At what point do you need to formalize process controls?

A

AJLenarz

#1
#1
Work Instructions

Currently, I am in a business environment where a lot of proto typing is being conducted. My division is considered as a "spring board" to new technology. Often, new products are developed and then transitioned to production operation in another location. Currently, individuals in higher management positions feel that detailed process work instructions need to be in place prior to the first part being sold to a customer. At the same time I contend that these are "proto type" operations, subject to constant change. It would be very difficult to document every change in the proto typing operations.

My question is, at what point do you need to formalize process controls in the transition from prototyping to pre-production to production processes? At what point do you need to have all of your "I's" dotted and your "t's" crossed?
 
Last edited by a moderator:
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
D

D.Scott

#2
#2
IMHO it is important to document every step and change in a proto-type process. The process, although it may change every day needs to reflect the changes and reasoning that went into every change. Once the process is ready for production, the procedure covering the process should go with it. Leaving the work instructions to be written in production is like turning your back on them. "Here, I made it now you figure out how to use it".

A fully documented proto-type process will save you countless time and money in development of future processes and will aid in continuous improvement projects on the processes you have already developed.

Any other opinions?

Dave
 
S

Sam

#3
#3
I agree with Dave. My work in engineering has always required a "book" relating to all of the activities that go on within the prototype process. A well documented protoype process will save time, dollars and a lot of headaches when the project goes to the floor. Been there, done that.

"Currently, individuals in higher management positions feel that detailed process work instructions need to be in place prior to the first part being sold to a customer."

I agree, in the automotive sector this method is called "PPAP", in the Government sector we called it "First article inspection/Test, Verification and Validation (V&V), among other things that I can't remember or is not printable.
 
Marc

Marc

Fully vaccinated are you?
Staff member
Admin
#4
#4
Yup. Call it a project folder, whatever. It builds as you proceed. As pointed out above, the process should be well defined. The 'work instructions' point D.Scott made is a good one.
 
G

Greg Maggard

#5
#5
:) Look at the system as a way to track or make foot step. Factual information to keep things in line as well as keep things from reoccuring. Be able to the the story from beginning to end.
Say it! Do it! Prove it!:ca:

Greg Maggard
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Le Chiffre At what point do you need to identify a U.S. Agent - 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Point Estimation - I need to use the Quadratic Regression Model - Minitab 14 Using Minitab Software 6
normhowe Deming’s eighth point Philosophy, Gurus, Innovation and Evolution 28
MDD_QNA Accessory or I-don't-know-what-to-call-it-at-this-point EU Medical Device Regulations 3
A Domain of the component (EASA CM No.: CM-SWCEH-001 Issue 01 Revision 02) Point 9.3.3 (Usage domain aspects) EASA and JAA Aviation Standards and Requirements 0
qualprod Stock Reorder point calculation Lean in Manufacturing and Service Industries 1
K Power point training slides on DOE (Design of Experiments) Wanted Training - Internal, External, Online and Distance Learning 2
S Recurring Natural Disasters in Contingency Plans - What's the point? IATF 16949 - Automotive Quality Systems Standard 7
S 510(K) change analysis - At what point should a 510(K) change analysis be performed? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Meaning of Annex II, excluding point Clause 4 conformity CE Marking (Conformité Européene) / CB Scheme 4
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
T Linear Measurement - Radius Center or Intersection Point? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C FMEA Starting point FMEA and Control Plans 7
T Single Point Contact / DoC CE Marking (Conformité Européene) / CB Scheme 2
dubrizo Internal Audit Value - What is the point of conducting internal audits to a checklist Internal Auditing 40
somashekar Uptodate.com: A clinical decision support resource - Point-of-care decisions Medical Information Technology, Medical Software and Health Informatics 1
D Bubble Point Testing of Syringe Filters Design and Development of Products and Processes 1
M Measuring the True Position of a Cylinder's Pierce Point Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C Is there a standard for testing equipment at a single point? General Measurement Device and Calibration Topics 13
U Accelerated Aging for Shelf Life - Beginning Point Difference CE Marking (Conformité Européene) / CB Scheme 2
ScottK Is there a point in your career where ASQ certs become meaningless? Career and Occupation Discussions 13
M Contract Manufacturer 510K Starting Point 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
Z One Point Calibration of Hygrometers General Measurement Device and Calibration Topics 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6
M Fixed Point Temperature Cells Calibration Method General Measurement Device and Calibration Topics 3
D Single-Point Scale Calibration - Very Large Scales General Measurement Device and Calibration Topics 3
R Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote? Quality Manager and Management Related Issues 6
drgnrider Documents: Reference Documents & Point of Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T At what point is a Supplier no longer a Supplier? Supplier Quality Assurance and other Supplier Issues 12
D Showing the Response Surface Experimental Point in MiniTab Using Minitab Software 5
P Critical Limits for Air Blower as CCP (Critical Control Point) Food Safety - ISO 22000, HACCP (21 CFR 120) 6
E Center Point Residuals on a Factorial Design using Minitab Quality Tools, Improvement and Analysis 3
Ronen E TGA may approve rapid HIV test, but only as PoCT (Point of Care Tests) Other Medical Device Regulations World-Wide 3
W Minitab I-MR Graph - How to delete a single data point from I-MR chart Using Minitab Software 2
M At what point should defective product be rejected? Manufacturing and Related Processes 11
J What point does the Accreditation begin in the process? ISO 17025 ISO 17025 related Discussions 6
A Request for Daily Talking Point and Meeting Ideas Misc. Quality Assurance and Business Systems Related Topics 15
Q How Demings Point 9 (of his 14 points) is related to the FDA QSR Quality Tools, Improvement and Analysis 3
A Is "0" an Acceptable Calibration Point? General Measurement Device and Calibration Topics 13
S Dew Point Meter: DPL4000 - help needed Manufacturing and Related Processes 1
B Customer is requiring an "Inspection Point Program" Document Control Systems, Procedures, Forms and Templates 6
C What is your point for the RoHS Control in Plastic Parts with Plating? IATF 16949 - Automotive Quality Systems Standard 1
N Laboratory that is able to Calibrate Dew Point Meter up to 60?Cdp - Needed General Measurement Device and Calibration Topics 1
K Change Point & Process Change - Differences Misc. Quality Assurance and Business Systems Related Topics 1
B Individuals 2 Point Moving Range Chart Statistical Analysis Tools, Techniques and SPC 6
C PPAP Submission - Point in Time Record or Live Document APQP and PPAP 4
G What may be the best way to determine if single point in subgroup is out of control Statistical Analysis Tools, Techniques and SPC 6
K Must every CCP (Critical Control Point) have a (documented) procedure? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
WCHorn Deming's Eleventh Point and AS9101D are Incompatible Philosophy, Gurus, Innovation and Evolution 19
R Are there any standards for Point-of-Care (POC) Diagnostic Devices? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom