Objective Evidence of Review

S

Steven Truchon

#1
A recent QS9000 surveillance audit resulted in a corrective action for the following in regard to 4.16.
The finding was in our Contract Review section where our procedure requires that PO's be signed "for a record of review". The QS requirement quoted to support the write-up was in paragraph 2 of 4.16 (3rd Edition), "Quality Records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system." We review everything during our contract review process that includes final approval signatures from all participating personnel, but there is no signature on the PO itself after we receive it. A signed acknowledgement is sent to the customer, but...
It was part of demonstrating conformance (ensuring that the PO was reviewed & approved) and of having a quality system that operates effectively that resulted in the auditor also stating that supplier certifications such as raw material, plating, heat-treating, etc, which require certifications also require that there be a signature, initials, a stamp, or something that would provide objective evidence that the document had been reviewed and accepted (or approved). I understand that this would be important for accountability purposes, but I have a question mark as to the validity of the auditors claim.
After reading about electronic record systems in these posts I can see some possibilities to facilitate the "reviewed and approved" signoff but its going to be a bit dicey to pull together.
To sign or not to sign... I ask and thank all for your input.

Steve


[This message has been edited by Steven Truchon (edited 28 July 2000).]
 
Elsmar Forum Sponsor
J

Jim Biz

#2
Wanted to bring this subject back to the top:

Our ISO 9002 auditors have indicated that we are required to "SHOW evidence that EACH purchase order is reviewed and verified to the current contract review records - Prior to a Work Order release for shop floor processing.

Our account reps handle 300 - 500 plus po's per month - many are nothing more than "repeat" (date release) of a prior accepted "contract reviewed" blanket order.

Should I now ask them to hand initial 4000-5000 documents yearly? - We could add this task electronically but - I'm unsure it would be effective and fairly sure it is not value added.

A case could be made either way that it is not effective "Evidence" every individual PO has actually been reviewed signed/ electronic input dosen't seem to matter??

Regards
Jim



[This message has been edited by Jim Biz (edited 31 July 2000).]
 
S

Steven Truchon

#3
Jim,
Your scenario seems it would be serious overkill. I suppose my only exception is that there is a quantity and delivery variable that becomes the point of "approval" into your system. I suppose in the interest of 100% On-Time delivery requirements, evidence of review and approval would fit as a requirement, also for it to be clearly auditable.

Regards,
Steve
 
#4
The requirement of 4.16 is to maintain quality records;
The requirement of 4.3.2 is to review "the submission of a tender, contract or order.
Nothing is said about signatures.

Incoming P.O's should be reviewed and documented as part of the APQP process, with the degree of review based on complexity of the order.

Outgoing P.O.'s are reviewed by members of the purchasing department (there responsibility). This can be done with the aid of a checklist developed during the planning process. Normally the name of the purchasing agent is on the P.O. therfore tracability for review is established.

Signing P.O.'s is not required by the standard. If, however, your procedure requires that P.O.'s be signed . . . . start signing or change your procedure.
 
S

Steven Truchon

#5
Regarding incoming or customer PO's, there does need to be evidence of purchase order review somewhere in the form of identification traceable to a qualified person. Tis would apply to blanket or multiple release orders as delivery dates are critical as well.

The same holds tru for certifications from material suppliers, platers, heat-treaters, etc. Certs need to have evidence of review by a qualified person with a sig, stamp, date, etc. Otherwise one merely has possession of a record that could say anything at all.
I was reminded that whenever considering a need or requirement in ISO or QS, one should always ask themselves, "What is the risk to my customer if I... or if I do not...?"

This came from two different registrars today and a prominent UK consultant recently.

Anyone agree or disagree with this?
 

CarolX

Super Moderator
Super Moderator
#6
Steve,

I am not very familiar with the QS requirements, but here's my thoughts ....

If you are making hard drive mounting brackets for a computer manufacturing, wouldn't this be overkill????

But, if you are making landing gear componenets for an aircraft builder, wouldn't you want a signed, certified material test report on your raw material???

It depends on what your making ... you have to determine the potential risks.
 
#7
"evidence of purchase order review somewhere in the form of identification traceable to a qualified person."
Refer to 4.1.2.2 - Who would be more qualified then the buyer? And for complex contracts; the APQP team.

"qualified person with a sig, stamp, date, etc."
Refer to 4.1.2.2 - Inspectors trained in the process of comparing certs to spec sheets


"I was reminded that whenever considering a need or requirement in ISO or QS, one should always ask themselves, "What is the risk to my customer if I... or if I do not...?"

Sounds good, but , ISO and QS contain requirements not needs. "Needs" are those additional steps you take to go above and beyond your customer requirements.
 
J

Jim Biz

#8
To clarify - my facilities position currently is that

1) we get an offer - Review & quote - stamp file reviewed - enter the information into a computer tracking system.

2) customer issues a partial (qty/date-due)Po to that part number/rev level information

Any further date "Release" comes in under the same Po number (blanket) - the information is updated in the computerized ordering/tracking system. Prior to shop/work order generation.

What they are explaining is that - by the act of entering the information into the system it is "evidence" of Po review - no initials - no sign-off etc. But if it "had not been "reviewed" it would/could not have been entered.

If/when/should the incomming information be in conflict with the revision level entered under the current reviewed information - it is Pulled from the files and returned to the review authority.

It remains to bee seen if this can be viewed as "objective" - although in physical practice it "is done" with each incomming purchase order..

Regards
Jim
 
S

Steven Truchon

#9
Jim, I agree, and I was informed by our registrar that entering the PO data into the system did in fact qualify as objective evidence, and in agreement with your post, it makes sense.

Sam, my focus is on the actual evidence of review, not specifically who performs it, although I appreciate your reference to 4.1.2.2

I suppose my best example of where evidence lacks is on a material certification that exists in a file and while I review this certification, how am I to know if the data contained on this certification has been reviewed for compliance to our requirements unless there is evidence present showing me that it was reviewed. Whether it be a stamp, initials, a log elsewhere that might reference this identifiable cert, etc.

This whole topic came up in response to the question of the presence of acceptable evidence of review and in what form(s).


Sam wrote "Sounds good, but , ISO and QS contain requirements not needs. "Needs" are those additional steps you take to go above and beyond your customer requirements. "

I said "requirements" and included needs. I wasnt implying anything beyond requirements however the consideration is a valid one. What is the risk to the customer? Its a effective safeguard whenever in doubt regarding a QS or ISO "requirement". If the result exceeds requirements and ends up as a legitimate added value then I dont see any problem.
 
J

Jim Biz

#10
Steve-Sam-Carol
We have an external - scheduled for later today - as this issue is a left over "non closed" minor I'll let everyone know if the approach is acceptable to our auditor.

Regards
Jim
 
Thread starter Similar threads Forum Replies Date
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
S Ways to demonstrate objective evidence that employee is trained and competent ISO 13485:2016 - Medical Device Quality Management Systems 28
G FAI Objective Evidence AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
R What kind of Objective Evidence - AS9100 Cl. 7.1.6 - Organizational Knowledge AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
R What objective evidence can/can't be supplied during a customer audit? General Auditing Discussions 3
Chennaiite Audit Objective Evidence - the holy **** Imported Legacy Blogs 1
Q Storage Temperature - Medical Device - Objective Evidence - MDD 93/42/EEC Other Medical Device Regulations World-Wide 1
B How is Objective Evidence Admitted in an Internal Audit? Internal Auditing 8
S Objective Evidence for 8.2.1 and 8.2.3 - Compliance with Management System Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q OER - Objective Evidence Report in AS9101D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
C Objective Evidence of Internal Auditors having Audit Clause 4.1. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
N Minor for no objective evidence in regards to Calibration - Clause 7.6 ISO 9001:2008 Nonconformance and Corrective Action 5
J Training Records - HR Functions at Corporate Office - Objective evidence of training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Solderability - Objective Evidence of Conformity to Standards - J-STD-610 Manufacturing and Related Processes 1
K Definition Statement of Fact - Considered Objective Evidence? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
I How make the objective evidence for the control of Foreign object damage? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
Coury Ferguson Customer Satisfaction - Objective Evidence AS9100, para. 5.2, 7.2.2, 7.2.3, 8.2.1 Records and Data - Quality, Legal and Other Evidence 3
A Timescales for Objective Evidence to be available for a Corrective Action Nonconformance and Corrective Action 5
Q Objective Evidence - Internal Audit Training in a Cargo Company Training - Internal, External, Online and Distance Learning 2
J Objective Evidence & Verbal Purchase Orders (PO's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A How much objective evidence is required for ISO9000 certification? Records and Data - Quality, Legal and Other Evidence 8
C Do you still collect hard copies of objective evidence when auditing? General Auditing Discussions 20
R What is Objective Evidence in an Audit? Written? Visual? Both? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
D Objective evidence for covering all shifts and locations General Auditing Discussions 6
T Can we remove a quality objective if we decide it is not measurable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Ashok sunder What are the criteria for setting a target KPI value against a quality objective? Benchmarking 7
L Inspection Plan for Microscope Objective Lens Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Q Is a Corrective Action Expected if a Quality Objective is not in compliance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
R Difference Process Objective/Opportunity for improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Department Expansion as a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O Is the Quality Objective for Company-wide Training as >90% too high? Training - Internal, External, Online and Distance Learning 4
Q Objective and Goals - ISO 9001:2008 Frequency Revision Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Jen Kirley Wells Fargo's fines came from Management By Objective Coffee Break and Water Cooler Discussions 4
R Why customer satisfaction is not appropriate regulatory objective in medical device? ISO 13485:2016 - Medical Device Quality Management Systems 8
F Quality Objective Reference Chart Customer Complaints 4
C Objective for Evaluation of Suppliers Supplier Quality Assurance and other Supplier Issues 4
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
W Quality Objective clarification - Requirements for "levels within the organization" Quality Manager and Management Related Issues 9
T Quality Objective related Surveillance Audit Finding IATF 16949 - Automotive Quality Systems Standard 6
M Using Continued Environmental Compliance as an Objective Miscellaneous Environmental Standards and EMS Related Discussions 7
N How would you approach failing quality objective measurables? Quality Tools, Improvement and Analysis 12
J Definition of "objective" in 0.2 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Laboratory to Calibrate Objective Micrometer needed General Measurement Device and Calibration Topics 4
K Does an Internal Audit provide Objective or Subjective Verification? Internal Auditing 14
P Quality Objectives - How can we make our quality objective? Quality Manager and Management Related Issues 32
A Process Objectives and Metrics - Should every documented process have objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R How to Achieve Multi Objective (Responses) Optimization in Minitab Using Minitab Software 17
R Can a Quality Policy include Health and Safety as an Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
S Environmental Objective, Target, and Performance Indicator - Differences? ISO 14001:2015 Specific Discussions 16
Similar threads


















































Top Bottom