The Project Mindset

The Project Mindset
I have been thinking about this topic for many years. Is the Project Mindset real? Is there a culture or a set of habits or behaviours that can define the Project Mindset?
What makes some people more suited to projects than others?
What are the traits to look for when selecting a team for a project that may not necessarily have direct project experience?

What basic knowledge sharing can happen so that the team members understand the project culture? Is this more intuition than knowledge?
Can operations and support staff run projects successfully? This scenario is becoming more prevalent in industry as operational staff in many organizations are increasingly expected to work on projects as they have intimate knowledge of the business processes impacted. Although operational targets are similar – they tend to be repeated so the team know how to achieve them and improve how they are done.

The Project
When we look at a project in general and key elements of a project, here are some of the ways in which a Project can differ from an operational environment.

• A Project has a beginning, it is not a pre-existing entity.
• A Project has an End – once the scope is delivered the project will finish.
• A Project is a temporary state – it will not continue for ever. Project teams, Rooms and Ways of Working are temporary.
• A Project is unique – even if the project is being delivered as part of a wider program – this project is unique to this team, this site and this installation. The same project will not be repeated.
• A Project is generally not part of business as usual. Processes, documents, tests systems are needed outside of normal business. Sometimes these need to be created.

Project Resources
Looking at the above features. The First two items, i.e. the Project has a beginning and an end are obvious to most people and need no explanation or introduction.

The other three elements Temporary State, Unique and Not Part of Business as Usual create some of the biggest challenges for Operations or Support teams that are suddenly thrust into projects or find themselves on a project team.

A Project is unique – even if the project is being delivered as part of a wider program – this project is unique to this team, this site and this installation. The same project will not be repeated.

Operations and Support teams are used to routine. Each week looks and feels that same, standard work practices, standard activity and a fixed meeting schedule for each week.
Project activity will vary as the pace changes from Kick off to Specification to Design to Build to Test to Qualification and into the Use phase.
Witch each of these project phases comes a different challenge, a different pace and the ability of the project resources to adjust the pace and change the level and type of activity is critical to the success of the project. This change of routine, pace and activity is what most operations based people can tend to struggle with for the first time they are working on a project.

Project Culture
A Project Manager or engineer with years of experience will instinctively know when to adopt a different pace within a project whereas the operations resources will just become comfortable with a way of working.
When the pace needs to change and changes some of these resources will adapt and deliver even if they are moving out of their comfort zone. Personally, I have always encouraged people to keep learning and to move out of that comfort zone from time to time – this experience will promote the growth of the individual.
As project leaders are we best to avoid this or to address this? Is prevention better than cure? i.e. If we know that someone has no project experience should we consider them for business-critical projects at all?
Or should we offer them advice, coaching and support to facilitate the transition from the “non- Project “ to a “Project” way of working. Are people capable of adopting the “Project Mindset”? This is an opportunity for you to develop as a leader by coaching someone into a position of confidence in their new role.

 

Team Selection
When selecting Operations based resources for projects the above items need to be considered.
Is the person suited to a change of pace, change of activity change of routine? Just asking the person directly may or may not yield the correct answer. You need to do a little research on the individuals as you would when recruiting for any role.
Find out if they have a track record of adopting change into their daily work. How have they responded in the past to new company policies, procedures, processes and systems? How have they responded to pressure situations in the past or to last-minute changes of direction?
You need to do your research when hiring project resources for several reasons but above everything else the biggest constraint is time. As projects generally have a fixed planned duration you may not have the time to take a risk on a resource.

In Summary
Moving from operations to project based work should be seen as an opportunity to grow as an individual and expand the capability of the person and the organization.
There are no hard and fast rules to selecting project resources but I look for the “Project Mindset”. I define this as a set of characteristics that will provide an indication of how a person will respond on a project.

How I summarize this is:

1. The ability to cope positively with change
2. A willingness to dig deep to complete a milestone
3. Does not tend to knee jerk react to every surprise that is encountered on a project
4. The Capability to move roles and/or work multiple roles to get the job done
5. The ability to switch off and chill after a period of high intensity working
6. Must not take any work-related discussions personally
7. Can keep focused on the end goal
8. Believe the end goal is possible
9. Can support the team to deliver the scope at all costs

Sounds easy, doesn’t it?
I would love to know your thoughts on this topic.
Need help?

If you are struggling to come to terms with repetitive project issues and you need some advice or support, contact us by email: info@systeme.ie with some background on your particular issue and we’ll be in touch.

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project management

Project Updates and Status Reports

The Report

No matter what size or type of project you are involved in in or managing, there is inevitably a status report required and update or steering meeting planned regularly.

There are numerous sources and recommendations of format, content and process of project status reports but these.
All organizations have their own preferences when it comes to style and format but the essentials don’t really differ from company to company.

The project status report must have a purpose. The first question to as is “Why?”
Some PMO (Project management Offices) in organizations sleep walk with their various templates and formats for these reports but ideally, they should be reviewed regularly.
The project status report is an essential element of Project Governance and control. Typical contents can include but is not limited to:

Current Status against Plan
Recent Activity
Planned Activity
Budget Performance
Resource allocation
Risks & Challenges

Within these headings all areas of the project can be discussed.

In addition to a communication of status this is also an opportunity to high-light any areas of concern and seek guidance, advice or support in the resolution of issues.

This may seem obvious but these meetings work best when a policy of openness and honesty is adopted.
Regular status reporting is necessary to be an effective means of communicating on all aspects of the project. It helps to maintain traction and visibility for the project. The frequency of reporting is often a function of the duration of a project and its importance to an organization. For projects with a short duration (i.e. less than six months), it is better to have weekly reporting so that issues are raised and dealt with sooner. For projects with a longer duration, bi-weekly or monthly reporting may be more suitable or desirable. As the project nears and end or a period of high activity the frequency may increase somewhat as required to manage that activity.

Project Report Content

When preparing the content, think for a minute before just blindly filling in the detail. Look for the reasons why the stakeholders may want certain information included in a report.
What is the next significant milestone?
Are there any blockers in the way to achieving the milestone?
Is the process to achieve the milestone fully understood?
Where there any contentious issues at the previous meeting – have they been resolved?

Remember that a project has been set initiated by a business to assist the business in achieving objectives or to reduce risk or resolve an issue. Always try to gear the project update into how close you are to making those business objectives a reality. This would by “Why” the project was initiated in the first instance.

Is there any important factor that needs to be discussed that is not included in the regular format of the project update meeting?
Be sure to raise it. If you are going to raise an issue it is always a good idea to have a solution or proposed way forward to present for the stakeholders to approve.

Delivery of the Project Status Report

The delivery of the Project status report is generally in the form of a meeting. These can be face to face meetings or web based meetings. Both have their advantages and drawbacks.
Face to face meetings are a great way to engage and build strong relationships. You can read the facial responses and body language and adjust your presentation to suit.
Web meetings force people to stick to an agenda and provide each participant with a specifc time slot – but talking over each other can have a negative impact on the meeting.
It is important to be clear and concise on all points to which you are presenting. Don’t say anymore that you must on any point. You may have someone in the audience who is out to impress and you or a project you are working on could be their target.
Limit your answers to yes or no and keep the detail to a minimum.
If you have some items you are uncomfortable discussing – then start with these and prepare a position on each of them. i.e. – What would you not like to be asked?

Format of the Project Status Report

Typically most organizations will utilise a format or a template whereby it is required to complete certain fields weekly for presentation to a steering team. In a new organization, it will always take a bit of time to get used to company jargon and pinch points. Don’t consume yourself too much with the template being used. This is unlikely to change in the short term so make your content suit the fields in the template. Too often I see Project managers complaining and wasting time on the report template when it is fixed and not changeable. Focus more on the facts of your project. You can always add in a comment verbally at the end of your presentation if needed. If you are asked to create a format then let the facts shape the format, do not let the aesthetics of a neat format guide your update.

In Summary – Project Updates

1. Preparation is Key.
2. Ensure your Finances, Risk Log and Activity Records are Up to Date.
3. If needed – speak to one or two of the stakeholders in advance of the update to float any potential sticky items past them.
4. Rehearse your Update in Advance (if you are expecting to deliver bad news – rehearse with a colleague)
5. Be Frank, Open and Honest.
6. Address any questions with short closed precise answers.
7. Don’t be afraid to ask for advice and Support.
8. Remember as soon as a project issue is identified – you can commence to work towards a solution!

Need help?

If you are struggling to come to terms with repetitive project issues and you need some advice or support, contact us by email: info@systeme.ie with some background on your particular issue and we’ll be in touch.

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CONSULTING

The Impact of Pharmaceutical Serialization in Your Organization

Pharmaceutical Serialization

Serialization in the pharmaceutical industry requires the individual identification of each individual saleable unit. i.e. each vial or syringe or pack of tablets must have an individual serial number identifying the pack back to source, date and time of manufacture providing full traceability.
Previously legislation only required products to be identifiable to a manufactured batch which can consists of thousands of units. The imminent Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company resulting in a wide reaching programme of business change.
The objectives of Serialization are:
To Prevent the introduction, distribution and use of counterfeit medicines in the global market
To facilitate the detection of counterfeit medicines
To Provide accountability for the movement of products by the supply chain participants
To improve the efficiency and effectiveness of recalls

Business Areas Impacted by Serialization

There is a significant impact on Packaging operations where serialisation data will have to be applied to product packaging at one or more levels. In the more complex serialisation models, this operational impact will extend into the distribution operations in central and/or local markets, where information on individual sale and shipment transactions needs to be gathered and added to the serialisation information. Particularly in the more complex track and trace models, significant IT capabilities will be required to manage serial numbers and track information related to the product and its movement.

Other impacted business areas include:

Commercial
Supply chain
Quality assurance and control
Procurement
Training
Legal
Regulatory affairs
Corporate

All these impacted areas need to be assessed for adoption of serialization and the appropriate solutions put in place. Given that these impacts affect many different functions and third parties, there is a high risk that solutions will not work well together unless the design of the overall solution is carefully managed and governed.

Managing Implementation of Serialization

Establish a programme of activity to build organisational and extended supply chain capability.
Be realistic about the emerging nature of these capabilities and build in adequate time and resource to effectively test and iterate solutions.
Design serialisation activities to closely couple related actions to minimise the possibility for errors due to abnormal events.
Design both the normal processes and the regularly occurring non-standard events to avoid product supply quickly grinding to a halt.
Ensure cross-functional teams are established to carefully design the interfaces between departmental and organisational boundaries.
Ensure adequate time is allowed for packaging design changes to be made to accommodate serialisation features required.

Ownership

As with any other key element of the business. There should be a local senior level sponsor that will take complete ownership for Serialization on site or within the organization. A common misconception here is that it needs to be an IT or a Software discipline that should own Serialization. Serialization is a supply chain solution and function but the means of delivery is via Software and Technology. The ownership should be with the Supply Chain team. One could argue that all departments are in the supply Chain in some capacity. Serialization is a key differentiator in the Pharmaceutical industry and is only in its infancy. The spread and impact of Serialization will continue to grow. A dedicated team will be needed to both implement sand run Serialization as part of the daily work on each site.

Summary

Deliver Serialization into your organization with an eye on the market for the next 5-10 years not just to get a system in place.

Assign a senior level owner for Serialization.

Build a cross functional Team with the capability to manage and expand the footprint on Serialization within the business.

Ensure the Success of Serialization in the business forms part of the indivdual and collective goals and objectives for the team.

Respond swiftly and decisively to Regulatory requirements

Implement and practice the same level of control that is in place with other site systems.

For more Information and Guidance on the Implementation of Serialization please email is at info@systeme.ie

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project management

The Challenging Ones and How to Manage Them

Trying Times with Difficult People

At some stage in your working life you are bound to come across the challenging people, the ones that are not cooperative and are sometimes downright difficult. This perspective of someone is generally defined by their behaviour.
This can include but is not limited to:

Disrupting Meetings
Taking Everything Personally
Not co-operating with anything
Getting in the way of progress
Not supporting the rest of the team
Delaying Projects

Like all challenges you will face – people challenges are no different. You need to get to the nub of issue.

Thinking about How to Manage Challenging Teams

The person in question has a reputation for negative behaviour. A reputation can only come from frequent consistent behaviour. If the behaviour is consistent then the behaviour is predictable. If you know how the negative behaviour is likely to manifest itself, then you can plan a response to that behaviour in advance of a meeting or encounter.

Planning to Manage Difficult People

In order to effectively manage negative behaviour or a negative reaction to something we need to pin it down to exactly what it is likely to be so if you really want to make progress, follow this approach.

1. Identify the behaviour you wish to challenge – i.e. during a meeting what is the most likely outcome. If the person has a consistent way of behaving – what is that specific issue? What is the trigger for this? Hot heads tend to have a trigger point around a specific topic that will trigger an outburst. If you are aware of this trigger then you can plan for it.

2. Once you have identified the negative behaviour, plan the response. Never react. Respond. A response has generally undergone some thought or planning.

3. If you haven’t already tried, meet with the person one to one. If that has not been productive then meet with other peers and colleagues.

4. Don’t provide any ammunition for the person to exploit. i.e. don’t start off negative looking for confrontation. Avoid leading questions that gives someone room to ramble and rant. Ask only specific topic related coherent questions, questions that only require a yes, no or another specific short response.

5. If you are looking for help, try to ascertain and get the person to state publicly if they “can’t” help or if they “won’t” help. If they can’t help, then what is the obstacle preventing this? If they won’t help – then ask why? Often you can tease out a personal grudge by asking this question. The answer will normally portray to everyone else that they are not behaving professionally.

6. Always be conscious of your and their rank and position within the organization or project. Keep the context of the situation in mind. All issues can be viewed from a number of perspectives.

7. If they decide to vent in the meeting, let them vent. Don’t respond until the venting has completed. Then calmly and clearly restate your view or perspective if appropriate or if needed for clarification. You may also need to ask for clarification on what was said during the rant. Choose your words carefully -ensure they are neither negative nor confrontational.

8. Always remain in control of what you are saying and how your are saying it. Make every meeting count.

9. Once the meeting has ended, issue minutes and actions immediately. The sooner you release them after the meeting, the more accurate they will be and the more likely people are to review and respond.

10. Stick to the facts, never get personal. Even when others may behave unprofessionally – don’t use that behaviour to combat that behaviour.

In Conclusion

After several meetings and encounters where your behaviour is consistent and professional, where all minutes follow swiftly on and are accurate. After numerous encounters where you don’t give negative behaviour any similar attention, the difficult person will identify your positive behaviour and will eventually learn to behave themselves in these scenarios. If they don’t learn then they will disappoint in other areas of there working life and eventually be exposed as not performing in some other area.

Whether you are in an operational, sales, support or project setting, negative behaviour can be managed. You can’t control how others behave but you can control your own response to this behaviour. Stay Positive.

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MENTORING & COACHING

The Difficult Conversation…….That Could Save Your Business

The Scenario – Non Performing Team Member

There appears to be an increasing reluctance for management to engage in the difficult or challenging conversations. Recently a client of mine called me looking for support in managing a difficult employee. The difficult employee happened to be an Operations Manager with a responsibility for running a department and training new staff.

My client first started to notice issues when he witnessed how the Operations Manager was treating people in general. He noted a couple of these events before he decided to speak to the person in Question. He arranged a meeting and spoke about what he had witnessed. The feedback did not go down too well and resulted in quite a heated discussion.

He let it rest for a while and then arranged another meeting to discuss the matter once more and bring the issue to an end. This time the meeting blew up and allegations of harassment were made. Knowing my client as well as I do I would have thought that this would be that last thing he would accused of in a professional environment.

To calm the situation, he decided to let it lie in the hope the issue would not resurface. The operations manager appeared calm and collected and wok continued in the expected way. A couple of weeks later one of the engineers in the office asked to speak with my client (The Business Owner). They went out for lunch and the engineer expressed concerns over some behaviours he had witnessed.

The week after that, a long established customer of the business than approached the client with some negative feedback on the Operations Manager. This time my client had a more urgent reason to act. It is one thing tolerating disharmony in within your own operation but when a client customer is brought into it, you need to act.

My client again met with the Operations Manager to discuss the customer feedback and this time the meeting descended into a finger pointing exercise with accusations of harassment being levelled at my client (the business owner).

He then called me for advice, explained the situation and asked if I could come in to help. After thinking long and hard about this one, I devised a plan to bring to the business to offer help and resolve the situation.

The Plan to Manage Performance

Instead of jumping in head first to tackle a difficult person the plan entailed a look at the business in general to see where savings could be made by making processes more efficient. The company were already on a lean Six Sigma drive so this approach fell in with the company strategy.

I arrived on site to introduce myself as a Project Manager and Management consultant. The purpose of my visit was to plan and run a couple of workshops aimed at two of the main business processes. Once the changes required for operational improvement were identified, I would support the team in putting a plan together to implement the changes, then monitor the progress weekly until the work was complete.

The Workshop to Tease Out the True Scenario

We agreed on a date and the workshop commenced. In typical fashion we looked at people, process systems and environment. I encouraged the team to be open an honest with each other. It became clear early on that change was not a welcome visitor in the world of the Operations Manager. At one point the person made that statement that “People just need to Listen and do their job, then there would be no need for this workshop.”

I immediately called a coffee break and asked the Operations Manager for a word in private. I basically made it clear that as a manager the role is to encourage feedback and openness in the team so that the real issues can be identified. A Manager making such a statement was likely to stifle any progress in the workshop as this was an indication that there would be no changes. The Operations Manager completely lost it with me and I let him vent.
Once the tirade was complete – I responded by saying this behaviour was not professional and he blew up again stating that he did not have to put up with this “Crap”.

He called the boss into the room and we explained the scenario. This time my client (the business owner) was prepared. He stated that the company objectives for this year were only possible if process improvements were in this department. The fact that a manager was not going to drive the change and was completely against them was not a tenable position.

We gave the Operations Manager an opportunity to restate their commitment to the process which he reluctantly did. The workshop continued and the day was a success.

Next Steps – Managing Performance

In the coming weeks it was performance review time and I was asked to support the performance review process. Within the review of the operations manager it could be seen that many operational objectives were met. So the “What “ was fine. When it came to the “How” it was delivered – it was clear that the methods of personal interaction adopted were negative to the point of being toxic.

The organization offered the individual support to understand how he could improve in these areas and I was put forward as the management coach. We ran through a few sessions but it was clear that the individual was not going to engage in earnest. We were then forced down the road of the disciplinary process within the organization. 1 week after the first meeting the Operations Manager resigned stating that the environment in the office was becoming increasingly difficult in which to work.

Conclusion – Difficult Conversation

When we look at all the scenarios although this outcome was not the original objective it did serve as a turning point for the organization. The individual was not aligned with the company objectives, not living company values and was extremely disrespectful to anyone with whom they disagreed.

The behaviours were not challenged and therefore continued. My client admitted that he was uncomfortable having that difficult conversation with the Operations Manager. Looking at the situation in retrospect he hadn’t been monitoring performance of the individual against the goals and objectives set out at the start of the year. This also did not help as the Operations Manager was not being held accountable.

The overall cost of not making people accountable for performance and delivery is huge and the financial cost is often the smallest part. Company culture can suffer if hardworking honest e employees see less committed employees being rewarded regardless of behaviours.

Recommendations  for Managing Difficult People

Make sure your employee performance goals are directly aligned with and in support of your business objectives
Make everybody accountable for what they do and deliver and place as much emphasis on how they did it.
Don’t be afraid to have the difficult conversation early on if someone is beginning to steer off track. You can only do this by staying engaged with your team, talk to people regularly. Get a number of perspectives before forming a point of view.
Above all – remind the team that they are all here to support the running of the business, if they all pull together as a team, support each other and understand they will be held accountable for delivery and how they treat each other, this can only serve to be positive for all involved.

 

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TRAINING

CAPA Management – Part 2

CAPA Management Part 2 – Continued from CAPA Management Part 1

Corrective Action Objective

To generate a plan of action that will that will eliminate or reduce the incidence of the root cause of the deviation, failure, or breakdown.

Developing the Corrective Action

Consider the following elements when preparing and documenting the corrective action plan
•Decide the means to implement the action
–SOPs
–Process changes
–Training or Retraining
–Implementation of automation or new equipment

Decide on the implementation time-frame
Determine the method of CA communication
Determine staff involved in carrying out the CA

Scope Of Corrective Action

Do not expand the corrective action beyond the identified root cause unless directly linked to another factor
The corrective action must match the root cause of the deviation.
If possible, build the corrective action upon existing or known barriers.
Remember that continuous correction is not quality improvement!

Effectiveness Evaluation

The objective of the Effectiveness Evaluation is to generate documentation that proves or disproves the following two statements:
The Corrective action was completed and implemented as planned
The corrective action was effective in the reduction or halt of recurring deviations.

Verify that corrective action was properly implemented
Determine data source for Effectiveness Evaluation
Determine when to perform Effectiveness Evaluation
Determine evaluation period
Consider impact of learning curve
Determine success criteria

Who Carries out the Effectiveness Review?

Operations management is responsible for the planning, completion and reporting of the effectiveness evaluation.
Reporting of the Effectiveness Evaluation consists of documented evidence of the effectiveness of the corrective actions taken for the event.

Timeframe for Evaluation

In most cases, the evaluation should be started no earlier than 30 days. This ensures that the staff is competent
and familiar with the corrective action submitted. Depending on the organizational SOP, the evaluation for
effectiveness should begin within 60 days of the corrective action plan implementation date.
Depending on the organizational SOP, the evaluation should be completed no later than 120 days after corrective action implementation.

Effectiveness Measurement

Observe staff directly involved in the execution of the corrective action alongside a small sample of other staff members (one to five) not directly involved in the corrective action.
Review source documents involved in the corrective action for one to three months post implementation. Look for omissions, corrections, or completion attributes that reflect a recurrence of the original deviation.

Staff may be interviewed individually or as a group to ensure understanding of the process
in question. Role playing exercises using corrective action scenarios may also be used
to ensure understanding.

Operations or Quality Assurance may perform a post corrective action audit to determine overall effectiveness.

Generate a presentation or internal document to ensure understanding of the process change initiated for the corrective action. Ensure that key stakeholders in the organization can articulate the problem. Run an update session with all teams and seek questions from team members about the issue and the investigation. If required make this memo part of the mandatory training for people affected. Supply a list of employees that have completed, including the date completed

For each effectiveness evaluation performed, a memo should be generated to document and summarize what was done for the evaluation and the resultant outcome.
Details including the date range, persons performing the operation, and specific root cause being evaluated should be documented in the memo.

In the Event of a Failed Evaluation

Issue a new deviation or nonconformity. The Root Cause Analysis will need to be redone.
Items to consider:
There may have been multiple root causes that were not initially discovered.
There may have been significant contributing factors that were not discovered.

To summarize an Effective CAPA Process

1. Define the problem.
2. Gather data/evidence.
3. Ask why and identify the causal relationships associated with the defined problem.
4. Identify which causes if removed or changed will prevent recurrence.
5. Identify effective solutions that prevent recurrence, are within your control, meet your goals and objectives and do not cause other problems.
6. Implement the recommendations.
7. Observe the recommended solutions to ensure effectiveness.

For more information Download our Troubleshooting and Investigation Guide here or contact us at info@systeme.ie

CAPA Management – Part 1

CAPA

CAPA (Corrective and Preventive Action) is a deviation management process that focuses on the systematic investigation of discrepancies, adverse events, or failures.

If used correctly, the CAPA process will provide a means to prevent the deviation from recurring.

How…?

•It provides a structured platform to conduct an
systematic investigation of the deviation.
•The investigation provides the means to develop a
permanent corrective action
•It provides a framework for documentation that the corrective actions are indeed effective.

Additionally, a CAPA system is the cornerstone of the organization’s Quality Management System (QMS).
21 CFR 1271.160(a) states:
General. If you are an establishment that performs any step in the manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality program must be appropriate for the specific HCT/Ps manufactured and the manufacturing steps performed. The quality program must address all core CGTP requirements listed in §1271.150(b).

CORRECTIVE ACTION

An action taken to eliminate the root cause and symptom of an existing deviation or nonconformity to prevent recurrence

This is a REACTIVE action that eliminates problems identified in products, services, or processes and takes care of the immediate problem.

This is an action taken to eliminate the potential causes of a nonconformity, defect, or other undesirable situation in order to prevent occurrence.

Corrective Action

An Immediate Corrective Action is essentially a description of the steps taken to gain control of a situation or product immediately following the discovery of a deviation.
The immediate corrective action keeps the deviation’s scope from expanding. It also quickly resolves or corrects a discovered event, problem, or situation until the root cause is determined.

Products
–Quarantined
–Isolated
–Discarded

Equipment
–Removed from Service
–Replaced

Processes
–Manufacturing Suspended
–Test Results Withheld
–Recovery Procedure Halted

PREVENTIVE ACTION

This is a PROACTIVE action which avoids deviations through planned activities. It also eliminates or reduces the recurrence of the problem.

Steps in a CAPA Process

Discovery of the Deviation
Documentation of the Events
Immediate Corrective Action
Investigation of the Root Cause
Causal Analysis
Corrective Action
Effectiveness Evaluation

Means of Detection of a Deviation

–External Audits
–Internal Audits
–Staff Observation
–Performing a task
–Inspection or Testing
–Process and Equipment Monitoring
–Record Review
–Change Control
–Material Review Boards
–Complaints
–Adverse Events
–Product Returns or Recalls
–Notification by a customer or a client

Document the Deviation

The objective is to create a document that is an accurate, complete description of the event so that anyone can understand it.
–External Auditors
–Internal Auditors
–Technical Staff
–Administrative Staff

Essentially, the document should contain all the details needed, without the use of jargon.

To create a well documented and effective narrative avoid the use of subjective, fuzzy, or longwinded statements.

Other documentation considerations:

–If it isn’t documented, it didn’t happen
–If it isn’t documented, it doesn’t exist.
–Precise, economical word usage

In describing the facts of the deviation, include accurate descriptions of the following details:
–What was discovered?
–Who was involved?
–When did the event occur?
–Where did the deviation occur?
–How was the deviation discovered?
–How frequently does the process occur?

Root Cause Analysis Principles

•Understanding of how or why the deviation occurred.
•Understanding of the circumstances at the time of the deviation
•Determination of other products, processes, or individuals were involved
•Gathering of data to aid in the accurate future determination of a root cause and development of corrective action.

As Part of the Investigation you must perform

•Interviews of Staff, Customers, Suppliers
•Review of Policies, Procedures, Forms
•Records Review:

Training
Production
Equipment
Computer
Environmental
Security (Room Entry)

The high level objectives are to:

•Discover the primary (root) cause
•Result in recurrence prevention
•Reduce operational risks
•Improve operations
•Maintain quality and compliance

•The conclusions derived from a RCA must be the result of a systematic process which contains well documented evidence.
•Any given problem will have more than one root cause.
•To be effective, the RCA must establish all known causal relationships between the root causes and the defined problem.
•Performance improvement measures directed at root causes are more effective than treating the symptoms of a problem.

A thorough investigation will provide the needed information to establish the root cause.
The following questions are useful in gathering data during a Root Cause
Analysis (RCA).

–Who was involved in the deviation?
–What was the deviation?
–Where did the deviation occur?
–When did the deviation occur?
–How did it happen?
–How frequently does it happen?

The questions serve to capture the maximum amount of detail regarding the deviation or occurrence. They help provide data to understand why the deviation occurred.

The Root Cause Analysis is also aided by asking questions that relate to barriers to deviation.
–Describe any physical, organizational, or process barriers in place to detect deviations.
–Were the barriers were in place?
–What was their level of effectiveness?
–Describe any barrier failures.

Are there environmental problems?
Are the work conditions suitable?
Are there process flow problems?
Are there facilities problems?
Are there any equipment or materials problems?
Are instructions for use clear?
Are there problems with staff communication or staff training?
Is there adequate supervision?
Are there problems with the methods, SOPs, forms, or task analysis?
Do the steps performed match the operating procedures?
Has a process recently changed?

Use a Recongnized Method of Problem Solving

Consistent application of one or more of these problem solving tools along with the questions mentioned will provide a good platform to arrive at an accurate determination of root cause or causes.

•5 Whys
•FMEA
•Pareto Analysis
•Fishbone
•Causal Factor Tree Analysis
•Barrier / Change Analysis
•Task analysis
•Observation

For more information Download our Troubleshooting and Investigation Guide here or contact us at info@systeme.ie

Part 2 of CAPA Management coming soon………..

project management

5 Key Components of Project Delivery

Project Execution and Delivery

Weekly priorities and goals need to be set from the beginning. Set out a culture of delivery and accountability from the very start. On large projects – some team members can coast their way through the first few weeks of a project and before you know it – you are behind schedule. The success of a project is the result of the success of the day, week month and year of the project. Get the team members into the habit if self-accountability – i.e. where they tell the Project Manager what they will deliver today or this week and how this will contribute to the success of the project. This is where team selection is key – ensure that there are no passengers on the project team. People who are not contributing will suck the life and enthusiasm out of the project team and make the project harder to manage.

Utilize Project Team meetings a means of:

Communicating Status
Reviewing Performance
Making Plans for the coming week
Discussing risks and issues

This type of meeting should be held on at least a weekly basis depending on the level of activity and customer expectation. Rotate the chair, keep accurate list if minutes and follow up on actions regularly

Another function of this meeting is to gather information required for project governance to a site leadership or above site team. These updates are typically summary of the weekly project meetings. These meetings are also a means of highlighting issues and or requesting guidance and support at difference stages of the project.

At each major point in the project, e.g. after every big deliverable or milestone is complete – conduct a brief, honest review of performance, a lessons learned session to take forward any learnings into the next stage of the project.

Project Reports and Communication

Different organizations and industries will have their own requirements on the level and type of reporting and communication. There may be different templates to be managed depending on the level of reporting required. It can be useful here to only maintain a single reporting template for each project. The reporting template for each project should not become the focus of the work but should be used as a means for communication. On a project with a long duration, this can take a while to get right as the audience may vary and their weekly focus can shift from cost to schedule to risk to resources at a minute’s notice. The only recommendation here is to be honest, clear and transparent – the earlier an issue is highlighted, the earlier a resolution or support can be sought. Communication should always come from the Project Manager – and the PM should assign a delegate in the vent of absence. Stick to a consistent form of communication.

Project Issues and Resolutions

Throughout the course of any project -issues will occur. They can be technical, logistical, resource, risk, budget or schedule related. Instead of worrying about unknown unknowns – focus on what the strategy is for issue resolution. An example of this is:

1. Problem Statement
2. Probable causes
3. Impact to the Project – cost, schedule, risk
4. Conclusion or Root Cause – Where appropriate
5. Proposed Solutions
6. Recommendations
7. Support or Direction Required from Site Leadership or Above Site Teams via governance

Having a structure will help frame every problem and get the team into the habit of managing problems effectively.

Regular, honest and transparent monitoring of key performance indicators such as schedule, budget and scope will enable you to capture a potential issue before it becomes a bigger challenge to manage.

Managing Project Scope and Delivery

This is probably the biggest challenge facing project – the control of scope. The scope is agreed at the outset of the project via the Project Charter and other associated contractual documents. The detailed plan assembled before project kick off helps to clarify the definition of the scope further. With the best will and intentions – this scope will be misinterpreted somewhere along the way. Expect a dispute on one of the finer points of detail – this typically occurs when interfacing with a different system or having to manage another vendor or third party. In order to reduce the occurrence of such challenges always build risk around system interfaces and third party deliverables.

Another area where scope can increase or begin to creep is during “Corridor” or “Watercooler” conversations. i.e. someone may mention that – “It would be very useful to have a report on this new system that showed Purified Water usage on a Daily, Weekly and Monthly basis.” The statement may be true – but if is not in the original scope – it is not in scope. To some end users – statements made during conversations are a contract, an agreement by the project delivery person to include this requirement in scope and deliver it with the original scope of work.

Many organizations have procedures for Project Change Controls and managing extras. This may indeed be a legitimate business need but the original project costing and plan – it is not in scope. In order to include this requirement in scope the following must happen:

1. The end User or Client – Completes a project change request
2. This is assessed by the technical SME
3. An Impact report is produced in terms of Time, Cost, Risk
4. The end user accepts this proposal
5. The change in scope is approved at the Project Governance forum
6. The new requirement is included in scope and the original contract is amended accordingly.

Different organizations will have variations of this process but essentially the process must be respected.
There may be more simplistic examples were for the sake of good customer relations or lack of clarity in interpretation of requirements – a decision is made to absorb a change request into the original scope of the project particularly where the cost and time involved is negligible and will not impact the original delivery budget or schedule.

As a default position – it is always best to utilise the process that is in place as a starting point.

Project Closure

A common oversight in industry today is the effective and complete handover of a system and closure of a project so that all legal, financial and logistical obligations are discharged and recorded correctly to enable a project to close completely.

Before closure it is wise to conduct a review of project delivery against actual performance and original intentions. This can include the learnings carried forward from earlier stages. It is also important to acknowledge any challenges experienced and that you have implemented measures to ensure that a recurrence of the same issues is greatly reduced or eliminated. Items covered should be –

What worked well?
What needs improvement?
What should we start doing?
What should we stop doing?

If you happen to do business with the same customer or end user again – theresulting report is always a useful starting point.

Other items to be considered at project closure:

1. Any warranty obligations are have been honoured
2. A support agreement for operational support has been set up
3. All items within the project scope have been delivered
a. Documents
b. Procedures
c. Test Results
d. Training Evidence
e. Software Versions
4. All contractual obligations on both sides have been agreed and closed off

Project closure generally takes some time but this can be formalized with a meeting between all stakeholders to gain official agreement and consensus that the Project is now closed.

Need help?

If you are struggling to come to terms with repetitive project issues and you need some advice or support, contact us by email: info@systeme.ie with some background on your particular issue and we’ll be in touch.

Download our project rescue guide here Project Rescue Guide

5 Steps to Kick Start Any Project

Project Charter

Draft a Project Charter that describes the project in concise terms.
What is the purpose of the project? (Why is the project being rolled out?)
What is the scope of the Project?
What are the main deliverables?
What are the key milestones?
List the risks, assumptions and interdependencies?
What is the project budget? Who is on the project team?
How is progress monitored and success measured?
The charter can be the basis for the formal agreement or project contract between two parties.

Define the Project Requirements

Are the user requirements clearly documented and understood? Is it clear how the main deliverables of the project will satisfy the needs of the business or end user? Has the scope of the project been assembled based on the user requirements?

Planning

In order to produce a plan – you need to understand every task that needs to be performed in order for the project to be delivered. Every task, every document, all items that need to be procured and installed, servers, software and the resources need to do each task. A work breakdown structure should be produced that details all the above-mentioned tasks.

Detailed Planning

There are no shortcuts here – you will need expertise from a number of areas to provide input in order to produce a detailed plan. This may take a number of workshop in order to gather the correct level of detail. Once the tasks have been listed – the order, inter-dependencies and estimated time can be defined. The tasks must then be assigned to resources to perform the tasks – from this the project cost can be estimated.

Depending on the business need to have the project implemented by a specific date – more resources may be required to deliver the project. But depending on the process of delivery – it may not be possible to resource load some elements of the project.

The team selection is crucial for success here – choosing the right people that will work together as a team is vital. Don’t go on experience alone – enthusiasm, attitude and personality will benefit a project and compliment technical expertise. Ensure that everyone is clear on their responsibilities and roles within the project.

Estimation

Now that the plan has been developed and the costs understood. The risks and dependencies need to be overlaid on to the plan to understand the potential impact of the risks in terms of cost and time. Once this final estimate is assembled there may be some higher level approval required so that all the main stakeholders understand and approve the project, the scope, the budget, the risks, the timelines and the key deliverables. This may be a formal approval in most organizations.

This is also an opportunity for all project team members to refine the plan and provide further input on the task estimation and duration so that they are comfortable with this prior to commencing execution.
Perform a detailed risk assessment in order to identify the potential impact on the project in terms of time, cost or scope.

Project Kick Off

Once the above criteria have been approved – a Project Kick off needs to take place. This is normally in the form of a day-long meeting / workshop and should include but not be limited to the following topics:

Summary of the Project – i.e. Run Through the Charter
The Objectives of the Project
Key Performance Indicators
Project Plan
Budget
Project Team
Risks, Dependencies and Assumptions
Monitoring, Governance and Reporting

Also as part of the kick off, define and communicate the Day 1, Week 1, Month 1 activities. This is basically a list of tasks for all project resources so that they are clear on what is expected of them within the first month of the project.

Need help?

If you are struggling to come to terms with repetitive project issues and you need some advice or support, contact us by email: info@systeme.ie with some background on your particular issue and we’ll be in touch.

Download our project rescue guide here Project Rescue Guide

TROUBLESHOOTING & INVESTIGATION

Want to Convince Your Clients? Just Be Honest.

Whether you’re in a direct sales role, in a support role or a technical role, you will be expected to convince someone to do something at some stage in your career. That may be a decision or a purchase or a choice of some description but we all need convincing skills. Look at the dictionary definition of the verb “Convince” – Convince – to make (someone) agree, understand, or realize the truth or validity of something.

I’ve looked at this from a number of perspectives over the years and what I’ve seen is that in order influence someone or convince someone you have to be credible. The best way to be credible is to be honest in your convictions.

The Sale
If you know your product and understand your business, then you will be more relaxed in front the person you are trying to influence. When we think of trying to influence or convince someone we can all cite examples of the door to door salesman or used car salesman trying to get you to purchase something that you don’t need or will not be of any real use to you. These guys are normally found out very quickly after the sale. They leave a bitter taste in your mouth and therefore a lasting distrust of salesmen.

OK so I’m not having a go at salesmen in general but think of the drive that the salesman has – commission. There’s nothing wrong with an incentive to perform but it can drive the wrong behaviour in the wrong person.

On many occasions I watched salesmen and women sell equipment, software, solutions and projects to clients and the clients were convinced they needed them. From the organization’s perspective the sales person had done his or her job, deal done – commission in the bag. Much of my work involved either delivering the project or solution and dealing with technical issues after the sale.

After the Sale
The after sales situation was often quite different. Typically following one of these sales there were some problems – the software or project was not fit for purpose. Once we got to the root of the client’s needs the actual requirement was something quite different from the solution they were sold. We then had to renegotiate to encourage them to purchase the right project or solutions and the sales pitch starts again.

Epiphany
As I became more experienced in the field of customer management, something quite profound occurred to me.

1. When I followed the lead of the sales team to just get the sale (i.e. Commission Driven), I found it very difficult to convince the customer to buy from us and trust us.

2. When I did what I believed was right for the client, when I had their best needs at the forefront of my objectives – the sale was easy.

This happened on more too many occasions to be coincidence. When I looked closer at the different approaches and listened to customer feedback, I could see the real reason. The customer was convinced because I was convinced. I was convinced that I was doing the right thing and I had complete confidence in what I was selling or what decision that I was advising them to make.

Previously I had overlooked that a lack of sincerity would not be spotted and would be challenged by our clients. When I asked one client for feedback on why he selected our company for the project we had just been awarded, he stated that it wasn’t price, nor the company reputation. He stated that it was because he was convinced that I believed that what we were offering was the best solution for the client. He chose us because he trusted why we were offering this solution. He believed that we were honest in our intentions and he trusted us. He could see in my demeanour and presentations that I was sincere.

Refer back to the dictionary definition above for “Convince”, does it have more resonance now?

The Story
In this particular case the original proposal material was adapted from a previous endeavour with another client and the solution was similar. At first I had spent so much time trying to make it fit, trying to adopt someone else’s creation to make it fit what we needed at the time I was blind to the above epiphany. I started from a blank document and produced a proposal that was a direct response to the needs of the client – not just a fabricated sales pitch that had the corners broken off it to make is suit the current customer needs. I completed the proposal swiftly and the resulting document was a very simple, clear description of what we would deliver, how we would deliver and ultimately why it was needed.
Since then I have always taken great time to get to know the client. Get to know why they need issues resolved and make clear to them the direct and indirect benefits of any solution that I have been responsible for delivering.

In Summary
No matter how big the organizations or how great the reputation, when it comes to big decisions, if they are honest, people do business with people. They do business with people they trust.
Once you are confident in yourself, confident in the solution that you are offering, and why you are offering the solution, the client will sense this confidence and will trust you. When they trust you and come to rely on you, you are destined for a prosperous customer supplier relationship.

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