Let Conformance Ltd support you with PAS7100 compliance
Are you prepared for a safety related recall affecting users of your products? With products routinely complying with many directives it only takes one non-compliance to potentially cause a recall or rework situation. Product recalls can lead to lost sales, loss of confidence in the products and damage to the company’s reputation, never mind the costs of providing consumers with replacements or refunds.
If it happens to your company tomorrow do all departments know what to do and how to coordinate their efforts to quickly resolve the situation?
Are you aware of your responsibilities under the New Legal Framework (NLF) CE marking directives?
The NLF directives place explicit requirements on ‘economic operators’ to manage the safety and other compliance issues for products they are responsible for placing on the market. The term ‘economic operators’ includes all parties involved in the supply of a product. The normal parties involved in product supply are:
- Authorised Representative
In the past such responsibilities were seen as those of the manufacturer. Now it is the whole supply chain which has the responsibility.
There are two urgent requirements in law if non-compliance arises:
- Take immediate action to resolve the issue and
- Inform the national authorities in the relevant Member States
Are you prepared? Do you know who to contact and how? How do you trace the affected products and tell users about it?
How Conformance can help you
We have over 20 years experience in safety related support for companies all over the world and team of experts available with wide experience in the requirements for most consumer and industrial products. Our experience includes helping manufacturers to assess products to identify faults. We carry out risk assessments to determine how dangerous faults are and advise on the appropriate corrective action.
We can provide consultancy support in five main areas:
1. Prior to any incident, we will support you to make sure that you are suitably prepared by working with you to create a Product Safety Incident Plan (PSIP). This is a document setting out in clear terms responsibilities and actions (who, what, where, when, why and how). It is important that all parties know what is expected from them and the senior management team fully supports the plan. We follow the format in PAS7100 and the PSIP normally involves all departments. If the company has an ISO 9001 system then we encourage the PSIP to be one of the documented procedures.
2. We can review the PSIP periodically to ensure that any company changes in staff, products, departments etc. are reflected in the plan.
3. Once a plan is in place we can then train all parties for their responsibilities and actions. This is especially important in the case that the media/trade press becomes involved and you need to ensure all staff respond appropriately to questions and know where to forward such enquiries.
4. If an incident occurs then we can help with its management of the recall by assessing the problem with a suitable risk assessment and ensuring the PSIP actions are carried out fully.
5. Once an incident is closed we can then review how the company handled it and provide feedback on issues to improve the PSIP.
Don’t leave it until you have a safety incident. You should be prepared and hope it never will be required to be used but if it does then it is ready to go immediately.