Product and process Deviation procedure

#1
Hi ,

I am developing a new & light "Deviations management procedure " and I would like your inputs to feed it .

Also one question, how do you ensure the operators are aware of the specification (Product/Process) temporary change without touching the Control Plan ?
Since the change in the deviation will be temporary, so I think there is no need to update the Control Plan and after the deviations update it back to initial revision?

What Kind of systems do you use to track and create deviations?

Thank you.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
If this sort of thing happens often enough that controlling it has become a problem, there are deeper issues that need to be addressed. I've seen instances where something called a Manufacturing Change Order is used to document planned excursions beyond the normal limits. Such a document would include:
  1. The exact nature of the deviation or allowance (specifications);
  2. The rationale behind the deviation;
  3. Customer approval, if required;
  4. The number of pieces that will be allowed to deviate, and/or the purchase order number affected;
  5. Notification of closure of the deviation.
Your documented requirements for this process should include specific responsibility and authority, and provide mechanisms for customer notification and approval and segregation of affected lots. The manner of notification of operators is something you should decide for yourself; in general operators should be made aware in the same way any other important information is communicated.
 
Last edited:
Thread starter Similar threads Forum Replies Date
somashekar Can Process Deviation be handled under control of Nonconforming Product? ISO 13485:2016 - Medical Device Quality Management Systems 2
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I Corrective Action Tracking for Product and Process in the same system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
V IATF 16949 Manufacturing Process & Product Audits IATF 16949 - Automotive Quality Systems Standard 1
I Process compressed air and contact with the product (ISO 8573-1:2010) Qualification and Validation (including 21 CFR Part 11) 0
M IATF 16949 - Cl. 8.3.3 - Product design inputs, manufacturing process design inputs IATF 16949 - Automotive Quality Systems Standard 4
C IATF 16949 - Product Safety Escalation Process Timeliness IATF 16949 - Automotive Quality Systems Standard 8
V For a Drug-Device Combination Product, 'Design Control' Process is triggered at? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I FDA Exempts Product Codes from 510(k) Process (Class II Medical Devices) US Food and Drug Administration (FDA) 0
G Process for Product Safety - Ideas for Documenting Process for 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 3
V Product Development - When to start calculating Process Capability Capability, Accuracy and Stability - Processes, Machines, etc. 3
M Compliance with IATF 16949 Clause 8.3.4.4 Product Approval Process IATF 16949 - Automotive Quality Systems Standard 2
L Return of Product Process - Procedure or Flowchart Misc. Quality Assurance and Business Systems Related Topics 14
R Testing a Product Recall Process IEC 27001 - Information Security Management Systems (ISMS) 8
P May I combine the Process Audit and Product Audit into Delphi's LSR? Customer and Company Specific Requirements 3
K Auditing New Product Introduction Process General Auditing Discussions 21
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
B ISO 9001: Question on Process Performance and Product Conformity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G ISO 14001 & Product Design Process Environmental Aspect Review Requirements ISO 14001:2015 Specific Discussions 7
J Should I have Process or Product Focus in PFMEA? FMEA and Control Plans 3
V Examples of Design and Process FMEA for Pharmaceutical Product Development ISO 14971 - Medical Device Risk Management 7
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
T Process Validation, NPD (New Product Development), and Supplier Management Qualification and Validation (including 21 CFR Part 11) 7
S Product FMEA vs. Process FMEA - Aerospace Industry Machine Shop FMEA and Control Plans 5
S What are your thoughts on Process vs Product Control Plans ? FMEA and Control Plans 3
G ISO 13485 Requirement on labeling product in WIP (Work In Process) ISO 13485:2016 - Medical Device Quality Management Systems 4
J Product and Process Audit according to ISO/TS 16949:2009 Process Audits and Layered Process Audits 9
J Introducing a new Product Variant - ECO Process? Document Control Systems, Procedures, Forms and Templates 3
T Requirement for a Documented Process for the Review and Release of Product For Sale ISO 13485:2016 - Medical Device Quality Management Systems 6
Q AS9100 Clause 8.3 - Control of Nonconforming Product Process for Approving Personnel AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L Supply Chain and Product Creation Process Improvement Quality Tools, Improvement and Analysis 1
B Product Realisation Process Map - Need some help, please review and comment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V Common Failure Modes for a Product/Process Line ISO 14971 - Medical Device Risk Management 1
D How to determine Equipment Tolerance Variation - Product vs. Process Tolerance General Measurement Device and Calibration Topics 7
V Defining Quality Assurance's Role in R&D (Product and Process Development) Design and Development of Products and Processes 11
T Is Positive Recall for in-process Product allowed in AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J How to define a Product's Realization Process and Scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P PDP (Product Development Process) and APQP Process Map APQP and PPAP 3
A How to calculate the Effectiveness of the Process and Product Audit System Internal Auditing 10
C Product Development Policy and Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Contents of PPAP Control Plan - Product & Process Characteristics? FMEA and Control Plans 10
W Authorizing Product Release while Eliminating In-Process Inspection Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom