who should do the dishes?

Have you ever look into the sink at home and noticing there's some dirty dishes, decided someone else going to do it? Truth to be told, it happened to me when I grew up I admit I did it numerous time and get frustrated that I am the only one doing it. I ended just washing my own and left the rest for other to clean. 

Someone will, perhaps my mom or dad. It never dawn on me, how I make subconscious decisions on washing or not washing the dishes will eventually set my character in the long run. I become calculative what I should do and only work the tasks given to me. (Spoiler alert, this changes as life happened). 

Those who decided other people should wash their dirty dishes, might become feeling privileged. Often they found shocking that life doesn't work that way. They will questioned why other people are not giving things that should be handed to them? They become spoilt. 

Perhaps, maturity will come to them eventually. So, next time you see dirty dishes in the sink, go ahead and wash them. Don't let them pile up and take longer to clean and you are less motivated to do it.

Risk in Containment process

The most common item to overlook in the CAPA process can be the easiest yet complicated section, Containment. 

What and how do you manage containment?

Containment process is a series of actions to limit or eliminate further non-conformance. 

The most common example of containment actions are:

1. Segregation of bad products at customer, transit and manufacturing site. 
2. Adding an alert or inspection steps. 
3. Modified process settings to mitigate problems.

Beyond the product itself, it is also recommended to be proactive and issue alerts to customers or provide alternative solutions such as compensations.

When recording the disposition of non-conforming products, it’s required to add date, responsible process owner(s) and type of resolutions. This includes scrap, rework, sorting or use as is. Containment process typically involves several processes ad cross functional team. MRB, RMA and customer waivers to name a few. 

If the above is addressed during containments process, potential findings can be averted. 

Let's talk about record control? How do you manage them?

Record control is a system how all records are kept and managed.  Record essentially is a completed forms that serve as evidence that process or task has been completed per given procedure.


This procedure is a compliment to Document Control process.
Record is a gain tedious but crucial in proving conformity during audits.  It is the OBJECTIVE EVIDENCE we talked so many time in my last post.
Record contain the following information:

• A unique reference number as document identification

• The record title (or suitable description of the form)

• The location of the record. (office, on website link, production etc)

• The retention period which applies (typically 3 years for quality record)

• The person responsible for retaining the quality record (most probably process owner)

How to comply to Document Control procedure?

The thing we always see at work are lots of documentations and as if that's not enough, every year, the process get more complicated therefore requiring more documents.  My head just hurt thinking about  photos taking, words to clarify each steps in the instruction and not to mention, changes have to be made when someone thinks the document is not "good" enough.  I am exhausted, this is a hard article. After the documents are in tip top order, people would come back and say, nobody reads them anyway 🙄. Explain to me why we need documentation again?

We have documentation to comply to all the ISO requirement specifically clause 4.2.3.
Per ISO 9001:2015: Documentation Control Clause 4.2.3 tells us that an organization must control the documentation required by the Quality Management System and that a suitable document control procedure must be implemented to define the controls needed to; 

• approve, 
• review, 
• update, 
• identify changes, 
• identify revision status and 
• provide access. 

The document control procedure must clearly define the scope, purpose, method and responsibilities required to implement these parameters.

These information normally available readily in the title block.  Changes regards as history on very last page while the scope, purpose, method and responsibilities is found right after title block.  Typical this a template is useful to ensure consistency.  

What about defect log?

Visual management is best implemented at shop or production floor. It highlights stuffs you need to watch out for during process without having to spend time on wordy documents.  Pictogram or photos of defects, mark and arrow with little words works wonders.  Associates on the job will be able to understand what to look for and where to detect defects.

Defect log typically include the following:

1. Part name:
2. Process/area:
3. Defect name:
4. Photo Defect (Not Good or NG)
5. Photo of Good part ( OK)

Two photographs to distinguish between good and defective parts are very simple way to add to existing appearance and defect criteria which has been created for individual parts.  It can also be used on Quality board or as part of customer presentation slides or 8D.

For administrative purpose, do remember to add document#, this can be added to footnote or on title block.

I am trying hard to make this electronically accessible but this is an uphill battle as kiosk is expensive and tablet tend to walk and never to be seen again. 😏 Hardcopy is good but you will need to keep tap on the current revision or document control.

Another great ideas is a daily defect log book, this provide updates on daily defects.  It can be a live document and used during short meeting/briefing before starting each shift.  

What is 8D?

Manufacturer always strive to deliver good quality products, however, when a complaint is received, more often than not, customer are willing to work with their supplier to achieve common goal which is to find root cause, mitigate the current issue and prevent them from recur.  Corrective action report is often used to ensure these activities are recorded and documented in proper manner.
Corrective action and Preventive action (CAPA) can be addressed in several format, most popularly request by customer is an 8D.  They are most comprehensive CAPA available and widely used by automotive industry.  Simply because it covers all the IATF requirement in section:
6.1.2.2  Preventive action
8.7 Control of non-conforming process outputs, products and services 

8D is short for 8 disciplines
0D
Define pre-requisite such as affected product, PO/SO#, owner, reporter, manufacturing plant, total product sent, total affected parts etc.

2D
Establish a team- Establish relevant owner from different function which would be a great source of knowledge and ideas during brainstorming session.  Yes, we sometimes hate to pull people away from their job, we are know they love their job and it's really hard to get away 😆 but it is necessary.  No, we don’t need to call in food every time we have a meeting, but I have to admit, you get full attendance if you do, just saying. 

Yeap, my kinda team. 😎

3D
Problem description, lot#, where it happened, what is the issue (may use the what, when, who, why,  and how method) 

4D
Interim Containment - locate all suspected products either at store, in-transit, customers site or on the field.  Be sure to check every area where the parts may have been transported to, or stored at or still waiting to be processed.

5D
Root Cause Analysis- Investigates how issues might occur through Fishbone method (also known as Ishikawa diagram or cause and effect diagram, this is part of 7 QC tool), you may also use the 5 whys method. 

This gets tedious but you have to exhaust all ideas until you kind of ran out of it.  For example,  Machine is faulty, why? Because the gear was damaged, why? Well because there was a nick on every revolution within the gear, why? Because sharp debris scrapped the wheel off during machining process....  

Figuring out how it end up in there...

6D
Solution and Verification- solutions can be training, new or change in procedures, design change, machines or process improvements. Best to match solution with root cause that was determined earlier so you cover all potential problems.

Ditto

7D
Preventive action to ensure proper doesn’t recur. This could be done by extending the solution to other product family or similar machines. (Eg.-Poka-Yoke, tool change, added software etc)

8D
Congratulate team.  Perhaps acknowledging them during monthly meeting or company newsletter.

Pretty much it!

Interview Questions for Quality technician/inspector

My last job, I took care of the company account. Yes, with this calculator.

One of the popular job I've seen in the market I am in is Quality technician or inspector.  They are not totally down on the totem pole and they are not on the level where accountability is demanded. At the pay scale of around $40K per year, I think it's pretty good living.

I did a few interviews and hire some of the best technician in my career, enough to know what fits what the job required,  instinct to read their character and a little luck to bring in good hard working team.

Here's are my choice questions:

Technical or job related:

1. Can you provide example some project or activities you work in your previous job?
2. What do you like about your previous job and why did you leave your previous job?
3. Have you ever work with ......? (e.g. SOP, certain test equipment, quality tools, Microsoft, SPC software etc)
4. Have you any experience working with......? (e.g. Engineering, sales, production etc)
5. How do you feel about putting extra hours/time if company requires it?

General:

1. What do you see yourself in 5 years? 
2. What do you consider your biggest weakness?
3. What do you know about our company? 
4. Why do you want to work with us?
5. Do you have any questions you like to ask us?

Notice that my questions are specific, and it meant to be that way because a technician job is critical, meticulous and detail oriented. I try to save time and keep the interview time down to less than one hour. With this said, it is critical to get as much information you can from this face-to-face interview. Basically you need to pay attention to how the candidate respond to the above questions, they may not have the exact experience require for the job but if they do have technical background such as doing lab work in college, it may work in your favor too.

I have a great sense of humor.

I know kungfu.

Hmm..they do background check.

How to Perform Product audit for IATF16949?

Product Audit is critical for automotive industries which to comply to IATF16949 certification.  The objective is to verify process to  ensure compliance to the 9.2.2.4 requirement.  The product audit requirement is as follow:

9.2.2.4 Product audit

• Must audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. 
• Where not defined by the customer, the organization defines the approach to be used.

Basically the guidelines was generic, this enable company to apply product audit process that would integrate customer requirement which is the input and customer satisfaction which is the output, and the production as the main process.  

Customer requirement--> Production--> Customer satisfaction

What it entailed?
People
Process
Documentation

As we mentioned earlier in my other post, I love to use a simplistic system.  I need to rally a team of auditor, identify our auditee and schedule time for audit.  Product audit is best to be performed during regular hours on real-time.  Auditor must understand the production process, which typical start with incoming material, then move to production, inspection or testing and finally shipping.

Each of the process there is at least an owner that perform the task.  The owner is auditee that you will interact in the process.  Ask several questions that related to the process, I would recommend to pull several samples (products) and verify the part#, lot# and their specification.  Review the product and match it to its specification (print, material sheets or measurement data). Ensure correct revision is used on every sample. Check for test equipment and verify their validity, make sure they are calibrated and within calibration date.  You may need to keep a copy of each objective evidence or record down the report reference so you can refer to it later on when you write up audit report.

Product audit is more extensive than internal audit, so you may require to follow where the audit trail leads you.  For instant, you may need to review incoming test result for material used to build the product. You may also require to check if operators training record is up to date.

You may repeat the similar system on each process (incoming, production, inspection, shipping etc)
Here's a simple template for product audit:

Product Audit

Auditor(s) name:
Date:
Process name: XYZ

Product information- verify product#, revision#, product print and specification, operators name(s) 

Test data-Review test data or result to make sure product has been verified as required on the customer or engineering print. (raw material test result, product test result etc) 

Calibration-Check that test equipment used on each station is within calibration.

Traceability-Product will need to have complete traceability from incoming raw material to product shipped out to customer.  (lot, production log or electronic log sheet etc.)

Nobody touching my bed, and I don't care if its full of hair.

How to create Certificate of Analysis for outgoing Quality Process

Certificate of Analysis or CoA is a report stating all criteria is met by supplier as agreed by customers during initial product review. Once customers has outlined what they need, suppliers will perform test to ensure product is conform to its fit and function.

CoA is tedious but necessary.

A generic CoA Template typically includes:

- Customer name

- Customers part #

- Customer PO#

- Supplier part#

- Supplier PO#

- Lot#

Report of analysis will include the following:

1. Performance data may include:
- max,
- min and
- average.
This includes stress test, air flow, density, tensile strength or anything required by customer. Be sure to check all units are accurate. It’s also best practice to include specifications on each required measurements.

2. Another information that might be critical is the part dimensions such as thickness, width, profiles, depth etc.

Last but not least is to ensure validity of the certificate. Report must be signed by qualified Quality personnel, preferably using an electronic signature. Copy must be sent using pdf format if send via email.

How to carry out Gemba Walk?

Gemba is a Japanese term means "the real place".   In manufacturing the gemba refer to factory shop floor.  It is also the place of construction, work office, sales office or customer service area.  In lean manufacturing, the best improvement ideas came during gemba, where all the error or problem could be easily seen during surveillance walk at gemba site.   Gemba walk is an activities where management or front lines look for Muda or any opportunities for improvement.

Gemba means if problem seen during gemba walk, an engineer or maintenance section will be called to check and review the situation, start the improvement program.

During Gemba walk, it is common to ask series of questions about the work or production that going on for the day such as:

1. Who responsible for the job?
2. How often does QA check the part?
3. What value the work does to the process?
4. Do you have idea to make the job faster? Easier?
5. How does the job affect the quality?

The focus of Gemba walk is to improve process quality as well as reducing the waste in production.  On top of that, by having management and front liner to make a special trip down to production floor or back end office will definitely increase the morale of the workers. 

During the gemba walk, nobody expect to find a perfect process in order.  There is a always issue to address,   new improvement or initiative to consider.  Either way, gemba walk help reduce mis-communication and a great practice for audit.

Steps for Gemba walk:

1. Select a theme for each walk.
2. Question the supervisors.
3. Listen attentively.  This is a learning exercise for the manager.
4. Share what you learned as you walk through the plant.
5. Write a short memo on what you learned and post it for others to see.
6. Follow-up to see the progress is made.

Indy 500 Centurion Race

SAFETY, SPEED, EFFICIENCY and QUALITY

"Ladies and Gentlemen, let start your engine!"

The Crowd

The Start

The Tower

The observation Tower

The Race Team

Team in Action

The Cheer

The Opening

Cameramen everywhere

100 Anniversary Indy 500

The Pagoda

Classic Indy Race car

Signed Engine Maker

Those olden days

It used to have very minimal Safety features then

The safety car now

The Engine

The sleek Silhouette  

How to calculate Takt Time

Takt time is synonym to cycle time, where it simulate the process of producing a part from start to end, or rather from  material input to shipping.  Takt time concept aims to match the pace of production with customer demand.

Takt time formulation are as follow:

T =  Ta / Td

T   = Takt time (Net time available for production in Minutes/ unit produced per customer demand)
Ta = Net time available ( minutes of work per day - this exclude rest/lunch/meetings etc)
Td = Time demand (customer demand) e.g. (units required/day)

For example:, if you work 8 hrs a day for 5 days a week. For a week, you have a demand of 100pcs, Then the Takt time calculation should be as follows:

Takt = 8 x 5 x 60 minutes/ 100 pcs
        = 24 minutes

By sticking to Takt time, we will have few advantage as follows:

• no over production
• no rush on order
• production planning easily done without interruption
• system work based on customer demand
• reduce or eliminate WIP

Lean Six Sigma

Lean for Production and Services
A popular misconception is that lean is suited only for manufacturing. Not true. Lean applies in every business and every process. It is not a tactic or a cost reduction program, but a way of thinking and acting for an entire organization.

Lean six sigma embraces 9 principles, these will in turn transform your view in life as general.  The nine principles required some understanding and practice in order to get you more proficient with Lean.

The 9 principles are listed as below:
Principle 1: Life and business are processes
Principle 2: All processes exhibit variation.
Principle 3: Two causes of variation exist in many process.
Principle 4: Life and business in stable and unstable processes are different.
Principle 5: Continuous improvement is economical, absent capital investment.
Principle 6: Many processes exhibit waste.
Principle 8: Expansion of knowledge requires theory.
Principle 9: Planning requires stability.

To accomplish this, lean thinking changes the focus of management from optimizing separate technologies, assets, and vertical departments to optimizing the flow of products and services through entire value streams that flow horizontally across technologies, assets, and departments to customers.

Eliminating waste along entire value streams, instead of at isolated points, creates processes that need less human effort, less space, less capital, and less time to make products and services at far less costs and with much fewer defects, compared with traditional business systems. Companies are able to respond to changing customer desires with high variety, high quality, low cost, and with very fast throughput times. Also, information management becomes much simpler and more accurate.

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!