7.2 Competence

Last week’s discussion was about “organizational knowledge” as a required resource.  We defined what sort of knowledge was required to successfully perform our processes and create a good product/service.  This week, we will discuss how we assess our required organizational knowledge versus what we actually have in terms of competence and then what to do if there are gaps.

This section of the standard is basic, clear and easily understood.  So why do so many organizations struggle in this area?  This is such an area of vulnerability for some organizations, even though the requirement isn’t that difficult.  This sections reads as follows:

“The organization shall:

a) determine the necessary competence of person(s) doing work under its control that affects its quality performance;

b) ensure that these persons are competent on the basis of appropriate education, training or experience;

c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;

d) retain appropriate documented information as evidence of competence.

NOTE:  Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons, or the hiring or contracting of competent persons.”

That’s it.  Pretty simple.  Determine what is needed/necessary.  Ensure persons are competent to meet those needs.  Where there are gaps, fill the gaps.  And maintain records.

Many organizations attempt to use job descriptions to satisfy requirement “a)”.  The assumption is that a job description will describe the duties to be performed by a person, and it is assumed that they will demonstrate competence in those activities.  The job descriptions are typically created and maintained under the human resources department and the human resources department is usually required to produce records of the job descriptions.  This is fine as a place to start, but falls far short of the remainder of the section.  And human resource departments may resist taking on further responsibility for the remaining requirements, leaving them to the quality department to fill in the gaps.

A quality department may often create supplement competence evaluations to satisfy the requirements of the standard, but then there tend to be lots of disconnects.  This model, though very popular, is messy and often frustrating for both the organization and the auditors.  There is a great opportunity in this section to tie together both the collection of organizational knowledge (discussed last week) and the assessment of competence against that.

Many companies take this opportunity to create a comprehensive training program that is fully integrated with the quality management system.  It begins with the identification of processes.  Then the processes are described and that becomes the basis of the training program – ensuring the persons performing the work understand the processes and are competent to perform them.  And as persons are chosen and assigned to processes, they are evaluated based on their previous education and experience versus the requirements of the process, and where gaps are identified, they are provided with additional training.

THIS WEEK’S HOMEWORK

How does your organization approach this topic?  Is your training program fully integrated?  Or do silos still exist?  Is your training aligned with your process based quality management system?  Or are they running in parallel?  Consider opportunities to streamline your organization to meet these requirements as simply as the requirements themselves are written.  I’d love to hear your thoughts.

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7.1.6 Organizational knowledge

Well, here we are at week 19 already!  I hope you’re enjoying the discussion thus far.  I have really enjoyed hearing everyone’s input (and on topics OTHER than risk based thinking!)  There’s a lot more to this revision than just that one hot topic!

Like I’ve mentioned in previous weeks, I’m still not a fan of the structure or layout of this particular section, with “resources” jumping back and forth from level to level, but I do like the content of this section.  But I like it for an unexpected reason.  I think I have a weird take on this one.

The revision states, “The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.”  What I like about this is its simplicity.  It really sets the stage to answer the question about how much documentation the organization should create.  Who’s following me here?  The whole problem with the ISO standards (or just about any standard for that matter) is the misunderstanding that they are all about documenting everything.  This simple statement helps draw boundaries about exactly how much stuff should be documented!  There are very specific places in the standard where it clearly states documentation is required (and those are more records than anything else).  But when an organization sets out to write a quality manual (which has been removed as a requirement in this revision), or procedures, how does one decide what should be documented?  One way is to ask “what knowledge do I need for the operation of my processes and to make good product/service?”  This section doesn’t say these things should be documented, but boy, it does say the organization must have a collection of knowledge, so what better option than a library of sorts or a learning plan for each position?  Could be a series of videos, could be a manual and procedures, could be just about anything as long as there is a known treasure of knowledge that is recognized and maintained (and continuously analyzed for gaps).

I like this particularly because I think it does a pretty good job at trying to build a bridge and dovetail training into the quality system.  Many companies miss this opportunity when constructing their QMS.  The quality system is its own thing (including procedures and work instructions, which ultimately are only used for audit purposes), and then training stands alone somewhere else with the “on the job and real knowledge” needed to actually do the work.   What a waste, and what a shame.  The most important procedures in the building are those which describe the processes well enough that the people can use them to do the work.  Anything beyond that is wasteful and unnecessary.  Writing and maintaining two (or more) sets of work instructions is crazy.

Which brings us to, “The knowledge shall be maintained, and made available to the extent necessary”.  These types of statements are intended to allow latitude in compliance so that there is some common sense in what is the “extent necessary” depending on the complexity and size of the operation.  But I think the real meat of this statement is the requirement that the knowledge be maintained and controlled.  First, we have to know what we need to know, then keep it alive and in good condition and accessible and available.

Next up is, “When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.”  Well, we are all here together to address a changing need (in the draft revision of this standard).  And there are many others.  Think about changes in methods, technology, communications.  How do we keep up?

The “notes” in this section are fascinating to me.  They smack of trying to capture the “tribal knowledge” all organizations share and then institutionalize it so that each generation needn’t revisit the same learning curve over and over.  Isn’t that something we all struggle with?  Think of tool and die makers and other very specialized skills.  These skill sets tend to be coveted by the people who have worked very hard to attain them.  And without a viable apprenticeship program (or understanding the knowledge we need), knowledge is difficult to capture and maintain.

“NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.

NOTE 2 To obtain the knowledge required, the organization can consider:

a)  internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization);

b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).”

THIS WEEK’S HOMEWORK

Look back at the processes you listed as critical for your organization.  These are the processes your organization must understand and have sufficient knowledge to support.  What is the process for understanding (inventorying) what knowledge should be maintained?  Is it reviewed?  How does your organization spot trends or changes?  How does it update its knowledge when it’s needed?  Look at the “notes” section as well.  Is there a system for addressing these opportunities in particular?  Please share your thoughts!

For more information on building your organizational knowledge, check out my book,
TRIBAL KNOWLEDGE – The Practical Use of ISO, Lean & Six-Sigma Together

Or let me work with you one-on-one.  My 8 Week Boot Camp is a powerful workshop to do a full review of each of your processes and build a robust quality management system and organizational knowledge base in as little as 8 weeks!

Stay involved and engaged – SUBSCRIBE!

7.1.5 Monitoring and measuring resources

Welcome back to the discussion everyone!  This is a rather wordy section, so let’s get right into it!

7.1.5 starts with “Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organization shall determine the resources needed to ensure valid and reliable monitoring and measuring results.”

Let’s be sure to understand that this is specifically about monitoring product (or service) for conformity.  This used to be included in “Production and Service Provision” in ISO9001:2008 and is one of the structural changes in the 2015 revision.  Monitoring and measuring the quality system has a whole clause (9 Performance Evaluation) dedicated to it.  Today, we are sticking with monitoring and measuring devices and equipment used to monitor the product (or service).  So, in keeping with this section, the organization must ensure they have identified and put in place the appropriate resources including (7.1.2 People, 7.1.3 Infrastructure, 7.1.4 Environment) and now 7.1.5 Monitoring and measuring resources.  Pretty straightforward, so how do we do that?

“The organization shall ensure that the resources provided:

a)  are suitable for the specific type of monitoring and measurement activities being undertaken;”

Simple enough, we have to have the right instruments and equipment on hand and they must be capable of determining “good” from “bad”.  The word “suitable” provides the expectation that the instruments be accurate, reliable and precise enough to make appropriate judgments about product (and services).  This includes the very common disciplines of calibration, reproducibility & reliability studies, etc to ensure the instruments used to measure product (and service) are suitable.  Moving on…

“b)  are maintained to ensure their continued fitness for their purpose.”

This means that once we have selected and confirmed the appropriate monitoring and measuring devices, we must have a surveillance program to ensure their continued suitability.

“The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring  and measurement resources.”  Of course, this means there should be documented records of these activities.

“Where measurement traceability is a statutory or regulatory requirement a customer or relevant interested party expectation or considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring instruments shall be:

– verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards.  Where no such standards exist, the basis used for calibration or verification shall be retained as documented information;”

This specifically refers to a generally accepted calibration program which should always include traceable standards and a schedule for verification/calibration.  The use of traceable standards is required because simply having something to measure your devices by does not necessarily ensure an adequate calibration program.  For example, using old worn gauge blocks, pins, hardness standards, etc is not a best practice.  Your standards (in addition to your instruments) should be maintained and traceable to an international standard to ensure the validity of your monitoring and measuring program.

“-  identified in order to determine their calibration status;”

This is the simplest thing to do – a simple calibration sticker will suffice.  Keep in mind that it is NOT required that stickers be on every device, but why not do it?  If each instrument has its own unique serial number and is properly identified and can be cross-referenced to its calibration status, that meets compliance requirements.  However, auditors just feel a better warm and fuzzy feeling if there is a sticker including “last calibrated” or “next calibrated”.  And even if you do have a database or master list of instruments which tells you the status of each instrument, a quick glance at the instrument itself doesn’t hurt to ensure your instruments are maintained 100% of the time.

“-  safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.”

Safeguarding from damage and deterioration is the simplest of these three.  Obviously protective cases, protective films, filters, etc keep an instrument in its tip top condition.  Regular maintenance helps too – removable of dust, atomized grease, etc.  Safeguarding from adjustments is a little more difficult, but can be easily achieved by removing adjustment tools from general use, using seals on access panels, etc.  Most auditors are reasonable with regard to this, however, if someone wanted to make an adjustment to an instrument, there are many ways to work around the safeguards.  It is unlikely to happen, and between calibration checks can add an additional assurance that instruments are safeguarded against adjustments.

“The organization shall determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary.”  This is clearly written and self-explanatory.  However, again, the addition of intermittent checks (between calibration checks) helps to mitigate the impact should an instrument be found to be out of calibration.  For example, if a micrometer is calibrated monthly and on today’s monthly check it is found to be out of calibration, every measurement it has taken for the past 30 days must be validated.  This can require isolation of product, product recall, etc in the absence of any other evidence of compliance.  Between calibration checks help to detect adjustments, errors, etc.

ISO9001:2008 used to include a reference to the “ability of computer software to satisfy the intended application shall be confirmed.”  This was an attempt to ensure that dependence on software be confirmed (rather than simply taking a computer’s word for it).  The idea was to prove out software and use common sense before turning it over.  For example, implementing the use of a coordinate measuring machine requires a great deal of validation.  A poorly programmed measuring routine can result in a software rejecting “good” parts due to measurement or calculation errors.  This section was intended to prevent that.  However, the language was not clear and was often met with blank stares by those who were asked to demonstrate compliance in this area.  So the specific reference to software was removed.  The use of the word “suitable” in the beginning of this section applies to all monitoring and measuring equipment (including software), so the removal of it has little or no real effect.

THIS WEEK’S HOMEWORK

There is probably very little impact on your current quality management system.  However, reread this section and ensure that you’re happy with its placement within your quality system.  Also, confirm that your records or “documented information” is maintained on your verification/calibration activities.  Perhaps take this week as an opportunity to do a quick spot check (or internal audit) on your monitoring and measuring system.  Do you have a master list of instruments?  Is it up to date?  Spot check an instrument on the list.  Can you find it?  Is its status known?  What standards were used on its last calibration?  Are they traceable and do you have evidence of their traceability?

Stay involved and engaged – SUBSCRIBE!

7.1.4 Environment 

In Week 15, we glossed quickly over “People as a resource”, due to the structure of ISO9001:2015, and we discussed how weird the layout is in this section.  We also debated heavily the term “resource” and everyone was very passionate about the inclusion of people in the discussion.  In Week 16, the standard was a little more straightforward as we discussed “infrastructure”.  Infrastructure is clarified to describe things like buildings, equipment, information systems, etc. And this made our discussion much easier.  (We still haven’t had the opportunity to really discuss people as a resource, because the standard doesn’t dive into the real “people” issues (like 7.1.6 Organizational knowledge, 7.2 Competence, 7.3 Awareness and 7.4 Communication) until later.

Here in Week 17, we really hit some quicksand, though.  I think it’s very interesting that the introduction of the idea of “risk based thinking” in the standard has generated so much debate and even outrage at the thought of its auditability.  But, this section has gone virtually undiscussed.

7.1.4 begins easily enough with “The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of its goods and services”.  [Check – no problem].  However, the “NOTE” adds, not clarification in my opinion, but a perfectly fashioned rabbit hole when it says environment can include “physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics, and cleanliness).”  Temperature, humidity, ergonomics, and cleanliness?  Ok.  Most organizations are pretty successful with this and it isn’t a common source of written nonconformances.  But, I’ve participated in audits where the auditor has chosen to debate some of these areas and even has demanded that these parameters be identified on paper and monitored to ensure they are maintained.  Either way, not an insurmountable task.  But back up just a second to….whoa….social and psychological?!  How does an auditor audit that?  What does that audit checklist look like?

I’ve known auditors who would do the logical thing and simply address this area in an anecdotal way.  S/he may interview a few folks and ask questions about training, communication, etc to assure compliance with the broader intent of the clause.  But I also know other auditors who could exploit the language and (incorrectly) demand social and psychological surveys as objective evidence in these areas.  This could sidetrack an audit for hours with debate, conjecture, etc.  Some might even use this opportunity as a strategic sidebar to avoid delving into meatier issues, but I digress.  With the often limited understanding of so much of the language between both the auditors and the “auditees”, dropping these words into the standard without more clarity is irresponsible.  Any standard which is written should also provide enough detail to clearly understand compliance v noncompliance for each of the requirements.  In my opinion, this section falls far short of that.

In the meantime, it is obviously critical that a suitable environment be maintained by an organization to achieve conformity of its products and services.

THIS WEEK’S HOMEWORK

Take a moment to think about this area of your quality management system.  Does your current status address each of these areas?  Are changes required to address each one?  What changes will you make?  What will your discussion be with your auditor when compliance to this clause comes along in your audit cycle?

Stay involved and engaged – SUBSCRIBE!

7.1.3 Infrastructure 

Boy oh boy!  Last week really got people talking.  “People talking about people” is always exciting.  Many of you made the point that the most important resource is always the people, without whom none of the other resources are relevant.  I couldn’t agree more.  There was also some debate about how organizations (and the standard) should address “people as a resource”.  Much of the discussion last week was about terminology and semantics.  And because of that, it makes getting to the nitty gritty of the issue very difficult.  If we can’t agree how people should be classified in an organizational discussion, (“calling people a ‘resource’ diminishes their value”), getting deeper into the subject is challenging.  Even (DIS) ISO9001:2015 hasn’t gotten the language (or even the organization of their thoughts, in my opinion) straightened out.

Having fumbled our way through the first reference to “People”, the next two sections are more straightforward.  The notes are helpful as well. Sometimes the standard doesn’t indicate the requirements very clearly.  In this case, however, it defines  “infrastructure” and and even gives examples in the notes for clarification.  (Stayed tuned next week when those helpful notes set a real snare on the subject of “environment” when they refer to the organization’s “social” and “psychological” environment).  But this week, we’ll focus on “7.1.3 infrastructure”.  It reads as follows:

The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services.

NOTE:  infrastructure can include:

a)  buildings and associated utilities;

b)  equipment including hardware and software;

c)  transportation;

d)  information and communication technology

The only relevant shall is that we must “determine, provide and maintain” that which is necessary to make conforming products (or services).  Pretty simple.  Compliance to this requirement would require evidence that the organization has, in fact, “determined”, and then continues to “provide and maintain” the required infrastructure.  (I’m not suggesting this be a document – consensus among those interviewed will suffice.  This also assumes there is consensus that the infrastructure is reliable based on its maintenance.)

The notes to support this area also specifically identify the types of infrastructure that might be considered (and these are the areas an auditor might look at):

a)  buildings and associated utilities – is the building and equipment suitable?  For example, if you are manufacturing metal stampings or storing metal products, a leaky roof, non-enclosed travel paths between buildings, etc may not be suitable to ensure you can consistently provide conforming products (if “rust free” is a requirement).  Water treatment services, beyond public water/sewer may be required to ensure regulatory compliance where processes produce waste water unsuitable for discharge into the sewer, etc.  This should be the focus of consideration for buildings and associated utilities.  Some auditors may inquire as to contingency plans to ensure your infrastructure is maintained.  Most organizations have at least a basic contingency plan either for compliance or customer assurance.

b)  equipment including hardware and software – this is pretty obvious that the organization must have the proper equipment, however the addition of the “hardware and software” wording has given pause to quite a few both in the 2008 version and in this one.  The intent is that the organization understand their equipment, but also maintain and upgrade as appropriate, the related software.  This may be specific to a piece of manufacturing equipment within the building, a measuring system or device in the lab, or it may also be the organization’s ability to meet the customers’ needs with regard to communication (such as being able to send/receive design files, programs for programmable machinery, etc). This comes up again in item d).  And the expectation is that someone knows the status of these items and has a plan to maintain them.

c)  transportation – again, this is pretty obvious.  If product must be maintained at a certain temperature, for example, the proper fleet (either internal or by an external provider) must be maintained.  If a certain number of trips is required to provide just-in-time delivery, a scheduling process must be maintained, etc.  And there should be a contingency plan in the event of service interruption.

d)  information and communication technology –  customer requirements often specify their preferred method of communication and order processing, and the organization must be able to meet their criteria (ie – electronic purchase orders & acknowledgements, advance ship notices, electronic billing, etc).

This week, we were fairly well able to stay on topic the way the standard is constructed.  However, next week may be a different story.  It should be fun as we discuss “environment for operation of processes” which starts out clear and then takes a crazy foray into the absurd with the standard including the provision of a “social” and “psychological” environment suitable for processes.

THIS WEEK’S HOMEWORK

Take a moment to consider how your organization “determines, provides and maintains” the four bullet items above.  Does your organization have evidence suitable for audit?  Again, this needn’t be a document, necessarily, but is there a person or persons with responsibility for this activity?  And will it be evident that these considerations have indeed been made and that the proper buildings, equipment, transportation, information and communication technology are being provided and maintained?

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7.1.2 People

“To ensure the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective operation of the quality management system, including the processes needed.”

First, I would like to take a moment to salute my readers who, last week, pointed out that when discussing organizational resources, one should always consider people as critical resources.  We hadn’t quite gotten there yet, but here we are this week to discuss the very same.

This section of the revision is a little befuddling to me – not the intent, but how it is organized.  (And if you wish to follow my rant, you’ll need to follow along in your copy of the standard).  The 7.1.2 “People” section contains just a general statement (above) requiring that the organization effectively “put enough people in the chairs”.  But it does little to discuss any more detail.  The sections following (which talk about other types of resources) provide details and examples of the resources to be considered – 7.1.3 Infrastructure suggests “buildings”, “equipment” etc, 7.1.4 Environment suggests “physical, social, psychological, etc” and 7.1.5 Monitoring Resources makes is clear the resources must be “suitable” and “maintained”.  But 7.1.2 simply says “shall provide the persons necessary”.

The standard identifies “organizational knowledge” in 7.1.6 as a critical resource, but treats it sort of like a much needed library of information which must be later connected back to the people (ie the organization must find a way to link the “people” with the “organizational knowledge” (library)).  The standard then jumps up one level to 7.2 Competence & 7.3 Awareness which is all about people and how the organization will be able to effectively use their knowledge and skills to meet its objectives.  But then in that same level, it switches to 7.4 Communication and 7.5 Documentation which are obviously relative to people, but not as directly.  In my humble opinion, the layout is awkward.  But I do like a lot of what is being said.

This week, our task is an easy one – we simply need to “provide the persons necessary” to keep our processes and QMS moving along.  (A few sections later, we will identify how we determine that we indeed have the “persons necessary”).

So this much awaited section 7.1.2 People leaves us a little underwhelmed.  It doesn’t say much about this treasured resource all organizations must continually develop and provide a culture where they may thrive.  It does, however, recognize the first step which is to evaluate what you’ve set out to do and then make sure you have filled your bench with the right team to do the job.

THIS WEEK’S HOMEWORK – NO HOMEWORK!  We will take the week off and wait until there’s something a little more meaty for us to work on (which will be next week 7.1.3 Infrastructure).

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(7 Support, 7.1 Resources) 7.1.1 General 

Welcome back to the discussion everyone!  Your input and feedback is helpful in how this discussion is created each week and it’s exciting to hear about the progress many of you are making.

In previous weeks, we’ve worked through clauses about identifying the organization and its context, customers and interested parties, the key processes needed to create a product or service which meets the organization’s (and its interested parties’ needs), and the objectives of each of those processes to ensure the quality management system is maintained effectively.

Now that all that planning has been completed and the organization has created methods for consistently communicating, monitoring and reporting on the objectives, there must be a plan to provide the resources needed to achieve the objectives.  Specifically the standard states “the organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system”.  And it goes on to give guidance on what shall be considered:

a)  the capabilities of, and constraints on, existing internal resources

b)  what needs to be obtained from external providers

This section uses an economy of words to say quite a bit about a critical planning activity that is sometimes overlooked.  This lack of planning can result in unplanned problems and an inability to respond to changing market conditions.  An organization must understand its capabilities and constraints and what it must rely on outside providers for those gaps in its internal capabilities.

Beginning with the capabilities and constraints of its existing internal resources, it is important to recognize that this will come up again later in this section as the standard does a nice job of rolling out this section just a little at a time.  This first subclause makes one think of the equipment, time, money, physical capabilities (in the aggregate) of the organization.  And each subclause after will give more specifics to exactly what should be considered.  This presents an opportunity for those utilizing lean and Six Sigma to introduce the use of those tools into the quality management system to ensure the system, process and its tools are clearly defined.

For those of you who thought the QMS and a Continuous Improvement program are separate, independent activities, you might want to take a moment and think about the possibility of integrating them.  Whatever works best for your organization is of course, your organization’s prerogative.  But for companies simultaneously maintaining certification to ISO9001 and attempting to improve their processes through a separate initiative of lean and Six Sigma, this is a good opportunity to join forces and create a robust QMS with a great arsenal of tools to achieve your objectives and continually challenge them.

But even after the organization has determined its capabilities, it must also deal with any gaps in those capabilities by soliciting help from outside.  This subclause, too, comes up again in more detail later.  As the planning is done and external support is needed, there must be controls in the quality management system to ensure the outside processes are closely monitored.

The section, overall, is very similar to the language to ISO9001:2008, but the additional detail is helpful to give the guidance needed to more completely plan for and provide the resources needed.

THIS WEEK’S HOMEWORK

Take a look at your quality management system as it stands today.  Have you truly adopted a process approach?  (ie. are all your necessary processes clearly identified?).  Have you created a quality plan identifying the objectives of each of the processes and a plan to achieve them?  Use this to identify the resources needed to support each of the processes and their objectives.  And identify where you will need help from the outside.  Put a plan together to manage those resources as well.

As you complete this exercise, be sure to share your discoveries.  Having done this activity, did you identify any hidden resource needs?

Stay involved and engaged – SUBSCRIBE!

6.3 Planning of changes

Our discussion the past several weeks has been about building infrastructure –  “pouring footings”, as it were, for the quality management system.  We’ve drawn a line in the sand by clearly stating our quality policy.  We’ve declared our objectives and organized our team with exactly what our objectives are and our strategy for accomplishing them.  We’ve issued marching orders to our team and orders to report back periodically on their progress toward the objectives.  But, what if we determine there is a need for change to the system?

This area is particularly challenging for many organizations for a number of reasons.  First, change is almost always a gradual process of a system degrading unnoticed until some negative effect is realized.  This is followed by many well-intentioned people offering their ideas for improvement and “throwing darts” at a solution until something begins to work.  This is rarely a planned, controlled or disciplined process and can have unintended consequences or may affect other processes.  So it is nice to see this addressed directly in ISO9001:2015.

The standard requires that the organization consider:

a) the purpose of the change and its potential consequences

b) the integrity of the quality management system

c) the availability of resources

d) the allocation or reallocation of responsibilities and authorities

Starting with a) the purpose of the change – it is important to consider and decide why a change should happen in the first place, and if implemented, if it will affect other processes.  This requirement strongly supports a “process focus”, which was introduced in ISO9001:2008, and which has been further emphasized in the 2015 draft.

Moving onto b) the integrity of the QMS – again, this simply supports a “process focus” wherein changes must be considered in their interaction with other processes.  A change in one area must not negatively impact another area.  If constructed properly, the system would consider the quality policy, the critical processes identified as well as the objectives of the processes.  If gains in one area create losses in another area, this is unacceptable and an alternative must be found.

Next is c) availability of resources – WOW, I really like this one!  As a “lean” practitioner, I appreciate this consideration.  Too often, “improvements” add layers to a process, rather than simplify it to make it more effective and efficient.  This requirement states that the organization must consider the resources required to support a change and ties it back nicely to 6.2.2 planning how to achieve the quality objectives.  Nice!

And finally, d) the allocation or reallocation of responsibilities and authorities – this reinforces the tie back to 6.2.2 and requires that changes be carefully planned, assigned and executed to ensure their successful implementation.

Another problem with change, overall, is that it just plain difficult to do.  A universal anecdote every organization has is a time they’ve tried to implement a good idea only to have it atrophy into a return to the “old way” of doing things, or into something worse than the original process.  Change management is its own industry, because it is so challenging.  So having a system for planning and implementing change in your organization is critical.  The requirements listed here do a fairly good job at defining the minimum components of an effective change management system.

THIS WEEK’S HOMEWORK

Review your change management process.  This does not only include your document change management system, but actual changes to your quality management system.  If your current system isn’t strong enough or does not address each of the requirements, shore it up with whatever it needs.

Stay involved and engaged – SUBSCRIBE!

6.2 Quality objectives and planning to achieve them

“What is the Goal?”  For any of you old-schoolers, you’ve probably read the old classic, “The Goal”, by Eliyahu Goldratt.  This story is intended to introduce lean and Six Sigma methodologies like Theory of Constraints, but understanding “the goal” is also apt for this discussion.  Throughout the story, several of the characters (who all work at the same company) have a different idea about what “The Goal” actually is.  And this is not an uncommon scenario among organizations.  Everyone must understand the objectives if the organization is going to achieve them.  Differing or competing objectives may make attaining them impossible.  Top management must choose the objectives carefully, communicate them clearly, and monitor them constantly if the quality system is to be effective.

ISO9001:2015 gives some solid, specific guidelines for a compliant quality plan.  And for a refreshing change, the language isn’t unclear.  And this hasn’t incited as much debate and controversy as some of the other clauses.

First, it says the organization “shall establish objectives at relevant functions, levels and processes.”  As is typical of ISO9001, there is some ambiguity about what is relevant, but at least it points out that objectives specific to functions, levels and processes should be considered.

It goes on to state that the objectives shall:

a)      Be consistent with the quality policy

b)      Be measurable

c)       Take into account applicable requirements

d)      Be relevant to conformity of products/services and the enhancement of customer satisfaction

e)      Be monitored

f)       Be communicated

g)      Be updated as appropriate

Each of these is pretty self-explanatory.  I enjoy the last one on the list – “be updated as appropriate”.  I guess that means we can’t just have a main objective of “satisfied customers”, but we must be a little more specific and apply that whole continual improvement thing.

Document Alert!  “The organization shall retain documented information on the quality objectives” – this requirement is one of the list of required documents or “documented information”, so be sure you have some documented information to support these requirements.

I especially like the next part as well.  It requires that the organization not only establish their objectives, but a logical plan on how they intend to achieve them PLUS accountability!

6.2.2 When planning how to achieve the quality objectives, the organization shall determine:

a)      what will be done

b)      what resources will be required

c)       who will be responsible

d)      when it will be completed

e)      how the results will be evaluated

Week 9’s discussion of the “Quality Policy” generated a lot of discussion.  Many people made the point that a policy isn’t enough and “sloganeering” doesn’t drive home the message of a commitment to quality.  I agree.  And I’m still not sure the ISO9001 standard states the requirement clearly enough.  Nor do organizations, at large, have a universally effective method of demonstrating the effectiveness of a quality policy.

Perhaps a more visible tie between the “Quality Policy” and the “Quality Objectives” would be a start.  And having those objectives identified using the criteria above – having them be relevant and measurable – and communicating to everyone in the organization exactly what, who, when and how they will be met would be a great way to get a quality system off the ground.  My humble opinion is that too many people skip ahead in the standard and really work hard on documenting other things and spend too little time on the actual bedrock of their quality system, which should be a commitment and solid objectives.  6.2 is a good sanity check for us all.

THIS WEEK’S HOMEWORK

Review your Quality Policy and your Quality Objectives.  (Remember, these should be documented in some way to meet the “documented information” requirement).  Does your system tie together clearly?  Ask around – does your team, for the most part, understand the connection?  Are they aware of the objectives?  Are they fully aware of the what, who, when and how of each one?  If so – great job!  If not, take the opportunity to really get this in order.  Review the objectives with Top Management.  Are they relevant?  Are they assigned and monitored?  Each of the points above is important, and sets the table for the future success of your quality system.  Give each of your objectives a thorough going over, and make adjustments where appropriate.

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Marnie Schmidt LLC recently partnered with Monin Gourmet Flavorings and would like to recognize them as their newest “Waste Warrior”.  A multinational company, Monin identified “information sharing” as key to the success of their business, as well as their superior quality system, which is SQF (Safe Quality Foods) certified.  According to SQFI (Safe Quality Foods Institute), “SQF certification assures buyers and customers that food has been produced, processed and handled according to the highest standards.”

Marnie Schmidt LLC, specializing in quality systems, lean and Six Sigma implementation facilitated a kaizen event with several members of the Monin team.  Kaizen events are high impact, blitz events designed to focus and improve a specific process.  A new process was identified, a document management system was constructed and populated, and workshops were held to allow members to practice in the new environment.

Mike Brewster, Vice President of Operations said, “We have a lot of work instructions and standard operating procedures that are regularly used for training and as reference documents.  They need to be easily accessible.  Content needs to accurate and up to date at all times.  The new user friendly SharePoint Library is compliant with SQF and FSMA standards, ensures format consistency between documents, provides content control and helps Monin staff manage annual reviews as required by our SQF practitioner.”

Johanna Velez, Vice President of Quality Assurance, Procurement and Sourced Products, who has primary responsibility for spearheading their SQF certification, said “So far everyone has embraced the system.  I have been getting notifications for changes and approval needed indicating that other departments are actively using it and the feedback has been positive. Users have taken ownership of their own documents and that makes me very happy.”

A team consisting of operations, quality and IT (information technology) explored many options and ultimately designed and constructed a brand new electronic library solution to provide access for everyone to the key information they need to support their world class processes.  The new library was introduced with a hand-on workshop where users practiced using an “information treasure hunt” to ensure their understanding and proficiency with the new resource.  One user, Brian Smith, said, “It will really streamline our work instruction review process and allow us to more easily manage and maintain their accuracy.  The added Search features will be great too to help access information, but also avoid duplication or errors.”

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