Difficulties with Process Approach - Defining 'Effectiveness'

#1
As I know the clause 0.2 "Process approach" in FDIS 9001:2000 again changed. Moreover there is an ISO/TC176' decision to produce special guidance module regarding this problem. Neverthless, how should I start, using cl. 4.1 of ISO 9001:2000?

4.1 a) Identifying processes
I identified
- 6 interested parties (customers,
stuff, owners etc.)
- 8 key production processes ( marketing, design, purchasing, production etc.)
- 7 main management processes (responsibilities,planning,recourses, measurement etc.)
So I have a matrix of 6*8*7=336 processes.OK
4.1 b) Determining the sequense and interaction of these processes. Ha-ha,
Shall I identify input and output for all these processes?
How shall I describe this interaction to stuff and auditors ( a matrix, a lot of flowcharts, in procedures)?
4.1 c) Determining criteria and methods required to ensure that both the operation and control of these processes are effective.
I don't know how to do it, because I understand that my internal and external auditors are not able to estimate: "Are operation and control really effective?".
And what is the noun for the adjective "effective" - effectiveness or efficiency. You know that it is a big difference between them.

Thank you in advance
 
Elsmar Forum Sponsor

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#2
"4.1 b) Determining the sequense and interaction of these processes. Ha-ha,
Shall I identify input and output for all these processes?
How shall I describe this interaction to stuff and auditors ( a matrix, a lot of flowcharts, in procedures)?"

Perhaps the best visual way to show interactions between processes is with a Venn Diagram. All will be disproportionaly affected in all probability. You may elect first to do some type of Regression Analysis to determine correlation between processes to help you create the diagram. Inputs/outputs is a good place to start.

Regards,

Kevin
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
"...4.1 c) Determining criteria and methods required to ensure that both the operation and control of these processes are effective..."

Inspections and tests.

"...I don't know how to do it, because I understand that my internal and external auditors are not able to estimate: "Are operation and control really effective?"

You determine this - not auditors.

"...And what is the noun for the adjective "effective" - effectiveness or efficiency. You know ..."

Effectiveness ~ Does it work and if so how well?

Efficiency is an input/output ratio in units appropriate to what you're looking at. There are natural gas furnaces which are 95% efficient and there are others which are 60% efficient. This is an instance of BTUs lost to entrophy (potential of the gas put in {input} vs the BTUs output to the home). In manufacturing processes things can get much more complex. Try an internet search for Machine Efficiency, for example. See what you get back...
 
A

Alan Cotterell

#4
I suggest it is worthwhile flowcharting the Product or service delivery process, at he 'macro level', before embarking on preparation of your Procedure Manual. You might have over 300 sub processes but only one or two product types which the manual should address.
 
H

HFowler

#5
Process Approach

I am developing a Quality Management System for a small company. I plan to use graphical process models like the one shown in the beginning of the ISO 9001:2000 Standard in place of writing text procedures, (except for the required 6) to describe our processes. Is anyone else taking this approach?
 
I

ISO in Baltimore

#6
We are using some process models to describe high level functions but we are mostly using flowcharts in place of text procedures. From the registrars and auditors we've talked to, flowcharts seem to be preferred over text procedures as much as possible anyways!
 
A

Al Dyer

#7
Just an opinion, but I find that the level 2 procedures lend themselves to be written documents that reference the work instructions that are flow-charted.

In reality, very few use the procedures, most use the work instructions and forms.

By flow-charting work instructions it makes it easier for the general work population to understand and perform.

ASD...
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#8
-> I find that the level 2 procedures lend themselves to be
-> written documents that reference the work instructions
-> that are flow-charted.

I disagree. I believe level 2's are the first to be flow charted. I haven't had a client use text level 2's since 1995.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#10
I suggest flow charts everywhere you can. Especially level 2's. Most larger companies have problems doing some lower level documents in flow charts such as work instructions and/or travelers because their MRP/ERP systems print them.

Almost any procedure can be, and should be, flow charted. Text documents are to be avoided at almost any cost.

At Harley we flow charted just about everything except the 'quality' manual and many assembly and other various documents which the MRP software spits out. My smaller clients do the same.

The problem at many companies is as you get down to the level of assembly / work instructions (in addition to any MRP/ERP systems problems) is the detail level necessary. It becomes harder (with some processes) to use flow charts because of detail issues.

David, you've been visiting the forums long enough to see my extreme Pro-Flow Chart bias. Not to mention my Flow Chart rants.

There are numerous examples in my Implementing ISO Guide (unabashed promo).

At the least, all level 2 'procedures' should be flow charted.

-> I haven't had a client use text level 2's since 1995.

This means I haven't had a client which used text documents as level 2's since 1995. They have all exclusively used flow charts.

-> Do you mean text only L2 procedures?

I'm not sure what you mean here - but if you are saying "Yes - use text only documents for level 2's", the answer is NO. Use Flow Charts for ALL level 2's and the majority of level 3's.
 
Thread starter Similar threads Forum Replies Date
C Difficulties getting RoHS/REACH for cheap parts RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Difficulties Controlling Foreign Suppliers Supplier Quality Assurance and other Supplier Issues 8
E What are the major difficulties when working as a consultant in your industry? Consultants and Consulting 20
E Internal Audit Difficulties - Am I headed in the right direction? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 34
R Program Start-Up Difficulties - Would anyone have a format to use? Manufacturing and Related Processes 8
P Conformity Assesment Review (Annex II) for a New Product - Difficulties EU Medical Device Regulations 5
A Difficulties in performing MSA on Rockwell Hardness Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
M Difficulties associated with implementing a QMS - AS9100 Startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Improvements and difficulties in implementing customer complaints procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R LEAN Difficulties - Why a company doesn't want to do LEAN Lean in Manufacturing and Service Industries 36
F Weighing Instrument Calibration Laboratory - Difficulties in Implementing a QMS? General Measurement Device and Calibration Topics 9
P Appearance Approval Report (AAR) Difficulties - Decorative Graphics Screen Printing APQP and PPAP 12
R Poll for six sigma project leaders: What are the difficulties and failure factors? Six Sigma 1
A Upgrading from ISO9001:2000 to AS9120 - Difficulties? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
A When someone refuses to follow a process.... Misc. Quality Assurance and Business Systems Related Topics 21
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Process mapping Process Maps, Process Mapping and Turtle Diagrams 1
R MDEL Process Canada Medical Device Regulations 4
optomist1 Rates Daily or Hourly Process Improvement Training Consultants and Consulting 2
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
B Toyota PPAP Process - Three Questions APQP and PPAP 3
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
V Laser Welding Process - Impact on Electrical Properties Reliability Analysis - Predictions, Testing and Standards 4
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3

Similar threads

Top Bottom