Is the Quality Objective for Company-wide Training as >90% too high?

#1
Hello Forum,
My company just received a non-conformance related to a failure to meet our Quality Objective for Company-Wide Training, which is currently set at >90%.

My data shows that in general Operations, Engineering and Quality are spot on. So I have no worries as it relates to product, etc. The areas that are consistently bring down the overall average is the Sales and Administrative Teams (Finance / HR), who don't typically interface with the Quality System.

I understand that per the regulation employees must be trained prior to performing a specific task, so I am not looking for what the regulatory requirements is. What I need, is feedback from the forum on what others are doing around establishing a Company-Wide Training Objective, Why, and if 90% is maybe an unrealistic goal.

Your insight is appreciated.
Mary
 
Last edited:
Elsmar Forum Sponsor
B

bigqman

#2
Hi onpoint. A couple of questions: Company-Wide Training - on what? What knowledge, skills, and behaviors is the training trying to impart? Are the knowledge, skills, and behavior needs the same in Operations, Engineering, and Quality as in Sales and Admin?
 

normzone

Trusted Information Resource
#3
Question - what standard is your company referencing for this requirement?

I'm not surprised that Sales is not your compliance star - coddled bunch of babies if you ask me ;-)

But that doesn't mean that you can't get them trained up. Devise a method to handle it remotely.

But your question was about the goal, and is it too high. How was this goal level set?

In my mind, I either have a process that has a high compliance rate, so I set the number wherever I damn well please, or I have a process that has a low compliance rate, and so I set the number at exactly where it is today and then begin trying to figure out why it's so low.

This is not of any help to you, but at least I got to slam Sales today, so at least I have something to feel accomplished about :)

Oh, and the person running the sales and admin areas are your reason for low compliance - task that person with getting it together.
 
#4
Hi onpoint. A couple of questions: Company-Wide Training - on what? What knowledge, skills, and behaviors is the training trying to impart? Are the knowledge, skills, and behavior needs the same in Operations, Engineering, and Quality as in Sales and Admin?
The Company-Wide training is related to the Quality System (E.g. Quality Manual, SOPs, Work Instructions etc.). The level of knowledge / skills are different based on the various functions. Our system takes into account by assigning the "Level" of training required: Level 1: OJT / Cass Room; Level 2: Self - Read & Understand; Level 3: Awareness - I know there is a procedure and it's purpose, but I don't perform the process. The procedures folks are required to train on is based on their Job Function / Description, to ensure that employees are required to train on more or in a fashion that is inconsistent with their responsibilities.
 
#5
Question - what standard is your company referencing for this requirement?

I'm not surprised that Sales is not your compliance star - coddled bunch of babies if you ask me ;-)

But that doesn't mean that you can't get them trained up. Devise a method to handle it remotely.

But your question was about the goal, and is it too high. How was this goal level set?

In my mind, I either have a process that has a high compliance rate, so I set the number wherever I damn well please, or I have a process that has a low compliance rate, and so I set the number at exactly where it is today and then begin trying to figure out why it's so low.

This is not of any help to you, but at least I got to slam Sales today, so at least I have something to feel accomplished about :)

Oh, and the person running the sales and admin areas are your reason for low compliance - task that person with getting it together.
The standard / regulations are 21 CFR part 820 and ISO 13485. Thanks for the input on setting it at demonstrated level for compliance, then figuring out how to bring it up.
 
Thread starter Similar threads Forum Replies Date
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
qualprod 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
Q Department Expansion as a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Quality Objective Reference Chart Customer Complaints 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
N How would you approach failing quality objective measurables? Quality Tools, Improvement and Analysis 12
P Quality Objectives - How can we make our quality objective? Quality Manager and Management Related Issues 32
R Can a Quality Policy include Health and Safety as an Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
P Can 'adding a new service' be a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Quality Objective Measureables - Please Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
N Quality Objective - Scrap Measureables ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P Quality Objective not being met - Nonconformance or Observation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
J Internal Audit NC ISO 9001 Clause Mapping - Quality Objective Achievement Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Criteria for setting a target value against a quality objective/KPI? Benchmarking 6
J Can "Compliance to ALL Requirements" be an Acceptable Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Tracking Delivery Performance - A "Quality Objective" is "On Time Delivery" Supplier Quality Assurance and other Supplier Issues 13
A Difference between a Quality Policy and a Quality Objective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Can CPK be a good manufacturing processor?s quality objective? Capability, Accuracy and Stability - Processes, Machines, etc. 14
A Can a requirement be a quality objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Is a Sales Growth Objective a 'Quality' Objective ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
C Customer Quality Objective - Mandatory to have documented inside QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Seeking sample quality objective(s) for IMPEX (Import / Export) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Vision Mission, Quality Policy, Quality Objective, Divisional Objective Misc. Quality Assurance and Business Systems Related Topics 10
J Calculating Repeat Business for the purpose of quantifying a Quality Objective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M How to define Quality Objective and How to breakdown ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Objective Tracking - Methods being used to track quality objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M ISO 9001:2000 quality objective vs acceptance criteria ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
H Updating Quality Manual to API Q1 Service Industry Specific Topics 4
R Electrical contractor Project Quality Management Plan Quality Manager and Management Related Issues 1
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 7
R China Quality Certification Various Other Specifications, Standards, and related Requirements 1
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
V Quality review Meeting with Customer for complaints we received Customer Complaints 6
F Supplier Quality Assurance Job Openings - 8/2020 Job Openings, Consulting and Employment Opportunities 0
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Quality, efficiency and effectiveness of daily work routines Misc. Quality Assurance and Business Systems Related Topics 4
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 10
Q Quality Technician (calibration / metrology) - Memphis, TN Job Openings, Consulting and Employment Opportunities 1
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Interview with Director of Quality Career and Occupation Discussions 18
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
B Quality manual for automotive industry wanted Quality Management System (QMS) Manuals 2

Similar threads

Top Bottom