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Your QMS can help you understand your customers! (pt 1)

Understanding your customers may seem like a no-brainer, but talking with company leaders across various industries the past seven years demonstrate just how difficult this can be in practice. One of the newest requirements to both ISO 2015 & AS9100 2016 is expanding the whole concept of who is a customer. The traditional definition of a customer is organizations that pay us for our product. The new requirement is to define the “Interested Parties” to the business, and to identify what their needs are.

Interested Parties are defined as any party that has an interest in how your company performs. This includes traditional customers, but also adds parties such as owners/stakeholders, employees, suppliers, banks, and the community. Only parties that have an interest in how your company performs and impact the QMS need be examined, although this should be a very short list. Because, as I preach to my clients, a “B” can be functionally swapped out for the “Q” in QMS as it is actually a Business Management System for the entirety of the organization.

How can this help? Excellent question, because any requirement comes with the expectation that something must be done. A simple analysis at the next management review meeting will suffice, using a tool such as my attached Interested Parties Worksheet. Refreshing this activity then becomes an annual exercise.

Stand by for Part 2, and contact me to help with your Interested Parties analysis

920-841-3478

Steve@tracQMS.com

www.tracQMS.com

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American Standard Circuits Recertified to AS9100D & ISO 9001: 2015

PRESS RELEASE

The Right Approach Consulting

September 19, 2019

West Chicago, IL

Congratulations to client American Standard Circuits, who have received their 3-year recertification to AS9100D & ISO 9001: 2015 from certifying body Intertek. The company continues to realize performance improvements as the QMS matures and evolves to support the rapidly growing company.

CEO Anaya Vardya commented:

“It is critical to maintain our quality certifications for a couple of reasons. First, the customers we serve are some of the most demanding in the business, and our certifications  are mandatory to retain their business. Second, with the complexity of the advanced technology we produce daily, we just can’t afford mistakes and our QMS gives us the structure and discipline to minimize them.”

About American Standard Circuits

American Standard Circuits (ASC) prides itself on being a total solutions provider, manufacturing quality rigid, metal-backed, RF/Microwave, flex, and rigid-flex PCBs for the medical, automotive, industrial, defense, and aerospace markets in volumes from test and prototypes to large production orders. ASC has the expertise to provide a wide variety of technologies in a time-critical environment.  Their qualifications include AS9100 Rev D, ISO 9001:2015, MIL-PRF 31032, MIL-PRF-55110, MIL-PRF-50884 certification and ITAR registration. American Standard also holds many key patents for metal bonding processes. For more information about American Standard Circuits services or to ask one of their technology experts a question, click here.

To download American Standard Circuits eBook, “The Printed Circuit Board Designer’s Guide to Flex and Rigid-Flex Fundamentals” visit their download site here.

To download American Standard Circuits eBook “The Printed Circuit Designer’s Guide to Fundamentals of RF/Microwave PCBs” visit their download site here.

 

 

 

 

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SMT Engineering achieves ISO 9001: 2015 Certification with a perfect audit!

PRESS RELEASE

The Right Approach Consulting

September 5, 2019

Appleton, WI

SMT Engineering achieves ISO 9001: 2015 Certification with a perfect audit!

I am proud to announce that client SMT Engineeringhas received certification to ISO 9001: 2015 from certifying body Verisys. The company made the decision to differentiate themselves from other design services by pursuing ISO certification, and their hard work was rewarded with a perfect audit. This was a particularly noteworthy accomplishment as the QMS was developed from scratch and had no existing certification as a baseline. Greg Goltz (Director of Engineering), Steve Spelbring (Sr. Hardware Engineer and Rachel Maslanka (Engineering Project Specialist) embraced the challenge and engaged the entire organization in the effort.

Director of Engineering Greg Goltz stated:

“On behalf of SMT Engineering, I want to thank you for your knowledgeable insight, guidance, and patience during our recent ISO journey.  I am happy to report the hard work paid off as we have obtained our ISO-9001, 2015 certification last week and our audit could not have gone smoother.  I know we spent a significant amount of time working on our process documents and your expertise was well worth the investment. Our first audit had no major or minor findings, but we did receive a number of very positive observations. 

We started this endeavor trying to develop the process documents on our own, but quickly determined we could not accomplish this without external help and you came to us as a highly recommended industry resource.  Thank you again!  I will definitely use The Right Approach Consulting for future work and will gladly recommend your services to anyone that wants to obtain ISO Certification.”

About SMT Engineering

SMT Engineering is a leader in the Electronic Design Engineering Services industry by providing leading edge product design and development solutions. Electronic Design Engineering Services are performed as an extension of customer capabilities and include both a la carte services and full turnkey engineering solutions. Services include design of hardware, firmware, software, PCB layouts, product verification, prototypes, and production test solutions.  Their Engineering Services guarantees the customer retains all intellectual property (IP) and design ownership including electronic documentation and design files.

For more information, they can be reached through their website http://www.teamsmt.com/solutions/#engineering

 

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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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