Compounding Process - Seeking Generic Process Flow Diagram for Compounding Process

D

davis007

#1
I have just started as a Manufacturing Quality Engineer after 8 years in Product development R&D and am a little lost in all the acronyms, methods, tools, etc. After reading information in several places it seems that the place to start is to generate a flow diagram of the process. (No my company does not currently have one.)

Can anyone point me to a general flow diagram for a compounding process? I realize that this would need to be tailored to my situation but was hoping for a starting point.

A more general question is do you know of a step-by-step set of instructions for developing and implementing a QMS at a company that does not have one currently?

Thanks for any help.
 
Elsmar Forum Sponsor

Miner

Forum Moderator
Staff member
Admin
#2
While this is not all-inclusive, there are some basic steps that you will need to take first.

1. Establish the structure of your documentation system. Questions to ask yourself are: Will it be policy, then procedure, then instruction or another format? How will you number the documents? Will it follow the sections in the ISO standard or your business processes?
2. Establish a standard format and required content for the documents.
3. Establish the document control system to immediately control the documents that will be generated.
4. Establish the record retention system to retain the records generated by the documents and the training.
5. Establish the training system to train personnel in the new documents.
6. Establish the Management Review system to track progress of the implementation.

After these initial steps, the sequence for the rest of the system is less critical.
 

Douglas E. Purdy

Quite Involved in Discussions
#3
Starting from scratch?

davis007 said:
Can anyone point me to a general flow diagram for a compounding process? I realize that this would need to be tailored to my situation but was hoping for a starting point.

A more general question is do you know of a step-by-step set of instructions for developing and implementing a QMS at a company that does not have one currently?

Thanks for any help.
I think that you have it right. Start with understanding a process and then manage that process by developing a continual improvement process. From there you can develop your system by standardizing the structural aspects of the system to ensure uniform understanding of the business processes and how to continually improve them.

As for a general flow of a compounding process, I have no idea what you mean. But you might want to start with generating a turtle (identifying the scope, the inputs and outputs, etc. - see attachments). From there you should be more capable of flowing the process. There are plenty of examples of flows on The Cove, and they come in different varieties.

Doug
 

Attachments

Last edited:
D

davis007

#4
Thanks to you both for the help and advice. I am still trying to get my mind around what type of process flow chart is most usefull, as there seems to be more than one to choose. The turtle form looks very helpful to start organizing the scope of the process.

Again thanks for the help.

Ed
 
D

davis007

#5
Sorry I also meant to clarigy "componding process" in the plastics industry often plastics are modified with adjucts such as color, filler or other plastics. The process of mixing these materials and forming new pellets (plastics generaly come in small bead called pellets) is typically refered to as a compounding process.

Ed
 

Miner

Forum Moderator
Staff member
Admin
#6
You are correct that there are several formats for process flows. The type that you select should be based on what you need. You can start with a high level flow called a SIPOC. This is a simple 5-column spreadsheet listing Supplier, Input, Process step, Output and Customer for each macro-process step. You can use this to identify critical process steps, then do a detailed drill-down which list the input variables (contol, critical, SOP, noise, etc.) and output variables. The Turtle format looks good also, but the selection should be based on your need.

Regarding the compounding process flow, I have prior experience in rubber compounding both as supplier and as customer, and have found that this would only benefit you at the macro-level. Once you get into the details, there are significant difference between facilities.
 
Last edited:
D

davis007

#7
Thanks for the info. I think, being new to this, I am confusing PROCESS diagrams with material flow diagrams and/or work procedures. Also, I am still strugling with the correct level of detail that I need to map the system. Perhaps more detail of what I am trying to achomplish would help the forum members help me.

We manufacture plastic parts using an injection molding process and a proprietary blend of polypropylene and additives. We manufacture the blend in house using a twin screw compounder. At times we have defects of various types in the parts. These defects are blamed by production on "variations" in the compounded material. At this time only one characteristic of the compound is measured, the loading of one of the several additives used.

I have been asked to:

1. Identify what about the compound is causing the injection molding problems.
2. Identify the key quality characteristic of the compound that will predict injection molding issues.
3. Identify testing methods for the key quality characteristics identified.
4. Identify curent and improved control methods for the quality characteristics identified.
5. Document the process for achieving 1-4 and loop through as a continuous improvement process.

What I am looking for from a diagram is two things.
1. Something to show managment that i can use to explain the system, process and controls.
2. A starting point for a logical approach to achiving my goals above.
3. A pictorial representation of the process to spure ideas for improvements.
4. A seperate diagram to document the process of continual improvement.

If any one has suggestions of how to attack this please let me know.

Thanks
 

Miner

Forum Moderator
Staff member
Admin
#8
What you are describing is an ideal Six Sigma project. I recommend that you develop a micro-level process flow that covers both the compounding AND the injection molding. Do not assume that the cause is from the compounding. Injection molding can also cause many defects. Both processes are suspect.

There are several tools to help you narrow focus to the higher risk operational steps such as a Cause/Effect Matrix followed by a Process FMEA. The next step is to identify all of the inputs to each step and label them as a controllable factor, noise factor (difficult or expensive to control), an SOP (Standard Operating Procedure). Then identify the process outputs from that step. This should meet your first three requirements.

The Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) process would address the fourth.

From prior experience in rubber compounding and injection molding, you will probably need to use designed experiments (DOE) to solve your problem. Both processes tend to have interactions that will foil one-at-a-time experiments. Before you start DOE's you will also need to validate your measurement systems.

On a final note: there have been many experiments run on the injection molding process that are available on the Internet. A little searching may help you better understand the process and what interactions to investigate.
 
D

davis007

#9
Miner:

Thanks for the input. I do not mean to be dense but when you say a "micro-level process flow" are your refering to a process flow that includes all the inputs to individual unit operations, power supply, cooling air, steam, etc., as well as higher level inputs such as trainning, documentation, etc? It seems that the diagram would get overwelming very quickly with both sets of details. I hope what you mean is to include only the inputs and flow for the items needed by each unit op, power, heat, etc.

Thanks
Ed
 

Miner

Forum Moderator
Staff member
Admin
#10
A macro-level process flow might be Op 1: Compound, Op 2:Injection Mold.

A micro-level process flow for compounding might be Op 1: Weigh ingredient A Op 2: Weigh ingredient B Op 3: Mix ingredients A & B.

Inputs to the micro-level Op 1 might be: moisture content, % regrind; for Op 3: mix speed, mix time. For an injection molding example, it might be injection speed, pressure, preheat time/temperature. etc.

Outputs from Op 1 might be weight; Op 3 might be viscosity, etc.

The level of detail should be enough to give you outputs that you can measure and inputs that you can manipulate.

Hope this helps.
 
Thread starter Similar threads Forum Replies Date
B TS16949 Clause 7.1 in plastic pellet 'color mixing' and color compounding' process IATF 16949 - Automotive Quality Systems Standard 1
D Chemical batch compounding software for lotions and solutions Manufacturing and Related Processes 1
I ISO 9000 series, 13485:2003, 15378:2006 - Small Compounding Pharmacy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Ronen E FDA Must Have New Authorities to Regulate Pharmacy Compounding US Food and Drug Administration (FDA) 8
K Justifying an Analogue Weighing Scale for Compounding Industry Measurement Uncertainty (MU) 6
D x-BAR, p or U chart? Plastics compounding line Statistical Analysis Tools, Techniques and SPC 1
D Measuring stability of flow - Compounding processes Manufacturing and Related Processes 4
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 4
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
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) 7
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 9
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 9100, Nadcap and related Aerospace 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
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
A Design process goal for ISO 9001 Manufacturing and Related Processes 23
S Process Map for Supplier Process Maps, Process Mapping and Turtle Diagrams 5
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Procedure equals a process? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 24
J ISO 14001 revision process ISO 14001:2015 Specific Discussions 1
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
M Process Creation Advice Needed Design and Development of Products and Processes 3
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
H Human Resources Process Document Control Systems, Procedures, Forms and Templates 2
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
M MSDS process audit - Can any one give idea for checklist of the same Occupational Health & Safety Management Standards 14
A How to set up Continuous CpK monitoring of an injection mold process Reliability Analysis - Predictions, Testing and Standards 7
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
J KPIs or Metrics to Measure a New Complaint Handling Process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Similar threads


















































Top Bottom