Search results

Lock-out Procedure

Although ISO 45001 does not include requirements for lockout/tagout, this does come under the clause 6.1.3, determination of legal requirements and other requirements, as there are many locations which have legal requirements for lockout/tagout procedures. As this is the case it is important to know what your applicable laws about lockout/tagout procedures are so that you can design your procedures to meet the requirements. The legal documents will tell you when a lockout/tagout procedure needs to be put in place.

In general, the idea is that when a piece of machinery is having work done to it outside of regular production, such as maintenance, you have a way to make sure that it is safeguarded against start up so that employees are not injured during the maintenance. One common method of doing this is to have each employee who is working on the machinery have their own tag or lock which they put in place to stop the machine from engaging; and only that employee can remove their tag or lock. These often go on the start mechanism such as the electric panel of the equipment. So, if 4 people are working on a machine, there will be 4 individual locks in place and only once the last lock is removed by the last employee is the machine able to start. Since no one but the employee who put the tag/lock in place can remove it, you are certain that all employees are safely away before start up.

For more on ISO 45001 legal requirements such as lockout/tagout and how to handle them, see the article: How to identify and comply with legal requirements in ISO 45001, https://advisera.com/45001academy/blog/2015/06/24/how-to-identify-and-comply-with-legal-requirements-in-iso-45001/

Root cause analysis and CAR form

To answer your question, I will address your overall question of how to effectively implement corrective actions, which incorporates the step of root cause identification. 

To address corrective action effectively, you will start with a documented procedure which specifies which events are considered to be deviating (nonconforming), as well as the processes (sequence of steps) that the laboratory must take when complaints are received, nonconforming work is identified, and corrective actions are required. This procedure will apply to all laboratory activities that may be the subject of complaints or nonconformities and will, therefore, cover technical and non-technical deviations from the planned objectives of the laboratory. The assigned responsible person must decide, after initial investigation, if a containment (immediate) action is required; based on the impact or seriousness of the complaints or nonconformity. 

A Corrective Action form must be used to capture all incidents, complaints and nonconformities to ensure the correct personnel are informed and the root causes of problems are identified. Getting to the root cause could involve a number of techniques, where the laboratory will select suitable tools from those listed in the procedure, for the specific type of event. Either way, it is essential to clearly state the problem in order to get to the root cause and thereafter select the appropriate action that will correct the issue and prevent it from reoccurring.  

These articles will provide further guidance. Written for ISO 9001, they are also applicable to ISO 17025:

Seven Steps for Corrective and Preventive Actions to support Continual Improvement https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/
ISO 9001 – Difference between correction and corrective action https://advisera.com/9001academy/blog/2016/02/09/iso-9001-difference-between-correction-and-corrective-action/
How to use root cause analysis to support corrective actions in your QMS https://advisera.com/9001academy/blog/2016/03/01/how-to-use-root-cause-analysis-to-support-corrective-actions-in-your-qms/ 

These ISO 17025 templates could also be of interest: 

Complaint, Nonconformity and Corrective Action Procedure https://advisera.com/17025academy/documentation/complaint-nonconformity-and-corrective-action-procedure/

Corrective Action Report (CAR) https://advisera.com/17025academy/documentation/corrective-action-report-car/

Conformance with ISO 13485

21 CFR 820 is the current quality system for medical devices used by the FDA. There is no requirement of conformance with the ISO 13485. Each standard (21 CRF 820 and ISO 13485:2016) may have additional requirements, but the requirements do not conflict with one another. While 21 CFR 820 compliance is required by law for the commercialization of medical devices in the United States, ISO 13485 is voluntary. 

If you need information on the Differences and similarities between FDA 21 CFR Part 820 and ISO 13485. please read article on the following link: 

https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/

6.1.2.b Environmental aspects / condition

ISO 14001:2015 does not include definitions for emergency or abnormal operation.

I use the term abnormal for situations different from normal operation. For example,

• During start or shutdown of an operation (during start or shutdown of a boiler, air emissions are very different from during normal operation)
• During a shift change over or during out of hours operation
• During the operation with inexperienced people or a machine breakdown 

Although abnormal the environmental impact is not severe.

I use the term emergency for an unplanned situation with severe environmental impact.

A machine break down is unplanned, and environmental impacts are severe (we have an emergency situation ) or not severe (we have an abnormal situation)

Requirement of 7.2.3

In IATF 16949 requirement 7.2.3 there are new requirements more demanding than in the previous version. 

Some of them are:

Using risk-based thinking, customer-specific requirements, quality technology and methods (core tools),
ISO 19011 as standard for audits
Knowledge for process-related risks analysis (FMEA)
Demonstrate technical competence of auditors
Also, maintenance of and improvements in internal auditor competence shall include minimum numbers of audits per year and knowledge maintenance. 

For more information, please read the article: 

Requirements for the competence of IATF 16949 Internal auditors https://advisera.com/16949academy/blog/2017/10/19/requirements-for-competence-of-iatf-16949-internal-auditors/

Accreditation bodies for training providers

The value added to a certification regarding its accreditation body will depend on the marketing or industry you are considering.

Considering ISO 27001 personal certification, the most recognized accreditation bodies for training providers are IRCA, PECB, and Exemplar Global (formerly RABQSA).

This article will provide you further explanation about ISO27001 lead auditor course:
- What does ISO 27001 Lead Auditor training look like? https://advisera.com/27001academy/blog/2016/08/29/what-does-iso-27001-lead-auditor-training-look-like/

This material will also help you regarding ISO27001 lead auditor course:
- ISO 27001 Lead Auditor course https://advisera.com/training/iso-27001-lead-auditor-course/

ISO 27001 Implementation Committee

ISO 27001 does not prescribe how an organization must define its information security structure, only that relevant responsibilities related to information must be defined, so organizations are free to define them as they see fit.

Considering this, your suggested areas are acceptable if your organization is a small or medium one (i.e., up to 500 employees). Please note that a committee's role is most related to making decisions about implementation steps, not executing them (this is part of the implementation team's responsibilities).

This article will provide you further explanation about responsibilities in an ISO 27001  implementation project:
- RACI matrix for ISO 27001 implementation project https://advisera.com/27001academy/blog/2018/11/05/raci-matrix-for-iso-27001-implementation-project/

These materials will also help you regarding ISO 27001  implementation project:
- Preparations for the ISO Implementation Project: A Plain English Guide https://advisera.com/books/preparations-for-the-iso-implementation-project-a-plain-english-guide/
- Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

Internal Quality Audit

It is possible to use an untrained auditor as part of his training program as a trainee auditor with the surveillance of experienced mentors.

For more information read our article: Requirements for the competence of IATF 16949 Internal auditors https://advisera.com/16949academy/blog/2017/10/19/requirements-for-competence-of-iatf-16949-internal-auditors/ 

Please also consider our article: „IATF 16949 audit types & how they affect process improvement“ https://advisera.com/16949academy/blog/2017/11/01/iatf-16949-audit-types-how-they-affect-process-improvement/ 

Green house reaching ISO 9001

Yes, ISO 9001 is applicable to any kind of organization, profit or nonprofit, in any economic sector.

The following material will provide you information about ISO 9001:

- What is ISO 9001? - https://advisera.com/9001academy/what-is-iso-9001/
- Free webinar – Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Timeline to close CAPA

I agreed when you stated that businesses should gather data about the happening of the problem. My friend wants to have CAPA Software to streamline their processes. I should advise him to go for it to predict challeges.