SQT Blog

How To Avoid Change Failure | Mind The Gap From Change Design To Execution

In this article, we discuss the challenges, traps and blind spots facing change and transformation leaders and map out the five things all change programmes need to do to avoid failure.  Our advice is applicable to all change programmes irrespective of size and scale, namely:

1. Change the composition of the change team at the execution stage.
2. Assess the change members belief and passion for the change goals.
3. Introduce new management practices.
4. Recognise and reward the right behaviours.
5. Be guided by the vision and ideals when making change adjustments.

Transitioning from the design to execution phase is fraught with risk.   To start with, if you have created a comprehensive transformation strategy, it will include a strong and compelling vision, end state design, detailed plans and roadmaps and a solid project governance structure. You and your team will be feeling good and will probably have generated the essential momentum and demand for the next phase.  However, if you have not achieved these design outcomes, then you do need to revisit the situation and invest in getting the set-up conditions re-configured and properly rooted.

The next stage requires two significant steps. First, successfully on-boarding colleagues beyond the core project team and second, driving actions and getting relevant things done.  This is where a transformation programme gets a reality check.  We outline below, five key recommendations that address the issues that arise, in moving beyond the transformation design phase.

1. Change the composition of the Change Team. This may seem foolhardy, particularly if the design phase was a major success.  This counter-intuitive approach reflects the fact that many of the skills and competencies required to design a change programme, are no longer required once you move into execution.  In fact, one of the biggest risks is to continue to over invest in the analytical capability of the team and then expect that this team can and will deliver the change.  Change at the implementation stage, is about investing in the emotional management of change. It quickly becomes about doing and not about thinking.  Whilst it may appear easier or simply about getting lower level people involved, it is one of the most difficult aspects of change.  Bringing on-board pragmatic doers, and key influencers from the mid-levels within the organisation, requires discipline and skill. It needs good listening skills and the ability to coach and mentor. The change leader needs to win the hearts and minds of the extended team and transfer the passion that the leadership team possess for the change programme objectives, to the wider team and employee groupings.
2. Assess the change members belief and passion for the change goals. It is one thing to have the ability to design great change programmes, but what if the passion and commitment is not there for the implementation?  Some team members are more comfortable planning and designing.  Furthermore, they may see themselves as managers who do not have to rollup their sleeves and get stuck in.  Keeping such team members engaged is a mistake.  Transitioning into delivering requires the leaders and members of the change team to walk the walk.  If they do not feel passionate about the programme goals, vision and destination for the change programme, they will not be able to bring along the wider team.  Recognising this challenge and addressing it now, is important.  Either the team needs to develop conviction for the programme or accept they need to move on.  Most hired consultants don’t invest in the required passion, and therefore, most organisations simply don’t get this from their external partners.  As organisations move from planning to execution, it will prove timely to replace resources and invest in injecting passion, conviction and belief into the team.  We strongly advocate using diagnostic listening and Commitment-based Management as the basis for assessing and injecting passion into the team.
3. Introduce new management practices. Once a change programme moves into the delivery phase, it requires a change to the project pattern and short-term rhythm and focus.  There is a requirement to shift the programme into getting things done.  The governance structures need to be reinvigorated.  The types of meetings, their frequency, content and structure, need to reflect a focus on getting things done and short-term outcomes.  Introduce high levels of personal accountability to deliver short-term action based results and track these actions through to completion.  Focus meetings on exceptional reporting. Do not tolerate those who deflect energy and determination to achieve the programme objectives or who are not forthright in coming forward and declaring a lack of progress.
4. Recognise and reward the right behaviours.  Stay attuned with the progress of the programme and reward team members that get things done.  Knowing what needs to be done, should be replaced by doing what needs to be done.  Introduce real-time training and learning.  Do not punish those that are trying but failing. These team members need to be managed carefully to see if they can become competent or, if not, they need to be sympathetically and carefully moved off the programme.  By adopting this approach, change and transformation leaders will demonstrate they are ‘walking the walk’ and stand as exemplars for the behaviours of the change team.
5. Be guided by the vision and ideals when making change adjustments. Implementing change requires hard work to change people’s mind-set and perceptions.  There are winners, losers,  resistor’s and advocates.  Successful change implementation works through the impact on individuals.  Individuals transition through several psychological stages when changing.  Therefore, even well constructed plans can never predict with accuracy, the human aspect of change.  The practical question remains, when is it okay to adjust the plan and revise the end destinations?  There is no black and white answer, however, leaders should ask themselves, ’does such an adjustment undermine the overall vision or ideals that underpin the rationale for the programme?’ If the answer is yes, then the adjustments need to be re-examined and changed.

Submitted by Ian Duncan, Ennovate, SQT Strategic Change Management tutor

In our EN 14971: 2012 blog, we discussed the changes to EN 14971: 2012 in broad terms and we have seen that to comply with the EN version of the standard, manufacturers will have to move away from the ALARP system of risk analysis and evaluation. This will mean significant changes to the risk management process. In this newsletter and subsequent newsletters, we will deal with each of the seven Content Deviations* in detail. In this newsletter, we deal with the first two Content Deviations: Treatment of Negligible Risks and Risk Acceptability Assessment. In Annex D8.2 ISO 14971 Standard indicates that the manufacturer may ignore negligible risks. However, the Essential Requirements of the three Medical Device Directives (MDD), state that “All risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device”

Content Deviation 1: Treatment of Negligible Risks

In Annex D8.2 ISO 14971 Standard indicates that the manufacturer may ignore negligible risks. However, the Essential Requirements of the three Medical Device Directives, state that “All risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device”

The first step in risk analysis process is to identify hazards – best practice is to identify as many as possible at the beginning of the process and divide them into two categories – those that need to be analysed for risk as they could cause harm and those that cannot possibly cause harm (even in the case of misuse) often due to the design of the device. If you choose not to analyse a hazard, you must record the rationale for choosing not to conduct the analysis. Another alternative is to analyse the hazard and show that it has been reduced as far as possible.

How to Address Content Deviation No. 1

Annex D8.2, of ISO 14971 indicates that negligible risks may be disregarded. However, the Essential Requirement 1 and 2 of the MDD specifically require that all risks must be considered. This means that where possible controls need to be generated for all risks listed in your risk analysis documents (such as FMEAs). If no further controls are possible, then record a statement to this effect in the risk analysis documentation. It is important to remember that even for negligible risks an economic justification is not permissible for not reducing the risk as far as possible (See also Content Deviation No. 3 Risk Reduction Economic Considerations the subject of our next Newsletter). In achieving compliance with EN 14971: 2012 the Treatment of Negligible Risk will not be your highest priority. Discuss with your Notified Body a timeframe for implementation of reducing Negligible Risk as far as possible.

Tip: Do not include business risks or risks to manufacturing personnel in the risk analysis that you conduct to fulfil the Medical Devices Directives; this will simplify your risk analysis and exclude a number of (negligible) risks that would otherwise have to be reduced as far as possible in order to comply with EN 14971: 2012 and the MDD.

Content Deviation No. 2: Risk Acceptability Assessment.

This Deviation relates to the process of evaluating risks. The ISO 14971 states that the acceptability of risk must be decided by the manufacturer. Clause 3.2 of the 14971 Standard, states that, “Top management  shall: define and document the policy for determining criteria for risk acceptability.”   The manufacturer’s risk management policy must define and record the criteria that it uses for deciding which risks are acceptable or not.   Essential Requirements 1 and 2 states that risks be reduced as far as possible, and that all risks shall be included in a risk/benefit analysis—not just the risks that meet a certain criteria. Therefore, the requirement to establish a risk policy for the acceptability of risk directly contradicts the MDD.

The question is: how does a manufacturer establish acceptability criteria?

Robert Packard of www.medicaldeviceacademy.com in his excellent blog on the Content Deviations recommends the following:

“For new devices, I recommend benchmarking the risks of the new device against existing devices. In other words, if the new device presents equal or lower risks than existing devices, then the risks of the new device are acceptable. For existing devices, I recommend performing a risk/benefit analysis, evaluating adverse events observed with the device against the benefits of using the device”.

 What is Acceptable?

In order to comply with the EN ISO 14971:2012 version of the risk management standard, you will need to implement risk controls for all risks, regardless of acceptability. However, you will also need to perform a risk/benefit analysis. The risk/benefit analysis should consider not only the benefits to patients and the risks of using the device, but the analysis should also consider relative benefits of using other devices.

The clinical evaluation report and the risk management report for the device should be based upon clinical evidence of the device for the intended use—including adverse events. For new devices that are evaluated based upon literature review of equivalent devices, Notified Bodies expect a Post-Market Clinical Follow-up (PMCF) study to be conducted in order to verify that the actual risk/benefit of the device is consistent with the conclusions of the clinical evaluation. In order to perform this analysis, a clinical expert is necessary to properly evaluate the risk/benefit ratio of the device, and to create a protocol for a PMCF study.

MEDDEV 2.12/2 rev 2, Post Market Clinical Follow-up Studies, indicates that the PMCF study protocol should indicate the study endpoints and the statistical considerations. In order to do this, your company will need to establish quantitative criteria for acceptability of the identified risks. Therefore, your documentation should make it clear that risk acceptability criteria should be based upon clinical data. Acceptance of risks should be conducted at a later point in the risk management process than under the ALARP system (e.g., – as part of the overall risk/benefit analysis).

How to Address Deviation #2

As your company becomes aware of the second deviation between the ISO 14971 Standard and the Essential Requirements of the MDD, your risk management team will need to change the risk management process to clarify when risk acceptability should be evaluated, and the risk management policy should specify how acceptability should be determined.

The risk management process at your company will need to specify that implementation of risk controls is required for all risks—regardless of acceptability. You should also consider eliminating the evaluation of risk prior to implementation of risk controls. Instead, your company should base acceptability of risk solely upon the clinical risk/benefit analysis, and should involve the manufacturer’s medical expertise in making this determination.

Finally, your risk management process should specify the need for Post Market Clinical Follow-up Studies in order to verify that actual clinical data supports the conclusion that the risk/benefit ratio is acceptable over the lifetime of the device.

The proper place to document this conclusion is in the conclusions of the clinical evaluation report and risk management report. Both of these documents should cross-reference to one another and the conclusion should be reassessed as new post-production data is collected over time.

*Content Deviation: During the process of making ISO 14971 an EN standard (a process known as harmonisation), it became apparent that the standard did not comply with all the requirements of the Medical Devices European Directives, namely 90/385/EEC, 93/42/EEC and 98/79/EC. The differences between EN 14971: 2012 and the Medical Devices Directives are known as Content Deviations.

 

The seven Content Deviations are:

• Treatment of Negligible Risk
• Risk Acceptability Assessment
• Risk Reduction Economic Considerations
• Risk-Benefit Analysis Not Optional
• Risk Control Options
• First Risk Control Option
• Labelling Information Cannot Influence Residual Risk

Submitted by John Lafferty, SQT Healthcare Tutor

A second committee draft (CD2) of the revised environmental management systems standard was published in October 2013 and ISO countries had until 23 January 2014 to vote on whether CD2 should become a draft international standard. CD2 has received overwhelming support from ISO members, ensuring the draft international environmental management system standard will progress to the next step. In excess of 80 percent of ISO members who were balloted voted to move the revision of ISO 14001 to a draft international standard.

The next meeting of the international working group that is drafting the standard takes place between 25 February and 1 March. It will consider the comments submitted during the latest consultation and look to build a stronger consensus on the changes that are being proposed.

Martin Baxter, executive director of policy at Institute of Environmental Management and Assessment (IEMA) and the UK’s appointed expert on the revision to 14001, said the response to the draft standard from environmental professionals had been “overwhelmingly positive”.
“The changes being proposed are significant, integrating environmental management into organisational strategy and decision-making and adding further emphasis on improving environmental performance,” he explained.

An increasing number of organisations are pursuing ISO 14001 certification. In its annual survey of certifications, the International Organization for Standardization said the number of ISO 14001 environmental management system certificates at the end of 2012 was up 9 percent to 285,844 over the previous year.

Revision timeline

Early 2014: IEMA submits comments on CD2.

Mid 2014: Final Ballot takes place for adoption of the new 14001 standard.

Jan 2015: Final Draft International Standard.

May 2015: The revised ISO 14001 will be adopted and published, and the transitional period for organisations with certifications will begin.

Submitted by Ronan O’Sullivan, Antaris Consulting

To read more blogs from Antaris, click here

 

Sources

http://www.environmentalistonline.com/article/2014-01-28/revised-iso-14001-to-become-dis

http://www.up-ltd.co.uk/news/3069

http://www.environmentalleader.com/2014/01/29/iso-14001-revision-receives-majority-support-moves-forward/

https://www.2degreesnetwork.com/groups/energy-carbon-management/resources/revised-iso-14001-standard-moves-step-closer/

https://www.iema.net/policy-iso14001revision