Defining the differences between Prototype vs. Production Guidelines?

A

aaron850

#1
A little background:
I am 6 months into a new manufacturing engineering role with a rapid prototyping company. It is set-up as a job shop, we do not perform any design work, we just simply receive 3D cad models and produce parts from the models or drawings.

Within the past 6 years, the company has grown 50% and along with still supporting rapid prototyping services for the ID industry, they now provide solutions for aerospace and commercial customers.

Our weakest process is contract review for production parts.
We complete a contract review for all jobs (which includes reviewing customer requirements, PO, schedule,ect), but production jobs require an even more detailed major contract review prior to starting work.

The problem is, we offer a wide selection of manufacturing technologies and there is no clear definition in the entire company of the difference between prototype parts and production parts.

Generally, prototype parts require very little measurement (6 point vs full FAI) and require nothing more than a C of C for traceability. Production parts generally are serialized, require secondary operations, material certs, and extra QA steps.

I wanted to get some suggestions on how to define the difference between production and prototype.

The definition list I have compiled so far consists of the following:

1. Customer End-Use - If the customer explicitly defines the end use of the product as prototype or production.
2. Customer imposed requirements - If the customer imposes requirements above and beyond, our standard capabilties, then they shall be deemed production parts.
3. Manufacturing Capability - If the parts require additional processing above and beyond our standard capabilties, then they shall be deemed production parts.
4. Critical Applications - For applications such as medical devices, UAV's, and aerospace, they shall all be deemed production parts.
5. Quantity - For any part orders over individual 50 pcs, they shall be deemed production parts.

The goal is to have this added to our quoting procedure and be the guideline for our sales staff and manufacturing managers to adhere to during major contract review and job costing.

When I bring up this lack of definition during staff meetings, everyone tells me it has been debated to death with no clear answer. I am fighting a big battle on this topic since everyone wants to bring up the one instance when something was quoted production as was only used as a mock-up or vice versa.

Any suggestions or insight would be greatly appreciated.
 
Elsmar Forum Sponsor
J

Johndeere42

#3
I like your definitions as stated. And if you beefed that up with some sort of statement during the contract review that required the customer to accept one or the other, then it should be a no brainer. Plus it helps avoid 'scope creep,' especially if the customer's source inspector comes in and he/she has not been part of any earlier discussions.

A previous employer of mine was experiencing the same issues you describe and once we had Sales start clearly stating what we interpreted the scope to be in our response to the RFQ, it made life a lot easier for all concerned. This is especially helpful if the parts in question are aerospace or gov't.
 
T

treesei

#4
In the company I work for (a medical device/electronics manufacturer), here is what our product life cycle is:

Concept: Just an idea. Initial customer contact.

Design: This is self-explained. In this stage, there may be a few samples built. We call them prototypes or engineering samples. By the end of this phase the design is pretty much finalized.

Development/pilot: In this stage, the focus is the process. by larger volume of "production", we fine tune the process. We call the products validation lots or the such. By the end of this stage, the design and process are finalized. All production related documents are finalized and controlled.

Production: This is the stage we mass produce the product using defined design and process. What manufactured are "production" products.

End of life.

So the fundamental difference between a prototype and a production is that the latter is produced using defined design and process, the output is what the customer exactly wants. The former has a lot of flexibility. If the customer wants to change specs in production phase, I may have to adjust my contract terms. On the other hand, if I want to change manufactuing process in that phase, I'd better get the customer's approval first.
 

Ajit Basrur

Staff member
Admin
#5
I agree with treesei.

In addition,

Wikipedia reference-linkPrototype#Differences_between_a_prototype_and_a_production_design tells the following differences -

In general, prototypes will differ from the final production variant in three fundamental ways:

Materials. Production materials may require manufacturing processes involving higher capital costs than what is practical for prototyping. Instead, engineers or prototyping specialists will attempt to substitute materials with properties that simulate the intended final material.

Processes. Often expensive and time consuming unique tooling is required to fabricate a custom design. Prototypes will often compromise by using more variable processes, repeatable or controlled methods; substandard, inefficient, or substandard technology sources; or insufficient testing for technology maturity.

Lower fidelity. Final production designs often require extensive effort to capture high volume manufacturing detail. Such detail is generally unwarranted for prototypes as some refinement to the design is to be expected. Often prototypes are built using very limited engineering detail as compared to final production intent, which often uses statistical process controls and rigorous testing.
 
A

aaron850

#6
thanks for all the insight, I've compiled all the bullet suggestions and hopefully I will be presenting this next year during our corporate strategy meeting.
 
Thread starter Similar threads Forum Replies Date
M Product Specification vs. Information Defining Product - The differences? 7.3.3.1 IATF 16949 - Automotive Quality Systems Standard 6
J Internal Audit Findings - Major vs. Minor Finding - Defining the differences Internal Auditing 14
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 3
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
K Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
V Defining Safety Precautions for Category 4,5 Molecules Occupational Health & Safety Management Standards 2
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
E Quality Techucuan (Technician) in Electronics - Defining Postion Requirements Career and Occupation Discussions 4
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
T Standards for defining audible alarms/warnings for OR instruments IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Defining Reliability and Confidence Levels Reliability Analysis - Predictions, Testing and Standards 8
J Defining Martial Arts and Gymnastics Statistical Techniques Statistical Analysis Tools, Techniques and SPC 4
V Defining the criteria for equipment to be qualified or requalified Qualification and Validation (including 21 CFR Part 11) 2
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Defining CCP (Critical Control Points) in a Rice Mill Plant Food Safety - ISO 22000, HACCP (21 CFR 120) 9
S Process Map and defining KPIs Misc. Quality Assurance and Business Systems Related Topics 5
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
G Points to consider while defining the Quality Policy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Developing Documentation and Defining Processes as Subcontractor IATF 16949 - Automotive Quality Systems Standard 6
C Defining ISO 9001:2008 Scope for a Sterilization Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Defining Skilled vs. Semi-Skilled vs. Unskilled Labor Manufacturing and Related Processes 1
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Defining Interaction of Processes in a Software Company Software Quality Assurance 3
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
R Defining the type of Applied Part - Metal Probe (Applied Part) employs Water Cooling IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Defining Security Interfaces for Scope for ISMS - Need help IEC 27001 - Information Security Management Systems (ISMS) 10
R Help defining Eyewear Customer Complaint Categories Customer Complaints 5

Similar threads

Top Bottom