Proving Process Capability of a Packing Machine

Solitude

Starting to get Involved
#1
We are looking at proving capability on an packing process. There must be a certain quantity in a box with no variance, e.g. 50 off or 100 off. Overs (and unders) are not allowed.

I think that we should conduct a binomial study as the pack either conforms or it doesn't.

We have had some discussions about could we prove the capability over different pack sizes, but this still relies on a binomial data set really, as there is no tolerance; it either conforms or it doesn't.

Is there anything else we could do to prove or demonstrate how capable the process is please? Thanks.
 
Elsmar Forum Sponsor

Miner

Forum Moderator
Staff member
Admin
#2
You could do a binomial capability and obtain a percent nonconforming as a capability. However, I would find it more useful to collect data on the actual quantities (raw or # off target). That would allow you to determine whether there was a high or low bias to the quantities as well as a frequency between miscounts. You could always convert that into binomial later and calculate a percentage.
 

Solitude

Starting to get Involved
#3
We have run 100 boxes through the process, and we have had no defects, i.e. all boxes contain 100off items.

There is no variation in the data, so everything that gets calculated is zero, and putting the data through Minitab throws an error. Any ideas on the best way to present the data would be appreciated.
 

Miner

Forum Moderator
Staff member
Admin
#4
Binomial capabilities take a very large sample size. With a sample size of 100, you may state that p_bar = 0 with an 95% upper confidence limit of 0.036 (3.6% nonconforming).

Increasing your sample size to 500 would reduce this to 0.007 (0.7%). Increasing to 1000 would reduce it to 0.004 (0.4%)
 

Solitude

Starting to get Involved
#5
Thanks Miner. Could you point me in the direction of how I can calculate or work this this information out please. Thanks for your help.
 
Thread starter Similar threads Forum Replies Date
D Proving Substantial Equivalence in Software Medical Devices Design and Development of Products and Processes 2
C Sewage Discharge Consents - Proving within Limits ISO 14001:2015 Specific Discussions 7
N Proving a Medical Device is equivalent to another device from Literature Review EU Medical Device Regulations 4
T Uncertainty of Proving Rings Measurement Uncertainty (MU) 1
M Need Advice About Proving the Value of ASQ Certification Professional Certifications and Degrees 8
A Provision of Resources - Proving resources to address Customer Satisfaction - 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
J Process FMEA Template with examples. FMEA and Control Plans 0
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 5
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 4
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 4
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
K Problems with process equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
W Need for current design or process control FMEA and Control Plans 2
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C OEE and In-process Inspection Manufacturing and Related Processes 2
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3

Similar threads

Top Bottom