Who is responsible for In-process Inspection?

A

aproddutoor

#1
I think in-process inspection should be done by the operator and if they find something during in-process they should call the Team Lead/QA Auditor to resolve it.

A part of a QA Auditors job currently is to verify the set-up for the process and do the final audit once the lot is completed.

We had an issue regarding QA not doing the in-process inspection and that being the reason for producing bad parts.

I think the operator should inform Team Lead/QA if the process is not running well. I don't think QA should be blamed for something like this.

I don't think QA should start doing in-process for each and every process. That is not possible.

Do you agree?
I appreciate if I can get any answers.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
I think in-process inspection should be done by the operator and if they find something during in-process they should call the Team Lead/QA Auditor to resolve it.

A part of a QA Auditors job currently is to verify the set-up for the process and do the final audit once the lot is completed.

We had an issue regarding QA not doing the in-process inspection and that being the reason for producing bad parts.

I think the operator should inform Team Lead/QA if the process is not running well. I don't think QA should be blamed for something like this.

I don't think QA should start doing in-process for each and every process. That is not possible.

Do you agree?
I appreciate if I can get any answers.
One Golden rule to drive it in and to keep always reminded is that the " Operator is the best Inspector of his job "
The moment this thought of " I do and you check " gets into the mind, its very difficult to get rid of it.
Is this post a result of some blame game and finger pointing that you have been facing in your plant .... ?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
The lack of an inspection step, or the non/poor performance of an inspection step, is not a cause of bad parts. It is a cause of bad parts not being detected.

That said, one can make the argument that the detection has a process impact, not unlike the question "If a tree falls in the woods and no one hears it, does it make a noise?" IF the following are satisfied:

(a) The inspection process is set up to detect the problem. This involves the personal attributes of skill and will, and the tangible attributes of adequate equipment availability.

(b) The detection recognizes what happened. If the inspection is done merely to sort and form a pile of scrap, in no sense does the step have an impact on product goodness.

The operator can certainly perform an in-process inspection, and the gradual push to "Make quality everyone's job" has included sharing responsibility for inspections, again IF adequate processes, skills, equipment and the will are all in place. A QA inspector can go around on a random basis and follow up to ensure the operator's inspection results indicate the in-process inspection steps are done in accordance with the developed plan.

So even though they are right to point to a lack of process, it was presented in a slippery looking way. Unless we find it okay to allow bad parts out the door, there should be some kind of grass roots effort underway to help ensure the right things get done. If there is antipathy to this, IMO you have a bigger problem to deal with than scrap.
 
D

danielmartinezjr

#4
I think in-process inspection should be done by the operator and if they find something during in-process they should call the Team Lead/QA Auditor to resolve it.

A part of a QA Auditors job currently is to verify the set-up for the process and do the final audit once the lot is completed.

We had an issue regarding QA not doing the in-process inspection and that being the reason for producing bad parts.

I think the operator should inform Team Lead/QA if the process is not running well. I don't think QA should be blamed for something like this.

I don't think QA should start doing in-process for each and every process. That is not possible.

Do you agree?
I appreciate if I can get any answers.
Quality needs to built into the process, and that includes operators checking their own work. If there is a problem the production lead should be notified.
 
J
#5
I think in-process inspection should be done by the operator and if they find something during in-process they should call the Team Lead/QA Auditor to resolve it.

A part of a QA Auditors job currently is to verify the set-up for the process and do the final audit once the lot is completed.
That is fine. What inpsection has the prodcution people determined for the process.

We had an issue regarding QA not doing the in-process inspection and that being the reason for producing bad parts.
Why should there be an issue? Wasn't Production aware of the existing system where QA verifies the output at the beginning and end of the run? Could they not deduce from that that it is their responsibility to assure the process remains good?

I think the operator should inform Team Lead/QA if the process is not running well. I don't think QA should be blamed for something like this.

I don't think QA should start doing in-process for each and every process. That is not possible.
QA should do whatever Job that it is provided the resourses and authority to do. However, in my experience companies are reluctant to provide these things. In the first place, they don't wan to hire enough inspectors (not value added) to sufficiently cover a given area and/or they don't want to give the authority to inspectors to stop the process, especially for what might be a marginal issue.

The underlying facts are these. Production has people, already hired and trained, who (I presume) are fully capable of measuring the critical characteristics of the output of a process. These people will generally have the time to make the checks as well. In addition such checks can be made more often and thus the process more closely monitored than QA could do it.

If the company wishes to insist that QA do the work, simply tell them to transfer all of the machine operators from production to QA. That way every machine will be run by an inspector and the Quality Manager will see that the machines only run when they are producing good parts. :tg:
Prodcution can supply some set-up people to get the machines ready and tooling people to assure that the proper tooling is available.:notme:
You can guess what their response would be to that.:mg:

Do you agree?
I appreciate if I can get any answers.
All kidding aside, Your situation is not uncommon and points to a system that is somewhat disfunctional. Your system is suffering from the, "It's not my Job" syndrome. I've been there. It's tough to change, especially if management has bought into it.
Those in production should have more pride in their work. They should be more than willing to check the parts to make sure that nothing they make ever gets rejected. No operator, no setp-up person, no supervisor should want anything they run to be bad.
Just my 2c

Peace
James
 
A

aproddutoor

#6
Why should there be an issue? Wasn't Production aware of the existing system where QA verifies the output at the beginning and end of the run? Could they not deduce from that that it is their responsibility to assure the process remains good?
In my opinion there shouldn't be any issue at all. It's just a bunch of people playing the blame game. Production was aware of the existing system and the inspection frequency. If the operator knew what he was doing he would have not made bad parts and called someone for assistance. This reflects the training of the operator and production is responsible for training them. So why are they blaming QA for it? They want QA to do random in-process checks and sign off every time they do it, which is ridiculous.


QA should do whatever Job that it is provided the resourses and authority to do. However, in my experience companies are reluctant to provide these things. In the first place, they don't wan to hire enough inspectors (not value added) to sufficiently cover a given area and/or they don't want to give the authority to inspectors to stop the process, especially for what might be a marginal issue.
I think we have enough inspectors for the job. As far as authority is concerned they have the authority to stop the process if it is running bad.

The underlying facts are these. Production has people, already hired and trained, who (I presume) are fully capable of measuring the critical characteristics of the output of a process. These people will generally have the time to make the checks as well. In addition such checks can be made more often and thus the process more closely monitored than QA could do it.


If the company wishes to insist that QA do the work, simply tell them to transfer all of the machine operators from production to QA. That way every machine will be run by an inspector and the Quality Manager will see that the machines only run when they are producing good parts. Prodcution can supply some set-up people to get the machines ready and tooling people to assure that the proper tooling is available.:notme:
You can guess what their response would be to that.:mg:
I think the operator has all the time in the world to make those extra checks if the process is running bad.

It would definitely be interesting to see their response to it.

All kidding aside, Your situation is not uncommon and points to a system that is somewhat disfunctional. Your system is suffering from the, "It's not my Job" syndrome. I've been there. It's tough to change, especially if management has bought into it.
Those in production should have more pride in their work. They should be more than willing to check the parts to make sure that nothing they make ever gets rejected. No operator, no setp-up person, no supervisor should want anything they run to be bad.
Just my 2c
I agree
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Eh?

I just read "I think" twice and "In my opinion" once. But these do not a process make.

If you expect a process to be followed it needs to be established, clear, agreed upon, and adequately resourced. An inspection plan is certainly a process where these are important.

Oh I can see a blame game going on, but if the process had the factors I listed above, there would be little room for this blame gaming.
 
D

DrM2u

#8
I might be looking at this the wrong way but, from what I am reading, I see two things sticking out:

- the duties and responsibilities are not clearly defined, communicated and/or understood (finger-pointing syndrome) :argue:
- there is no balance between responsibilities and authorities (Production authorized to produce the product and QA responsible for the quality of the product) :cfingers:

It might or might not matter too much who is assigned to perform the in-process inspection as long as they are aware of it (communicated, not implied or suggested by deduction) and there is a balance between authority and responsibility (I cannot be held responsible for the national defficit, only for my personal budget that I have control over).:uhoh:
 
J

JaneB

#9
The lack of an inspection step, or the non/poor performance of an inspection step, is not a cause of bad parts. It is a cause of bad parts not being detected......

Unless we find it okay to allow bad parts out the door, there should be some kind of grass roots effort underway to help ensure the right things get done. If there is antipathy to this, IMO you have a bigger problem to deal with than scrap.
Yes, I agree.

two things sticking out:

- the duties and responsibilities are not clearly defined, communicated and/or understood (finger-pointing syndrome)
- there is no balance between responsibilities and authorities (Production authorized to produce the product and QA responsible for the quality of the product)

It might or might not matter too much who is assigned to perform the in-process inspection as long as they are aware of it (communicated, not implied or suggested by deduction) and there is a balance between authority and responsibility
Yes, agree. All good points. It doesn't, in the end, matter who is responsible, as long as everyone is clear about WHO (as DrM2U says) and that they have the authority (not just the responsibility) to do it. ie, If someone is responsible for detecting bad parts, they must also have the authority to stop it going 'out the door'.
 

foxwilds

Starting to get Involved
#10
Hello,

I'm kinda in the same boat. We are an injection molder of plastic jars and caps. Pretty simple part and process.The operators are responsible for part quality, all visual. Quality pulls a shot (sample) from each machine on first shift only and performs dimensional measurements. There is no actual "final inspection" for product release. How should I respond when the auditor ask's about final audit and approval?

Best Regards,

Perry
 
Thread starter Similar threads Forum Replies Date
Z Who is responsible for writing the validation of a new process? Manufacturing and Related Processes 7
K Which Department or Process is Responsible for Leading the PPAP Process? APQP and PPAP 3
N UK Responsible Person - Termination UK Medical Device Regulations 2
E MDR PRRC "jointly responsible" EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 10
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
E Company A supplies pharmaceuticals to the MOI - Who is responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
K Packaging and Damaged Parts returned from a Service Provider (Anodize) - Who is Responsible? Manufacturing and Related Processes 20
C Advice on becoming a AS9100 Auditor - Need to audit organizations that are Design Responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
C Person Responsible for Regulatory Compliance - The RA guy/girl Employment Act EU Medical Device Regulations 4
M Specifications Aerospace - Who is responsible for providing the correct specification(s) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
I Who is responsible for signing the Declaration of Conformity and what is their liability Imported Legacy Blogs 0
D Responsible for regulatory compliance (Article 15 of MDR 2017/745) Quality Manager and Management Related Issues 4
M Prescription Devices - Who is Responsible / Liable? Other US Medical Device Regulations 9
J Not Design Responsible - Can we exclude all or parts of AS9100 clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Functional group / area responsible on a Control Plan IATF 16949 - Automotive Quality Systems Standard 1
Ronen E New Service Offer - MDR's Person Responsible for Regulatory Compliance Paid Consulting, Training and Services 6
U Who is responsible to initiate a Supplier Corrective Action? Supplier Quality Assurance and other Supplier Issues 13
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
Jen Kirley Shared responsibilities in Responsible Care 14001 ISO 14001:2015 Specific Discussions 2
insect warfare New home for the R2 (Responsible Recycling) standard Miscellaneous Environmental Standards and EMS Related Discussions 2
H Different Plants responsible for different parts of the TS16949 Standard IATF 16949 - Automotive Quality Systems Standard 4
Ninja Blind Gopher Auditors Comment - Who is responsible? Registrars and Notified Bodies 23
insect warfare New R2:2013 (Responsible Recycling) Standard has been Released Miscellaneous Environmental Standards and EMS Related Discussions 6
N Who is responsible for conducting Root Cause investigation? Problem Solving, Root Cause Fault and Failure Analysis 8
M Corrective Action not being done by the responsible person Misc. Quality Assurance and Business Systems Related Topics 5
M Design & Development - Only 1 Engineer - Who is responsible for Approval? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Should HR Job Titles match Procedure Responsible names? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Integrating ISO 14001 and EPA Responsible Recycling (R2) ISO 14001:2015 Specific Discussions 4
Q Definition Design Responsible - Good Definition in the context of AS 9100 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Q Assigning Responsibilities - Responsible Department or positions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Design History File Maintenance - Who is responsible for the Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Where to get NAID and EPA Responsible Recycling Certification Training? Training - Internal, External, Online and Distance Learning 7
B Who is responsible for Translation Compliance EU Medical Device Regulations 6
T Does person responsible for standard have to be the Managment Representative? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Who is responsible, the department head or people under him? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
E Who is responsible for RoHS Declaration? RoHS, REACH, ELV, IMDS and Restricted Substances 3
B Who is responsible for cleaning medical devices before return for repairs? Other US Medical Device Regulations 13
P Who is responsible for CAME Amendment - Part M AMC M.A.704 (6) EASA and JAA Aviation Standards and Requirements 6
C Configuration Management requirements if this facility is not design responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Is a Distributor responsible for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Scope of Registration ? Design Responsible ? Outsource Design??? IATF 16949 - Automotive Quality Systems Standard 2
Anerol C Where should I start as the person responsible for the calibration laboratory? General Measurement Device and Calibration Topics 7
M IMDS Submissions for multiple parts requested, but not Design Responsible IATF 16949 - Automotive Quality Systems Standard 13

Similar threads

Top Bottom