Clause 8.5 Production and Service Provision (secrets)

Table of Contents

• Availability of Documented Specifications
• The Results to be Achieved
• Monitoring and measuring resources
• Implementation of Monitoring and Measuring Activities
• Suitable Infrastructure and Environment
• Competence Requirements
• Validation for Non-verifiable Outcomes
• Human Error Prevention
• Product Release and Delivery
• Important Verbs of ISO Standards
• For auditors:

All of the work you have performed to satisfy the clauses of 8.1-8.4 has been the preparation required to begin product production or the implementation of a service. This clause intends to ensure that your production or service provision activities achieve their intended outcomes as per the criteria of all your previous planning. This is the stage where production, manufacturing or service implementation begins and you are trying to ensure that there are no non-conforming products or services. The requirements for process planning and control are described in clause 4.4, but these requirements are focused more precisely on production.

8.5.1 consists of the requirements listed as parts a-h and includes:

Availability of Documented Specifications

(a) 1. Availability of documented specifications; where you provide clear and precise documented information that describes the characteristics and criteria of the product to be produced or the service to be delivered. This information is the output from all of the work you performed during clauses 8.1-8.4. and must be effectively communicated to all interested parties. These are things such as product specifications, service delivery details and work instructions etc. It could include the detailed instructions that a machine operator might require for the machine setup before production or the timings, materials and mode of service delivery for machine maintenance and service.

The Results to be Achieved

(a) 2. The results to be achieved; is your product or service performing in the way in which it was designed to do? This is where verification and validation activities happen to check and test. You might check that all of the design requirements are matching the customer’s requirements. Next, you check that a product is performing in a way that it was designed to do such as a washing machine achieving a 10.000 rpm spin speed or that service has performed according to the requirements of a contract.

Monitoring and measuring resources

(b) Monitoring and measuring resources; does your product or service production require the use of calibrated devices such as that used to measure the strength of a weld or the parts per million of a contaminate inside a closed space? This subject was discussed in more detail during the examination of clause 7.1.5 requirements. What devices you require will depend on your organisational context and the characteristics of the product or service that you are producing. There are no requirements for anything other than the devices that you have deemed to be necessary. However, if a device is required but it is not available because it’s broken or away for servicing, then you might have a problem in the eyes of an auditor.

Implementation of Monitoring and Measuring Activities

(c) Implementation of monitoring and measuring activities; you may have to use calibrated devices or verification and validation activities but they are no good unless they are used. Roles, responsibilities and authorities need to be assigned and forms need to be completed and entered into the management system to verify that these activities are happening and are being reviewed for effectiveness. Here again, a risk-based approach will dictate how often monitoring and measuring activities will occur and how often they are reviewed. For the production of high-risk products or services, these activities will happen more frequently.

Suitable Infrastructure and Environment

(d) Suitable infrastructure and environment; do you have the right equipment and suitable working conditions to produce your product or service? Infrastructure requirements were discussed in detail in clauses 7.1.3 and 7.1.4. I’m sure that during the planning for products and service production and delivery you might have identified any shortfalls in equipment requirements and made plans to purchase what is needed. If you have entered into a new maintenance or service contract, do your service engineers have the correct tools and PPE that enable them to perform their tasks efficiently and safely?

Competence Requirements

(e) Competence requirements; the production of products and services might involve a great many departments in which there could be thousands of people performing various tasks of differing skill levels. Skills range from basic to highly specialised and you are being asked to ensure that the persons performing them are suitably trained and experienced. Competence was discussed in great detail at clause 7.2 but you are being reminded here about the skills linked to production or service delivery. A little cautionary note here, be careful when employing temporary staff to perform specialised tasks that might require special skills and training. A 3^rd-party auditor might pick up on this and questions might arise about competency.

Validation for Non-verifiable Outcomes

(f) Validation for non-verifiable outcomes; this is an odd one, how can you verify a process where the outcome is unknown or unverifiable? Well, you might have a process for implementing a rescue situation that has never occurred before, and the only way that you can validate it is when the real rescue situation occurs. You might be producing a machine part for a deep-space satellite and the only way that it can be truly validated is in deep space. You might apply simulated testing or destruction testing procedures (and retain records) but you might never be able to claim 100% validation testing as in these examples.

Human Error Prevention

(g) Human error prevention; in an ideal world human error would be eliminated, but no harm in wishful thinking. Human error can be caused by a variety of things but it commonly occurs due to tiredness or a lack of training. To reduce tiredness and fatigue, try to limit or reduce working hours and also repetitive tasks. Repetitive tasks are magnets for boredom and monotony and are known to be associated with human error. You can mitigate against this by introducing variety into a worker’s task duties and providing them with an adequate ISO training course. Task rotation is an easy way to achieve this and it also offers the opportunity to have a multiskilled workforce. A lack of training is against the requirements of clause 7.2 and can have serious consequences such as accidents etc. There is no excuse for a lack of training. For processes where human error could be very serious, then software and/or robotic control might be the options to consider. You might also consider failsafe steps into production processes such as from the Japanese concept of Poke-yoke.

Product Release and Delivery

(h) Product release and delivery; do you perform after-sales maintenance, servicing or offer warranties? Have you got a process for final inspections and testing? You perform final inspections to ensure that the product can be released to the customer. Release for service is when the service is implemented and becomes live. How is the product going to be delivered to the customer? Do you require a special carriage license such as for explosives? Certain products require refrigeration while in transport, do you have a process for when the refrigeration might fail? Certain towns and cities in Europe are now banning carbon powered vehicles and only allowing electric vehicles to enter, have you made plans for this if it affects you? There have been many publicised instances of product recall costing hundreds of thousands of pounds where a common fault has been identified post-release. The one that comes to mind here in the UK was a recall of a certain make of tumble dryer that had been found to cause many house fires.

I think it’s a good idea to remind you of the verbs that are used by the standard because their application to the requirements from your perspective is critical. An explanation of the verbs used is provided on page V and is as follows:

Important Verbs of ISO Standards

In this International Standard, the following verbal forms are used:

• “shall” indicates a requirement;
• “should” indicates a recommendation;
• “may” indicates permission;
• “can” indicates a possibility or a capability.
  
  

The reason that I’m referring to these verbs is that all of the points for clause 8.5 (a-h) are listed under the verb ‘should’ and not the usual ‘shall’. This indicates that they are recommendations and not requirements that you must meet.

If you study the points from a-h you will see that it’s all very much common sense and I should imagine most of which you are already doing. In fact, the same could be said for most of what is in the standard, it’s all something that you are already doing. The standard can be quite frightening for many people because it formalises most of what you are doing but often in a language that is difficult to interpret. I suppose that’s the reason for writing this book, to try and explain the technical language in easy to understand language.

For auditors:

• Check for a criterion that controls process production or service delivery.
• Check for product or service release and acceptance criteria.
• Check for monitoring and measuring processes and resources.
• If calibrated devices are required, check for calibration verification records.
• Check for competency requirements and records of training.
• It’s worth checking if any non-conformances were caused by human error, and if so – follow the usual corrective action process through to eventual continual improvement.
• Check the process for non-conforming outputs.
• As always, check roles, responsibilities and authorities for all of the above in terms of competency and awareness etc.
  
  

Further questions that I will answer in future articles:

• What is the service provision process?
• What is a product provision?
• How do you incorporate quality into your product/service provision?
• What is ISO 13485 service provision?
• How do you control production and service of provision?
• What are identification and traceability?
• What are externally provided processes?
• What is the difference between verification and validation?