Lean Manufacturing

LEAN is a production practice that considers the expenditure of resources for any goal other than creation of value for the end customer to be wasteful, and thus a target for elimination.

Lean is centered on preserving value with less work.  Lean manufacturing is a management philosophy derived mostly from "Toyota Production System" (TPS) in  the 1990s. TPS is renowned for its focus on reduction of original "seven wastes" to improve overall customer value, but there are varying perspectives on how this is best achieved.  One of the lean "tools" are Value Stream Mapping, 5S, Kanban and Poka Yoke.

Lean manufacturing is a variation on the theme of efficiency based on optimizing flow. Irregular production with ups and downs in production levels would be considered waste.  Some practitioners have combined 6 Sigma ideas with Lean Manufacturing to yield a methodology called Lean 6 Sigma.

6 Sigma Project follow two project methodologies inspired by Deming's Plan-Do-Check-Act Cycle.
These methodologies compose of DMAIC and DMADV.

DMAIC is applied on projects focused on improving existing business process.
DMADV is applied on projects to create new product of process designs.

DMAIC method has 5 phases:

• Define the problem
• Measure Key aspects
• Analyze the data
• Improve or optimize
• Control the future state process

The core of lean is founded on the concept of continuous products and process improvement and the elimination of non-value added activities. Improving the flow of material through new ideal system layouts at the customer's required rate would reduce waste in material movement and inventory. 

PDCA - Plan-Do-Check- Act

PDCA cycle utilized in the manufacturing as problem solving tools, this include to identify problem, to analyze those issue involve, implement and carry out trials on countermeasures and establish new standards or procedure.

PDCA (Plan-Do-Check Act) or Deming circle pretty much used by small group teams to address everyday issues at shop floor.  By working on PDCA, it helps to boost the team member morale as each members were able to brainstorm, work on the issue and solve the problem as a team.  The team members were taught to use the 7 tools in the PDCA process, and they were given ownership to the projects until the project are completed.

Plan - Product design related to the planning phase of the product management
Do - Related to Production of parts-manufacturing of the design product.
Check - Checking on sales figure to verify the target.
Action - Researching on the product method and procedure to standardize them.

PDCA has gone through many improvement and slight change to fit the organization needs.

However the basic concepts are as mention above. The PDCA were repeated once a cycle has been completed until the sales/scrap objectives are achieved.  However the concept of PDCA are required contribution from different section in the organization. They are assigned as follow:

Plan - Design Department
Do - Production Department
Check - Sales Department
Act - Quality Department

If the cats used PDCA, they would probably be having bird for lunch by now.

How to use 7 Quality Tool?

As a Quality Assurance personnel, it is very critical to be analytical the way we solve a quality issue.  It is a stressful job specially dealing with issues at hand, therefore we need to use a proper tool to detect and solve problem effectively.  The 7 QC tools basically are:

Pareto Diagram
The diagram divide problem or defects based on the cause, they are graph according to priority using a bar chart on the X-axis.  The Y-axis represent the % of defect or value scrap which is accumulate up to total as it moves to the right.

Cause and Effect Diagram or famously known as the fishbone/Ishikawa
These diagram are shaped like a fish with bones.  Normally they are applied in the shop floor to analyze the characteristic of a process or situation and a factors that contribute to them.  The four major factors are Men, Machine, Material and Method.

Histogram
The frequency data obtained from collection of measurements display a peak around certain value.  The variation of quality characteristics is called " distribution".  The frequency in the form of pole is referred  to as histogram.

Control Chart
There are two type of variations, the inevitable variation that occur under normal conditions and those that can be trace to a cause.  The later are abnormal variation.  The control limit were between top and bottom line limit.  Collection of data were graphed so process control are easily monitored.

Scatter Diagram
Two sets of corresponding data are plotted to form scatter diagram.  The relation between these scatter diagram represent the relationship between the corresponding data.

Graphs
These comprise varieties of graph parallel bars, lines graphs, pie chart, radar and etc.  These graphs are useful for data analysis and presentation.

Check sheet
Check sheet are applied at any stage of the process for routine check. 

These tools will benefits you in a long run, help you to become more proficient and professional when presenting your work.  Maybe even help you to sleep better at night knowing you did an awesome job!

How to Prepare for a Quality Audit

Does anyone like audit at all? It may be a nerve wrecking situation when it came to audit.  Did anyone notice that many employees tend to take day off on audit day?  They were afraid that they will be accountable to any mistake made on audit day.  Is this true? I am surprise how this will effect other employees but with much preparation, I am sure we can address many fear or uncertainty on the audit day.  Most auditors do not look for problems rather they rather find improvement to enhance the Quality System.

Before you become a good auditee, you have to learn to know how to become a good auditor.  When I started to be involved in auditing,  I realize that documentation is a must have.  We also need to study about the process or the organization, the best way to do this is by establishing a creating a checklist.  Here's a step by step process on how to develop one with ease.

Documentation : Checklist

Six steps for developing process checklists

Step 1: Consider the overall business goals.

Step 2: Review the core process(es) and required outcomes

Step 3: Review of any documentation relevant to outcomes.

Step 4: Establish process issues critical to outcomes

Step 5: Prioritize the points.

Step 6: Prepare the checklist

The Audit Visit:

The Auditors will normally visit the Auditees on their 'home territory'.  So obviously as anditee, you have a upper hands on the situation.  

During the audit, the Auditors should be:

• Clear on the aims of the audit
• Clear on the Scope/boundaries of the audit
• Polite at all times
• Courteous
• Confident
• Well prepared
• Thorough

There are 3 stage of audit:

The Audit Visit: Stage I Audit

Auditor will look at the process as presented by the Auditees and whether or not:

• the Auditees follow the process as presented
•  the Auditees understand the process as presented
• the Auditees recognize the process as presented
• the Auditees find that it works
• Where there is no documentation the Auditors should ask for an oral account of the procedure(s) that are followed for the particular process being audited. In such cases the audit report will include a strong recommendation that the procedures are documented.
• If there are 'Service Standards' connected to the process or function they should be uncovered, but not imposed if there are none to begin with.

The Audit Visit: Stage II or Follow-Up Audit

• It is expected that, by this stage, the process has been documented, so the audit will look to see if the process is being followed as stated by the staff that use it.
• The audit will also look for continual re-evaluation of the working practice and procedures and any improvement necessary. In addition the Audit will ensure that all staff involved with the process have understood and incorporated any changes made.
• The ability of the staff to reflect on their work should be aided by the independent and unprejudiced nature of Internal Quality Audit.
• Auditors when making their visit should take into consideration the Company’s Plan where that plan contains targets pertinent to the process being audited.

Conducting audit:
When auditing, we have to consider some techniques/communication to ensure we achieve the audit objective and get as much information and objective evidence as possible.

The audit techniques are:

• 7% Verbal
• What was said

• 38% Vocal
• How it was said; pitch, rhythm, enthusiasm

• 55% Non-verbal
• Body language, gestures, culture, personalities, space and setting, word meanings, emphasis and punctuation

There are also non-verbal action which help to draw out information from auditees.  This will help auditees to feel comfortable and more confident answering your questions.

Non-Verbal Actions

• Positive Non-Verbal Actions
•  Leaning Forward
• Eye contact
• Facing the person
• Relaxed posture

• Negative Non-Verbal Actions
• Leaning away
•  Avoiding eye contact
• Standing above or behind auditee’s (confrontation)
• Standing/sitting too close
• Sitting on auditee’s work bench
• Carrying clipboards
• Loud emotive tones
• Threatening gesture
• Pointing directly at auditee’s

What else???  

Most auditors need to acquire these skills as well:

• Effective listening
•  Hearing is not listening
• Aids to effective listening
• Use attentive body language
• Learn to use your thinking time wisely
• Become an observer (control your mouth)
• Listen with open mind
• Listen all the why through (don’t make assumption)
• Effective Observation
• Observation must be substantiated with objective evidence.

Once you understand how an audit works, you should be able to sit back and enjoy your day..

How to Create Internal Quality Audit Questionnaire

I've been doing alot of presentation on how to conduct IQA, sometimes old habit die hard, I tend to be technical with the jargons, so since my posting is derived from my presentation, I hope I can enlighten you with the audit methods.


When you come to the place to audit, introduce yourself and inform your auditee the reasons for the visit. DO not intimidate your auditee, auditee suppose to assist the auditee and not find faults on the audit site. (You should have with you, Quality Questionnaires and Quality Control Plan)



Here's are more example on questions you may ask during your audit?

1. Do you know what is the company quality policy? (make sure the policy is visually display)
2. Do you know how to operate this machine? Can you show me how to conduct quality check/test?
3. Where's the quality tools? (check if the tools have proper identification, calibrated & easy to access)
4. Where is the SOP? (Check if the SOP has validation, updated and easy to understand)
5. Do you go through any training? (check his training records to verify)
6. Where are your checklist?
7. How often do you check the item?
8. If you are on day off, who take over your job as operator/QC checker?
9. Who is the QMR (Quality Management Representative?(we need to ensure quality is communicated throughout the organisation, from top down)
10. How do you address complaints?
11. Do you carry out supplier audit? How do you ensure material received are within specification?
12. other relevant questions.

Remember to cross reference with records or other employee to verify the answer.
Once the audit is done, thank the auditee and do share some improvement activities for the site too.

How to conduct Internal Quality Audit?

Plan your audit way ahead..

What is Internal Quality Audit?

Known as 1st party audit whereby the company aim to provide a mechanism for ensuring conformity to the quality system and to assist in the ongoing improvement to the system.
What is the objective?

Record the approved procedure (this protects it against the unexpected such as sudden illness)
Ensure the approved procedure is followed
Question existing procedures - has the context within which the procedure operates changed enough to make a revised procedure more effective and efficient?



What are the requirement of an audit?

• People
• Documentation
• Process

1. People
The internal audit should conducted by competent team and lead by skilled Internal audit Lead auditor. How to ensure this by having all the team member to attend Internal Audit Training. The lead auditor should has experience with quality assurance background,preferably has attended the Lead Quality Auditor/ Accessor course.

2.Documentation:

ISO9001:2015 Structural of new standard

• Section 1: Scope

• Section 2: Normative references

• Section 3: Terms and definitions

• Section 4: Context of the organization

• Section 5: Leadership

• Section 6: Planning

• Section 7: Support

• Section 8: Operation

• Section 9: Performance evaluation

• Section 10: Continual Improvement

Objective Evidence
Data Supporting the existence or verification of something.

Documented Requirement:

• Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
• Records of training, skills, experience and qualifications (clause 7.2)
• Product/service requirements review records (clause 8.2.3.2)
• Record about design and development outputs review* (clause 8.3.2)
• Records about design and development inputs* (clause 8.3.3)
• Records of design and development controls* (clause 8.3.4)
• Records of design and development outputs *(clause 8.3.5)
• Design and development changes records* (clause 8.3.6)
• Characteristics of product to be produced and service to be provided (clause 8.5.1)
• Records about customer property (clause 8.5.3)
• Production/service provision change control records (clause 8.5.6)
• Record of conformity of product/service with acceptance criteria (clause 8.6)
• Record of nonconforming outputs (clause 8.7.2)
• Monitoring and measurement results (clause 9.1.1)
• Internal audit program (clause 9.2)
• Results of internal audits (clause 9.2)
• Results of the management review (clause 9.3)
• Results of corrective actions (clause 10.1)

Objective evidence may verify:

• That specific requirements have been fulfilled.
• That requirements for specific use/application have been fulfilled.
• Suitability, adequacy and effectiveness to achieve established goals.
• Format may include hard or softcopy documentation, forms, record, verified statements of fact, observations or other information relevant to the audit.

3. Process:

Method of conducting an Internal audit process are as follows: 

• Identify Audit Scope
• Select Audit team
• Plan Initial audit meeting
• Audit team briefing
• Audit visit
• Feedback from auditees during visit
• Report to auditee for comment
• Confirm report
• Feedback of report from auditees

Other Administration stuffs:

1. Identify quality contacts (Quality Manager, Quality Engineer, Management Representative)
2. Identify auditee (if you are not familiar with the department, be sure to contact quality contacts at relevant department for direction)
3. Schedule an audit with auditee (you could schedule  pre-audit before going on full audit)

Once you have figure out all this, it should be easier to handle the internal audit.

What is 7 Muda (Wastes)?

Reducing waste in order to bump up profitability is a no-brainer.  Waste is normally created in production process.  The principle of 7 wastes or known as muda was originated from Japan.  It was originally developed by Taiichi Ohno from Toyota as part of Lean project.


The seven muda are:
Defects
Quality defects usually resulted to rework or worst scrap.  These contributed to huge chunk of cost and effecting the production yield.  Cost included in defects are rescheduling for parts replacement, rework, re-inspection and delivery.  Defects reduction can be done through employee improvement projects.


Over-production
Over production mean manufacturing products even before order is received.  Over-production is done to build up stock in order to cover for scraps.  One ways to avoid this is by practicing the JIT or just in time which encourage the production of only what is demanded by customers.  This way company will be able to avoid storage and material cost. 


Waiting
Every time products sit on the storage mean waste due to waiting for delivery.  A lot of production lead time were tied up waiting for the next process, these process are called WIP and this take up storage.  This situation were caused by bad material flow or lack of resources.  This can be resolved by studying and improving the value stream mapping.


Non value process
Over engineer processes or high tech equipment to run a simple process could result to non- value process an inappropriate processing.  The cost to cover high amount of asset will eat into the bottom line.


Transportation
Delivery of products from point A to B could lead to unnecessary cost depends on the distance.  Material handlers normally hired to ensure continuous material supply to production floor, however the amount of time to do this will be costly, leading to expensive selling price.


Inventory
Work in process or WIP is the result of over-production and waiting time.  Excess inventory is costly specially when a company has a limited space to spare.  By doing value stream mapping,  excess inventory can be improved and eliminated altogether.


Motion 
When you watch process flow in manufacturing flow, you can normally see what might cause excess in motion through distance of parts from the operators. This also related to ergonomics, where the movement of operators need to be taken into consideration as some process could cause health hazard.

In a nut shell,  being lean doesn't mean cutting corners on quality but more on redesigning process or stream lining them to ensure smooth manufacturing flow.  This will lead to reducing or eliminating the above 7 muda and eventually add to profitability.

What is Poka-Yoke?

What is Poka-Yoke?

Poka-Yoke means fool proof which later called as mistake proof was coined by Shigeo Shingo in the 60s while working for Toyota.  Poka-Yoke technique was use to prevent defect from occurring the first time.  Poka-Yoke was apply in process at production floor after defects was identified to prevent it from happening.   Poka-Yoke basically a simple low cost tools or device fabricate to fit its purpose.


Preventing error is crucial in process or service to avoid unnecessary cost incur.  Error was identified through preventive process such as FMEA (Failure Mode and Effect Analysis).


What are Errors:

1. Process error - process which is missed or not performed as per SOP (standard operation procedure)
2. Set-up error - Wrong tool or machine setting.
3. Part Missing - Missing parts during assembly.
4. Improper part/item - Wrong part used or included in process.
5. Operation error - Wrong specification
6. Wrong measurement - error in machine calibration, adjustment, wrong test or measurement.

Poka-Yoke Type:

1. shut out type - prevent an error being made
2. attention type - highlight error (eg. limit switches, automatic shut-off)
3. electrical, mechanical, procedural, visual, human or any other form that prevention to avoid error in processing.

The use of poka-yoke can eliminate both human or technical error.  This tool is part of lean management when apply could improve design and process efficiency and increase product quality.


Examples of everyday Poka-Yoke:

• Card slot at ATM (notice that the machine can only accept card when enter correctly)
• High speed camera system on production floor to identify wrong parts.
• Edge guides to prevent rolls goes off tracks.
• Sensor to stop machine if product was distorted.
• Template used at production floor to identify missing parts.
• Car reverse sensor.
• Shut-off valve when liquid meet certain pressure/air flows.
• Go-no-go gauges for testing purposes 
• Laser curtain 
• Temperature sensors

Poka Yoke on ATM

Poka Yoke on defensive design

Poka-Yoke using jig design

Design to only enable insert to its port in one direction/orientation

                                           

Why is Quality important?

Quality control is crucial especially when safety criteria is involved. Most people thought that quality of product is the least important factor to the manufacturer, the reality is, it is the high priority for all end user. We expect good product because we pay to get a good product.  If we don't get it, we either complain, never return to the supplier or request for refund.  

 

Either way, the manufacturer or supplier will lose customer confidence and sales in the long run.  The demand is even greater now that not very long ago, tainted milk product found in China dairy product has lead to their consumer’s health hazard. 

The government and private organization is striving even more fervently to tighten the products quality control. Public awareness on product quality has increase through media and internet exposure on (food) products quality.  Therefore more consumer will choose to go for products that has Quality certification for example UKAS (United Kingdom Accreditation Service, BSI (British standardization Institute), Japan Quality Association (JQA) and SIRIM (Standard and Industrial Research Institute of Malaysia) and etc.   The above list of quality accreditation bodies would determine that the company's quality management system is established and within the QMS (Quality Management System) requirement.

For HACCP (Hazard Analysis Critical Control Point) certification, it is a accreditation bodies such as the above mention. The HACCP is a systematic analysis to identify food hazard and it is an important measures to ensure food safety assurance. 

Over-inspect maybe?

So next time when you shop for home essential, please ensure your product is certify by genuine certification bodies.  Don't cheapen your way of life just to save a few bucks.  Love your self, buy a quality products!

What is 5S?

What is Quality without continual improvement, one method to include in the improvement project will be the 5S projects.  It could be simple as housekeeping activities to more refine such as conducting monthly audit and award system. Either way it works toward achieving quality workplace.

Supermarket best place to find 5S practice

5S practice is a technique to establish and maintain quality environment in an organisation. The 5S's are a group of techniques to promote workplace organisation, ensure adherence to standards and foster the spirit of continuous improvement.

Principles/ Key Attributes
To successfully convey the message of 5S across the organisation, achieve total participation and systematically implement the practice, establishing effective quality processes as pre-requisites for good products and services, the following step-by-step approach should be adhered:

• Sort (Seiri)

The objective of sorting or organisation is to get rid of unwanted items by focussing on the core items that are needed to fulfil the requirements of the job and discard items that are not needed. This could focus on the elimination of excess inventory affecting, warehouse space, transportation, labour costs, needed items, and redundant parts, for example.

• Set in order/Neatness (Seiton)

Neatness focuses on efficiency, with the main objective being on how quickly one can get the things needed and how quickly those things can be put away. This is achieved through locating a specific place for specific items of a specific quantity, where needed.

• Shine/Cleaning (Seiso)

The objective of cleaning is to identify abnormalities and areas for improvement. This is achieved through a combination of cleaning the workplace and at the same time focusing on the identification of abnormalities or out of control conditions.

• Standardization (Seiketsu)

The objective of standardization is to consolidate the first 3 S’s by establishing standard procedures. This activity is carried out to determine the best work practices and find ways of ensuring that everyone carries out an individual activity the same ‘best’ way.

• Sustain/Discipline (Shitsuke)

The objective of discipline is to sustain improvements and make further improvements by encouraging effective use of the ‘Check-Act-Plan-Do’ cycles. This is achieved through strict adherence to current improvements and the development of an environment for future improvements.

The Impact on functional Activities
The approach embodied with 5S will effect everyone and everything within an organisation. The technique of 5S begins with a promotion plan for the sole purpose of promoting the establishment of the 5S’s. This incorporates everyone within the organisation from the highest level to shop floor level consisting of a blame-free environment. To instill all viewpoints at each level a steering committee is formulated and is responsible for the implementation of 5S.


The next stage is Awareness Training focusing on the dissemination of the 5S plan and its objectives and incorporating suggestion schemes for the ‘buy-in’ of all employees. An Internal Audit highlighting areas for improvement.

By working on 5S, company will be able to reduce tremendous amount of waste in terms of time, space, movement and cost.  5S is a great way to start on lean management, as the principles are basic and easy to apply throughout the organization.