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Quality Improvement: SPC 101 pt 1

Introduction

Many companies get caught in data traps. They focus so heavily on cost and survival that they end up using data as merely a marketing and sales tool. In doing so, they fail to realize the true power of data: It can transform every aspect of a business.

Survey Says…

A recent survey by iConnect007 revealed just how important data is to our industry, and also just how difficult it is to get accurate, actionable data to drive our businesses. The key takeaway from printed circuit executives was that their greatest need is accurate, real-time process data. When you apply process metrics and dashboards to your data tools, data can not only drive improvement, it can drive innovation. Companies struggle with data; how to get it, is it the right data, is it accurate, is it automated or a manual process? This is where using statistical analytics can help any business to improve their business, and not just in manufacturing but also in areas like your customer and employee hiring processes.

Data should never be pigeonholed or feared. Instead, it should be used to better understand your company. By breaking down the silos that exist within your organization you will generate new perspectives, ideas and performance levels as departments begin to measure their performance against the new metrics. Did you just realize that your company has fallen into a data trap? Luckily, it’s easy to break free from its chains, and using statistical data will reveal just how efficient and innovative your business can be.

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Give me a call to help turn your QMS into a competitive advantage!

920-841-3478

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QMS or BMS? Well…

Quality Management System

The first thing we need to get straight is that a Quality Management System (QMS) is actually a Business Management System (BMS). Your Quality Management System will encompass every business process from quoting through shipping (and after sale service), so the QMS is not a “quality thing”, it is an “everyone thing”.  I occasionally run into companies that still have the attitude of “we are only doing this to satisfy ISO, there is not much value to the company.”

This is wrong-headed thinking on so many levels.The true benefits of an ISO system are that it should be used to run the business. The process metrics established for ISO should be discussed at every production and managers meeting. Internal audits should be used to improve every process on an ongoing basis. Customer feedback should drive organizational improvement, and so on. In fact, I would be hard-pressed to find a single requirement of ISO that just doesn’t make good business sense.

The ISO powers that be have emphasized this point with the 2015 revision by requiring top management to be fully engaged in the entire system and not just their own sandbox. This is a good thing.

Contact TRAC

Give me a call to help turn your QMS into a BMS!

920-841-3478

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Guerrilla Tactics to Pass any QMS Audit – Tactic 10 Tips To Reverse a Finding

Williams’ Law 10

The more “wins” you can bank with an auditor/customer, the greater the chance they will write-off a negative observation as an “isolated anomaly”.

Conversely…

The more “findings” an auditor/customer identifies, the deeper they will dig in all subsequent areas.

The key to reversing an auditor’s QMS audit finding is on-the-spot corrective action. Responsive, ultra-prompt action is required as well as the aforementioned political savvy of the Management Representative in administering the techniques discussed below.

Guerrilla Tactic 10: Techniques to Reverse a QMS Audit Finding

Page Swap

A Page Swap is a technique that can be employed to correct minor mistakes or omissions in a procedure. This technique is perfectly legal as long as there is a Page Swap clause in the Document Control procedure outlining the rational and rules for its use.
If an error and/or omission is identified by an auditor, utilizing the Page Swap technique to immediately correct the error and present the auditor with a corrected procedure before he/she finishes the audit will generally result in a non-finding.

Situations that allow a Page Swap:

  • Swapping a single page in a QMS procedure
  • Does not require re-approval of the entire procedure
  • Page content integrity remains intact
  • Page numbering does not change
  • Typos
  • Minor wording changes
  • Missing word/phrase
  • Where obvious intent was implied

Instant Procedure Revision

On-the-spot procedure revisions are the reason that key employees and procedure signatories must be present and available for all major audits and customer visits. The ability to rapidly change, approve and distribute a procedure revision in reaction to an auditor’s finding will be the difference between a formal finding and a clean audit.

If you missed any of the prior Guerrilla Tactics you can find them all at https://tracqms.com/blog/.

Contact TRAC

Contract me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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Guerrilla Tactics to Pass any QMS Audit – Tactic 9 Tips To Avoid Audit “Dings”

Williams’ Law 9

Teach it, preach it, and audit to it! Prepare so that no question should be able to be asked that an operator does not know the answer to.

Guerrilla Tactic 9: QMS Documentation Tips To Avoid Audit “Dings”

Tip 1: KISS

Keep It Simple Steve; the goal is to develop a system that is:

  • Value-adding to the organization
  • Easy to understand
  • Flexible
  • Reducing opportunites for error
  • SIMPLE

Tip 2: Standardization

Develop standardized QMS procedure template

  • Standardize sections e.g.:
    • Scope
    • Responsibilities
    • Terms & Definitions
    • Instructions
    • Reference Documents
    • …etc.

Facilitates:

  • Ease-of-use
  • Training
  • Recall
  • Memorization of “structure”, not procedure
  • Time-to-retrieval

Tip 3: Verbiage

  • “Functional Vagueness”
    • Precise enough for functionality
    • Vague enough for practicality
  • “Shall/Must”
    • Critical
    • Non-compliance would jeopardize operation
  • “Should/May”
    • Non-critical
    • Non-compliance would not jeopardize operation
    • Leaves room for external circumstances

Examples

“Bath pH shall be verified and logged onto form 203-004 every 2 hours.”

“Workplace should be kept clean on a continual basis.”

Designee

  • Try to always use this term
  • Don’t: “The Molding Supervisor shall review & sign-off on the daily SPC results.”
  • Do: “The Molding Supervisor, or his/her designee, shall review & sign-off on the daily SPC results.”

Contact TRAC

Contact me to start your Quality Management System Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

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Guerrilla Tactics to Pass any QMS Audit – Tactic 7 MBWA

Williams’ Law 7

You can’t manage from your office; if you don’t constantly monitor the pulse on the shop floor it is easy to lose control.

 

Guerrilla Tactic 7: MBWA

My good friend Tom Peters, author of the “Excellence” series of books and one of my favorite management consultants, coined the phrase MBWA (Management By Walking Around). This is another of those concepts that seem so obvious, but how many of us actually do this?

This powerful technique applies equally to the leader of a quality management system as it does to a Fortune 500 CEO. This is a rhetorical question, but really, how often do we go out on the shop floor and just observe what is going on? I don’t mean tracking down orders and making sure people are working, but how does the facility look? Do the workers look happy? What are they saying? Are we working smart or overcompensating by working hard? What would I think if I were the customer? You can’t answer these questions sitting in your office!

Contact TRAC

Contact me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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Guerrilla QMS Tactic 6 to Pass any QMS Audit: Train, Train & Train Some More

Williams’ Law 6

If an auditor waits longer than 15 seconds for a response, they will wander around and invariably find something you don’t want found.

Guerrilla Tactic 6: Train, Train & Train Some More

  • Don’t focus on QMS procedural memorization; key is ability to quickly retrieve information from procedure
  • Certified Operator Program
  • Simple Training Records
  • Utilize proficiency tests
    • Demonstrates understanding and competence
    • Rev change recertification
  • Visible training status
    • Make it easy to verify that auditee is trained and certified to task being performed
  • Badge, color coding, training matrix card, etc.
  • Clearly identify Temps and Trainees
    • Auditors will typically not question these employees

 

Contact TRAC

Contact me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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Guerrilla Tactics to Pass any QMS Audit – Tactic 5

Williams’ Law 5

Every time you volunteer something not asked for, you will end up sharing something you don’t want shared.

 

Guerrilla Tactic 5: QMS Audit Tactical Strategies

Don’t volunteer anything!

Teach all employees to:

  • Listen to the question
  • Be polite, courteous & helpful

But…

  • Answer the question, and only the question!

 

Teach it, preach it, and audit to it!

 

Develop a QMS Audit Vacation Policy

  • No vacations for “key” positions
    • Procedure approval signatories
    • Department supervisors/leads
  • Mandatory vacation for “suspect” employees

 

Get In & Get Out

  • Job One is to get the auditor out of each department as quickly as possible!
    • Every manager, supervisor and operator must be proficient at this
    • Efficient, informative, polite, professional
    • Employees must be comfortable dealing with auditors
  • Practice Steve’s 15 Second Time-to-Retrieval Rule
    • Within 15 seconds any operator should be able to:
      • Physically secure procedure
      • Find answer in procedure
      • Provide proof of operation (completed form, history, log, etc.)

 

Teach it, preach it, and audit to it!

 

Contact TRAC

Contact me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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Guerrilla Tactics to Pass any QMS Audit – Tactic 4

Williams’ Law 4

Find your own dirty laundry.

 

Guerrilla Tactic 4: Internal Audit Strategy

While a robust Quality Management System (QMS) internal audit system is a bit of a given in a good quality program, there are some strategies that, if employed, will provide a number of intangible benefits during any quality systems audit.

The key with audits is to find your own dirty laundry; you don’t want your customer/registrar to find things that you should have discovered during internal audits. The other “soft” benefit of audits is that every single one is an opportunity to properly condition the workforce. It is easy for the management representative or department supervisor to have all the right answers, so encouraging auditors & customers to interact with the employees actually doing the job will demonstrate the strength and competency of the workforce, and the quality management system. The internal audit program should be used to help condition employees to be comfortable in this situation.

  • Audit trainer should be formally “lead-assessor” trained
  • No “conflict of interest” auditing
    • Cannot audit your own process
  • Train auditors to “see as the customer sees”
  • Complete system cycle each 6-months
    • Calibrate with 6-month surveillance audits
  • Closed-loop follow-up audit for findings
  • Develop procedure specific audits
  • Integrate common system level questions into every audit
  • Audit employees ability to recite the Quality Policy and Battle Cry
  • Audit line workers, not supervisors
    • Supervisor can assist, but not answer for employees

 

Contact TRAC

Contact me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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Guerrilla Tactics to Pass any QMS Audit – Tactic 3

Williams’ Law 3

First Impressions Count!!!

Guerrilla Tactic 3: QMS Visual Management

The Japanese word for visual controls is Andon, and QMS visual management is a key to success in any system. One of the mistakes many organizations make is to cultivate an environment of secrecy when it comes to organizational performance, as if this knowledge is dangerous to share with employees. Quite the contrary is true; displaying accurate, timely metrics on a Visual Management Board will both engage employees and instill a sense of ownership in the company’s performance.

Key visual management metrics:

  • Quality goals
  • Revenue
  • Internal quality defects/yield
  • External customer returns and survey results
  • Kaizen Events
  • SPC data
  • 6S successes
  • PIT Crew activity and successes
  • Continuous Improvement Awards
  • Rally schedules, minutes, pictures
  • Audit (customer visit) schedules

Contact TRAC

Contact me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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Guerrilla Tactics to Pass any QMS Audit – Tactic 2

Williams’ Law 2

When things are fun, things get done!

Guerrilla Tactic 2: Make it fun!

QMS: Why Make It fun?

  • Fun is free
  • Fun enhances communication & builds relationships
  • Fun makes people want to perform well at work
  • Fun energizes creativity and problem-solving abilities
  • Fun pleases customers, team members, and co-workers
  • Fun makes boring tasks easier to do
  • Fun breaks down enormous undertakings into manageable tasks
  • Fun lets people relax and perform better while under audit/customer pressure

Develop A Battle Cry

  • A common theme for the Quality System
  • Hold a contest to develop the Battle Cry
  • Memorize along with Quality Policy
  • Print it on T-Shirts
  • Put it on posters & plaques
  • Give out as ISO rewards
  • Wear during major audits/customer visits

Benefits of Making It Fun

Customer’s Notice Employees that:

  • Enjoy their job
  • Like their company
  • Embrace the quality policy
  • Believe in the culture
  • Talk the talk, walk the walk

Contact TRAC

Contact me to start our Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com

 

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