Changing to Work Cell Audits - Need Advice

M

mike101338

#1
Time for me ask a question. I tried the serach function but didnt locate an answer to this. I want to change our company's method of auditing some procedures. We have always performed procedure based audits, registered for 4 years now, but I think we could gain more if audits were completed differently.

Our current method is to audit each documented procedure we have two times annually. These audits are performed by a group of 8, paired in teams of two for each audit. All auditors have other job functions not usually related to the quality department.

Has anyone tried the approach of supervisors auditing work cells in other areas? What I envision is a supervisor from one cell going into anther cell and looking for evidence of multiple items. This would include training records, id of material, handling of NC product, proper work instructions, and everthing else necessary to meet the standards we have established. Each auditor would be provided with an outline of what to look for and a time frame for completion.

The goal behind it is increased frequency of audits in areas, increasing the number of auditors and increasing the team aproach. The two biggest obstacles we continue to face are consistency (once an audit is over people put less of an empahsis on items they dont feel are improatnt but required in the standard) and team buy-in (the feeling that I'm just a pee-on and what I say or do isnt improtant in the grand scheme of things).

Any one auditng like this? Any thoughts on a method like this? I'll consider any feedback good feedback. :)
 
Elsmar Forum Sponsor
T

Teri - 2011

#2
We just implemented this. Our supervisors were doing a much shorter version, just prior to an external audit, just as a double check. I took their check list, explanded on it, and now we use it as an internal audit, with all work areas being done on every shift as least once yearly.

As this is new to us, I would love feedback from anybody that cares to comment.

Hope this helps you some!!
 

Attachments

D

dokes

#3
Sounds like a great idea. In an organization operating based on a lean (e.g., Toyota Production System) philosophy the job of supervisors is to monitor whether their workers are performing activities according to work standards (e.g., sequence of activities, inventory levels, time required to complete one cycle). If not, the assumption is that there is a problem with the system (e.g., equipment, materials ...) that needs to be rectified. Having your supervisors audit other work cells would help get them in the mindset of ensuring that their own work cell is operating according to defined policies/procedures.
 
T

Teri - 2011

#4
I think I might be careful in "saying" supervisors are "auditing" (at least formally),,, otherwise won't you get into the auditors training? At least in TS16949, unless I train all of my supervisors in our internal auditors class, I won't formally include their "audits" in my records. IMO
 
M

mike101338

#5
Teri, if you don't call the Supervisors doing the audits auditors what do you call them? If a system is set up to require periodic inspections of work cells by supervisors that are not auditors then it would seem to me that the areas would still need to be audited. That would double the work load for the company.

I was assuming I would have a frequency schedule put in place to qualify the supervisors as in-training, probationary and qualified. As the number of acceptable audits increase I would move them up the chain and reduce the amount of review they need until reaching the qualified level.

BTW, I like the attachment you provided. Looks much like I was thinking. :applause:
 
T

Teri - 2011

#6
mike101338 said:
Teri, if you don't call the Supervisors doing the audits auditors what do you call them? If a system is set up to require periodic inspections of work cells by supervisors that are not auditors then it would seem to me that the areas would still need to be audited. That would double the work load for the company.

I was assuming I would have a frequency schedule put in place to qualify the supervisors as in-training, probationary and qualified. As the number of acceptable audits increase I would move them up the chain and reduce the amount of review they need until reaching the qualified level.

BTW, I like the attachment you provided. Looks much like I was thinking. :applause:
Yes, I was thinking the same as you,,,, qualify the supervisors to do these. For right now, and until I get a more formal schedule, only trained internal auditors are doing this. I want to work out all the kinks, then "train and qualify supervisors" to these. Glad you liked the attachment!:thanks:
 

RoxaneB

Super Moderator
Super Moderator
#7
We have a system in place where an individual who supports production, but does not directly work for it, performs an activity called 'job audits'. A job audit focuses solely on the job...not on the system as internal audits do. A job audit is also schedule 4 times / year (once per crew) for all positions. This job audit is performed concurrently with a safety observation.

Should the standard not be followed, this leads to one of three conclusions:
  • The individual simply will not follow the standard
  • The individual was not trained on the standard
  • The standard is incorrect

Root cause will impact how we resolve the situation.

Like Teri, though, these job audits are a distinctly separate activity from internal auditing.
 
W

WALLACE

#8
Internal systems

Depending on your internal system and, in particular, your approach to internal systems and their performance measures would be the key to successful internal auditing.
At My Ford location (AS I have said in many post's) we use the FPS (Ford Production System) internal measurements of SQDCME (Safety, Quality, Delivery, Cost, Morale, Environment). search the Cove for this measure and you'll be presented with many threads, posts and visuals that, may help you gain a broader benchmark
I have witnessed many audits where supervisors take part in an audit of a colleagues area or zone within production. I'm not too keen on supporting such approaches as, it became very clear that, auditing a colleagues work area or zone becomes a very politically charged activity.
The fact that Ford are a unionised, makes the internal auditing activities very sensitive to processes and procedures that may affect Mangement/Union relations.
Wallace.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
S Changing revision status of a reviewed document Manufacturing and Related Processes 4
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6
M Changing a Chinese Legal Agent China Medical Device Regulations 5
B Changing dimensional tolerances to approve rejected product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Change Control Requirements when changing Suppliers IATF 16949 - Automotive Quality Systems Standard 4
P Changing from contract manufactured to self manufactured 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom