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.