Aiding compliance with hazardous substances regulation

The international specification IECQ HSPM QC 080000 takes the basic management system requirements of ISO 9001 and applies processes to identify, control, quantify and report the amount of hazardous substances in electrical and electronic products and components to satisfy customer requirements and legislative compliance.

The HSPM certification scheme essentially piggy-backs onto ISO 9001, which is also the same for a number of other standards such as AS9100 (Aerospace) and ISO 13485 (Medical Devices). With IECQ HSPM, additional aspects have been added to make it more specific to the electronics industry – mainly focusing on compliance with legislation such as RoHS, REACH and WEEE.

Venner commented: “When specifiers are sourcing electronic components they need to ensure the products are of the highest quality and reliability for their intended use. We can help our clients gain IECQ HSPM to provide their customers with the assurance that their products comply with relevant standards and technical specifications as well as offering a valuable supply chain management and control system. It also ensures the products are meeting the relevant health and safety and environmental legislation.”

All-encompassing

A key element of the standard is that it not only focuses on the electronic component but also, all the elements connected to it – plastic components in the product, semiconductors etc. Venner added: “It’ll also look at the manufacturing process, looking at whether the product is being manufactured correctly and that it’s not being cross-contaminated – improving the competence of the product. ISO 9001 does this but IECQ goes to the next level. It’ll ask what coolants are being used for example, and whether they are hazardous. So, it doesn’t just look at the product, it looks at how the product is made, where the materials are sourced and the supply chain being used.”

As part of the standard there are ten hazardous substances listed, of which four are banned completely. Venner continued: “There are certain substances that are allowed under a specified level and then we’ll check that the client has done all that they need to do, however, we’ll also look at whether they can do anything differently to replace the hazardous substances that they’re using. So not only are we looking at whether they are compliant, we are also looking at whether they are improving and whether they can remove a certain substance altogether. Regulations are getting tougher and companies should be looking forward to take substances out of their processes all together.”

Breaches in legislation could result in serious fines depending on how big the product is in the market. So manufacturers need to make sure they are compliant but also, if they are importing products, they are additionally responsible if they are selling them into the market, so there is an increased need to know who you are buying from and that what is being sent to you is correct.

The compliance process

Detailing the process of achieving compliance, Venner continued: “We’ll do a contract review in the first instance and gather as much information as we can to determine how much time we need and then go in and audit. At stage one, we’ll just see if they’re ready and whether they have the correct policies in place – then we’ll conduct the stage two assessment which is what will get you certified.”

“We will audit initially (around once a year depending on the organisation), we will issue the company with any non-conformances and it is then up to them to correct it. It depends on what that non-conformance is as to how far we have to go – a larger breach could mean calling the regulators which could lead to product recalls. We will have procedures in place for the client to fix what’s wrong.”

The IECQ HSPM certificate lasts for three years subject to the client remaining compliant via annual audits. The following year will include a surveillance visit which won’t necessarily be all-inclusive, but will focus efforts on a certain value stream, as will the following year’s surveillance visit. Then there will be a reassessment which will focus on trends over the three years, looking at what improvements have been made - then the cycle starts again.

A new version

In September a new version of the ISO 9001 standard was introduced which centred a lot more around leadership within organisations. Traditionally compliance issues were passed from top management onto quality personnel. The new version aims to promote a much more hands-on role for management. Venner added: “This was something that has always been implied, but it wasn’t really done properly - now it’s more enforced. This is due to tightening legislation but is also down to the need to improve confidence – if management is involved and takes more ownership of compliance (and it’s not just the responsibility of one guy on the shop floor) then there’s more chance things will be done properly.”

Cuts in the UK have also meant that the resources used for updates on legislation and what’s applicable to a given organisation are no longer in place, so the current environment is very challenging for an organisation that hasn’t been exposed to the legislation – not only to find the relevant standards, but to digest them and know what’s applicable. In addition they are not written in layman’s terms so a lot of individuals won’t have the tools to interpret the standards adequately.

“If something goes wrong clients have really got to perform root cause analysis – not just fix the problem. They’ve got to find out why it went wrong in the first place so it doesn’t happen again – that’s a big factor as many people don’t understand the concept of root cause and corrective action. It’s something that we’re constantly trying to drum into our clients and we’ve produced guidance notes to help them.

“The client will submit their actions - if it’s a really serious issue or something that we can’t verify off-site then we’ll go back to the client for a follow-up visit. If these issues aren’t resolved we may suspend the organisation and during this period their certificate is suspended - they’ve got a certain amount of time (a maximum of around six weeks), to get themselves back on track. We’ll then verify the changes they’ve made and reissue their certificate.

This could of course impact quite significantly on a client’s business - it does depend on the nature of their initial suspension and their customers, but they could be prevented from shipping. It’s ultimately up to the customer as to whether they’ll allow shipping of a product but IMS has had incidents where a client has been prevented from shipping for quite a few weeks.

In between there will of course be standard changes where the goalposts move. 2015 was a big year for new standards – ISO 9001 and ISO 14001 were updated for example. More importantly a foundation standard was created which all standards now follow. Annex SL sets out ten key clauses to help all standards follow the same pattern, making them easier to integrate. The problem with that of course is that when Annex SL updates, all standards will need to update. So it’s hard to keep up.