Seeking: Process Change Control Sample Procedure / Help

Q

qsmso

Process Change Control

Dear all Cove members,
In order to handle manufacturing process change such as material change, inpection method change, some Identification code change, process parameter change, do you have some idea for how to handle this systematically.
We do have Engineering Change Procedure. But I don't think it really apply to process change.
I need some sample procedure or suggestion.

Thank you very much

QSMSO
 
T

Teri - 2011

We use an engineering change notice,,,, for us, it applies to process change also. All dept. managers must sign this notice, that they were made aware of it. Then each has a "cheat" sheet, to remind them of all the documents that they need to look at to see if they need updated due to the change.
 

Geoff Cotton

Quite Involved in Discussions
Do the process changes impact on any automotive customers. If yes you need to consider Customer Specific Requirements relating to SREA.
 
R

ralphsulser

qsmso said:
Dear all Cove members,
In order to handle manufacturing process change such as material change, inpection method change, some Identification code change, process parameter change, do you have some idea for how to handle this systematically.
We do have Engineering Change Procedure. But I don't think it really apply to process change.
I need some sample procedure or suggestion.

Thank you very much

QSMSO

I will attach a sheet we use to request and track related changes. Hope this helps.
 

Attachments

  • QC-SD-010 Chg.req..xls
    20 KB · Views: 632
G

Greg B

QSMSO

I have attached part of our Procedure for Change. It is called a 'Continuous Improvement Suggestion' and we use it for all chnage be it Quality, Safety, Environment etc. People make a suggestion and justify it, it must be evaulated and agreed upon and signed off etc before being implemented. I have also attached the form. It is very basic yet the operators use it constantly. I have an average of 10 x CISs submitted each month ranging from submissions for new chairs in the lunch rooms (cost us a few thousand dollars) to purchasing electricity from the national grid in 30 minute intervals rather than fixed price contracts (Saved us $100's of thousands of dollars). Each suggestion is given the same treatment and each originator gets feedback. The majority of the CISs submitted deal with change to documentation and processes. After crews review documents and procedures they submit them via a CIS with a marked up copy of the change required attached. Simple.

http://elsmar.com/Forums/attachment.php?attachmentid=1843

http://elsmar.com/Forums/showpost.php?p=68282&postcount=15

Hope you get some use or ideas.

Greg B
 
Last edited by a moderator:
Q

qsmso

Change Criteria

Thank you for all reply.
As the quality control, I would like to set the rules for manufacturing about process change criteria.
Can you please recommend what items that when change, Mfg. need to inform QC to verify or approve.
Right now, Mfg just indicate their process change in term of revise WI and get approval from QMR only. We set this rule and we follow, but I feel like not quite suitable. So, I am willing to change, but need some good advice.

Thank you.
QSMSO
 
S

Sam

qsmso said:
Thank you for all reply.
As the quality control, I would like to set the rules for manufacturing about process change criteria.
Can you please recommend what items that when change, Mfg. need to inform QC to verify or approve.
Right now, Mfg just indicate their process change in term of revise WI and get approval from QMR only. We set this rule and we follow, but I feel like not quite suitable. So, I am willing to change, but need some good advice.

Thank you.
QSMSO

Refer to 7.1.4 Change control; . . . ."the effects of any change , . . . . "
Also refer to 7.3.1.1 Multidisciplinary approach; . . " shall use MA to prepare for product realizaton . . "

Any and all changes require evidence of assessment, verification and validation.
This assessment is a team effort, not a one department effort.
 
Thread starter Similar threads Forum Replies Date
B Severity Reduction by Product or Process Design Change? Seeking Good Example Design and Development of Products and Processes 2
D Seeking help in validating a cleaning process. Manufacturing and Related Processes 5
D Seeking Corrective Action Process Examples Nonconformance and Corrective Action 3
P Seeking Information on ISO 15504 - Information Technology Process Assessment Other ISO and International Standards and European Regulations 3
M Seeking input for a process-based quality management system training course ISO 13485:2016 - Medical Device Quality Management Systems 1
D Seeking material on the Construction Process in IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
R Seeking Medical Device Registration Process in Korea Other Medical Device Regulations World-Wide 4
J Seeking advice on how to handle a Special Process Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
A Seeking CQI-11 (Special Process Plating Assessment) Training Training - Internal, External, Online and Distance Learning 4
D Risk Assessment - Problem Management Process - Seeking Model/Example Software Quality Assurance 1
M Process Audit Final Report (Seeking example) Process Audits and Layered Process Audits 4
K Process FMEA (PFMEA) For Plastic Injection Molding - Seeking Example FMEA and Control Plans 17
Q FMEA Methodology Used for Process Audit Preparation - Seeking Example Process Audits and Layered Process Audits 5
B ESD Work Instruction or ESD Process Flow Chart - Seeking example Various Other Specifications, Standards, and related Requirements 5
PatMaz Layered Process Audit Procedure - Seeking an example Process Audits and Layered Process Audits 5
P QMS Training - Purchasing Process - Seeking suggestions and comments Training - Internal, External, Online and Distance Learning 8
A Seeking 'Process Performance' information and resources QS-9000 - American Automotive Manufacturers Standard 5
M Seeking guidance documents for Non FDA Regulated Process Validation - New Equipment Statistical Analysis Tools, Techniques and SPC 3
D Compounding Process - Seeking Generic Process Flow Diagram for Compounding Process Manufacturing and Related Processes 12
B CAR/PAR (Corrective Action / Preventive Action) process flow - Seeking example Nonconformance and Corrective Action 7
S RFQ's and job tickets/travelers - Seeking Example of forms and process flow Document Control Systems, Procedures, Forms and Templates 2
S Engineering Process - Drafting a turtle diagram - Seeking examples Process Maps, Process Mapping and Turtle Diagrams 15
M Seeking: Good process definition (map or whatever) for an installation business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
W Seeking process flow examples for software devlopment Software Quality Assurance 3
C Capability for small number of parts process - Seeking free tool(s) Statistical Analysis Tools, Techniques and SPC 1
M Process control methods - Seeking Examples ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Seeking: Process Link Chart example IATF 16949 - Automotive Quality Systems Standard 1
B Process Flow Software - Seeking reviews and recommendations Quality Assurance and Compliance Software Tools and Solutions 19
R GM Layered Process Audit - Seeking the actual General Motors requirements Process Audits and Layered Process Audits 36
J Seeking comment for our company's process map Process Maps, Process Mapping and Turtle Diagrams 4
C Converting to Process Audits - Seeking: Process Audit Form layout Process Audits and Layered Process Audits 4
C Process Descriptions: Seeking guidance and examples ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Design Control Gating Process - Seeking work instructions and discussion Design and Development of Products and Processes 20
RoxaneB Process-based auditing in 14001 - Seeking Reviews: Audit Schedule Content Feedback General Auditing Discussions 9
B Seeking: Life success stories of how the APQP process and tools helped your company APQP and PPAP 2
Howard Atkins New to Internal Process Auditing - Seeking Sample Process Audits Process Audits and Layered Process Audits 31
A Seeking: Process Interaction Example ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Seeking Critique: How Does Our Process Map Look? Process Maps, Process Mapping and Turtle Diagrams 5
A Seeking Ideas: Raw Material Storage Process Failure Modes FMEA and Control Plans 3
L Seeking TS 16949 Software that deals document control process linkages? Document Control Systems, Procedures, Forms and Templates 4
J Seeking: Process Flow Diagram Form - Format and Content Document Control Systems, Procedures, Forms and Templates 13
K SPC (Statistical Process Control) Training and Courses - Seeking suggestions Training - Internal, External, Online and Distance Learning 2
M Seeking: Process Audit Examples Process Audits and Layered Process Audits 9
A Seeking: Element 9 Process Control procedure example Other ISO and International Standards and European Regulations 12
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
J New QMS Auditor - seeking opportunities to gain audit experience Career and Occupation Discussions 3
M Seeking mentor/consultant for orthopaedic soft goods regulations Job Openings, Consulting and Employment Opportunities 0
M Seeking Consultant for Orthopedic Start Up company Other Medical Device and Orthopedic Related Topics 1
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 7
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1

Similar threads

Top Bottom