Google Analystics

Saturday, 17 June 2017

What can "little ol me" do about child labour?

As consumers, we need to acknowledge our part in supporting child labour by squeezing retailers for the lowest prices. We need to change the way we consume.

This, and choosing to buy Fairtrade products wherever possible, is the bottom line conclusion in the following reader's letter to the Toronto Star published Saturday, June 17, 2017 under the line -

Fairtrade helps fight child labour

Re: Caution: Children at work, June 13

There is one simple way to ensure child labour has not been used to produce your coffee, chocolate bar, leather jacket or cotton T-shirt: Fairtrade.

Fairtrade-certified products have been produced by farmers and workers who follow strict standards that protect people’s rights and the environment. This means no child or slave labour, sustainable production methods, safe working environments and a premium for producers that is invested in local projects such as education, health care, environment, and training.

All of the products sold through Fairtrade are equatorial, which we consume in mass amounts but cannot produce: coffee, tea, cotton, sugar and chocolate are just some examples.

The supply chains for Fairtrade-certified products are completely transparent, which means you can determine the producer and the location.

On first glance, Fairtrade-certified products are slightly more expensive but, in fact, these prices represent the true cost based on fair wages, safe working conditions and sustainable production methods. Items that are cheaper and not Fairtrade, especially chocolate, leather and coffee, use free child labour.

As consumers, we need to acknowledge our part in supporting child labour by squeezing retailers for the lowest prices. We need to change the way we consume.

Wednesday, 7 June 2017

ALARP, Safety Integrity Level (SIL), Risk and Common Sense

Whether or not you feel strongly one way or another about the Kinder Morgan pipeline through the Rockies, this presentation by activist Bob Bossin paints some beautiful illustrations of good and bad safety precautions around risk and functional safety  - and how ALARP can be arbitrarily and, even, politically expedient.

Friday, 28 April 2017

Internal Audit Question: What about out-of-scope NC's?

So your company is certified to ISO 9001:2015 and you are the lead auditor on a team of two for an internal audit. The scope for this audit is Planning (Clause 6), for which you are interviewing, and Operation (Clause 8), for which the other auditor is interviewing. On reviewing the records for Design and development inputs (8.3.3) the other auditor finds that the latest specifications have not been reviewed and approved as is required in the Product Design SOP and writes up the following:
7.5.2(a) When creating and updating documented information, the organization shall ensure appropriate review and approval for suitability and adequacy.
Interviewed Engineer Abel Baker. Sampled design specs for Project "Daisy Chain". The following design records have not been reviewed and approved: DES-677, DES-678, DES-679.

The Engineering Manager cries foul, that the finding is out of scope.
What do you do?

This case is easy because the requirement for review and approval is stated in the company's own requirements for its quality management system: the Product Design SOP.

Internal audits are mandated by clause 9.2 of the ISO 9001:2015 Standard which states in 9.2.1:
The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.

The Engineering Manager was half right. The N/C as stated was, indeed, out of scope. Nevertheless, it was an N/C, but against the organization’s own requirements for its quality management system. The wrong requirement was stated by the internal auditor.

Third Party (CB) auditors have to audit to the Standard - whichever standard they are certifying to. But it is a mistake to think that internal auditors have to audit in the same way as third party auditors and always quote a requirement from the ISO Standard. The Standard merely states WHAT is required. It is the Quality Management System (QMS) in the form of a Quality Manual (QM), Standard Operating Procedures (SOP's) and Work Instructions (WI's) that describe HOW the requirements of the Standard will be implemented in the form of integrated processes.

On certification the CB auditor has already declared that the QMS effectively implements the Standard. Really, employees of the company, including internal auditors, should only have to worry about the processes documented in the QMS.

Friday, 23 September 2016

Is ISO 13485:2016 applicable to distributors of medical devices?

A question I have been asked is: To what extent is ISO 13485:2016 applicable to distributors of medical devices? They import devices and sell them locally as is.

The answer to this question depends on answers to the following questions.

- Are you marketing the medical devices that you sell? What claims do you make in your marketing and can you show verifiable evidence from the manufacturer/supplier that the medical device actually satisfies those claims?
- Are you providing any training regarding installation, set up and configuration, operation or maintenance of the device?
- Are you providing after-sales support of any kind?
- How do you handle and track customer complaints?
- How do you track and handle recalls?
- Do you do any kind of inspection or sampling to ensure that the devices you receive function correctly before shipment or collection of the device?
- Are the medical devices approved for import and sale by you in the country in which you operate?
- What is the medical device classification in your country of operation?
- Are you registered with a healthcare regulator as an importer/distributor? What healthcare laws and regulations are you subject to? How do you demonstrate compliance?
- What due diligence have you conducted to qualify and approve the manufacturer and supplier of your medical devices?
- What technical or professional competence is required or expected of your staff? Do they actually have the required training or experience?

- To the extent that any of the above apply to you, what processes do you have in place to ensure quality and compliance?
- What records can you show as evidence of quality, consistent conformity with the above answers or compliance with healthcare regulations?

These questions and their answers are all relevant to ISO 13485:2016. I am sure other people in the industry could think of still more questions.

Friday, 26 August 2016

Quality is about time...

by Philip Scalise, an online colleague and acquaintance whom I have met and interacted with on LinkedIn. Philip does Quality System Administration and Development based in Utica in the New York area.

Re-posted with his permission from his LinkedIn post.

People who find QUALITY to be an abstract concept contribute to why it is so. The lack of “common” understanding regarding quality is self-perpetuating. Just as oxygen fuels life it also fuels the flames of confusion. While I am neither a professor nor writer I do have a diverse background in quality and I am one to see things for what they are. Quality is about time, my time and your time. While I understand the traditional definitions of product & process quality and the methodologies utilized to achieve the condition, I need to stress this is not some high minded lofty diatribe, nor do I seek to solicit clientele in its offering. In fact, this is nothing more than a straightforward logical perspective on quality from the common of man. As such I will use every possible practical minded real world example at my disposal to substantiate this point. In the spirit of simplicity I have decided to use time as our least “common” denominator. I will be as direct as possible and not waste any of “our” time.

First let’s understand something. Those who appear not to understand every possible nuance or gradation of quality, in fact do have their own understandings they are just not the same as yours. When an honest person does not understand something we ask questions. Asking questions of people that lack the knowledge or the integrity to admit it is at the very root of this self-perpetuating cycle of misunderstanding. As a result, even more questions come up providing fog and even cover for the smoke and mirrors folks. These are people who use their time to play a shell game with your time. Questions and concerns multiply and grow into a giant sized mass of industry feeding confusion. Once upon a time smart minded business women asked me if I could define quality for her. When I told her I could not, she asked me why not? I explained “if you do not know what quality means to you how can I possibly define it for you?” There are far more people who cannot explain quality than there are those capable of doing so, but make no mistake about it, many of them are doing business just the same. Quality (good quality) is properly defined when things work. Conversely poor quality is defined when things do not work. For example I am writing this right now because of the time I have available while not edging my lawn and waiting for a refrigerator repair person to enter through the front door.

Why not edge the lawn?

Well, it’s about time. You see my WORKS (spelled with an x) lawn and garden tool does not work at the moment. It is a quality tool but it appears the replacement spools sold at area retailers are not. The quality condition of the spools that come with the unit are good quality and worked just fine, however, understanding quality, manufacturing and supply chains as I do, I was not in the least bit surprised to find the replacement spools are not of this same quality condition. It seems, this time, the private labeling business may have been “outsourced” to another organization other than the OEM (original equipment manufacturer). These replacement spools come in a two pack which one might expect to last a few years, but, when I put the first one in it continued to unwind until I lost my patience and threw it away. Trust me Mother Teresa would have done it sooner. When I tried to install the second one I had no chance at all, but this time for far different reason. After spending close to 20 minutes studying the spool with my needle nose in hand, I simply could not find the end of the line to install the damn thing, so I just gave up and came in for lunch when I remembered “do not to open the refrigerator.”

Why am I waiting for a refrigerator repair man?

Well, it’s about time, the refrigerator (a samsung) purchased through best buy and whose geek squad has been here multiple times now, is in the “process” of spoiling our food. Unfortunately for us and not for the folks at best buy or samsung, this time, there is no time for them to return for a third time. So this time at an unknown time they will send yet another repair agency because we are short on time. Surely it will be this person’s first time spending time on my time repairing the refrigerator for the third time, so I trust it will not be a good time.

Why will the repair person need to come through the front door?

Well, it’s about time, you see my kitchen is directly off the garage so this time when I opened the door for the repair man so he could roll his tool box into the house to dismantle the unit yet again, well, this time my garage door opener broke. This door opener is only a matter of years old, but here is the thing, you need only hit a button and the door opens along a threaded screw about 10 feet long. Well, as it turns out (yes pun intended) this ten foot long screw is not 10 ft. long? It actually comes in three sections so it can be easily packaged and home shipped as opposed to store bought. This allows the OEM to reach a greater customer base which is great for them, but surely not me! So this time I will need the coupling that is worn down from the multiple times the door has gone up and down wearing down this all important part that the genie door people no long provide. This time I will need more time to invest in the repair or replacement of the unit. Seems this could take some time, but hey, exactly whose time is it anyway…

All that said and in closing allow me to say this about that, when and if you struggle with your understanding of “quality” just recognize that no business on this planet has any such dilemma. They do not struggle with their definition of quality they struggle with yours. If we all woke up in the morning with the very same definition of quality in mind, well, to that my one and only response would be…well, it certainly is about time!

Friday, 8 July 2016

Risk Based Thinking (RBT) in ISO 9001:2015

What is risk based thinking as required in ISO 9001:2015? How do you implement it?

This 17 minute presentation expands on the guidance provided by TC 176.