Contract / Customer Order Review Checklist Needed

Nicole Desouza

Involved In Discussions
#1
Hello,
I am trying to create a contract review checklist that will mistake proof our contract review / customer requirements review process. We have been making mistakes such as not verifying that we have the latest revision of drawings or not verifying that we have the correct part # or material specs. I am new to this company and they did not have any type of quality system in place prior to my arrival. I would like to see them verifying with a checklist to alleviate future problems.
Does anyone have a checklist that might be helpful?

thanks,
Nicole
 
Elsmar Forum Sponsor

qualprod

Trusted Information Resource
#3
Hello,
I am trying to create a contract review checklist that will mistake proof our contract review / customer requirements review process. We have been making mistakes such as not verifying that we have the latest revision of drawings or not verifying that we have the correct part # or material specs. I am new to this company and they did not have any type of quality system in place prior to my arrival. I would like to see them verifying with a checklist to alleviate future problems.
Does anyone have a checklist that might be helpful?

thanks,
Nicole
Could You tell us what manufacturing field you work at?
So that we can give the right help?
 

Tagin

Trusted Information Resource
#4
Hello,
I am trying to create a contract review checklist that will mistake proof our contract review / customer requirements review process. We have been making mistakes such as not verifying that we have the latest revision of drawings or not verifying that we have the correct part # or material specs. I am new to this company and they did not have any type of quality system in place prior to my arrival. I would like to see them verifying with a checklist to alleviate future problems.
Does anyone have a checklist that might be helpful?

thanks,
Nicole
It will be specific to your organization and the mistakes that 1) have been happening and 2) are likely to happen.

If there are review requirements arising from specific QMS standard (e.g., 9001) requirements, customer requirements, etc., you'd probably want to include them on your checklist. Otherwise, it is an exercise in risk management; so you'll want to look at those known/potential risks and weigh them against making the checklist onerous and ineffective. Maybe an FMEA approach?
 

Golfman25

Trusted Information Resource
#5
It will really be what is specific to your company. But you just identified what you need -- part number, rev level, quantity, price, delivery, etc. You many just want to mark up some orders in stead of a checklist. Might be more helpful. Good luck.
 

Nicole Desouza

Involved In Discussions
#6
Could You tell us what manufacturing field you work at?
So that we can give the right help?
Hi,
we are a small custom plastics extrusion company and we have newly acquired a contract to make some aerospace parts. This factory has not been using any type of formal quality management system for over 20 years and the culture is very difficult to thrive in due to the lack of importance which has formerly been placed on overall quality. I have to make very gradual steps in implementation here. I have been trying to study the current culture and capture unofficial processes in writing as much as possible. Implementing something as basic and simple as a checklist is like giving birth to triplets.
 

Nicole Desouza

Involved In Discussions
#7
It will be specific to your organization and the mistakes that 1) have been happening and 2) are likely to happen.

If there are review requirements arising from specific QMS standard (e.g., 9001) requirements, customer requirements, etc., you'd probably want to include them on your checklist. Otherwise, it is an exercise in risk management; so you'll want to look at those known/potential risks and weigh them against making the checklist onerous and ineffective. Maybe an FMEA approach?
Hi,
thanks for this comment. Now I have another related question. We will need to be ISO 9001 2015 certified as well. Can the checklist serve as documented evidence that we need to satisfy this requirement?
ISO 9001:2015 Requirement

8.2.3.1

Ensure that the organization has the ability to meet the requirements. The organization must conduct a review before committing to a customer. This review to include:
a) requirements specified by customer
b)requirements not stated by the customer, but necessary
c)legal requirements
d)contract or order requirements differing from those previously expressed

Ensure that the requirements differing from those previously defined are resolved.

Confirm the requirements with customer if the customer does not provide a documented statement of their requirements.

8.3.2.2
Retain documented information
a)on the review results
b)on any new requirements
 
Thread starter Similar threads Forum Replies Date
B How to Conduct a Review of Customer Order (Contract Review)? Contract Review Process 5
B Interesting Discussion The legal aspects of Customer Specific Requirements (Contract Law). IATF 16949 - Automotive Quality Systems Standard 12
I Implant Raw Material Supplied from Customer to Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
R Customer Feedback - ISO 13485 Section 8.2.1 - Small Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
W Supporting the Customer after Termination of a Contract Other Medical Device and Orthopedic Related Topics 2
M Tainted wipes maker Triad sues contract manufacturing customer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R 7.2.1 Customer Requirements Checklist for a Small Contract Manufacturing Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Document Control: Contract between my company and customer Document Control Systems, Procedures, Forms and Templates 4
E Customer Satisfaction - Customer Perception of Government Contract Officers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Inspection by Attributes to ensure a 99% Confidence in a Customer Contract Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
T Electronic Industry Contract Manufacturing - Customer notification needed? Supplier Quality Assurance and other Supplier Issues 1
Q Question about Circumstances - Customer Prints and Changes after Contract Acceptance Misc. Quality Assurance and Business Systems Related Topics 12
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
R Looking for an efficient contract management solution Contract Review Process 1
W Staffing/Contract Labor Provider Service Industry Specific Topics 3
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
shimonv Working with a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
S Who is technically and legally a "Contract Manufacturer"? ISO 13485:2016 - Medical Device Quality Management Systems 4
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Component manufacturer or contract manufacturer ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
K Do Contract Manufacturers need a complaint procedure? Medical Device and FDA Regulations and Standards News 9
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
J Need a contract monitoring Tool General Information Resources 0
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
C SharePoint Contract Management Software General Information Resources 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
T Selection Of Contract Manufacturers Supplier Quality Assurance and other Supplier Issues 2
chris1price Contract Sterilization Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 5
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 11
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 5
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14

Similar threads

Top Bottom