Employee Competence in ISO 9001:2015

Training Management Software
This blog refers to ISO 9001:2015 Clause 7.2 “Competence” and is specifically relevant to organizations seeking to implement or update to the latest ISO 9001:2015 version -.

At the heart of creating Excellence in People is building a high-performance culture. That’s why various global excellence models such as EFQM and Malcolm Baldrige Excellence frameworks and even global quality awards such as Deming Prize have given due focus on “People”. ISO 9001:2015 is no different and recognises the importance of people by emphasising their “competence”.

In today’s economy, many organizations are experiencing high employee turnover which increases the operational challenges for organizations in terms of effectiveness and efficiencies..

People run organizations therefore they are indispensable necessities! However, it is equally important that they are competent (to do their job), aware (about Organizational priorities) and should be able to communicate (with each other). This is what the authors of ISO 9001 have always emphasised and have clearly stated in the latest version of the international standard under the following clauses:

7.1.2: People
7.2: Competence
7.3: Awareness
7.4: Communication

Although the requirement stated in version 2015 is almost the same as what was required in version 2008; the revised version clarifies to apply these requirements to all personnel under the organizations control if they “affect” the organization’s management system performance. Which means it also includes contract workers and any other personnel undertaking outsourced work. Along with that ISO 9001:2015 requires records be retained as evidence of competence.So, what is required? Well, we’d say KEEP IT SIMPLE! And, follow P-D-C-A!

PLAN

  • Determine what competencies are needed in line with the stated job functions. Then, you prepare a detailed Job Description (JD) with the responsibility and authority associated with that particular job function and the necessary skills associated with the natural abilities and talents needed to perform the job role efficiently.
  • Determine if any additional competencies will also be required in due course of time.
  • Then you may also include the succession planning and create a delegation matrix for various job roles hence the relevant competency determination for the new successor or delegate.
  • These needed skills to be further evaluated and linked to a detailed qualification matrix in order to identify the skill gaps and thereafter bridge those gaps through various training programs.
  • It is advisable to perform a Pre-Training evaluation to determine the expected level of proficiency from the desired training program and then compare it with a Post-Training evaluation to measure the effectiveness of the training.
  • Then identify the resources within the organization to support bridging the identified skill gaps. It will not only prove cost effective to you but also boost employee morale by recognising and utilising their knowledge and give them an opportunity to further develop. Nothing helps an individual more than to be given responsibility and know they are trusted!

DO

Ensure that the training programs are delivered as plan. Ensure the necessary resources, type of training programs, such as in-house or open-house training programs, are carefully chosen and executed.

Then, focus on On-Job-Trainings (OJT) to ensure effectiveness.

Also try to introduce some Mentorship programs. It will also help you reduce training costs by way of one-on-one interaction.

CHECK
Evaluate the effectiveness of actions taken on the required competency of individuals including the contract and outsourced labour.

Monitor the effectiveness level of the Training Plan and ensure timely management intervention/review to support wherever training is lagging.

The Post training feedback reports, tests and interviews are major part of the plan and their records are to be retained as version 2015 specifically requires such information is retained.

ACT

Any areas that fall below the required performance level must be addressed.

Hence, effective action will be required wherever the gap between actual performance and required performance remains unbridged. This may include:Re-Training with a focus on specific areas.

Reassignment to a different position where substandard skill is ether not needed or matches with the existing level. Sometimes redefining the position, itself may be the solution by excluding the skill or further outsourcing can also be considered.

It will be helpful if an efficiency check is performed after a reasonable time has gone by to prove whether the actions taken were

really effective. And, if not then simply repeat a PDCA!Hence, the dynamics of employee

turnover calls for an effective way of managing the Organizational competency development program.Get control of your organizational competence risk by using the Qualityze EQMS solution!The Qualityze’s Training Management Module offers an integrated closed-loop-system for managing competence within your Organization to ensure effective compliance.

To discover more about Qualityze EQMS solutions,

Request a demo:

Phone: +1-877-207-8616
e-mail: info@qualityze.com

ISO 9001:2015 – Revealing Perspectives of Outsourced Process

This blog aims to help organizations understand the meaning and interpret the requirements stated in ISO 9001:2015 concerning “outsourced process” and how to carry out a meaningful gap analysis against your current processes and procedures.
The Clause 8.4 in revised standard specifically talks about control of externally provided processes, products and services.
There is a noticeable change in terminology of the revised ISO 9001:2015 standard that “Purchasing” and “Outsourcing” are now referred as “externally provided processes, products and services”.
However, that doesn’t mean that you have to change or update your terminologies, but you may continue to use terms which suit your operations such as “supplier”, “partner” or “vendor” rather than “external provider”. Though intent is the same as what was in the 2008 version since purchasing includes products and services you acquire from suppliers and outsourced processes.
So, let’s dig a little deeper and get a better sense of how this requirement can be understood clearly in a different way.
Take a look at the figure below:
Audit Management SoftwareHence, it is clear from the above figure that regardless of the size and interacting phase of the outsource organization the specific outsourced activities shall always be liable to take under the purview of your QMS and therefore you may demand your suppliers comply with the requirements.
Clause 8.4.1 specifically requires you to record the results of various supplier activities such as evaluation, selection, monitoring of performance, and thereafter the re-evaluation.
The organizations which were not doing this before will now have many new implications. Thus, it requires them to revisit their supplier activities in a holistic manner. For example, reassessment of supplier is as important as supplier on-boarding, therefore the importance of performance data is really needed for it.
While setting up the criteria, the organization should not limit themselves only to quality parameters, timely-delivery or cost focus; but you can also include collaborative innovation and sustainability road map. You may extend it to your energy & environmental requirements as well!
As the revised standard focuses on “control” over outsourced processes it can be extended to your secondary party audits through which you can set your own criteria and assess the suppliers for fulfilment of requirements.
Here lies an important fact to bear in mind concerning clause 4.1. It requires you to determine external issues such as emerging from external providers which affect the organization’s ability to achieve the desired outputs. Thus, monitoring and reviewing such critical issues be highlighted in your management review.
Another important aspect that is described is the communication to external providers under clause 8.4.3.
Apart from the required product features, design, drawing, etc. the necessary information in regards with special processes, equipment, quality targets, communication or escalation protocols and insight on future project deliverables will also be helpful for your suppliers.
Finally, clause 8.5.3 should also be considered for the preservation of external providers property.
For this, you may list all such assets of the external provider and perform a periodic asset verification audit and inform suppliers of any adverse findings. This also needs to be documented.
Needless to say, the supplier activity data should be a part of your management reviews for effective management of external providers risks and the opportunities as well!
Discover how Qualityze EQMS solutions provide an integrated approach towards management of your Suppliers.

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After an Audit, What Next?

Audit Management Software
Have you ever felt anxious about something that was about to happen at your workplace.? Imagine if the “something” was called an audit, increasing your anxiety to a stratospheric level regardless of the preparations you have made for it.

Well, Product Audit, Process Audit, System Audit, Safety Audit, 5S Audit, Internal Audit, External Audit, certification audit, re-certification audit, surveillance audit, environmental audit, energy audit… the list goes on and when it’s an ISO certified site it gets worse.   People working ISO Certified facilities get familiar with all different audit types mentioned above and in some way all of the different types of audits types can be addressed by using an effective QMS system.

In quality management the audit is considered as an indispensable activity which fits perfectly into the ‘Check’ stage of P-D-C-A cycle which is actually the heart of the Quality Management System process.

Once an audit is complete; the findings can be reported in terms of positive outcomes and also some negative outcomes that you may not have been expecting.

So, what should you do next? This article will help you to know what to do after an audit.

Though there cannot be just one absolute answer, but all audit findings must be looked at and evaluated for appropriate next steps.

Some audit outcomes are more critical than others and therefore need immediate response while some may be limited to just re-education.

Starting with post audit activity, you must put together an overview of negative findings that document all deviations that the auditor observed along with any other problematic findings noted during the audit. We do not want to forget these findings as possible recommendations for improvement regardless if they are not part of the formal Audit Report. You may also include other important remarks made by auditor during the audit closing meeting.

So, let’s break down some of the possible audit findings and next steps:

If your audit findings were spectacular with no serious observations; then the obvious next step can be a congratulatory communication which may be announced as a “way to go” in your next release of the company newsletter!

The first level of audit outcomes can be serious nonconformances (NC) which must be dealt with using a proper NC handling process. We would suggest involving your compliance team and the external consultants (if any).

The next level of audit findings can be defined in terms of minor deviations which may not be a compliance issue or significant breach of policies however they require a CAPA to identify the root causes and effective action plans. This prevents reoccurrences even if findings are considered ‘minor’ deviations.

If you have been informed of an undesirable issue then you must address it properly, regardless of its severity. Having knowledge of a problem and not remediating, is worse than never finding it in the first place.

So, here are five ways that will surely help you in your post-audit journey:

  • Build an eye for details:

Having the staff cooperation with the auditors for a healthy flow of information between the staff and auditors is important. If it is missing, then try to find out the reason and fix it properly.

Also, have a review for any serious disputes or difficulties encountered by the auditors during the audit. It is very common thing if some tension was created between the auditor and auditee, during the audit. However, make sure that such issues if resolved during the audit were not in favour of the auditor to just hush up the issue without a proper justification.

Apart from this, you should also share your candid feedback with the audit program manager, if you have any concern about the scope, nature, and timing of the audit. After all this is also a post audit activity!

  • Build your analytical muscles:

During the audit, the auditors rely heavily on the availability of objective evidences and thorough analysis of data. Sometimes you miss the audit score not because data was not there but, it was not easily available to show during the audit or the integration/interrelation of data could not be established between the different functions.

Building latest technology in analytics and have a data-centric approach to problem solving will help make audits shorter and improve your performance in future audits.

  • Need for Change Management

You many come across personnel who tend to block the audit fieldwork or provide insufficient information during the audit. They may resist or disregard the audit findings because they may not like to be told what to do especially by auditors who they consider an outsider and complicating their job routine. Or it may be just a case of they may not like being under scrutiny.

Hence, during implementation of the action plan; a change management considering a cultural change can handle the objections without damaging long-term collaboration.

  • Keep on Learning

For both the auditor and auditee, the audit compels to acquire the needed skills and attitude concerning their functional areas. Hence broaden your mind, evolve your thinking and always take audit points as an opportunity to improve which often requires you to acquaint yourself with industry standards best practices for your operational area(s); thereby, you always keep on learning!

  • A CAPA is more than just a CAPA

And finally, understand that a CAPA is more than just a CAPA!

The CAPA is an essential element of ISO compliance through which risks are addressed, problems remedied and permanently eliminated from reoccurrence.

Many companies fail in ‘closing the loop’ for a CAPA. For example, while executing CAPA many tasks are defined and needed to be implemented. But during the manual deployment of actions, often it is experienced that there is no method to check the effectiveness or even the completion of these tasks, without which the loop cannot be closed.

And this is where Qualityze closed-loop EQMS system helps you ensure an effective problem-solving system in place.

The embedded functionality for creating various types of audit programs and their processes of execution ensures audit processes are completed as intended and the same incidents are not repeated in the future.

The Qualityze product suite ensures an Effectiveness Review task is followed to document the verification plan, objective evidence and success of action plan being implemented, by making it a ‘true’ CAPA.

It also separates the reporting of the CAPA in terms of correction, corrective action, risk-based analysis and even ensuring best practices are followed.

Hence, audit is a great role to bring improvement into organizations and a lot is needed to help you through your post-audit process. What do you think?

So, all the best for your future audits and let us know if we can help in any way.

Discover more about Qualityze EQMS solutions.

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e-mail: info@qualityze.com or call us on below numbers:

USA: +1-877-207-8616

India: +91-96864-97136

Requirement of Knowledge Management in ISO 9001:2015

Requirement of Knowledge Management in ISO 9001:2015
This blog refers to ISO 9001:2015 Clause 7.1.6 “Organizational knowledge” and is specifically in relevance to organizations seeking to implement or update to the latest version of ISO 9001:2015 along with anyone thinking about implementing the international standard.

“You know more than you can tell”

Albert Einstein’s research assistant Michael Polanyi outlined a fine distinction between tacit and explicit knowledge through the above sentence. And so has the ISO organization through this revised version of ISO 9001:2015.

This is the first time that ISO has taken cognizance of knowledge as a ‘resource’ by publishing it in an international standard and specifying its management.

In fact, the clause 7.1.6 in ISO 9001:2015 looks to be the only clause that is completely new as compared to other changed requirements which all have equivalents in the earlier version.

Though clause 7.1.6 doesn’t specifically require any documented information on organizational knowledge; however elements of a formal knowledge management are incorporated in it and due emphasis is given on ‘tacit’ knowledge which is gained with experience but may not be addressed merely through control of documentation.

ISO 9001:2015 expects organizations to determine their ‘needed’ knowledge in the contextual conditions, be made available to all concerned, preserved and protected along with acquiring new knowledge for operation of its processes and ensure conformity of the process outputs.

The revised standard talks about Explicit knowledge (which is open and easy to express) and the Tacit knowledge (which is generally silent and difficult to express).

For example, the explicit knowledge in terms of documented Work Instructions or Procedures will be easier for you to derive, made available or convey further. However, extracting the full ‘Tacit’ knowledge of an experienced soccer player who never missed a penalty shot is comparatively difficult such as to extract his 100% soccer skills and then build the same level proficiency for other players by transferring his unique anticipation skills.

Also, tacit knowledge is more difficult to manage as compared to explicit knowledge.

One of the key challenges organizations faced today is they do not know what specific kinds of knowledge individuals know therefore, they keep reinventing the wheels.

Hence, the need for “knowing what we know” is becoming more important in today’s competitive environment.

A fine example can be taken of the Dutch technology company Philips who introduced the concept of “Yellow Pages” listing of domain experts on its intranet where one can just type the specific domain and within seconds the system will fetch you the domain experts in Philips across the globe who has the expertise on the queried topic.

Another example of knowledge management practices can be learned from auto majors such as Volkswagen and Toyota who promote mass level internal employee exchange policies for longer duration training in existing factories before commissioning the new assembly line to ensure finely tuned production systems in the new facilities.

However, be mindful that the ‘need’ for knowledge and its management varies under contextual conditions of an organization such as its scope, industry and other influencing factors hence the QMS implementers and the auditors can narrow down their choices and approach in their respective areas in consideration with the context of the organization.

So, to comply with this new requirement of organizational knowledge in the revised standard, the organizations can formulate its knowledge management framework with below in mind:

  • It’s better if Leadership can come up with an in-house Knowledge Management Policy with their expectations, setting up accountabilities and commitment for the time and resource needed to manage knowledge within the organization.
  • Establishing a knowledge management strategy to identify the knowledge needed, identifying knowledge gaps and thereafter the necessary activities to bridging the gaps.
  • Wherever possible a well chalked out knowledge management plans can be conceptualised such as at different projects levels to determine the knowledge ‘needed’ for the activity and thereafter to document the knowledge ‘created’ after the activity.
  • Retaining of knowledge from business partners as well as the customers.
  • Introducing mentor-mentee programs, an appropriate succession planning and further knowledge sharing.
  • Establishing an appropriate system to capture the lessons learnt and the Best Practices being followed within the organization.
  • Create an appropriate system to monitor the knowledge gaps being created under dynamic work environment and thereafter acquiring the additional or new knowledge needed for the same activities.
  • If possible then separate ‘knowledge management audit’ can be conducted to identify gaps as well as the best practices.

Finally, another important fact to bear in mind is that one should not restrict itself to clause 7.1.6 for management of knowledge but its implications to clause 7.2 should also be taken into consideration which talks about organizational competence.

It pays to remember that the new standard has focused on ‘effectiveness’ of the actions taken for competency development such as training and retaining of such records for evidence purpose.

With inclusion of Knowledge Management in the internationals standard, it is evident that intellectual resources are a key organizational asset that enable a sustainable, competitive advantage for all types of industries and therefore requires a systemic approach.

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What to think for Risk-Based-Thinking (RBT) in ISO 9001:2015?

Risk Based CAPA
The ISO standards are reviewed every five years and accordingly revised if needed.

This is mainly to keep pace with changing business environment and to provide effective tools to tackle new industry challenges. It also clearly reflects in Mission & Vision statement of ISO Subcommittee for Quality Systems (ISO/TC 176/SC 2)

The latest version of ISO 9001:2015 edition has replaced the 2008 version which has High Level Structure (HLS) with identical subclause titles, identical text, common terms and core definitions.

In this restructured international standard; a key focus is given on the risk-based-thinking (RBT).

TC 176 has ingeniously rebranded the Preventive Action as risk-based thinking (RBT) by allowing not to specifically include any actual requirements such as records, procedures, processes or evidences rather it mainly focuses on “Thinking” approach.

Now, ISO 9001 being intended for Third Party Assessment; it becomes very challenging for the organizations to prove their “thought-process” to external auditors for a considerate effort towards “risk”.

So, what to really think for Risk-Based-Thinking in ISO 9001:2015?

Even the ISO also approves of the fact that “Risk-based thinking is something we all do automatically in everyday life.” However, during the organizational risk planning, a viable approach towards this can be applied in terms of the “contextual” conditions of the organization.

Although Clause 6.1 in the revised standard does not mandatorily requires any documented information on actions to address risks and opportunities, it does described in new guidance for documented information which is needed to be “maintained” and “retained”. Hence, it can be taken into consideration and accordingly be produced during the certification audit for demonstrating risk-based -thinking at the organizational level.

For example, the records of management review (9.3.3), Audit Program (9.2.2), organizational knowledge (7.1.6), calibration (7.1.5.2) and the competence (7.2) constitute amongst the key elements of controlling risk; hence they are mandatorily required to retain the documented information.

Another risk-based approach in terms of Quality Management System can be taken with a “31:31:31” Approach!

So, what is this “31:31:31” approach? Well, it’s not a universally recognised terminology, but we just try to point out an easy-to-remember term for establishing the compatibility to QMS by implementing ISO 31000 as a formal approach towards Risk Management and its supporting Standard IEC/ISO 31010 under which 31 Risk assessment techniques are provided.

Although, some may criticise the 31 tools being statistically oriented and ISO 31000 being viable mostly for large organizations (under a given context) the benefits of the approach cannot be overlooked as it applies to many company situations.

On the introduction page itself it narrates that the provided principles and guidelines in ISO 31000 is “for managing any form of risk in a systematic, transparent and credible manner and within any scope and context” hence giving it a try can be worthwhile to think about risk-based-thinking and have holistic risk management perspective.

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CAPA by filtering – It’s not everything that requires a CAPA!

EQMS Software for Medical Devices

Oftentimes in business it is felt that in the quest of excellence organizations tend to capture all adverse effects (events) to initiate Corrective Actions by overlooking the question of its criticality.

Surprisingly it happens in both type of organizations – one where QMS is comparatively immature and the other where organizations primarily work towards an improved excellence level. The former striving to attain stability and the latter to achieve consistency.

However, by indulging in attaining such perfection level they end up in slowing down the situation and loosing efficiency due to the absence of a filtering system that separates the critical from the non-critical events.

Reason being; in due course of time this accumulated mammoth figure of corrective actions will add up and cause a bottleneck for the organization as influx of data that becomes stagnant, because the addressable problem process is jeopardized.

Thus, manually addressing such a large number of corrective actions creates complexity and requires more processing, losing cost and productive time.

Hence it is advisable to have a filtering system in place to be a truly efficient organization which can identify high risk events to separate and address on a priority basis rather than concentrating on less critical events that can be easily corrected with a one-off basis.

Now, that is where the automation is required to speed up the decision-making process.

An automated CAPA system provides the organization the ability to automate their Problem Addressable Methodology and the associated CAPA processes to filter the critical from the non-critical events.

This is actually the crux of 80:20 Principle… to apply it in phase wise manner to attain the zero-error strategy model.

Hence, now a days it is becoming indispensable for organizations to have an effective and efficient EQMS in place as an automated responsive tool.

And that is where Qualityze Inc. comes…

With a proven history in EQMS space we believe in providing quality solutions for all and focuses on delivering closed-loop quality management solutions.

Qualityze’s CAPA management solution has built-in powerful analytics and reporting capabilities that provide you an early indication of quality issues, so the organization can take simplified corrective actions.

The flexibility of Qualityze’s CAPA system helps and allows you to treat the most important part of a CAPA system, The Root Cause Analysis, in an efficient way by prioritizing the critical events and helping you make right decision – every time.

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Phone: +1-877-207-8616
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