Process software
The benefits from using modelling software to define processes (as compared with pen and paper) relate to the fact that a digital model is produced, as opposed to just a picture. A picture only delivers benefit when it is looked at. A digital model, on the other hand, can be subjected to a range of analytical tools and techniques, delivering against the precise requirements of your organisation. This can range from the very simplest functional capabilities (such as spell checking and keyword searching) to the more sophisticated capabilities such as static and dynamic simulation, workflow implementation and process optimisation.
There is one question you must be able to answer to understand which software tool is right for your requirement: who are the customers of the information contained in the model?
Broadly speaking, customers of process models can be classified into one of the following groups:
Staff: widespread, non-specialist, non-technical workforce who need straightforward information to help them perform the processes they are responsible for on a day-to-day basis
Process professionals: a group comprising roles such as quality managers, project managers and process improvement managers. Basically those with responsibility to influence the documentation, execution or development of business processes
Developers: strongly technical customers such as programmers, systems integrators and database developers. These are the people for whom the process definition represents a working model of a software system to be developed.
Software modelling tools tend to specialise in delivering against the needs of these different groups of customer. Table 1 gives a flavour of the differing needs of each of the customer groups, and some of the software capabilities required to satisfy each.
The biggest pitfall is not knowing who the intended customers of the information in question actually are. A common mistake here is for organisations to over-specify their modelling software: Developers need standards they can rely on, translate between models and use to validate their work. Conversely, staff need models they can understand rapidly and with minimal learning, or they simply won’t be able to reference the model.
Root cause analysis software
Software for non-conformance management and root cause analysis falls into three primary categories:
Visual assistance
You can gain visual assistance to your investigation and thought process by creating Ishikawa (cause and effect) diagrams. Even with this category the programs vary considerably in ability and cost. They can be as simple as a drawing package, where you draw the diagram as you and your team investigate and brainstorm. They range right through to those where you simply enter the steps and possibilities in plain English and it draws the diagram for you, effectively visualising your thoughts in a text-to-chart conversion.
Non-conformance reporting
General non-conformance reporting and analysis covers a wide range of businesses. This type handles a wide range of incident models, such as customer complaints, rejects at inspection, audit findings and issues like health and safety or the environment. Accumulating data from across the organisation and reporting in a consistent way will enable you to identify nonconformance trends before they seriously affect the business. The corrective, preventative and improving actions are then tracked and monitored for successful implementation.
Industry-specific
Specialist industry-specific, root cause analysis software is the final class and is ideal for high risk, high impact activities such as medical care. These have very specific capabilities and often come with an ability to suggest possible root causes based on your input. It may ask a series of questions, and based on the answers, the software will suggest possible causes. From this you can design a specific response plan involving a range of actions.
Choose the software for you
When you decide to proceed, start by reviewing the basic problem:
Are you in a high-risk business where failures are rare but the consequences are serious and investigation difficult? Medical, pharmaceutical or aerospace roles for example? Look for an industry-specific tool for serious incident management, and then review general tools for nonconformance management.
Do you experience a high volume of non-conformances with occasional potentially serious incidents? Then it is best to review a general tool. This will enable you to analyze the reason for issues arising anywhere across the business, giving management the information to initiate a root cause investigation based on high volume, low risk incidents. This in turn dramatically lowers the cost of non-conformances and continuously improves quality.
Do you experience a low volume of non-conformances with occasional potentially serious incidents? Select a process-visualising tool capable of quickly generating and amending Ishikawa (cause and effect) diagrams.
There are, however, many challenges that can hinder your return on investment. Some of these hindrances to be most wary of are:
- managers not buying into the process
- failing to adapt to the tool. This is always difficult, but if you are buying a commercial ‘off the shelf’ package, you should expect to have to adapt the way you work to some extent
- failing to adequately train staff to use the software. Note that the cost of training is normally at least 50 per cent of any good software implementation.
Software can’t be a panacea of root cause analysis, but it can help you reduce the cost and time involved. It also frees up the time to concentrate on the nonconformities that really matter.
ISO 9001 software
You be may be finding that the demands set by scope, scale and information on your quality management system (QMS) have been steadily increasing. This is especially true if you are managing more than one site. If this is the case, the answer may be to implement web-based software.
Software used for ISO 9001 must support the process of implementing and maintaining a management system certifiable to ISO 9001. At the very least it should provide features to communicate and maintain quality control policies and procedures. In addition, it should identify issues and analyze failure mode and effects and risk-assessments, maintain a register of legislation, and set quality objectives and targets.
It’s also useful for automatically creating task lists with email reminders and overdue action-item notifications. You can track and report product non-conformances and corrective actions, conduct and report on audits, and manage product specification, verification and validation.
Here are some more tips to keep in mind when using software to support your QMS.
Consistent framework
Software can deliver a single, consistent framework across all sites for all QMS documentation and processes. Paper-based management systems are notoriously difficult to keep accurately updated, and stand-alone tools (such as Excel) often fail to produce a clear audit trail.
Legislation
Create an electronic repository including summaries of legislation, permits and codes of practice. Associate such records with regulatory authorities, processes and activities by references to other documents, websites, even videos. Compliance starts with ready access to such information and changes to it by appropriate users so they can take relevant action, such as arranging further training. Software can import such changes and be set up to provide faster notification to users who are affected.
Document management
Software provides automatic document control. This is so that whenever any changes are made, there is a clear audit trail to identify who changed what, when and whether it was approved, and that only users with validated rights can access, make or approve, and report on such changes. This means users can concentrate on analysis and decision-making, rather than system maintenance.
Equipment inventory
Tracking of all equipment, access to maintenance and calibration records, and provision of reminders for inspection and calibration review can be readily achieved using software. Other systems can be slow, cumbersome, difficult to maintain, inflexible and lacking in audit trail visibility.
Action plans
Create action plans and allocate responsibility to define task dependencies and milestones. Having identified via software traffic-lighting on your individual dashboard what is good and what is bad (or turning bad), an action or series of actions should be created to close the loops of non-conformances within a timescale (and the allocated owners notified). If not achieved by the due date, automated escalation by email should advise line management so they can take the necessary follow-through action.
Training
Document training courses and procedures, and identify training needs by role, process or activity. Software can better manage the correct matching of training to the job. To help cope with training issues arising from absence, holidays, promotion, or staff turnover.
Management review
An essential part of any management system is to schedule management reviews. Software solutions can not only set this up and notify the right people, but can be used to document and share agendas, attendance and minutes, as well as automatically create action plans and tasks arising from these reviews.
Nonconformance reporting
If an audit uncovers something that is not in accordance with pre-defined quality parameters, software can raise and document such non-conformances. You can subsequently create linked action plans to remedy this, all of which needs to be visible at all levels in the organisation.
Reporting
Detailed site reports for all workflows can be included in an electronic management system. These include extensive category and query filter options and email reminders for overdue and pending tasks.
Objectives and targets
Rather than creating a culture of ‘fire-fighting’, software can assist in setting, managing and reporting on objectives and targets. It is also easy to overlook the usefulness of reminders for completion dates and reviews, as well as assigning responsibilities to individuals, roles and teams. All this enables the vital process of moving to a performance improvement culture.
Audit
The basis for getting a real view of what is going on is the audit process, both internally and down the supply chain.
Software helps to schedule and conduct audits, to customise audit checklists, guidance and scoring and to run detailed, summary and site-ranking reports. This whole area is getting higher visibility, and a web-based quality management system should incorporate supplier self-assessments, management of internal audit team actions and results. This should also include third party certifying body reports and recommendations arising from on-site audits. Remote access to nonconformance reports and actions closed off since the last audit saves valuable time you would otherwise spend waiting for report delivery.
Quality control
Using the right software can help quality control in a number of areas, not least in sharing issue identification, failure modes and effects analysis and risk-assessment. This also includes creating standardized and administrable assessment methodologies, and issuing details and categories. All of these can all be achieved and improved upon using software correctly.
Conclusion: what are the key benefits of using software to help?
- improve customer relations and focus on customers
- reduce costs, liabilities, and risks due to quality issues
- improve corporate brand reputation and recognition
- increase consistency of data across multiple sites; comparable assessments
- provide instant executive visibility on enterprise-wide compliance to your quality measurements with focused reports using traffic-light performance dashboards
- provide processes continuous quality improvement and business performance