equate to compliance. Compliance with an identified requirement (such as 8.7) would be judged based on whether your implementation is suitable, adequate, and effective in meeting that requirement.

I suggest you ask a more narrow question.
Yes. My question is…is having two SOPs are allowable? Currently our Deviation SOP defines Non-Critical vs Critical. Next step is if Critical, proceed to Non-Conformance (follow NC SOP). Is this approach aligned with Pharma Industry Standards?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
I am not sure there is a verbatim rule on this. Your processes must be in a state of control along with your QMS. A NC is when something occurs outside of prescribed "Controls"

You can have multiple SOPs just make sure they are controlled, tested, trained on, and the batch records for processing define which SOP was used per product batch.

Fundamentally an output either meets or does not meet the requirements for that process. Maybe I am confused.


8.3 Control of nonconforming product
8.3.1 General
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The organization shall document a procedure to define the controls and related responsibilities and authorities for the identification,
documentation, segregation, evaluation and disposition of nonconforming product.


The evaluation of nonconformity shall include a determination of the need for an investigation and notification of any external party responsible for the nonconformity.

Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisions shall be maintained (see 4.2.5)
 
Last edited:
#5
I am not sure there is a verbatim rule on this. Your processes must be in a state of control along with your QMS. A NC is when something occurs outside of prescribed "Controls"

You can have multiple SOPs just make sure they are controlled, tested, trained on, and the batch records for processing define which SOP was used per product batch.

Fundamentally an output either meets or does not meet the requirements for that process. Maybe I am confused.

Definitions (21 CFR 820.3) • Specification any requirement with which a product, process, service, or other activity must conform [21 CFR 820.3(y)] • Product components, manufacturing materials, in-process devices, finished devices, and returned devices [21 CFR 820.3(r)] • Nonconformity the nonfulfillment of a specified requirement [21 CFR 820.3(q)]
Sorry for the confusion. We’re in the process of docs development before IQ/OQ/PQ. And yes we’re developing SOPs for QMS, Non-Conformance, Deviation. I don’t feel confident in the current approach of QA department as they use the definition of “Deviation” for “Non-conformance”
Also, aren’t Deviation and NC two different categories? I also don’t understand my QA’s rationale to have Deviation SOP (covers Validation activities) classify Non-Critical vs Critical. Then Critical will proceed/follow Non-conformance SOP (covers everything in the definition of “Deviation”). Does this comply or follow standards?
 
Thread starter Similar threads Forum Replies Date
CaliperJim Uncertainty and Accuracy Requirement Deviation Provision General Measurement Device and Calibration Topics 2
B Wrong standard deviation calculation in AIAG SPC manual? Capability, Accuracy and Stability - Processes, Machines, etc. 13
L Temporary Product Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Product and process Deviation procedure Manufacturing and Related Processes 1
E Annual PPAP+ deviation request ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P ECO Disposition - Deviation Needed for Use As Is? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Class Fixed ME Equipment (US Deviation) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
M Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
E IEC 60335-1 power input deviation - Table 1 Values Other ISO and International Standards and European Regulations 0
P Large data sets of continuous individual data - Estimated or actual deviation Capability, Accuracy and Stability - Processes, Machines, etc. 2
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C Deviation in Design verification Other Medical Device Related Standards 6
S When should a note-to-file be used in a QMS vs Deviation Report ISO 13485:2016 - Medical Device Quality Management Systems 1
Coury Ferguson MiniTab 17 Question-Standard Deviation Default Capability, Accuracy and Stability - Processes, Machines, etc. 5
S When a deviation is opened but what does it mean to close a deviation? Misc. Quality Assurance and Business Systems Related Topics 1
K Please Help! what is ARL for the range and standard deviation Statistical Analysis Tools, Techniques and SPC 0
S Standard Deviation Selection on Control Charts - Minitab "pooled deviation" Statistical Analysis Tools, Techniques and SPC 3
T IATF 16949 - Customer Authorization for Concession or Deviation Permit IATF 16949 - Automotive Quality Systems Standard 22
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
G Should the Quality Department originate a Request for Deviation to the Customer? Nonconformance and Corrective Action 3
V Looking for advice on Pooled Standard Deviation between Minitab and MS Excel Statistical Analysis Tools, Techniques and SPC 1
V Difference between Non-Conformance, Variance and Deviation ISO 13485:2016 - Medical Device Quality Management Systems 9
A How to calculate Mean and standard deviation without sample size in Minitab Using Minitab Software 5
knightarmourus Initial Samples with dimensional deviation in Serial Production Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Standard Deviation vs. Standard Deviation of the Mean (Standard Error) Measurement Uncertainty (MU) 7
B Historical Standard Deviation or Select Parts for MSA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
alonFAI AGILE PLM - Deviation - What is the "Assigned Owner" Field Quality Assurance and Compliance Software Tools and Solutions 3
F How to Calculate the unbiased Standard Deviation in Excel using Minitab Formula Capability, Accuracy and Stability - Processes, Machines, etc. 6
Chennaiite Can an Auditor question Top Management decision to approve deviation? IATF 16949 - Automotive Quality Systems Standard 30
C 95% CI vs Mean +/- sample standard deviation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G MS Excel for LSL, USL in Histogram and Standard Deviation Six Sigma 26
T Deviation/Waiver Requiring a Nonconformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
J EN ISO 14971:2012 Annex ZA Deviation #4 Clarification ISO 14971 - Medical Device Risk Management 3
J Annex ZA of ISO 14971:2012 - Deviation 7 - Incorrect Interpretation ISO 14971 - Medical Device Risk Management 10
K Marking Aerospace parts after concession/deviation & use as is dispositioning AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 30
E RSD (Relative Standard Deviation) Calculation for two series of numbers Statistical Analysis Tools, Techniques and SPC 4
somashekar Can Process Deviation be handled under control of Nonconforming Product? ISO 13485:2016 - Medical Device Quality Management Systems 2
S Definition Deviation and Nonconformity - What is difference? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Combining both Deviation and Non-Conformance Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Standard Deviation Estimation Formula - Student Question Statistical Analysis Tools, Techniques and SPC 4
M Using Minitab to Compute & Compare the Mean and Standard Deviation Amount Using Minitab Software 7
V PPAP to Customer with Deviation Request APQP and PPAP 4
B Corrective Action for Deviation (delay) in the Delivery Schedule Quality Manager and Management Related Issues 10
T Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Documenting Exceptions and use of Deviation Request Form APQP and PPAP 2
Q What is the relationship between Standard Deviation and 6 Sigma? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B "Historical std deviation" (Standard Deviation) in Gage R&R study Using Minitab Software 6

Similar threads

Top Bottom