Are "process based" and craftsmanship mutually exclusive?

T

triver525

#1
I am working on an ISO 9001 implementation for a manufacturing client. The product they manufacture is large, low-volume, and engineered specific to each application/customer. They are widely recognized for producing a high quality product which we attribute greatly to the level of craftsmanship exemplified by the fabrication staff.

We want to implement ISO 9001 to improve the repeatability of quality and reduce the risk of negative quality impacts caused by loss of knowledge (staff leaving etc.). However, we are hesitant to create detailed work procedures for fear that this would undermine the craftsmanship culture.

Can anyone suggest a way to document the Product Realization portion of the QMS without adding restrictive processes?
 
Elsmar Forum Sponsor

normzone

Trusted Information Resource
#2
Possible approaches to your perceived challenge (note that I don't know enough about your product to agree that there is a challenge yet)

Start by documenting what actually happens in broad terms. Perhaps you don't need a "detailed work procedure".

"without adding restrictive processes" is a difficult thing to achieve. If the company wants to play in the ISO 9001 arena, there are some guidelines to color within, and your mileage may vary. What you might see as a "adding restrictive processes" I might view as "documenting what really happens and keeping the customer happy"

Or, ask the persons who perform the work how they would choose to describe what they do, and in how much detail.
 

John Broomfield

Staff member
Super Moderator
#3
I am working on an ISO 9001 implementation for a manufacturing client. The product they manufacture is large, low-volume, and engineered specific to each application/customer. They are widely recognized for producing a high quality product which we attribute greatly to the level of craftsmanship exemplified by the fabrication staff.

We want to implement ISO 9001 to improve the repeatability of quality and reduce the risk of negative quality impacts caused by loss of knowledge (staff leaving etc.). However, we are hesitant to create detailed work procedures for fear that this would undermine the craftsmanship culture.

Can anyone suggest a way to document the Product Realization portion of the QMS without adding restrictive processes?
triver525,

I agree with you. We should not insult the craftsperson by issuing them with work instructions.

Take a look at clause 7.3 for design. A plan is specified, inputs are specified, outputs are specified as is verification and validation of the design. But the designing work itself depends on competent designers.

Computer programs are verified as suitable for use just as the craftsperson's tools are. And both processes are monitored for their effectiveness by the people doing the work.

Likewise, your craftspeople have their competence verified, they work to a plan, their inputs are verified and their outputs are verified. That's enough for effective planning, operation and control per 4.2.1d.

No work instructions are necessary for competent craftspersons.

Just as trainee chefs may need a documented recipe until their competence to work without one is verified; apprentices may need to document what they are learning before they are declared competent.

But do not forget that product realization runs from taking the order and planning thru process monitoring and product verification (both by the competent craftsperson), labeling, packaging and delivery. These activities or processes may benefit from documented procedures.

John
 
T

triver525

#4
Here's an example scenario that we are concerned about:

Joe is a welder with 20 years of experience and 10 years with the company. He knows that when he's building Widget A he needs to weld together parts 1, 2, and 3 as per the drawing. He knows how those 3 parts need to fit together in order for the final product to meet spec and what he needs to do if they require minor modification due to a problem in the upstream cutting process.

If we had to write the process such that a new-hire apprentice could do the same thing we would potentially bog down Joe with checklists and paperwork. Ultimately this scenario boils down to the impacts of a non-conformance between the cutting and welding processes. The last thing we want is anyone on the shop floor developing an "it's not my fault" mentality or not caring enough to recognize a problem and taking the time to fix it.
 

JLyt207

Involved In Discussions
#5
We have a similar situation. We do special aerospace tooling. It is close to the situation you describe, including outstanding quality levels. The way it was handled here was that we do not go into detail. We rely more on procedures and have very few work instructions. Even then our procedures would state that a manufacturing plan is developed for a tool and not say what the plan looks like, just the format it is in. What we do have is more reliance on extensive training records. We prove the workers are capable of making the decisions needed to complete the tool.
 
T

triver525

#6
We have a similar situation. We do special aerospace tooling. It is close to the situation you describe, including outstanding quality levels. The way it was handled here was that we do not go into detail. We rely more on procedures and have very few work instructions. Even then our procedures would state that a manufacturing plan is developed for a tool and not say what the plan looks like, just the format it is in. What we do have is more reliance on extensive training records. We prove the workers are capable of making the decisions needed to complete the tool.
What kind of training records do you keep? Internal or external? We have been talking about using competency and training in lieu of written procedures but my concern was that would put us in a position where we would have to develop a lot of in-house training procedures/standards because a craftsmanship certificate isn't something that is offered in trade schools.
 

Pancho

wikineer
Super Moderator
#7
I am working on an ISO 9001 implementation for a manufacturing client. The product they manufacture is large, low-volume, and engineered specific to each application/customer. They are widely recognized for producing a high quality product which we attribute greatly to the level of craftsmanship exemplified by the fabrication staff.

We want to implement ISO 9001 to improve the repeatability of quality and reduce the risk of negative quality impacts caused by loss of knowledge (staff leaving etc.). However, we are hesitant to create detailed work procedures for fear that this would undermine the craftsmanship culture.

Can anyone suggest a way to document the Product Realization portion of the QMS without adding restrictive processes?
The craftsmen should own their procedures. You can achieve this by having them write, edit, be featured in, and/or teach the procedure to others. They should have authority to modify the procedure when and if required, or to effectively request such modification.

Properly written procedures will never restrict craftsmanship. They will enhance it.

If a craftsman complains that a procedure is restrictive, ask why, how and what part of it. Then fix that part so that it isn't restrictive - with the expert's input.


Here's an example scenario that we are concerned about:

Joe is a welder with 20 years of experience and 10 years with the company. He knows that when he's building Widget A he needs to weld together parts 1, 2, and 3 as per the drawing. He knows how those 3 parts need to fit together in order for the final product to meet spec and what he needs to do if they require minor modification due to a problem in the upstream cutting process.

If we had to write the process such that a new-hire apprentice could do the same thing we would potentially bog down Joe with checklists and paperwork. Ultimately this scenario boils down to the impacts of a non-conformance between the cutting and welding processes. The last thing we want is anyone on the shop floor developing an "it's not my fault" mentality or not caring enough to recognize a problem and taking the time to fix it.
I'm not sure about this example. Welding is a "special process", where NCs often aren't apparent in the finished product. Any welder working in a shop with AWS, API, ASME or ISO welding certification are used to working to WPSs and lots of records.

It is not a question of having a newbie follow a restrictive work instruction to do the same thing as an expert welder. It is the experts themselves that need to follow very detailed instructions and keep complete records to produce good quality. Newbies have to go through lots of training and their performance in a particular type of weld needs to be qualified before they can be assigned a job that involves such weld.
 
Last edited:

JLyt207

Involved In Discussions
#8
What kind of training records do you keep? Internal or external? We have been talking about using competency and training in lieu of written procedures but my concern was that would put us in a position where we would have to develop a lot of in-house training procedures/standards because a craftsmanship certificate isn't something that is offered in trade schools.
It is tough to explain without turning this post into novella length. In brief, new hires are paired with an experienced employee. Based on their experience coming in each training and orientation is unique. We have both internal and external records that we keep. For example, our welders have both their AWS certifications (i.e. AWS D1.1 6g) and internally we have a matrix of skills that they prove they can perform. (i.e. read and understand WPS) The matrix is divided into departments. HR signs off on things like employee handbook, company policies, I perform training and sign-off on AS, FOD, ITAR training. Then the department head signs-off on skills used in that area. As an example, one line would be drill press operation or torch operation. By signing off on that line they confirm that the employee can use that equipment or perform that process to meet our craftsmanship standards. In your example about Joe, he would fit the 3 pieces together and our department head would review the dry fit before it goes to weld. If it passes then he would sign-off on the dry fit line. When it was welded and the welds and look of the tool meet our craftsmanship requirements then they would sign-off on the MIG or TIG line. All that would be separate from our WPS and his certification to D1.1 for position 3g, etc. Please note we don?t have those craftsmanship requirements defined in writing because that delves into requiring an aesthetically pleasing look, etc.
 

somashekar

Staff member
Super Moderator
#9
What kind of training records do you keep? Internal or external? We have been talking about using competency and training in lieu of written procedures but my concern was that would put us in a position where we would have to develop a lot of in-house training procedures/standards because a craftsmanship certificate isn't something that is offered in trade schools.
Triver...
Your thread title weighs more than the stuff you have said in the first post. You are talking about special skills. You can have your training records as a dynamic skill matrix. Each cell of the matrix will map a special skill vs person. Each cell can then have four levels, viz. NOT TRAINED / UNDER TRAINING / TRAINED / TRAINED AND ALSO CAN TRAIN.
Any person moves from the not trained level to the can also train level and the time it takes is all your decision. What each level means in terms of the job a person can do can also be clearly detailed. Demonstration of skill at any level is visible for all to see. Effectiveness monitoring can be demonstrated in terms of process rejections / rework., Yield., Customer returns and complaints record.
There is no need to force yourself to make any detailed work instructions. This is purely your risk based decision and when you are both comfortable and confident, the skill matrix will support your training record, and the actual work is there to see for what product realization you are getting out from your special skilled personnel.
 

John Broomfield

Staff member
Super Moderator
#10
Competence is the requirement, not training.

Training is just one way of acquiring skills and knowledge.

Training may or may not create competence.
 
Thread starter Similar threads Forum Replies Date
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
M Informational Critical Thinking and the Process of Evidence-Based Practice Medical Device and FDA Regulations and Standards News 0
T GRR based on part tolerance or process variation. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
M APQC PCF (Process Classification Framework) and ISO 9001 - Processes Based Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
A Suggestions for a UK based course in Process Auditing wanted Training - Internal, External, Online and Distance Learning 2
W AS9100C Process based manual Design and Development of Products and Processes 4
T Where in the ISO 9001 standard it asks for process based auditing? Process Audits and Layered Process Audits 6
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Introducing Process based approach on Production Floor Manufacturing and Related Processes 6
M Seeking input for a process-based quality management system training course ISO 13485:2016 - Medical Device Quality Management Systems 1
B Sample Size based on Process Capability Indices (Pp/Ppk)? Capability, Accuracy and Stability - Processes, Machines, etc. 20
V Relevance of Process Based Auditing (PEAR) to regulated industry. US Food and Drug Administration (FDA) 3
M Changing PFMEA (Process FMEA) RPN Values based on a Rejection FMEA and Control Plans 4
J Integrating a Project Model in a Process Based Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Z Reduced Sampling based on Process Capability (AS9100 Standard) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Process4.biz and other Visio based Process Management Tools Human Factors and Ergonomics in Engineering 2
T Are MSA?s (Measurement System Analysis) Process or Gage Based? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
V Internal Audit - Process based vs. Procedure based AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
U Process based Audit Approach vs. Clause based Audit Approach Process Audits and Layered Process Audits 49
P Definition Dock-to-Stock Process based on Historical Quality Performance of a Part and Supplier Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
5 Process based Internal Audits, instead of auditing to the elements of the standard Internal Auditing 21
N I'm still not grasping the idea of Process Based Internal Audits Process Audits and Layered Process Audits 19
V Process Based Organization Chart that lists processes instead of departments? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
M PFMEA Severity - What is Process FMEA Severity estimation based on? FMEA and Control Plans 77
S Getting started with statistically based process improvement The Reading Room 12
Manix What provision is made for the Process of Implementing Project based work in TS16949? IATF 16949 - Automotive Quality Systems Standard 3
T Implementing the Process Based Approach - Reality check needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
F How to use Total Variation based on Process or Tolerance? Page 60 of the MSA manual Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
V Process approach based internal auditing Internal Auditing 1
A Where's the value add in product audits when your process is inspection based? IATF 16949 - Automotive Quality Systems Standard 9
C Simple four-box process model - Referenced in ASQ Process-based auditing course General Auditing Discussions 5
RoxaneB Process-based auditing in 14001 - Seeking Reviews: Audit Schedule Content Feedback General Auditing Discussions 9
L 20 Factors based QMS to TS 16949 Process based Quality Management System IATF 16949 - Automotive Quality Systems Standard 1
I ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based Internal Auditing 26
Gman2 MY thoughts on 'process based' auditing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
D Feature-Based Processing Recommended Business Process Guideline (THE-5) Various Other Specifications, Standards, and related Requirements 0
M ISO 9001:2000 Process Based Internal Quality Audit Plan General Auditing Discussions 11
Marc Functional vs Process Based Documentation Document Control Systems, Procedures, Forms and Templates 13
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 2
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5

Similar threads

Top Bottom