Regulatory Compliance is Not an Alternative to a Culture of Caring

This article appeared in today's Toronto Star:

Watchdog raises alarm over restraints used on children in care.

The article is on  a new report by Ontario’s Advocate for Children and Youth into the province’s (troubled) system of residential care with the subline: Confused, incomplete reporting of serious incidents makes it hard to know if guidelines on restraints followed, children’s advocate says.

Many people, both inside and outside regulated care organizations such as those for foster and group homes for youth, for people with mental health challenges and for seniors, confuse regulatory compliance with quality care. There is an assumption by outsiders, including governments, that enforcing regulations with inspections and a big stick will achieve the standard of care needed for vulnerable populations. Such people, and many inside these organizations - management and staff - who should know better, insufficiently grasp the important role of organizational culture for achieving a quality standard of care. Many managers and staff don't know or have forgotten why they're there and so, not being mindful of why they should do what they have to do, they take short cuts for convenience, defeating the purpose of the regulation or quality standard.

On top of it all, they are under-staffed and misunderstood which exacerbates everything.

Yes, we absolutely need adequate inspections for regulatory compliance, and getting further certification and accreditation to standards can also help, but we also need senior organizational leaders with vision who understand what Peter Drucker meant with his now famous quote, "Culture eats strategy for breakfast." If changing the culture is not part of the strategy, the strategy is doomed.

Why do I do what I do?

People ask me, what do you do?

When I wake up in the morning, what I want to do is make the world a better place. Most of us, if not all of us, walk around with problems, some personal, but also many business or professional. What fires me up professionally is to help leaders in small and medium size organizations approach their problems as challenges, as fish to be caught, and then help those organizations fashion fishing rods or fish nets for themselves to catch these fish and turn them into opportunities; opportunities to make their organization, including their staff, more successful in achieving their vision and objectives, more successful in meeting and exceeding customer and client expectations and, as a consequence, more profitable.

How do I do this?

Credit: advisera.com

I am a big believer in process; namely, a consistent way of taking things as input, and turning them into some valued output, whether as a product or service. When you break it down, any enterprise uses a system of processes to do what it has to do - whether those processes are formal and written, or informal and intuitive. I have yet to find a production or service problem that cannot be tied back to a process. What I do is help organizations improve their system of processes to be more effective and efficient, and to eliminate or mitigate problems, especially problems that lead to client or customer complaints.

Beyond the short term, the cost of improving process effectiveness is a lot less than the cost of perpetuating a process that keeps spawning problems. It's a bit like the leaky tap or faucet: at some point the cost of water wastage exceeds the cost of repair and, at that point, the total cost is the cost of repair plus the cost of all the water that had been wasted in the meantime.


So that's what I do, and why I do it. If you would like to see whether and how your processes can be more effective and less wasteful, please talk to me. Let's continue the conversation and make the world a little bit better, together.
Leave a comment below or CONTACT ME.

Risk-based thinking: new in ISO 9001:2015

A significant innovation with the 2015 revision of ISO 9001 is the new emphasis on risk-based thinking which has acquired the acronym, RBT, in quality circles.
It is a sad fact that many organizations only considered the risks associated with failure when there was, in fact, already a failure or product nonconformity of some kind and they were engaged In corrective and preventive action. To counter this, the new Standard no longer has a requirement for a distinct preventive action process associated with corrective action but rather calls for RBT to be applied at various stages in the planning, design, development and release of products and services. Your third party auditor will be asking to see evidence that this is being done and you, yourselves, will want to be looking for this in your own internal audits.

There is nothing stopping you from continuing to follow a preventive action process after corrective action - and a lot to recommend that you do continue, but that will not be sufficient to satisfy the requirement for risk-based thinking.

By risks we are talking not only about potential hazards to health and safety but also the risk of damage to property and/or financial loss whether for the customer, a third party, or the organization itself. The presumption is that one important purpose of a quality management system is precisely to prevent bad things happening. Thus Risk based thinking will weigh risks against the benefits of proceeding or not proceeding with a course of action, and decide on implementing mitigations or not.

RBT: Middle road - out of the weeds to left and right?

By introducing the concept of risk-based thinking into ISO 9001, the technical committee that produced the 2015 revision tried to walk the middle road between an insufficient consideration of risks and benefits on the one hand, and the more formal risk analysis and management required in, say, the medical device or aerospace standards. RBT has become one of the most discussed and hotly debated ISO 9001 topics in quality circles and forums. Some people welcome RBT, others consider it 'fuzzy thinking'.

ISO 9001:2015 - FAQ's in support of Annex SL in ISO Standards

I came across this document while I was looking for something else and got distracted by it: JTCG Frequently Asked Questions in support of Annex SL. It is put out by an esoteric group who call themselves, "ISO/TMB/JTCG Joint technical Coordination Group on MSS (TAG 13)". Who are they? If you have to ask the question then you probably won't find the answer terribly interesting. Let's just say they are something to do with ISO, the international organization for standards that develops management system standards (MSS) among other kinds of standards.

Logo of the ISO organization

I found some of the FAQ's interesting and relevant to some discussions I have followed on Linked, especially with regard to the newly released ISO 9001. Anyone needing to transition from ISO 9001:2008 to ISO 9001:2015 may find this of interest.

4. What was the Vision behind Annex SL ? 

All ISO management system “requirements” standards will be aligned and ISO will seek to enhance the compatibility of these standards, through the promotion of identical:
• Clause titles
• Sequence of clause titles
• Text, and
• Terms and definitions that are permitted to diverge only where necessitated by specific differences in managing their individual fields of application.

7. What benefit is there to harmonization ? 

Where organizations are implementing and operating several Management Systems they are often confronted with different and sometime contradicting requirements, terms and definitions. Annex SL will be particularly useful for those organizations that choose to operate a single (sometimes called “integrated”) management system that can meet the requirements of two or more management system standards simultaneously.

10. Why does the common text not include a specific clause on “Preventive Action” ? 

The high level structure and identical text does not include a clause giving specific requirements for “preventive action”. This is because one of the key purposes of a formal management system is to act as a preventive tool. Consequently, a MSS requires an assessment of the organization’s “external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)” in clause 4.1, and to “determine the risks and opportunities that need to be addressed to: assure the XXX management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.” in clause 6.1. These two sets of requirements are considered to cover the concept of “preventive action”, and also to take a wider view that looks at risks and opportunities

15. What is the difference between the terms "determine" and "identify" ? 

The terms are used interchangeably in general English but "identify" can have translational problems, as it can be mistaken for e.g. putting a label on something to identify it.
"Determination" is an indication of an assessment rather than "identify" which indicates that something has been noted.
Dictionary definitions give:
Determine = establish or find out with certainty by research, examination or calculation
Identify = establish the identity of something or somebody

16. Why is there explicit distinction between requirements for "top management " and "the organization" ? 

The success of the management system depends on the leadership and commitment of top management; however it would be unreasonable for top management to perform all activities within the management system, therefore it is necessary for such tasks to be assigned to other roles within "the organization"

19. What does “issues” mean ? 

An "issue" is "an important topic for the organization, problems for debate and discussion, or changing circumstances".
This term was used in Annex SL identical text after referring to dictionary definitions (e.g. the Oxford English Dictionary).

20. What is the difference between “stakeholder” and “interested party” ? 

Traditionally management systems standards used the term "interested party" because "stakeholder" created translation problems for a number of languages. The term "stakeholder" has gained wider acceptance even in translation, and some MSS now have chosen to use the term. The two terms are defined as being interchangeable, but with "interested party" as the preferred term.

22. What is the difference between “as applicable” vs. “as appropriate” ? 

Dictionary definitions give:
Applicable = relevant; appropriate; possible to apply
Appropriate = suitable (for, to)

In most cases appropriate implies some degree of freedom, whereas applicable implies that if it can be done it shall be done.