BUSD 2027 Module 4: Implementation of Quality Management

Module 4: Implementation of Quality

Management
Introduction
From Module 3, we now appreciate that quality management involves the whole organization, in
partnership with its suppliers, to meet customer requirements. It follows, then, that to implement
quality management means to impact all the people of an organization, as well as all the supplier
relationships upon which that organization relies. This is not an insignificant undertaking, to say the
least.

Quality management is driven by top management. Without their endorsement, direction, and
support, attempts to implement quality management will create confusion and anxiety in the
organization with the result of diminishing quality rather than improving it. Top management is the
key ingredient to a successful implementation.

Another essential ingredient is involvement of all the employees and suppliers of the organization.
Without their participation and acceptance, the work of implementation, and subsequently following
the new processes, cannot be assured.

To that end, the implementation of quality management has as much to do with organizational and
cultural change as it does with process improvement. The following implementation approach
brings in elements of both disciplines to increase the likelihood of success.

One should also note that there is no magic involved in managing quality. In fact, organizations are
already doing it. Even though they might not have a process for strategic planning, they have
developed a strategy. Even though they don’t formally record and review customer requirements,
they endeavour to understand them and produce products and provide services to meet them.
Without documenting the formal process, some requirements are, no doubt, missed and the
customer may not be entirely satisfied with the initial transaction. But the organization will
endeavour to make it right with the customer, even though the organization doesn’t have a formal
customer complaint or non-conformance process or a reliable corrective action process documented
to explain step by step how to go about “making it right” with the customer. Equipment is
maintained with some frequency, but the maintenance process may not be efficient and may not
include final checks to be sure that the repaired equipment meets all the needs of the process.
People may have training and experience, but they may not be aware that their training certificates
have expired, and they may not have the most up-to-date knowledge necessary to work with new
technologies. Although there may be agreed-upon best practices, not every employee can be
counted on to follow them. Some people just like to do things their own way. When employees
leave the organization, they probably leave with valuable process experience that cannot be shared
with new employees, resulting in the organization having to relearn some painful lessons. If
someone needed to confirm what was shipped or when, there might not be any records on which to
rely for the information.

Question for thought: Looking at the table of ISO 9001:2015 Elements (Module 3), what process or
processes would cover each of the challenges described in the previous paragraph?

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Implementing quality management starts with articulating the quality management “system,” that
collection of interrelated processes that manage quality that already exists in an organization, and
showing how to improve the component parts by eliminating duplication of effort and improving
communication and planning.

Step 1: Map Processes Relative to ISO Requirements

As mentioned above, the endorsement of top management is essential. To secure that
endorsement, top management will need to see what the result of the implementation of the
quality management system will look like and what the implications (risks) of the project are.
Completing this step involves creating a project charter, which includes a sequence and interaction
diagram.

Project Charter
A project charter is a document that includes the components discussed below. Included are
suggestions for tailoring a project charter to support a project to implement a quality management
system for your organization.

Project Title

This should be quite straightforward. Pick the title carefully. It should be easy to say, relatively
informative about the purpose and scope of the undertaking, and not too long. “Quality
Management System Implementation Project” might do. “QMS Project” would also work. The key is
to recognize that this project is going to be around for a few years, and we don’t want people to
hate the name before they even start the work.

Brief Background

Background information helps to put the project into context. What brought about the need for this
work? What problem(s) are we trying to solve? Who first identified the need and how? A bit of a
narrative in two to three sentences will help support the objective and approach that is described
later in the document.

Objective

It is best to describe the objective of a project in terms of what success will look like. The object is
not to complete a sequence of steps; the objective is to achieve results! This section should include
statements about what the results to be achieved will look like and the impact they will have on the
organization.

Constraints and Boundaries

Recognizing that resources are limited, it is important to state the scope of the project. Is there
a financial limit to how much the project can cost? Are there limits as to how much of the
organization will be involved? Perhaps you want to focus on a specific geography, branch, or
department. List any assumptions about what you think are reasonable limits so that top
management has a clear understanding of the project’s scope.

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Risks and Opportunities

Risk-based thinking is a characteristic of ISO 9001:2015, so it makes sense to include an

assessment of risk in the project charter. Risk takes into consideration the external and internal
factors that can influence the organization’s ability to deliver products and services. Implementing
a quality management system is a significant undertaking, and top management should go into
such an understanding with their eyes “wide open.” Consider each factor (refer to the Context
section of Module 3) and state what risks are present, including their potential impact (severity)
and likelihood (probability). Risks might include a reluctance on the part of staff to adopt new
procedures for doing their work or a limit on time or resources to complete the necessary training.
State the risk, its impact, and any mitigating strategies to limit or overcome the risk.

Leader

Every project has a leader, the go-to person who is the face of the project for top management. If
you know the name of the leader, provide it. Sometimes, top management will assign a leader
when they approve the project.

Project Team Members

This is the first step in involving the organization in the implementation project. Consider who in
the organization should help you with the project. This is not intended to be a complete list of
everyone who works in the company. Although everyone will be involved, a few key people will
ensure that the project gets done. There should be representation from a variety of departments
and regions on the project team. List your suggestions, along with the individuals’ specific areas of
responsibility in the project.

Sponsor

The sponsor is a member of top management who is a resource for the project team and the
project leader. The role of the sponsor is to ensure that the project has access to a decision maker
who can clear barriers to project success, wherever they may be identified in the organization. The
sponsor is not an active member of the project team but is kept informed of developments. The
project leader should meet with the sponsor frequently to discuss project issues. The sponsor will
often have insight and guidance that will make implementation happen more smoothly.

Stakeholders

In addition to top management, there are other stakeholders in a project, including association
representatives, members of the board of directors, labour organization representatives, and so on.
The names of such stakeholders should be listed so that they can be included in project
communications. For each stakeholder, it is helpful to note if they should be consulted regarding
project issues as well as informed about project progress.

Project Milestones + Start and End Dates

Any project can be broken down into broad steps that happen more or less in sequence. The
implementation project approach suggested here shows six steps, including this Step 1, which is
about getting the project approved. In this section of the project charter, list those broad steps and
indicate the date by which each step should be completed, assuming that the project and the

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proposed start date are accepted. This is a high-level indication of the timeline of the project, not
a comprehensive work breakdown structure such as will be created in the Implementation Planning
phase, which follows. It approximates when the project will conclude and the benefits realized, and
should show a range of dates for the conclusion of each step that reflects the risks listed earlier.

Costs

The resources needed to complete the project are converted to costs and listed in this part of the
charter. Costs can be divided into internal and external costs. External costs include consultants,
contractors, suppliers, and so on that may be used to provide guidance, training, and templates for
documentation, for example. Internal costs should include the labour costs associated with the
time that members of the organization spend on project work. Costs should also include
opportunity costs—the value of goods and services that would otherwise have been made and sold
using the resources that would have been available were it not for the time being spent on the
project. The opportunity cost is the net difference between the revenue that would have been
generated and the variable and direct costs associated with the production activity. Involve your
organization’s accounting department when calculating these costs. Also provide a schedule that
shows when the costs are to be paid during the project. Labour and consultant costs are usually
paid monthly. Software licences are usually charged up front, and certification expenses happen at
the end. “Cash is king” in most organizations; knowing when a bill is due is as important as
knowing how much something will cost.

Approvals

Find out from your sponsor who is accountable for quality management activities and who needs to
“sign off” on this project. Add those names to the charter in this section. Provide a signature block
at the bottom of the document to record their names, titles, dates, and signatures.

Sequence and Interaction Diagram

For a quality management system implementation, the sequence and interaction diagram is a very
useful document that serves two purposes. Firstly, it shows top management how the processes of
the system work together to manage quality. Secondly, it is a requirement of ISO 9001 that a
sequence and interaction diagram be created, so you might as well do it up front.

As was stated earlier, organizations manage quality from the moment of their birth. The processes
for managing quality are essentially the same as those used to manage the business generally,
with bits added here and there to complete the functionality.

The sequence and interaction diagram is a pictorial representation—a block diagram at the highest
level, not a detailed flow diagram of each process—that arranges the organization’s processes on
a page and shows how each process interacts and shares information or materials with other
processes. This diagram also shows which processes are in contact with the customer and which
are in contact with suppliers. Added to these processes are the names of the corresponding ISO
elements (see table in Module 3).

The processes in the diagram are usually organized according to their relationship with the
customer and the business of the organization. The customer is at the top of the diagram. The next
layer displays those processes that directly affect the customer, such as sales, shipping, and

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service provision. The next layer shows the procurement and production processes, followed by
design, development, and training. The lowest level includes the fundamentals of quality
management such as internal audit, control of documented information, correction and corrective
actions, and management review.

For the purposes of the project, it is helpful to show on the document which processes (blocks) are
already in good shape, which need some modification, and which lack an agreed-upon approach
and will require a great deal of work to prepare. Colour-coding the blocks as green, yellow, and
red, respectively, and including a legend on the diagram will aid top management in understanding
the level of cultural transformation required during the implementation.

Step 2: Create the Implementation Plan

The implementation plan is the project plan for an implementation project. As such, it outlines the
processes for executing, monitoring, and controlling the project, and includes such considerations
as those discussed below.

Create the Plan

Schedule Management Plan (Including Baseline)

The most familiar activity of project management is tracking progress against a schedule. At this
stage of the project, it is necessary to convert the basic project timeline included in the project
charter into a detailed schedule of activities. This information is often displayed graphically in the
form of a Gantt chart or as a work breakdown structure. Each of the broad steps in the project
charter is broken into its component sequential or concurrent steps, with each step assigned a
resource (a person assigned to take care of that step) and a duration. Drawing a timeline, starting
at the project start date, and lining up each step end to end shows the overall duration of the
project.

Here is an example of a Gantt chart:

Gantt Chart by AnnaKorlyakova, available under a CC BY-SA 4.0 licence at

https://commons.wikimedia.org/wiki/File:ConceptDraw_Project_Gantt_Chart.png

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The project team will create the first draft of the project plan as the baseline schedule for the
project.

Quality Management Plan

An implementation project is a process like any other, and as such has characteristics that are
critical to quality that can be monitored and measured to indicate how the process is performing.
Whether the project is on time and on budget are common indicators of how the project process is
performing. In addition to monitoring the process, the project team may want to manage
complaints, enquiries, and feedback, as well as the control of documents.

The project team will want to establish their processes for managing the quality aspects of the
implementation project.

Human Resources (HR) Management Plan

Obtaining and training participants can also be a part of a project, especially construction projects,
for which each new employee will need safety training and on-site orientation. The HR
management plan would include the elements of quality management related to tracking
competency and certification, as well as how to recruit, hire, and onboard new project participants.

Procurement and Cost Management Plans

Procurement management relates to how money allocated to the project is spent on the assets
under the control of the project. Software represents a significant expense, as do most pieces of
equipment. These often have lead times that need to be included in the project schedule. The
procurement management plan is to a project what the purchasing department is to an
organization. The project team will want to set up the requisitioning, approval, and procurement
processes that will be followed during the project.

Project Review and Risk Management Plans

Just like management review of regular operations, the project team will undertake regular project
review meetings to monitor how the project is going. During these meetings, each of the plans is
reviewed, starting with the schedule, to identify whether the project is on track or whether an issue
has been identified that has potential project implications. Risks to the project are then assessed,
and the risk management plan is modified to include contingencies and triggers for addressing and
containing the risks. How project review meetings will be conducted and risks addressed are the
subjects of the project review and risk management plans, which the project team will set at the
beginning of the project.

Change Management Plan (Including Scope and Requirements Management)

If changes are needed to address the risks identified during the project review, how changes are
approved, implemented, and verified is addressed in the change management plan. Scope creep is
always a concern to project managers. After a project begins, lots of ideas emerge and are
suggested as improvements. Some of these can be incorporated as time goes by, but some of
them might exceed the current scope of the project. Scope creep is the incremental expansion of
the original project, usually without approval, that drains away limited project resources on
activities that don’t advance the original plan. Scope creep often leads to failure to complete the

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project on time and on budget. An effective change management plan, including how to address
requests for changes or additions to scope, should be established by the project team at the
beginning of the project.

Another aspect of change management relates to managing the natural resistance or aversion to
change that is inherent among all employees. Inevitably, employees who are currently working in
the process will resist change until and unless they can be convinced of the benefits to them of the
new process. The people in the best position to do the convincing are co-workers who are
themselves already convinced. Employees involved in making changes to a process take ownership
for their work and become advocates for the improvements they make. These advocates reduce
the level of resistance and shorten the time for their co-workers to adopt the new process. Change
management, therefore, is an important part of every implementation project, and a change
management plan must be included in the implementation plan.

Communication Plan

To ensure that the organization remains engaged and receptive to the project and to keep the
naysayers at bay, the project team will want to set up a plan for regular communication of project
developments to keep everyone informed. The plan should include who should receive
communications, the type, content, format, medium, and frequency of each communication
category, who should supply the content, and who will be responsible for ensuring that the
communication plan stays on track. At the very least, the communication plan should detail how
the project launch will be advertised.

Pull the Plan Together

Not all of these plans need to be included in the implementation plan. The project manager and the
team can work with the sponsor to determine which plans are required and the degree of detail
that needs to be included in each plan.

Prioritize the Work

It can be enormously disruptive and risky to attempt to implement all of the QMS processes at
once. It is highly recommended to identify which process, if improved, would have the greatest
impact on quality. Start there, then move to the next process, and so on.

To determine the schedule of QMS implementation, top management needs to determine which
processes need improvement and in what order. The project manager will want to review the
sequence and interactions diagram with top management to prioritize the processes and include
that prioritization in the project schedule.

Although the main “pain point” for the organization might be in relation to shipping, operations, or
sales, it is advisable to create or improve some of the foundational guiding processes early in the
implementation so that they can support the creation of the remaining processes that might be
unique to the organization. Controlling non-conforming outputs, continual improvement, correction
and corrective actions, and management review are good processes to undertake first. They can be
rolled out to the whole organization, and management can start building good habits regarding
addressing issues and improvement ideas.

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Once the project plan is in place, the launch party is over, and everyone is excited about the
project, the next step is to start the work.

Step 3: Improve the Process and the Culture

There are two important objectives at this stage in the project: (1) to change the process and (2)
to change the culture of the organization to accept the new process. Changes that occur from
within are most likely to stick. When employees receive power and control over their processes,
inputs, and outputs, they respond with a commitment to improvement (Hartz & Crosier, 1992).
That is why the change management plan stresses using employees within the organization to
drive change. To accomplish both the process change and the cultural change, appoint employees
to work as process action teams (PATs).

The actions discussed in this section should be completed for each process in order of priority
according to the plan created in Step 2. More than one process can be launched simultaneously;
however, since each process will require personnel from regular operations, there is a limit to how
many processes an organization can take on at once. A general rule of thumb is that participation
in a PAT should not occupy more than 10% of an employee’s time on a weekly basis, and should
not extend beyond 14 consecutive weeks. Such a burden can be absorbed by most employees
without interfering with their regular duties. An employee should not be asked to devote most of
their time to the project unless they are on the project team. Doing so isolates the member from
the process and bestows an air of elitism that interferes with the cultural change component that is
so important to a successful implementation. PAT team members should retain their regular
responsibilities.

Create a Process Action Team

The quality of a process is controlled 100% by the employees who work in the process; therefore,
it is critical to the success of the implementation that employees who work in the process are
involved in improving it. After all, they know what works and what doesn’t. They have the best
understanding of what the current process is, including the hidden steps, tips, and tricks that are
not documented anywhere. They know what knobs to turn and which settings work. Their
involvement is an essential part of the change management plan.

The ideal number of employees involved on a process action team (PAT) is between five and seven.
Having too few participants means that not enough different perspectives are represented to
inspire creativity. Having too many participants results in belaboured discussions and bogs down
the process.

In addition to the employees who work in the process, it is important to involve at least one
internal customer and one internal supplier. These outside perspectives widen the focus and keep
the conversation real. It’s hard to gloss over the tendency of the process to produce poor quality
when the customer is in the room; likewise, it’s hard to blame the supplier when they’re in the
room. An ideal team would include three to five employees representing all shifts, all locations
where the process is used, and all the procedures involved, plus one internal customer and one
internal supplier.

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Finally, have a member of the project team facilitate the discussion. It is better for an outsider with
some experience in processes similar to the one being worked on to moderate the discussion and
bring out all points of view without pushing a particular perspective or opinion. The project team
member selected to facilitate the PAT should not come from the same department or process, or
the supplier or customer processes. The individual should not have an “axe to grind” with regard to
the process or be in a position of authority over any of the PAT members. This is an area where
investment in facilitation training for the project team will pay dividends.

Document the Current State

Use the PAT to create a process map of the current state of the process. From a quality
management perspective, a process is an interrelated set of procedures that work together for
a common purpose. Define the individual procedures that make up the process. Include details on
the flow of information as well as material inputs and outputs. Identify who is involved in each step
of the process—a particular type of process map called a swimlane diagram is useful for presenting
this information.

Identify Current Issues

Ask the PAT to talk about the current performance of the process. What is working and what is not
working? What bothers members of the PAT about the performance of the process or the quality of
the products? What kinds of communication problems exist? What audit findings or customer
complaints have been received in the recent past regarding the process?

Recommend Improvements
Identify both what is working well and the current issues, and attempt to find solutions for the
issues while maintaining or improving those parts of the process that are working well.

Review the Standard for the process in question, and verify which requirements are being met.
Determine how to meet the requirements of the Standard when necessary. Consider how the
process interacts with other processes, and confirm whether information and materials are flowing
efficiently through the system. Resolve duplication of effort between two processes wherever
possible; for example, data collection—rather than have two processes collect data, collect the data
in whichever process encounters it first and allow subsequent processes to access that data
automatically rather than go back to the source a second time. Add in the components that are
necessary for quality management, such as planning, monitoring and measurement, release of
outputs, and control of documented information.

Refine the process map, incorporating suggestions for improvement. Whenever possible, test the
improvements on a small scale to verify that the suggestions will resolve the target issue without
creating new challenges or exacerbating existing ones. Create any forms necessary for data
collection and retention of documented information. Determine the method for acquiring the data
required to fill out each field of the forms, and confirm that such methods are practical and
consistent with the culture of the organization. There is no point in recommending an odious or
rigid procedure that no one will be inclined to follow.

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Document the Future State

Create a process document that captures the details of each procedure. A process document is a
summary of a collection of procedures that share the same purpose in supporting the business of
the organization. It contains a detailed, step-by-step description of each procedure, including
decision points and approval stages. It also contains a statement of the purpose and scope of the
process, the roles and responsibilities of the participants, and a list of documents to which the
participants can turn for additional information and guidance.

However, the process document should not describe precisely what each employee is to do at each
stage of the procedure. That detail is left to work instructions, which are described later. The
process document should not be based on the technology. It should describe the general steps in a
process, not the step-by-step instructions of logging into and completing the forms of a software
package. Software can come and go, but the underlying steps in the process should endure.

The process document will serve several requirements pertaining to the control of documented
information if it includes the following sections:
 Purpose
 Scope
 Roles and responsibilities
 Materials and equipment required to carry out the process
 Documentation that is referenced or supported by the process document
 A section for each procedure in the process, including planning and the retention of
documented information

Work instructions serve to provide specific roles with precise instructions at key points in a process.
They are written in great detail and often include photos and diagrams to illustrate how to interact
with equipment, fill out forms, or use software. A work instruction is typically followed by one
employee to complete one step in a procedure. Not all steps require a work instruction. Create
work instructions as required to support the process document.

Once the process is documented comprehensively, review it as a group to confirm how it fits with
the culture of the organization. As mentioned previously, it is critically important that the
recommendations be done in the current culture. If it is unlikely that employees will fill out a form
in triplicate and then walk the form around for approvals before taking action, then don’t make
such a recommendation. Find a way to meet the requirements of the Standard to the extent
necessary with the minimum of rigour, duplication, and authorization. Whenever possible, allow the
employees to control the process, since they alone control the quality.

Present the Findings

To understand the importance of presenting the findings to top management, one must reflect on
the governance model for quality management.

Recognizing that employees control 100% of quality, quality management is achieved through
three organizational constructs.

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The first organizational construct is the hierarchical relationship among all the employees in the
organization. The line organization chain of command maintains a focus on quality through a series
of “supervisor-direct report” relationships cascading from top management to each employee. This
construct is responsible for workplace culture and confirming the competency and engagement of
employees in pursuit of quality objectives.

The second organizational construct follows the transformation of process inputs into process
outputs through a series of cascading “customer-supplier” relationships among employees in
different divisions and functional groups. Each such relationship is involved in identifying and
fulfilling customer requirements and exceeding customer expectations from first contact with the
customer and interested parties through to final delivery of service.

Finally, the organizational construct of process monitoring and evaluation, the simplest of the three
constructs, exists on a single level and has five principal roles:
1. Top management
 Approves each process as recommended by its process owner
 Mandates process owners to monitor their processes and report any issues or opportunities
for improvement
2. Process owner
For each process, the owner
 Monitors and evaluates the process performance
 Advises the organization on how to apply the process to new and emerging opportunities
within its mandate
 Communicates issues and opportunities to top management for consideration and action
 Ensures that training and documentation remain up to date
3. Process action team
 Creates new processes or addresses issues or opportunities as required by top
management following the change management protocols of the organization, including
 Developing the solution
 Communicating and providing training for the new process
 Following up on the implementation to ensure that objectives have been achieved
 Handing the process off to the process owner
4. Quality management representative
 Collects information from process owners (or delegates) who are monitoring all the
processes
 Evaluates the effectiveness of the QMS in achieving the vision of the organization
 Reports their findings to top management
 Routinely prepares for and facilitates the management review activities of top management
5. Internal audit team
 Supporting the quality management representative, the internal audit team conducts the
audits necessary to evaluate and report on the effectiveness of each process and the
effectiveness of the QMS

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This third construct represents the governance model that defines the existence and importance of
the process action team. The team is struck to create and improve a process but does not have the
authority to implement the recommendations. That authority rests with top management. To that
end, top management must review and approve the recommendations set forth by the process
action team.

Once the documents are complete, arrange to present the process to top management. Create
a formal presentation document that concisely yet comprehensively presents the features and
benefits of the recommendations as well as the changes required to achieve the benefits. Such
a presentation should include the following:
 Agenda
 Purpose and scope of the process being reviewed
 Definitions of key terms
 Requirements from the Standard that apply
 Why this process is important
 The benefits to the organization of implementing the recommendations
 The new process
 Recommendations
 Next steps

Provide the presentation documents to top management at least a week in advance of the
presentation to speed up the approval process.

Step 4: Train

Prepare the Organization to Succeed

Assuming that the process documents have been reviewed, revised as necessary, and approved by
top management, it is time to implement the recommendations.

It is possible that other projects might need to be completed before the new process is launched.
For example, providing training about a piece of equipment before it arrives will only cause
confusion and additional work that will need to be repeated when the new equipment is finally
installed. Sometimes, even if equipment or software changes will not be made for six to twelve
months, changing to the new process now may yield benefits that make implementing the process
recommendations immediately worth the effort. The project team will want to decide the best time
to launch the new process in relation to the ever-changing context of the organization.

Provide Detailed Training

When the facilities and equipment are in place to support the new process, provide detailed
training to the employees directly affected by the changes. Have the process action team members
do the training. Remember that these are people who already work in the process—those who are
in the best position to advocate for the process, address objections from their co-workers, and
support the change management process.

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Training involves six key steps, and these steps should be incorporated into the training approach
of the organization:
1. Assess the level of experience of the personnel to be trained and adjust the detail of the
training to match that level:
 Light overview for experienced operators
 Detailed explanation for inexperienced employees
2. Review the process document, work instructions, and other reference material with the
employees being trained so they know where to go for answers when the training is complete
and they are back on the job.
3. Demonstrate the process, procedures, and work instructions so that those being trained can
form a link between the printed word and the real world.
4. Have the employees being trained work through the process with coaching from an instructor
until they are comfortable with the process.
5. Have the trainees “fly solo,” demonstrating their understanding of the whole process without
input from the instructor. Once they can do the job without a coach, they can be released to
the floor as trained employees.
6. Record the results of the “solo flight” as documented evidence of the training, according to the
competence and awareness processes of the QMS.

Occasionally, suggestions will come up during training that should be incorporated into the process.
If the changes don’t exceed the scope of the process document and are aligned with the spirit of
the documents approved by top management, the process can be altered to incorporate the
suggestions. If not, then it is recommended that the process continue as approved and an
“improvement idea” created to capture the suggestion for management review in the future.

Provide Awareness as Required

If you just introduce employees to the documents and send them on their way, then you are only
providing awareness of the documents and not actually training anyone. This is okay for those
employees who interface with the process but don’t work in it. It is helpful for these employees to
know what the purpose of the process is and what is expected of their co-workers so they can be
proactive in providing the necessary support. This is an important part of the change management
process and should not be overlooked.

In general, to engender a sense of cohesiveness and shared purpose, employees involved in

a process should be given detailed training and everyone else in the organization should receive
awareness of the process.

Step 5: Go Live

Communicate the Starting Date

Everyone in the organization should be informed in advance of the launch of a new process. Since
a number of processes may launch sequentially over several months, public launch notifications will
provide several opportunities to reinforce with the organization the benefits of the implementation,

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recent successes, and future goals. Each launch notice can build excitement toward the completion
of the project. This is of enormous benefit in enabling the culture to receive a new process with
minimal disruption.

Communicate the changes with enough lead time to allow any concerns to be addressed. Be sure
that everyone knows how the jobs of their co-workers will change as of the go-live date and what
everyone else can do to support them. Forewarned is forearmed, as they say. Having advance
information and support from supervisors will help the launch go smoothly.

Ready, Set, Go
In preparation for the launch, the PAT should do some risk-based thinking to identify the following:
 What could go wrong on launch day?
 What contingency actions should be contemplated?
 Should those contingency actions be incorporated into the launch plan or await a trigger?
Contingency actions should include how to do a complete rollback to pre-launch conditions if it is
determined within the first 48 hours after launch that the process as planned has run into
unforeseen issues that cannot be resolved on the fly. In other words, there must be
a plan to recover from the changes that were launched, should the need arise.

On the day of the launch, the PAT and the project team should be on hand to observe the process
in action and handle any issues that arise. A series of test points should be established as part of
the start-up to receive documented evidence that the process is working as it should. Are the
forms being filled out? Is the data being entered at one end of the process showing up in reports at
the other end of the process? How do the product and process inspection and test results look
relative to the standards and acceptance criteria? Does everyone know what they are supposed to
be doing?

Step 6: Follow Up

Within the First Three Weeks

Recall that individual processes will be launched every two or three months throughout the
implementation of a QMS. For each process that is initiated, the PAT should complete a review of
the process about three weeks after its launch date. At this time, any issues regarding the process
should be evident, and the PAT should investigate those issues to determine whether
 The results of the process are within specifications
 Employees are following the process as written.

If the process is being followed but the results are unacceptable, the PAT will need to
 Address the issue and identify its root cause
 Modify the process accordingly and get management approval for the changes
 Update the training and repeat Steps 4 and 5 to relaunch the process with the changes.

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If the process is not being followed, the PAT will need to determine whether it is because
 The process has flaws, or
 The training was insufficient.

Once the reason for the process not being followed has been established, the PAT must respond
accordingly.

Generally, after three weeks, if there are any issues, then training will need to be reviewed,
improved, and repeated. It is possible that the process will have to be reviewed and improved as
well. It is essential for the PAT to stay with the process until it is deemed that the results are
acceptable and the process is being followed consistently. Remember: “Failure is not an option.”

Within the First Year

Within six months of the last process launch, and within a year of the launch of any individual
process, the project team should conduct a formal audit following the organization’s internal audit
process. All processes should be included in the audit, and all documented evidence should be part
of the review, including the evidence of management review and strategic planning. Any issues
arising from the audit should result in corrective actions that are undertaken according to the
organization’s process for corrective action. Once the corrective actions are shown to be effective,
the audit report and follow-up corrective action reports will then serve as the closing report for the
implementation project. The project team should present these reports to top management, and
top management should, by all means, recommend a celebration of this great success.

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Works Cited
Hartz, M., & Crosier, T. (1992). Process action team handbook. Rome, NY: Reliability Analysis
Center, U.S. Department of Defense.

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