Example of documentation template for Design and Development

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The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Design and Development dept. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. ​​If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1.Design & Development – Cross Functional Team

Job No.            :                                                           Record No.       :

Product            :

The following are the team members participating in the design and development process

Sl. No.NameProcessQualificationExperience
    
    
    
    
    
     
     
     
     

2. Design & Development Plan

Sr. No.StagesSourceRequirementsResponsibilityTarget date of completionActual date of completionReview
1Design & development planCustomer & Standard requirements     
2InputCustomer PO / Contract Review     
Applicable Statutory requirements (Legal)     
Required Product Specification     
API Spec requirements Scope     
Size & Material designations     
Service Conditions     
Methodology , assumptions and formulae documentation     
Requirements for Manufacturing process     
Risk Assessment & Management     
Resources     
API Monogram requirements     
3OutputApplicable Statutory requirements     
Methodology, assumptions and formulae documentation     
Material qualification requirements     
Dimensions and Design acceptance criteria     
Identification of products of components deemed critical to design     
Special characteristics for safe and proper use     
Risk Assessment & Management     
Appropriate information for Purchasing     
Requirements for Manufacturing Process     
Verification, Validation and Testing processes     
API Monogram requirements     
4ReviewProduct Requirements     
Legal Requirements     
Dimensional requirements and Critical components     
Material Requirements     
Purchasing Requirements     
Manufacturing Requirements including Traceability     
Testing Requirements     
Verification and Validation requirements     
Risk assessments     
API Monogram requirements     
5Verification & Final ReviewAlternate calculations     
Inspection Reports     
Surface NDE Reports  (     
Hardness Test Report     
Dimensional Report     
6Validation & Approval Test     
7Control of ChangesEngineering changes     
8API Monogram MarkingAPI Monogram Marking procedure     

3. Design & Development input

SR.NODESIGN INPUTS REQUIREMENTSRESPONSIBILITYDESIGN INPUTS
1Customer Requirements Customer PO  
2Contract review  
3Applicable Statutory requirements  
4  Required Product Specification  
1) 
2) 
3) 
Service conditions 
5Material Designations  
6Methodology , assumptions and formulae documentation  
7Historical performance and other information derived from previous similar designs  
8Requirements for Manufacturing process  
9Testing & verification  
10Validation  
11Results of Risk Assessments  
12Availability of Raw Material  
13Resources applicable for manufacturing  
14Special resources required  
15API Monogram Requirements  

4. Design & Development Review

Doc No. : PRODUCT:Planned Dt. 
PROJECT NO.: Part No.   :Actual Dt. 
CUSTOMER:Rev No. 
* After contract review
PARTICIPANTS      DEPARTMENTSIGNATURE
   
   
   
   
   
POINTS CONSIDERED FOR THE REVIEW
Review on Customer specific requirements identified  in the contract review checklist 
Product description 
Methodology, assumptions and formulae documentation 
Results of calculations 
Historical Performance and information derived from previous Similar design 
Verification of dimensional measurements and acceptance criteria 
Are tolerances compatible with accepted manufacturing standards 
Identify products or Components deemed critical to Design 
Special characteristics for safe and proper use 
Requirements for Manufacturing process 
Traceability requirements 
Technical Requirements including test methods, requirements for Verification and acceptance criteria 
Functional requirements including validation of product manufactured and acceptance criteria 
Is the specified test sampling size and / or frequency feasible 
If required, has customer approval  been obtained for test equipment 
Environmental condition, in which the test is to be performed. 
Availability of Machines/Equipments/Tools 
Availability of Procedures / other documentation 
Applicable Statutory requirements 
Results of Risk Assessments 
Any other points to be considered? 
 
Prepared by     Reviewed by Approved by 
Name Name Name 
Sign Sign Sign 
Date Date Date 

5. Design & Development output

Record No. : Part No. :
Job No : Date & Rev No. :
Description :

SR.NODESIGN OUTPUT REQUIREMENTSRESPONSIBILITYDESIGN OUTPUTS
1Product Specification    
2Applicable Statutory requirements  
3Methodology, assumptions and formulae documentation including Historical performance and other information as applicable  
4Drawings including the Design acceptance criteria  
5Identification of products of components deemed critical to design  
6Special characteristics for safe and proper use  
7Bill of Materials  
8Results of Risk Assessments  
9Approved list of Critical Suppliers, Selection of suppliers  
10Raw Material  
11Requirements for Manufacturing process,  Testing & verification  
12Quality & Production Plan  
13Traceability marking like Heat number & Serial number  
14Machining as per Requirements  
15Welding Operations in accordance with SOS approved WPSs  
16NDE(MT, Hardness testing and PT on ring grooves)  
17Verification, Validation & Testing Methods  
18API  Monogram requirements  
19Availability of resources – Machines/Equipments  
20Procedures / Work Instructions/ Operational Control Procedure (Procedures)  
22Special resources required  
Prepared by Reviewed by Approved by 
Name Name Name 
Sign Sign Sign 
Date Date Date 

6. Design Verification and Final Review

Part No.: Part Name:Record No.:Date & Rev No.:
Job / WO / Project No.: Sl. No.:
DESIGN VERIFICATION
S.No.REQUIREMENTINPUTOUTPUTREMARKS
1Required Product Specification,   
2Material Designations   
3Methodology , assumptions and formulae documentation   
4Requirements for Manufacturing process   
5Testing & verification   
6API Monogram Requirements   
TECHNICAL VERIFICATION
S.No.STAGE DESCRIPTIONSPECIFICATIONVERIFICATION METHODRESULTREMARKS
1Raw Material Inspection    
2Material Composition    
3Material Mechanical Properties    
4NDT    
5Finished component verification    
6NDT    
7Special Compliance    
Prepared by:Checked by:Approved by:
Name:Name:Name:  
Sign:Sign:Sign:
Date:Date:Date:
Issue / Rev No.: 02 / 03
Rev. Date:14-11-2019

7. Transmittal

From:Department:
 Project:
To:Department:
 
Please find attached herewith the following documents for:
 [    ]  I    (information)[    ]  A  (Approval)[    ]  C  (Construction)
 [    ]  N  (With our comments)[    ]  R  (Revision)[    ]  N  (With our comments)
 [    ]  T  (To be returned with your comments)[    ]  V  (Revised according to your comments)[    ]  X  __________________
NoDocuments transmitted:DescriptionRevisionNo. CopiesFormat
1    .dwg / .pdf
2    .dwg / .pdf
3    .dwg / .pdf
4    .dwg / .pdf
5    .dwg / .pdf
6    .dwg / .pdf
7    .dwg / .pdf
8    .dwg / .pdf
9    .dwg / .pdf
10    .dwg / .pdf
11    .dwg / .pdf
Please return a signed copy of the present transmittal for acknowledgement.
Signature:
Department:Department:
Iss.No./Date:xx/xx.xx.xxxx
Rev.No/Rev.Date:xx/xx.xx.xxxx

8. Design & Development validation

Part No.: Job / WO / Project No.:Record No.:
Part Name:Sl. No.:DATE & REV No.:
DescriptionObservations and reviewReviewed byRemarks
1. Prototype tests
Performance test certificate   
Mechanical test   
Hardness test   
2. Functional and/or operational tests of production products
Pressure test certificated   
Any other test   
3. Tests specified by industry standards and/or regulatory requirements
Reference Standard:
Test description   
4. Field performance tests and reviews
Field performance test result if any   
 
Prepared by:Checked byApproved by:
Name:Name:Name:
Sign:Sign:Sign:
Date:Date:Date:
Issue: xx, Rev. No.: xx
Issue / Rev. No Date: xx-xx-xxxx / xx-xx-xxxx

9. Document Progress Register (DPR)

IDDepartmentDisciplineDocuments transmittedDescriptionRev.SheetFormatRemark
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
Iss.No./Date: xx/xx.xx.xx 
Rev.No/Rev.Date: xx/xx.xx.xx 

10. Design Change Note

REQUEST NUMBER: DRAWING / SPEC / TECHNICAL DOCUMENT NO.:DATE:
CHANGE NUMBER:DRAWING / SPEC / TECHNICAL DOCUMENT DESCRIPTION:
DESCRIPTION OF CHANGE:
REASON FOR REQUEST:
1. CUSTOMER
2. PROCESS IMPROVEMENT      
3. PRODUCT IMPROVEMENT
4. SUPPLIER
5. ERROR
STOCK DISPOSITION:
1. USE “AS-IS” 
2. SCRAP
3. REWORK
4. N/A
COPIES OF ECN TO BE DISTRIBUTED TO:
1. PURCHASING
2. QUALITY ASSURANCE
3. OPERATIONS
4. STORES
5. QUALITY CONTROL
6. OTHER (SPECIFY)
COMMENTS:
CHANGE EFFECTS THE FOLLOWING WORK ORDERS:
Requested By:Reviewed by:Approved By:
Iss.No./Date: xx/xx.xx.xx
Rev.No/Rev.Date: xx/xx.xx.xx

Published by Pretesh Biswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt .

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