7.2.2 - Confirming Order if the product requirements are not provided in writing?

Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
In many companies, including mine, we make a written memorandum of the verbal confirmation (very frequent occurrence in "redlining" changes during a prototype installation when every minute an airplane is on the ground costs someone big bucks.) Copy of the memorandum is sent at later date (hours or days later) to the person making the verbal confirmation and copy is placed in product/project file. Other copies may be distributed as needed.

Ultimately, someone responsible signs off on the changes.
We once did a million dollar installation on a verbal. The guy issuing the verbal subsequently died of a stroke. The successor signed off without blinking an eye.

It is "nice to have" when a customer issues a nice, perfect purchase order which is then examined by a multi-discipline team as part of Contract Review before acceptance. Many times, though, the pressure of business requires telescoping the timetable for procedures. It does not, however, remove the requirement for maintaining a record of some kind, even a unilateral one.

Consider buying groceries at your local supermarket. Do you issue a purchase order? Probably not, but the store issues a unilateral receipt for your money, listing the products you purchased. It also keeps a record of the transaction for future reference. Is any manufacturing or service concern less capable than a grocery store?
 
#3
Douglas E. Purdy said:
What is meant by the organization having to confirm the order if the product requirements are not provided in writing?

Thanks,
Doug
The customer ordering the "this or that". is usually not in the least interested in how you produce it. He just wants the product.

You, on the other hand are very interested in knowing that you are in fact able to produce it, right? So, if the customer provides insufficient information it's up to you to fill in the blanks, and get the confirmation within your organization as necessary: Yes, we can do this.

In it simplest form it may concern having a peek in your product programme and picking a std product. Some times it may involve starting a project...

/Claes
 
#4
Douglas E. Purdy said:
What is meant by the organization having to confirm the order if the product requirements are not provided in writing?

Thanks,
Doug
Think of it this way Doug, ISO is meant for any business. So you call my company (at 1-800 Jerky Me) and want to order 500 lbs of my finest buffalo jerky. The order is verbal (over the phone). It is my responsibility to make sure you wanted 500 lbs of jerky at $50 per pound. If I either heard it wrong or wrote it wrong, and you only wanted 5 lbs at $.50 per pound, there would be a lot of trouble. Therefore, I need to confirm the order. :thedeal:

BTW, I do not have a jerky business, and I have no idea what would happen should you dial the above number. :eek:
 

SteelMaiden

Super Moderator
Super Moderator
#5
Douglas E. Purdy said:
What is meant by the organization having to confirm the order if the product requirements are not provided in writing?

Thanks,
Doug
I can't add a whole lot, but, your confirmation needs only to meet the requirements of your business. Micky D's reads back your order at the drive thru. The grocery cashier asks if you found everything you needed. My company faxes an order acknowledgement.
 

Douglas E. Purdy

Quite Involved in Discussions
#6
Wes, Claus, & db,

Thanks for your response. I ask because I did not see in the dictionary (Merriam-Webster Online) the concept that the information taken from the requester is to be sent to the requester for verification. With synonyms like substantiate, corroborate, verify, authenticate, does taking the verbal order over the phone by writing it down on your internal form and repeating the specifics back on the phone sufficient for 'confirmation.' To satisfy 7.2.2, do I have to send the order in writing back to the requestor for them to confirm or verify that I have written the order properly? Or is it sufficient to authenticate the verbal order by writing the specifics on an internal form and verbally confirm the information is correct over the phone, write the name of the requester as confirmed by?

Thanks!
 
#7
Douglas E. Purdy said:
To satisfy 7.2.2, do I have to send the order in writing back to the requestor for them to confirm or verify that I have written the order properly? Or is it sufficient to authenticate the verbal order by writing the specifics on an internal form and verbally confirm the information is correct over the phone, write the name of the requester as confirmed by?
All you have to do is to confirm them. Verbal confirmation over the phone during the order would be sufficient. Documentation of this confirmation is required to the extent that you can show records of the review and to ensure you are meeting the requirements.
 
#8
Um... Hang on a sec... Am I missing something or are we mixing 7.2.2 and 7.2.3 up here?

What 7.2.2 tells us is: Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

7.3.2b deals with ...effective arrangements for communicating with customers in relation to

b) enquiries, contracts or order handling, including amendments, and...


/Claes
 
#9
Claes Gefvenberg said:
Um... Hang on a sec... Am I missing something or are we mixing 7.2.2 and 7.2.3 up here?

What 7.2.2 tells us is: Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

7.3.2b deals with ...effective arrangements for communicating with customers in relation to

b) enquiries, contracts or order handling, including amendments, and...


/Claes
I was looking strictly at 7.2.2. Why do you ask?
 

Douglas E. Purdy

Quite Involved in Discussions
#10
db,

Thanks! I read 7.2.2 as my action with an in-coming verbal, which would be different if I was the purchaser with an out-going verbal.

Clause,

No, I was not trying to confuse 7.2.3 with 7.2.2. I was only trying to obtain the understanding of 'confirm' from the person receiving a verbal, as oppose to 'confirm' to the person receiving a verbal.

I think!

Doug
 
Thread starter Similar threads Forum Replies Date
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
A Confirming IVD exemption from WEEE Misc. Quality Assurance and Business Systems Related Topics 2
M ISO 9001:2008 clause 7.6 - Confirming and Reconfirming Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Color Management - Confirming Color for Injection Molded Plastic Parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Using a CMM for Confirming Circular or Total Runout?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Marc Getting the Most out of Internal Audits - Confirming to Innovating General Auditing Discussions 8
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
P GM TWO (Temporary Work Order) - Is there a specific GM format for the TWO# to be sent with the material? IATF 16949 - Automotive Quality Systems Standard 1
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12
R Purchase order forms - who keeps them? ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Icy Mountain Engineering Change Order...Modification Order Document Control Systems, Procedures, Forms and Templates 18
M Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 Medical Device and FDA Regulations and Standards News 0
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
J Lean MFG (manufacturing) process and Work order templates Lean in Manufacturing and Service Industries 6
K Work Order Form (Controlled Document)? Document Control Systems, Procedures, Forms and Templates 5
S Engineering change order versus a design change request ISO 13485:2016 - Medical Device Quality Management Systems 1
J Is order acknowledgement enough? Contract Review Process 6
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
J Order and Need for Professional Certifications Professional Certifications and Degrees 20
J KPI's for AS9100 Cl. 8.2/8.5 - Bids/Contract Review/Order Entry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
J Purchase Order Quality Clauses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Order Confirmations 7.4 - Tracking Purchase Order Confirmations from Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Change Order necessary to document FMEA Updates? FMEA and Control Plans 1
T EASA P 145: What mandatory information should on the purchase order of the customer ? EASA and JAA Aviation Standards and Requirements 2
J AS9102 - What needs to be Bubbled on a Contract or Purchase Order AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P Multiple Certifications - Is there an order of precedence? Other ISO and International Standards and European Regulations 3
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Following Order of Work Instructions ISO 13485:2016 - Medical Device Quality Management Systems 23
M PPAP Language for Purchase Order APQP and PPAP 3
P Basic questions about earning TSOA (Technical Standard Order Authorization) and PMA Federal Aviation Administration (FAA) Standards and Requirements 2
P Is it a rule to fill in all the 5 why in order to get the actual root cause? Quality Tools, Improvement and Analysis 5
somashekar FINAL ORDER: Premarket Approval for AED Systems: Other US Medical Device Regulations 0
B Medical Device Labeling - Order No. 6 Effective Oct 01, 2014 China Medical Device Regulations 7
N Interesting Purchase Order for its Terms and Conditions Quality Manager and Management Related Issues 82
S Already Existing Customer Open-PO (Purchase Order) Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K 7.6 c) c) Have Identification in order to determine Calibration Status Calibration Frequency (Interval) 3
M ECO (Engineering Change Order) Record Filing Question Records and Data - Quality, Legal and Other Evidence 1
J Nadcap Processor PO (Purchase Order) Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
L Client's Order Dock Inspection before Shipping Manufacturing and Related Processes 5
P When do parts have to be released? When we accept order, buy from CM or when we ship? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
9 Ideas for reducing Human Error during Order Receipt Quality Manager and Management Related Issues 4
E Validation of SAP Purchase Order and Sales Order modules Software Quality Assurance 7
M Should we analyse risk at the quotation phase or after the order is received? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N Change Order Problem - Want to change things "on the fly" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Purchase Order requirements Gage Blocks sent out for Calibration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom