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Procedure for non conformity and corrective action
Answer:
You can follow the steps below:
1) Stablish how to report the non conforming product or service and determine who will consider it
2) Determine what to do with the non conforming product or service, such as marking or storage it.
3) Set how to deal with the non conforming outputs using different methods like correction, return, reuse, etc.
4) Determine the criteria to decide if a corrective action is appropriate
5) Implement the corrective action
You can download a free preview of a Procedure for management of non conformities and corrective actions here: https://advisera.com/9001academy/documentation/procedure-control-non-conforming-products/
These materials can help you to create a procedure for non conformities and corrective actions:
- Article - How to write a good ISO 9001 audit non conformity: https://advisera.com/9001academy/blog/2018/04/24/how-to-write-a-good-iso-9001-audit-nonconformity/
- Article - Five steps for ISO 9001 nonconforming products: https://advisera.com/9001academy/blog/2014/01/13/five-steps-iso-9001-nonconforming-products/
- Article - 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/
- Book - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on line ISO 9001:2015 Foundations course: https://advisera.com/training/iso-9001-foundations-course/ -
Documented information in ISO
Answer:
A procedure is the specified way to carry out activities making up a process, while an instruction describes the sequence of steps to conduct the tasks making up an activity.
Regarding the documented information, the standard differences between documented information to be maintained, commonly known as procedures, and documented information to be retained, known as records.
I relation to the structure of the documentation, although it is not mandatory you can follow this documentation hierarcy represented in a pyramid: 1) manual, 2) policy, 3) procedures, 4)work instructions, 5) records.
These materials can help you to learn more about documented information :
- Article: How to structure quality management system documentation; https://advisera.com/ 001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- Article - New approach to document and record control i ISO 9001:2015: https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- Book - Managing ISO documentation: a plain English guide: https://advisera.com/books/managing-iso-documentation-plain-english-guide/ -
Assets inventory
If we take some examples of the asset list we could easily do a risk assessment of the building or the server room and come to the same risks. f.e. threat: theft and vulnerability: inadequate procedure for protecting the “keys” or threat: interruption of power supply, vulnerability: old “UPS” with no maintenance, etc.
I can come up with many other examples such as air-conditioning, alarm etc. as the risks could be found with other related assets. How should we deal with this ? I suppose it doesn’t matter ? As long as we identify the risks ?
Answer:
The lists provided in the templates are only suggestions for you to use if you can't come up with your own elements, so you can use only your own assets, threats and risks to build you inventory and risk assessment (it seems to me that by your examples you already understood the concepts for performing risk assessment).
It is important to note that you can also group the assets if threats/vulnerabilities are similar.
These articles will provide you further explanation about inventory and risk assessment:
- How to handle Asset register (Asset inventory) according to ISO 27001 https://advisera.com/27001academy/knowledgebase/how-to-handle-asset-register-asset-inventory-according-to-iso-27001/
- ISO 27001 risk assessment: How to match assets, threats and vulnerabilities https://advisera.com/27001academy/knowledgebase/iso-27001-risk-assessment-how-to-match-assets-threats-and-vulnerabilities/ -
Convincing top management
Answer:
What is your first purpose, it is not clear from the question:
1. Do you need to convince top management that your organization needs to certify?
2. Do you need to convince top management that you are the right person to lead the certification project, already with a go decision?
If your situation is 1, I advise you to tell them about the advantages of certification for the organization. Use their language and motivation: profit, market share, new customers, ...
If your situation is 2, tell them about the advantages of being you the leader of the certification project: your motivation, your knowledge of the organization and its people, your experience, and if you can imagine that they will pont your weak weak points be prepared to presente them a list of actions that you will execute to minimize them.
For both situations you can try to find a sponsor, someone with influence over top management that can be your ally.
The following material will provide you information about convincing top management:
- ISO 9001 – 4 crucial techniques to convince your top management about ISO 9001 implementation - https://advisera.com/9001academy/blog/2017/12/05/4-crucial-techniques-to-convince-your-top-management-about-iso-9001-implementation/
- free online training ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/
- 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/ -
Compliance obligation in ISO 14001
Answer:
In the courses we talk about compliance obligation refered to these two sections, 6.1.3 (compliance obligation) and 9.1.2 (evaluation of compliance). Environmental obligations and legal requirements will vary depending on the country, state and even local regulations, so it is not feasible to cover this topic in the course. Usually this kind information is available and easy to obtain from your local authorities.
For more information about legal requirements and environmental obligations, see these materials:
- Article: Compliance requirements according to ISO 14001:2015 - what has changed: https://advisera.com/14001academy/blog/2015/09/14/compliance-requirements-according-to-iso-140012015-what-has-changed/
- ISO 14001:2015 Foundations Course: https://advisera.com/training/iso-14001-internal-auditor-course/
- Book - The ISO 14001:2015 Companion: https://advisera.com/books/the-iso-14001-2015-companion/ -
Flowcharts, tables and processes
Answer:
Many organizations use a high-level flowchart, called map, that describe the processes that constitute the management system and their interrelationship.
For example, a process map for a manufacturing company could be:
Besides mapping processes, some organizations also use tables to clarify what happens inside each process with: main tasks, responsibilities, records, performance indicators, …
For example, consider process “2. Win order”: who’s in charge? Who does what? What are the main tasks? What is kept as records? What are the performance measures?
The use of both tools simultaneously is not incompatible. Truth be said, most companies instead of tables use procedures.
The following material will provide you information about process determination:
- ISO 9001 – ISO 9001:2015 proces s vs. procedure – Some practical exemples - https://advisera.com/9001academy/blog/2016/01/19/iso-90012015-process-vs-procedure-some-practical-examples/
- 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/ -
AS9100 RevD Human Factors
Answer:
The AS9100 Rev D standard does not use the aviation acronym PEARs (People, Environment, Activities, Resources), but instead talks about human factors and human error. This concept only appears in three clauses. First, in a note to clause 7.1.4, Environment for the operation of processes, where it highlights that a suitable environment can be a combination of human and physical factors. Secondly, in clause 8.5.1, Control of Production and service provision, where one controlled condition that should be included are actions to prevent human error. Lastly, clause 10.2.1b where it talks about including human factor considerations when determining the causes of process nonconformities while investigating corrective actions.
For more on human factors see our article, “12 most important human factors to consider according to AS9100 Rev D”, https://advisera.com/9100academy/blog/2018/05/24/12-most-important-human-factors-to-consider-according-to-as9100-rev-d/ -
ISO 9001 is not a requirement for ISO 14001
Answer:
No, ISO 9001 is not a prerequisite to implement ISO 14001. Of course, many requirements related with ISO 9001 can also be found in ISO 14001
The following material will provide you information about implementing an environmental management system, and an integrated management system
· - ISO 14001 – List of ISO 14001 implementation steps - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-iso-14001-implementation-steps/
· - How to integrate ISO 14001 and ISO 9001 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/how-to-integrate-iso-14001-and-iso-9001/
· - free online training ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
· - book - THE ISO 14001:2015 COMPANION – A A Straightforward Guide to Implementing an EMS in a Small Business - https://advisera.com/books/the-iso-14001-2015-companion/ -
FMEA training
Answer:
The organization must demonstrate technical competence of employees who are performing FMEA analysis (both PFMEA and DFMEA).
There is no requirement for specific training, but if someone is involved in FMEA core team, the organization must demonstrate that they are competent for that.
If with „basic“ training you can demonstrate the competence of personnel than it is enough, but please do a risk assessment for this decision.
Please find out more about FMEA in the following article:
- What is FMEA, and how to apply it in IATF 16949 https://advisera.com/16949academy/blog/2017/09/06/what-is-fmea-and-how-to-apply-it-in-iatf-16949/ -
Video content
Answer:
First of all, sorry for this inconvenience. Every time you find such discrepancies between the tutorials and documentation, please use the information in the templates, because they are the most updated version.