Consulting Blog

New IATF 16949 Documented Policies and Documented Processes

3 Documented Policies required by IATF 16949:2016
#     Clause     Requirement
1      5.1.1.1       Corporate Responsibilities policies, including (minimum)
                         a.    Anti-bribery Policy
                         b.    Employee Code of Conduct Policy
                         c.    Ethics Escalation (“whistle-blowing”) Policy
2      5.2.1        Quality policy
3    7.5.3.2.1     Record Retention policy


21 Documented Processes required by IATF 16949:2016

#    Clause        Requirement
1    4.4.1.2       Product safety
2    7.1.5.2.1    Calibration/verification records
3    7.2.1    Competence - supplemental
4    7.2.3    Internal auditor competency
5    7.3.2    Employee motivation and empowerment
6    7.5.3.2.2    Engineering specifications
7    8.3.1.1    Design and development of products and services – supplemental
8    8.3.3.3    Special characteristics
9    8.4.1.2    Supplier selection process
10    8.4.2.1    Type and extent of control - supplemental (outsourced processes)
11    8.4.2.2    Statutory & regulatory requirements
12    8.4.2.4    Supplier monitoring
13    8.5.6.1    Control of changes - supplemental
14    8.5.6.1.1    Temporary change of process controls
15    8.7.1.4    Control of reworked product
16    8.7.1.5    Control of repaired product
17    8.7.1.7    Nonconforming product disposition
18    9.2.2.1    Internal audit program
19    10.2.3    Problem solving
20    10.2.4    Error-proofing
21    10.3.1    Continual improvement - supplemental
 

 

Strong Correlation between Project Management and ISO 9001:2105

Strong Correlation between Project Management and ISO 9001 2015Our General Manager US and Managing Director SA had the pleasure of giving a presentation to The Citadel on Project Management and its correlation to ISO 9001:2015. It was great information and bridges the gap between the two. We thought you would like to see the presentation as well. Please feel free to download the PDF of the presentation slides here.

As always if you have any questions or would like to find out more about how Concentric can help your organization don't hesitate to contact us at info@cmsicharleston.com.

ISO 9001:2015 May Webinar is now posted

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry specific (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

ISO 9001:2015 Forum - April Webinar

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001). If you want to attend for ISO 9001:2015 - May Webinar register here.

Lean Healthcare: Standard Work is Not So Standard

Lean Healthcare Standard Work is Not So StandardIn lean healthcare, it’s amazing how often standard work is missing. Observe the workers and note the variability of the processes. One shift does a task a certain way or an individual has developed their own technique; this variability in healthcare at times is seen as a badge of pride and honor. There are areas in healthcare where individuality can shine but in many areas, standard work should be imperative. One example of process variability that should have a healthcare facility concerned would be the sterilization/instrument decontamination area. If this area cannot produce a written standard work, then the instrument cleaning process more than likely is only as good as the last trainer. That should concern the surgeon as well as the whole operating room staff. Things as easy as labeling blood vials could use a standard work. Do you circle the date or write the date? Does the collector put three initials or just two? I bet most would say that’s all common sense, but do a Gemba and observe the variation. If there is a lot of variation in the simple but important tasks of labeling vials, then it can be assumed variation exists at some magnitude for the more difficult tasks of the decontamination process. Maybe its time to evaluate or start creating standard work. So how does the standard work get developed? One way is to research best practices.

  1. Write the standard work: By putting it in writing, it is more likely to become the standard and remain the standard.
  2. Train to standard work: No more as good as the last trainer. It’s the standard!
  3. Post it: You do not want, “out of sight, out of mind.”
  4. Audit: It enforces, “It’s the standard.”

Have the staff and subject matter experts involved from the start, writing the standard work. Communicating the “why” is paramount when developing and sustaining the standard work. Minimizing process variability which leads to process predictability is great for the patient, the provider and the payer.

Once the variability is gone, then true continuous process improvement can start.

Concentric has SMEs in Quality Healthcare so if you are looking for a healthcare quality assessment or training in lean in healthcare please feel free to reach out and see how we can help.

Risk-Based Thinking with ISO 9001:2015

Risk Based Thinking with ISO 9001 2015, AS9100, riskIts projected that starting late 2015 many organizations (thru the quality professional) face the prospect of installing a risk management process into their ISO 9001:2015 quality management system. There are several questions to be answered: [bulletlist]

  • What is risk-based thinking?
  • How extensive does it have to be?
  • How much more work will this be?
  • Could I do this quick enough?
  • How do I get started?

[/bulletlist]

How extensive does it have to be?

Risk-based thinking will be new for ISO 9001:2015. In the aerospace industry, risk-based thinking has been required as a part of the AS-series of standards for years. The federal government and NASA also have standards addressing risk management. The AS9100 standard does not specify how to implement a risk management process.

How much more work will this be?

Actually, risk-based thinking could prove to be a very valuable process for your company. Risk entails a probability and impact of a loss or gain. Some useful risk publications include:

[bulletlist]

  • ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk.
  • (Sept, 2012). NIST Special Publication 800-30 revision 1: Guide for conducting risk assessments.
  • Project Management Institute. (2013). A guide to the project management body of knowledge (PMBOK Guide
  • Prichard, C., & Tate, K. (2013). The risk management memory jogger.
  • ISO Guide 73:2009, Risk management - Vocabulary complements ISO 31000 by providing a collection of terms and definitions relating to the management of risk.
  • ISO/IEC 31010:2009, Risk management – Risk assessment techniques focuses on risk assessment.

[/bulletlist]

Can I do this quick enough?

Get started now! There have been some articles on risk-based thinking in Quality Progress (ASQ magazine). See Palmes, P. (Sept 2014). “A new look: 15 things you must know about the upcoming ISO 9001 revision”. Also, there are opportunities to network with experts through ASQ section meetings and through webinars.

How do I get started?

Seek advice from your Registrar about how they are directing their auditors to assess risk. You may want to write a new risk management procedure containing the concepts and body for a risk-based thinking process. It should follow the steps of the standard you want to use, such as NIST SP80-31. (The NIST standard and NASA procedures/ standards are free to the public.)

There will be more blogs on details of risk-based thinking to follow. Of course, Concentric is in place to be the external resource for you to succeed in implementing a good risk-based thinking process. For Glenn's full article register for our upcoming ISO 9001:2015 Forum - January Webinar. You can get update on all the changes including risk-based thinking. Register online here.

Lean: A Prescription for Improved Healthcare

Lean HealthcareBased on the common symptoms of waste, delays, errors, redundancy and lack of employee engagement, Healthcare has begun looking to “Lean” methods for the solution. The symptoms were exacerbated with changes in financial reimbursements, the public reporting of quality measures, social media, and the need for employee engagement in healthcare as well as the growing demand from consumers for a better product. For healthcare organizations to remain competitive in the coming years, lean as the treatment plan must become the culture to allow healthcare to flourish. Optimizing financial reimbursements can be thought of as the lifeblood of the healthcare industry. In the past, reimbursements were based on volume without regard to outcomes and often at a higher price. Studies have shown that higher prices for a procedure do not translate to better outcomes. Some practitioners refused to use “Best Practices” because standardization of treatment had not been established and the services were disjointed or described as siloes. For certain diagnoses, if an individual was hospitalized a second time in less than 30 days for the same illness, reimbursement for the second hospitalization maybe denied. All this changed when reimbursements from some payers were established based on best practices and outcomes.

Over simplified but the point remains, for best outcomes the treatment must be standardized, coordinated and thorough with a clear plan after discharge. Without these lean principles in place the financial losses quickly accumulate. Currently, the discharge plan should start the moment the patient is admitted to decrease the chance of a readmission. The lean approach includes such things as checklists, decrease delays in starting antibiotics, standardizing treatments to include best practices and following a plan on discharge that includes access to their treating physician with minimal delays. This is good for the payer, good for the hospital and great for the patient.

Also, Medicare requires public reporting of certain healthcare metrics. These metrics measure a patients’ perspective of their hospital care, if care was timely and effective, as well as the readmission rates for specific diagnosis and certain complications. Having the information available to the consumer encourages more informed decisions and the ability to shop for healthcare based on the metrics. Currently, payers and vendors are probably the biggest user of this information. Consumers will be slow to change but change will occur. Using standardize processes, eliminating waste and utilizing the voice of the customer tools will enhance the metric scores and make it a truly patient centered experience.

Reported metrics for hospitals can be found at www.medicare.gov/hospitalcompare.

Similar to most other industries, social media has become relevant. A large portion of the population admits to using social media to guide choices of physician and/or hospital. Wait times, duplication of questions and poor quality provides the substance for social chatter that can reach hundreds of people in a short length of time. Through scripting, eliminating waste and focusing on the value added services, consumer chats turn to recognition of exceptional service. Defining exceptional service should be a priority in the continuous improvement process.

Marketing says, “no one ever remembers the status quo,” so plan to excel to get noticed because people talk and they talk on social media.

Finally, employee engagement can determine the success of Lean. Research shows that increasing employee engagement has a direct correlation on the quality of service. A facility looking to increase quality because it leads to higher reimbursement and increased customer happiness would seem to be a “no brainer.” Lean provides the mechanism for employees to contribute, problem solve and align to the values and expected behaviors of a facility.

[Tweet "“Lean” appears to be right treatment plan for the healing of the healthcare industry."]

As with any treatment plan, the user must determine if it’s right for them. If waste, delays, duplications and poor work practices are evident on your next visit to a healthcare provider, then you might want to ask if this is the right facility for you or is this a “Lean” job opportunity.

A lean practioner should be hearing the chants of process mapping, voice of the customer, waste elimination, standardizing, scripting, checklist and many other lean tool opportunities. All of these lean tools lead to increased reimbursements, better publically reported healthcare scores, better social chatter and improved engagement of employees.

ISO 9001:2015 Changes: What It Means for You

ISO 9001, ISO 9001:2015, new standards, international standard changes, change management, planning for change, leadership, tips for preparing for change, QMS changes, quality management, quality systems By now, you’ve surely noticed the buzz around the upcoming changes to ISO 9001. ISO 9001:2015 is projected to be approved and released in Q4 of 2015. If you haven’t heard the buzz, then perhaps you need to subscribe to a blog or two, pick up Quality Digest or raise your head a bit from the rock you’ve been hiding under! All rocks aside, this revision looks to have several significant changes to the standard including the overall structure, basic terminology as well as what is NOT going to make the cut for the new release.

What you can do to start preparing now.

The reality is quite simple. Change happens whether we like it or not. Markets change. Businesses change. Customers change. Nearly everything changes. Most of the time we hate change. Our brains are just programmed that way. We don’t like what we don’t know, but we know what we like. As quality practitioners in particular, our job as change agents tend to be easier when WE are driving the change versus times when we are being asked to change ourselves.

This round of ISO 9001 revisions will undoubtedly be the most significant change to international QMS standard in the past 15+ years. We have seen a draft that gives a little understanding of what to expect with the changes ahead (ref. http://www.acommoncenter.com/iso9001_2015). But what are you doing with the proposed changes, if anything? Are you preparing your organization’s risk management efforts through the use of tools such as the FMEA? What is the appropriate amount of control needed for any process that effects the customer or “other interested parties” (do you know what that means)? Have you appropriated defined expected process outputs by ensuring proper management of customer-specific requirements?

I encourage you to set aside 30 minutes to review this Google+ Hangout video titled ISO 9001 revision - Conversation with Nigel Croft. Mr. Croft is the Chair of the Subcommittee revising the ISO 9001 standard (aka “the horse’s mouth"). Watch the YouTube video here.

Our philosophy is that it is better to be proactive than reactive. While we don’t currently know all of the requirements that will make the final cut, we do have several opportunities to begin to be proaction with the changes ahead. It is at least time to start discussing potential changes to the requirements in order to think strategically about potential impacts and resource needs over the next 3-5 years.

What are some of your thoughts on these big ISO changes that are being proposed in the current draft? How are you preparing for these proposed changes? Let us know in the comments and share with the community. And if you are interested... keep up to date with our upcoming forum and online discussions in September.

Writing a Nonconformance (NCR)

NCR can find broken processes and really help with profit improvement "A problem well stated is a problem half solved." - Charles F. Kettering, American Inventor & Social Philosopher

The first step in solving a problem is to ensure you fully understand what the problem actually is. I regularly see horrible examples of this in practice inside some of the companies I work with. One classic example was in Atlanta, GA a few years ago. Here is the scenario...

Operations Manager: "What the h@!! is going on? Logistics has dropped the ball again! Our #1 line is down because they can't get their heads out of their a$$e$ and keep up with ordering the resin we need. This is our biggest customer!"

The scenario, at least in the mind of the Operations Manager, was that the Jack-Wagons working over in the Logistics Department simply couldn't count. I didn't buy it. In this case, as in most cases where suppositions seem a bit unlikely, I decided to do something I typically do during an audit - walk the audit trail by following the process upstream. This seems like such an obvious move... 1. There's a problem. 2. Walk the trail to find out the source. 3. Ask questions and "show me, show me, show me". HOWEVER, in many organizations, the minute an employee crosses the line into another department he/she is outside of their home turf. A defensive culture will likely breed a departmental approach (staying in your own neighborhood) versus a process approach. If you are not familiar with the process approach, you can learn more about this methodology here from a March 2011 post.

After walking the trail and crossing the territorial boundaries of Production into Scheduling and on to Logistics, I was able to trace back the material in the ERP system with the status "On Hand" and location "Op 120" -  which was the Molding Operations where I had started my hunt. After circling back around to the Operations Manager and hearing another string of Logistics bashing, I started to do some real snooping in the surrounding areas.

Standing at what I'd like to call the base camp of "Mount Unknown Product", I rolled up my sleeves like a eager bidder on Storage Wars and sifted through stacks of components, raw materials and residual miscellaneous. No luck there, although I noted the lack of control and visited that area later in the audit. After asking several questions of several Molding Operators, one of the ladies jumped in with "Oh yeah, that's probably that skid over there in the corner." Sure enough, the skid we were looking for was off in the corner with a simple 2"x2" yellow sticky label on it marked "BAD PRODUCT".

After pointing out to the Operations Manager that the source of the problem was likely one of his team members as opposed to those fools in Logistics, I asked him to consider a better solution. I then pointed out how I would be writing a Nonconformance Report for this finding, and how my nonconformance statement would clearly define the problem at hand. I jokingly stated, "If you want, I can write this NCR in a similar way as that sticky note? I can simply write 'Bad Process' and let you try to remember what I actually meant." He didn't think it was funny.

There were several missing links to the materials and inventory control process I observed during this audit; none that included someone coming to work deliberately trying to screw things up. Links that were obviously broken were the identification of product, controlling suspect or known nonconforming product, use of approved documentation and recording the instance of a nonconformity. An important transactional control was also missing, which was the signal used to notify Logistics that the parts were now unavailable. That signal should have been an ERP move from "Op 120" to "Op 120 Hold". That move to Op 120 Hold would have signaled the Logistics group to order another batch of components in order to keep the customer's order moving forward.

At the end of the day, the use of a simple 1-page Nonconformance Report (NCR) that forces the Originator to follow a simple process checklist (i.e. Yes/No - Did you move product out of IN PROCESS into a PRODUCT HOLD Operations?) may have prevented a late shipment. By the way, the company's poorest performing KPI (key process indicator) was "% On Time Delivery". This KPI was also tied to their variable compensation profit sharing process.

Nonconformance Report (NCR)

Here is an example of a simple NCR Form that may be useful in improving YOUR bonus payout. Click on the image to launch the product and view the PDF or download the native version. Who would have thought a simple form could make your customer and your wallet happier?

Cheers,

Jim Blog Signature

Improving Your Corrective Action Process

If I had to pick one area to focus on within all of the hundreds of management systems I’ve audited over the past 19 years, I would definitely choose the corrective action process. From my experience, and the war stories I hear from other auditors and quality professionals, most organizations just don’t get it. What makes this circumstance even worse is when management insists on “More audits! More Audits! MORE AUDITS!!!” while doing little to nothing about the previous audit findings, repeat customer complaints or piles of supplier issues. That would be similar to handing out tickets for traffic violations with no means of collecting money for fines. (Note: I’m not suggesting that auditors are Police officers.) Here are 10 questions you may want to consider to help improve your procedure for handling nonconformities (actual or potential) and corrective actions as first steps to improving your corrective action process.

1. Are the roles within your corrective action process defined? The following list of roles is a good place to start. Document these roles, ensure these roles are clear and understood, and document them in your written procedure.

[bulletlist]

  • Originator
  • Assignee
  • Sponsor or Process Owner (if different than Assignee)
  • Problem solving group team members
  • Review Board
  • Approver
  • Evaluator or Effectiveness Checker

[/bulletlist]

2. What are all of the sources of your nonconformities? List them out using the following categories as a guide (think “CIS” with a stutter):

[bulletlist]

  • Customer complaints – External Customers (includes campaigns, field returns, warranty issues, service reports, etc.)
  • Customer complaints – Internal Customers (sister plants, corporate office, etc.)
  • Internal Product Nonconformities
  • Internal Process Nonconformities (all management system processes apply, not just production)
  • Suppliers – Internal Suppliers (sister plants, corporate office, etc.)
  • Suppliers – External (goods & service)

[/bulletlist]

3. How are these various nonconformities initially captured?

[bulletlist]

  • Is there a single depository for collecting all types/sources of nonconformities (recommended)?
  • Are there multiple tracking tools for capturing the various types/sources of nonconformities (not recommended)?

[/bulletlist]

4. How are nonconformities reviewed and ranked in order to analyze severity, trends or systematic failures?

[bulletlist]

  • How severe is the occurrence of a single nonconformity (1X)?
  • How often does this nonconformity occur (1X, 15X, 23056X)?
  • If nonconformity X “snuck into your facility”, how likely would you be to detect its presence vs. passing it along to the next process or customer (1X = easy to detect and 10X = impossible to detect)?
  • Note: Some organizations use a formal ranking system for severity, occurrence and detection to provide an actual score for how risky or significant the nonconformity is or could be. Want to learn more about this approach? Read our FMEA blog.

[/bulletlist]

5. When are nonconformities escalated in order to eliminate the cause to prevent recurrence of the issue via a formal corrective action request or a project (i.e. formal CAPA, major capital project, 6S project, Problem Solving Group, Value-Stream Mapping, etc.)? How does this escalation process work? Who studies the business impact of X and decides which course of action should be taken?

[bulletlist]

  • Do you have a Nonconformity Review Board (NRB)?
  • Is the escalation automatically based on a scoring system (see item #3 above)?
  • How do you ensure there are not duplicated efforts or assignments? (18 CARs issued to the Purchasing Manager for the same issue is like telling your kid she’s grounded 18 times. One “grounding” should cover it.)

[/bulletlist]

6. What type of progress tracking mechanism is used to ensure clear assignments, appropriate deadlines, progress tracking, etc.? At a minimum, this progress-tracking tool should include:

[bulletlist]

  • Serial # (unique identifier)
  • Source of the nonconformance
  • Assignee
  • Short description of the issue
  • Expected due date
  • Date done
  • Progress indicator (i.e. % complete)
  • Additional comments field

[/bulletlist]

Ensure the tracking tool is visible and highlights those items that are on schedule, approaching a due date or past the expected due date. (Note: I like red/yellow/green indicators).

7. What types of problem solving tool(s) is/are used in order to clearly identify the root cause?

[bulletlist]

  • Does your problem solving group facilitator know how to properly use the prescribed root cause analysis tool?
  • Are there multiple root causes considered in the tool being used?
  • Can data be captured to support the root cause(s) analysis conclusion such as % of contribution (i.e. P-value, Pareto, Histogram, etc.)?

[/bulletlist]

8. How are necessary actions determined and assigned during the problem solving process?

[bulletlist]

  • How is progress reported? (Note: Generally, I would recommend a macro view and top 3 micro view weekly in a top management meeting.)
  • How are assignees of action items notified?
  • Is there a process for acknowledging the action assignments in a timely manner?

[/bulletlist]

9. How is corrective action(s) taken reviewed to ensure it has been effectively addressed?

[bulletlist]

  • Verification by the assignee or the applicable Process Owner (must be done first)
  • Verification by the Assignor, Originator or via the Internal Auditing Process (must be done second)
  • How is long-term effectiveness evaluated? Consider giving each incident an “effectiveness grade” based on the overall method and evidence. The grade level should be directly proportional to your confidence level in the failure mode never showing its ugly face again.

[/bulletlist]

10. How is the problem solving process documented and recorded for future reference?

Has the initial tracking tool described in item #2 been updated?

Are results of the “Lesson’s Learned” available and shared with other areas, sister plants, stakeholders of similar goods, services or processes within your organization?

[bulletlist]

  • Has the action to prevent future occurrence been monetized?
    • What is the cost of this instance of the failure mode X (CoPQ or cost of poor quality)?
    • What is the estimated total historical cost of X since inception?
    • What is the value of cost avoidance based on historical costs and future forecasts?
  •  Note: Validate these financial figures by getting input and approval from your CFO, Controller or other Financial Leader.
  • Keep in mind the key to record retention is record retrieval. A good tracking tool with specific codes for each failure mode (i.e. X, Y and Z, etc.) makes future analysis of data much more likely.

[/bulletlist]

Check out The Ultimate CAPA Report below to help you drive the right behavior. Stay posted to future blogs regarding corrective action tools and templates. These will be available on our products store. We also offer CAPA training.

Ultimate CAPA Report

 

Development of ISO 9001:2015

With ISO 9001 and ISO 14001 currently in the development stages for what could be rather significant changes, quality and environmental professionals gather on the fringes to get a sneak peek of what's to come. Before speculating on projected changes, let's first review the process for the development of ISO standards. Stages of Standard Development

  1. New Work Item (NWIP)
  2. Working Draft (WD)
  3. Committee Draft (CD) - Often times there may be CD1, CD2, etc. for multiple drafts
  4. Draft International Standard (DIS)
  5. Final Draft International Standard (FDIS)
  6. Published International Standard (IS), Technical Report (TR) or Technical Specification (TS)

ISO Standards Development SequenceThe current stage in which the ISO 9001 sits is at "ISO/CD 9001" as of June 3rd, 2013. This means that the document is at "CD" Stage (#3), with a due date for submission of comments and votes on this draft by September 10th, 2013. Significant chatter typically means that there could be a second or perhaps even a third round within the committee draft (CD) stage. While the expectations for release in the "IS" phase is in the year 2015 - hence the frequently referenced ISO 9001:2015 - the final release depends directly upon the voting member bodies. Publication as an "International Standard" requires approval by at least 75% of the member bodies casting a vote.

Stay tuned to the updates by registering to attend our free ISO 9001:2015 Forums.

K. Bird, Head Communication & Content Strategies for ISO posts, "Experts continue to meet to discuss any problems or questions highlighted, until a Draft International Standard is published. The draft then goes out for public comment. Anyone who is interested can contact their national member body with feedback on the draft standard. This is likely to take place during the first half of 2014."

With regard to your current use of ISO 9001:2008, Bird continues by saying "We expect to publish the new version of ISO 9001:2008 by the end of 2015. At that point there will be a transition period (usually two years) before ISO 9001:2008 officially becomes out of date."

So what are some of the projected changes that may be significant to you and your organization?

  1. The replacement of the term "product" with "goods and services". For years, service organizations (like Concentric) have felt a bit left out due to the constant use of the word "product". What if you don't have a physical product? This potential change in terminology could help service organizations better understand how ISO 9001 requirements pertain to them.
  2. Context of the term "the organization". There may be requirements to better clarify what "the organization" means as it pertains to the intent of it's offerings, the context of it's offerings, what an interested party might expect from it's goods and services, and how customer needs are defined.
  3. Process approach. This addition may require subscribers to better adopt the process approach by adding requirements that actually use the words "process approach" rather than hiding this intent in a preface or supplemental document such as ISO 9004. No one cares about how great your department is. We only care about how great your process output is.
  4. Risk vs. preventive action. This is the change that we're rooting the most for - with spirit and banter! Most folks don't really understand what the hell "preventive action" is anyway. However, "risk" is fairly well understood. Most companies we work with have hundreds of corrective actions (reactive), but very little evidence to show deliberate and methodical steps for risk reduction/mitigation or emergency preparedness (proactive). In my opinion, this change is welcome and long overdue. It would also allow for a better integration with standards in health, safety, environmental and responsible care management systems.
  5. Documented information. The terms previous referred to separately as "document" and "records" may be replaced by a single term referred to as "documented information".
  6. Control of external provision of goods and services. This potential change may not be as significant to some sectors such as automotive and aerospace, as the requirements for controlling outsources processes have been backed into ISO/TS 16949 and AS9100 for some time now. This potential addition to the ISO 9001 standard would require controls to be in place for all forms of external influences on goods and services. In short, it may be harder to say "Hey... it's my suppliers fault!" once the new standard is released.

Whatever changes do finally come from the ISO 9001 updates, we here at Concentric are very hopeful that the standard encourages organizations and practitioners alike to bridge the gap between the priorities of top management and management system implementers. Developing systems that maximize the potential of any organization is depend on a unified approach to managing individual processes. Having multiple systems, conflicting objectives and a "silo" approach to management is still one of the great challenges of our generation. I am confident that the next release of ISO 9001 will continue to improve management system structure as organizations worldwide continue to strive towards excellence.

Stay tuned to the updates by registering to attend our free ISO 9001:2015 Forums.

Customers Hate You?

Here's a quick challenge and reality check to ring in the 2nd month of 2012.  Take an honest look at your customer-facing processes as if you were the customer.  I'm not talking about "...but our company's internal data for defects per million shows that we're making pretty good parts".  I'm talking about taking a long, hard look at customer perception.  How does your customer perceive the overall quality, service and ease of doing business associated with their relationship with you? Customer satisfaction is not always about facts, figures and statistics.  Sometimes it's all about asking this simple question:  "Dear Mr. Customer - How likely it is that you would actually take the time to recommend me to a friend or colleague?"

Do you measure customer satisfaction by the number of customer complaints you have?

The lack of a formal customer complaint is not a reliable indicator that the customer is satisfied.  Customer complaints are more often a sign that the customer is so extremely dissatisfied that they feel obligated or angry enough to tell you about it.  What about the other portion of customers that simply turn and walk away?  In most business circumstances, by the time a customer has left you, its too late to regain their trust.  You've lost them and they're not coming back.  In fact, there are a certain set of customers that will spend their nights and weekends talking trash about you, your company and their horrible experiences in dealing with your sorry butt.

Ok... now that I've made you feel like a complete loser, let's at least have a little fun here.  Sit back, grab your cup of coffee and feel the pain associated with being a dissatisfied customer.

Want to gauge your customer's perception of you?  Here are some tips and techniques that we've seen work out in the real world:

SIMPLE & LOW COST:  Ask your customer to help you in getting 100% by partnering with you on the solution of 100% satisfaction.  Rather than asking "Is everything ok?", try asking "What would I have to do in order to receive an A+ or 100% rating?"  This approach invites the customer to give you pointers on improvement rather than the traditional invitation for feedback (i.e. "Y'all doing ok?").  By making it an "Us (you and your customer) against them (bad grades)" you create a partnering perspective with your customers in order to solve the puzzle (how to get an A+) together.

MIDDLE OF THE ROAD:  Use a process to measure how likely your customers to "promote" your organization called by using a grading scale called the "Net Promoter Score".  Learn more about this process here:  www.netpromoter.com/np/calculate.jsp

COMPLEX & HIGHER COST:  If you are in an organization that can spare a few more bucks, consider using a product like Online Survey Software from Qualtrics.  It is complex software on the back end but simple for your customers to complete on the front end.  Questionnaires and data from survey results are kept on a cloud for simple analysis, quick feedback on-going monitoring of key metrics.  www.qualtrics.com/survey-software-video

10 Pitfalls in Implementing Management System Software and How to Avoid Them

As the global economy continues to grow, so do customer expectations for higher quality products and services at a lower cost.  In order to satisfy increasing customer demands - and management quick change while growing the bottom line - management system excellence is a must.  Management system software is a key tool in achieving organizational excellence.  However, like any tool, the results of use are only as good as the product’s design in combination with proper project management. Achievement starts with proper planning.  Proper planning prevents poor performance (“The 5Ps”).  The following list represents potential pitfalls based on our real-world experiences that could impact the results of management system software rollout, along with tips on how to avoid these pitfalls.

#1 Pitfall:  Building without the proper blueprint - Organizations rollout new software with a “plug and play” expectation.  Only a portion of the resource needs are considered for initial planning, launch, infant care and long-term maintenance.  Many projects fail due to insufficient resource planning necessary to do the job right.

Avoiding this Pitfall:  First and foremost, you need a strategic plan for bringing this new software tool on-board.  Start with documenting clear targets for cost, quality, delivery and service - just like any other process.  Once the targets have been documented, discuss the reality of these objectives with others that have experience with the product at hand (the software supplier, other colleagues within your industry, internal IT personnel, etc.) and make adjustments accordingly.  Be conservative with your timeline.  Do not start out your project by over-promising and under-delivering.  Allow sufficient time for testing.

#2 Pitfall:  Lack of making a business case - Trying to motivate and modify the behavior of your colleagues using “Because ISO 9001 says so…” or “Because the corporate policy states…” isn’t going to work in the long-run.  Many times, lack of support and progress on a project is due to the assignee’s disconnection to the short and long-term benefits.

Avoiding this Pitfall:  SELL the project to future users.  You must get the attention and support of future users by selling how the product will make their lives better, or by making day-to-day tasks more efficient.  Gather a short list of wastes or difficulties associated with the current method of operation, followed by a demonstration of how this product will improve these difficulties.

#3 Pitfall:  Disconnect with business objects - Coming up with a slogan, motto or other “cheer” may sound great, but how does this high-level goal relate to the applicable members of your team?  Establishing goals without converting these goals into clear objectives - at relevant levels and functions - may lead to groupthink.

Avoiding this Pitfall:  Once objectives and targets have been established, connect these measures to your rollout team members’ work plans.  Create “employee contracts” while ensuring that an adequate portion of each team member’s participation is committed to your project.  Often times, project managers have no authority over their team members.  In order to retain a bit of control and predictability, ensure there is a written agreement supporting the project with a record of management approval.

#4 Pitfall:  Shoving your business into the software box - Each organization has its own culture and rhythm in its day-to-day operations.  A one-size-fits-all solution is very rarely an effective one.  In order to optimize profitability, software must be made to fit the demands of general customer needs.  Trying to abruptly change the language or other basic habits of your organization to align with a foreign product is a quick way to lose buy-in from users and top management.

Avoiding this Pitfall:  The best way to ensure that all parties are on the same page is to have a clear, documented agreement with your software provider.  Ensure the following details are addressed in your contract.

  • Identify who will take care of you by ensuring a dedicated supplier representative(s) is identified for the project.
  • Use your supplier representative to validate the objectives you’ve created to avoid Pitfall #1.
  • Document your training needs and what is needed from your supplier for prototype, pre-launch & production phases.  The best time to negotiate service agreements and potential contingencies, should they be needed, is during the contract phase.

#5 Pitfall:  The Army of ONE (rollout in a vacuum vs. cross-functional team rollout) - Trying to implement change without consideration and perspective from multiple disciplines will often result in negative impacts that were not initially detected.  While process change may benefit one area of your organization, it may hurt or hinder another.

Avoiding this Pitfall:  Clearly define ownership of the product during prototype (if applicable), pre-launch & production phases.  In most cases, the team that is rolling out new software will not maintain ownership in the long run.  Brainstorm with your team using a tool like Fault Tree Analysis (FTA), Cause & Effect (C&E) Matrix or an Ishikawa (Fishbone) Diagram to discuss potential risks associated with software implementation during all phases of use; including an exit plan should the software fail to meet your long-term needs.

#6 Pitfall:  Insufficient testing throughout the realization phase - The software is rolled out too quickly without validating that the product works as it was intended.  System interactions are not completely tested to ensure data integrity remains after manipulation, such as, importing, exporting or communication with other products.

Avoiding this Pitfall:  Define pilot lines/departments that can be used for learning, debugging and other customizations.  Create scenarios based on real-world experiences and use the product in a test environment under various conditions.  Process various scenarios using your current information system and compare the results to your new software solution.

Conduct a measurement system analysis (MSA) to identify any variation from one data entry instance to the next (repeatability) or variation from one user to another (reproducibility).

Finally, spend time analyzing the user experience (customer perception) in order to evaluate simple modifications or areas where more in-depth training will be necessary.  Provide a clear process for user feedback in order to quickly detect and discuss any concerns before they grow.

#7 Pitfall:  No internal sales & marketing of the product - A solution has been created, but very few members of the organization know of its existence.  Communication has been limited on the solution’s capability and how it can benefit the organization, department or individuals.

Avoiding this Pitfall:  Make sure to communicate before, during and after implementation by creating a communication plan for your implementation team.  It is critical that top management be kept in the loop on the progress of the project.  Ask management to allow time on recurring meeting agendas for project updates – good or bad.  Early identification of additional resource needs, small successes and overall project status will give the leadership level of the organization a sense of ownership and responsibility.

Internal postings on communication boards, all-employee meeting presentations, articles in the company newsletters or discussions with smaller targeted teams (focus groups) may also be options to ensure buy-in.

#8 Pitfall:  Improper change management - There is no formal process for making updates to user access or document ownership as employees move within the organization.  Records such as customer complaints, return material authorizations (RMAs), corrective or preventive actions (CAPAs), etc. may lie dormant due to an incorrect electronic assignment.  Without an effective interaction between the software administration process and the human resource management process, document assignments are inevitably going to become inaccurate.

Avoiding this Pitfall:  Connect employee movement to the software administration process.  While Human Resources may be a bit reluctant to provide too many details about personnel shifts, a process for quick change to roles and records assignment can be done with limited sensitive information exchanged.  By adding a member of the HR or Finance groups to your project, a simple process can be created to ensure assignment accuracy of documents.

#9 Pitfall:  Seek customer feedbackThe communication regarding a new or changing tool is a one-way street, giving little or no consideration to the internal or external customer.

Avoiding this Pitfall:  Create a forum(s) for regular feedback from your internal customer (the end user).  Users should be given an opportunity to give honest feedback on their perception of the new tool.  Besides, your users will rely on this new solution as a part of their delay work activities.  Feedback should also be solicited from internal administrators or advanced users to ensure that the back-end is running efficiently, reports are easy to create and problems are resolved in a reasonable manner.

#10 Pitfall:  Lack of a long-term control plan for sustainability and continual improvement - A software solution has been adopted, but there is inadequate planning or resource allocation for maintaining the tool.  Without a caretaker and plan to improve the functionality over time, users inherently seek out shortcuts or other solutions.

Avoiding this Pitfall:  Initial project plan should consider recurring development, refresher training and improvement forums.  Like any asset, there is a cost associated with maintenance and improvement.  Most software products include occasional upgrades, bug fixes and other enhancements.  By documenting long-term maintenance activities and responsibility, the product is more likely to be utilized to its full potential.

In conclusion, an organization’s chance of achieving or surpassing their objectives is higher with a proper plan for software rollout.  Beware of the pitfalls.  These pitfalls are not new.  Embracing lessons-learned from experienced team members or other organizations is critical to minimizing failures.  Be honest about your resource needs, particularly team member availability.  Regular monitoring of your objectives versus actual performance will ensure you get the most out of your investment.

---

CMSi recommends CEBOS and it's product MQ1 for your management system needs.  Learn more at www.cebos.com.

Satellite or Baseball?

Does your management system look like a satellite or a baseball? The following question is meant to challenge management system professionals and their respective organizations.  How are you using your management system?  Is your management system being used as the foundation within your organization to build control, predictability and improvement processes for total performance optimization?  Or is your management system simply a "satellite" that hovers around the organization occasionally communicating back to planet earth?

The following short presentation can be used to prompt these questions and explore the whether you are meeting the INTENT of registration processes such as ISO 9001, ISO/TS 16949, AS9100, etc.

Presentation: Http://www.acommoncenter.com/wp-content/uploads/2011/06/asq-presentation-satellite-or-baseball-6-28-11.ppsx

Assessment Worksheet:  Http://www.acommoncenter.com/wp-content/uploads/2011/06/priorities-gap-assessment-6-28-11.docx

Lean Documentation

I was asked an interesting question this week from a colleague.  "Should I start over from scratch or fix my current mess of documents?"  This seems to be a theme lately that many of us are seeing.  I'd like to think of it as a very good question and a sign of good things to come.  When businesses start asking questions like this, my hopes are that they are no longer fighting to stay alive, but now in a mode to fight.  I'm hoping this by asking this question, a key player in an organization is taking his or her initial steps towards a lean document system that allows for quick reference to key documents, rather than system that is comparable to a needle in a haystack.  Now on to the answer I gave... At the most fundamental level, you need to start with standard requirements and/or the intial intent of documents.  What is the purpose?  What do you want to get out of these organized bits of words and wisdom?

Unless there is a special business requirement from a Customer, organizations need to keep in mind that every document created comes at a cost.

I see organizations on a regular basis with hundreds or thousands of different documents claiming to be of value.  Past experience with a "say what you do, do what you say and document it" approach sometimes makes one blind to the original intent.  As an example, ISO 9001 only requires 6 documented procedures. Unless there is a special business requirement from your Customer, organizations need to keep in mind that every document created comes at a cost. The cost can add up quickly in two ways - cost of maintenance and cost of distracting from (or "watering down of") more important documents.

Start at the highest level possible and create a blank slate for storing the Top 20 procedures (or whatever number makes sense that is less than 20). The "blank slate" could be a fancy database or literally a BLANK SLATE.  From there, clear ownership needs to be assigned for each document, ideally adopted and maintained by each actual process owner within the organization.  Secondary procedures, instructions, forms, etc. can be referenced from there.  We strongly recommend that each document, at all levels, have a parent procedure that is tied back to a specific requirement or business need.  (The preference is a link back to the business need such as a business plan line item or corporate guidance manual.)

Like any 5S exercise, the orphan documents without a home or business need should be sorted out and archived so the valuable documents have the best chance to be used as the valuable business tools that they are.

Problem Solving Workshop

Concentric offers a state-of-the-art Problem Solving Workshop that can be used to both train employees on problem solving tools/methods while also solving the organizations most troublesome problems.  This is an outline for the 40-hour workshop:

 

Outline for Team Problem Solving Workshop

1.    The PDCA Cycle 
2.    Form a Team 
    a.  Who should be on the team?
    b.    How the team should be organized
    c.    The Team Leader
    d.    Responsibilities of team members
    e.    Consequences if this step is skipped
3.    Define the Problem 
    a.    Using the 5W2H method
    b.    Tools to use
    c.    Determining if the problem is related to measurement (MSA) or process 
    d.    Consequences if this step is skipped
4.    Containment Action 
    a.    Protecting the customer
    b.    Validating the action
    c.    Verify that the containment action works
    d.    Consequences if this step is skipped
5.    Find the Root Cause: Tools and Techniques 
    a.    Tools to use (Ishikawa “Fishbone” Diagram, Brainstorm & Rank)
    b.    The 5 Why’s - Ask why five times
    c.    Is/Is Not Tool
    d.    Consequences if this step is skipped
6.    Corrective Action 
    a.    Action, responsibility, due date
    b.    Verify that the corrective action effectively addresses the cause(s)
    c.    Improve the quality system by looking at all aspects of the quality system 
    d.    Consequences if this step is skipped
7.    Evaluate effectiveness & Corrective Action Impact 
    a.    Monitor/Evaluate long-term effectiveness
    b.    1st Piece verification + Last-off comparison
    c.    Process audits
    d.    Application of actions taken to similar products or processes
    e.    Consequences if this step is skipped
8.    Preventive Action 
    a.    What is preventive action (vs. corrective action)?
    b.    Preventive action tools & techniques
    c.    Use of C&E Matrix to prioritize by highest risk
    d.    Deep dive into FMEA
9.    Management Review 
    a.    How to structure a follow up meeting
    b.    Reporting the status of Corrective & Preventive Action
    c.    What should management review?
    d.    Consequences if this step is skipped
10. Improving the Problem Solving Process
    a.    Using PDCA to improve the Team-based problem solving process
    b.    TGR/TGW Analysis
    c.    Evaluating the tools & techniques used
    d.    Reporting results to top management
    e.    Evaluating management commitment
    f.     Updates to procedures
    g.    Identification of new training & competency needs
    h.    Other resources needed for continual improvement

Problem Solving Workshop

Concentric offers a state-of-the-art Problem Solving Workshop that can be used to both train employees on problem solving tools/methods while also solving the organizations most troublesome problems.  This is an outline for the 40-hour workshop:

 

Outline for Team Problem Solving Workshop

1.    The PDCA Cycle 
2.    Form a Team 
    a.  Who should be on the team?
    b.    How the team should be organized
    c.    The Team Leader
    d.    Responsibilities of team members
    e.    Consequences if this step is skipped
3.    Define the Problem 
    a.    Using the 5W2H method
    b.    Tools to use
    c.    Determining if the problem is related to measurement (MSA) or process 
    d.    Consequences if this step is skipped
4.    Containment Action 
    a.    Protecting the customer
    b.    Validating the action
    c.    Verify that the containment action works
    d.    Consequences if this step is skipped
5.    Find the Root Cause: Tools and Techniques 
    a.    Tools to use (Ishikawa “Fishbone” Diagram, Brainstorm & Rank)
    b.    The 5 Why’s - Ask why five times
    c.    Is/Is Not Tool
    d.    Consequences if this step is skipped
6.    Corrective Action 
    a.    Action, responsibility, due date
    b.    Verify that the corrective action effectively addresses the cause(s)
    c.    Improve the quality system by looking at all aspects of the quality system 
    d.    Consequences if this step is skipped
7.    Evaluate effectiveness & Corrective Action Impact 
    a.    Monitor/Evaluate long-term effectiveness
    b.    1st Piece verification + Last-off comparison
    c.    Process audits
    d.    Application of actions taken to similar products or processes
    e.    Consequences if this step is skipped
8.    Preventive Action 
    a.    What is preventive action (vs. corrective action)?
    b.    Preventive action tools & techniques
    c.    Use of C&E Matrix to prioritize by highest risk
    d.    Deep dive into FMEA
9.    Management Review 
    a.    How to structure a follow up meeting
    b.    Reporting the status of Corrective & Preventive Action
    c.    What should management review?
    d.    Consequences if this step is skipped
10. Improving the Problem Solving Process
    a.    Using PDCA to improve the Team-based problem solving process
    b.    TGR/TGW Analysis
    c.    Evaluating the tools & techniques used
    d.    Reporting results to top management
    e.    Evaluating management commitment
    f.     Updates to procedures
    g.    Identification of new training & competency needs
    h.    Other resources needed for continual improvement