Tips_and_Tricks

Technical Education

7/18/2024

Tips_and_Tricks

Transcript

00:00Number 1. Establish commitment. Implementation takes time and resources. Make sure you have

00:22commitment before starting this project. Tips. Know why you're implementing the ISO 9001.

00:32Is it because a client or a market is asking for you to register? Is it for the internal

00:37benefits? Is the motivation coming from executive management? Keep the reasons for implementing

00:44visible during the project to retain commitment and stay focused on the end goal. Assign an

00:51ISO steering team. This team should be made up of management from the different areas of the

00:58company, including the management representative and the people that have the authority to devote

01:03resources to the project and remove roadblocks. Common setbacks. Assigning responsibility for

01:12implementation to one person or department. The ISO 9001 quality management system is a

01:20management system. It is not a quality control program and cannot be implemented by quality

01:26assurance alone. Losing commitment during the project. During implementation other projects

01:32come up that compete for people's time and resources. Ask decision makers if the ISO

01:37implementation is still a goal. 2. Prepare an implementation. A good project plan is a key part

01:47of a successful project. Tips. Conduct a gap analysis. Compare your current system to the

01:55requirements of the standard. Determine what's already in place and what needs to be implemented.

02:01From this you can prepare task lists for each of the sections of the standard. Have the ISO

02:07steering team create point teams for each of the sections that apply to your organization.

02:12Determine team members and the timeline for each team. Use information from the gap analysis and

02:20task lists to determine the appropriate people for the teams and establish the timeline.

02:26Common setbacks. Proceeding without a plan. Without a plan projects tend to run indefinitely

02:34without showing measurable progress. By having a plan you have a specific deadline to meet. You

02:42can show progress as you meet the deadlines and take actions if you're not meeting the deadlines.

02:47Not having the ISO steering team approve and support the plan. The ISO steering team will

02:55be watching the timeline, coordinating and implementing the plan. They should have the

03:00input and the approval of the plan or better yet prepare the plan. Kick off the project in a big

03:10way. Let everyone in the company know you have started the project. Hold basic ISO 9001 training

03:17sessions for all employees. Tips. Include some sort of celebration in the kickoff. Examples include a

03:26lunch for employees, a picnic, prizes or a cake. Use a training and celebration to inform employees

03:33of the plan and timeline. Tell the employees how they'll be involved and how they'll be affected

03:39by the project. Communicate why this will be good for the company and good for the employees.

03:45Common setbacks. No kickoff. Employees that are working on the project are aware but others in

03:54the company are not. When the new procedures are implemented employees don't know why and there's

03:59little support for the ISO project. Non-conformances are commonplace in this environment. Training on

04:07ISO 9001 but no information on why the company is doing this or how the employees will be involved.

04:15This can result in the employees thinking another management program. How long will this one last?

04:21Number four. Design and document the QMS. Use information from the gap analysis in the project

04:30plan. Use people currently involved in each process to make changes to the existing process

04:36and bring it into compliance with the standard. Tip. Use the ISO steering team and the point teams

04:43for the design and documentation. The ISO steering team meets on a regular basis. During these

04:50meetings the team reviews the timeline, reviews what the point teams are working on, removes road

04:56blocks, resolves conflicts and reassigns resources as needed to keep the project on track. The point

05:04teams meet on an as-needed basis according to the timeline. When the point teams meet they address

05:11the tasks on the task list. Spread out the point teams on the timeline so you don't have too many

05:20meetings at one time. For example you may want to have the document control team meet early in the

05:25project to establish the system to collect and control the documents that will be generated but

05:31the internal audit team would meet later in the process because audits will not begin until the

05:37system is complete. Keep the point teams on schedule. Review their task lists and the ISO

05:45steering team meetings. Watch for problems and delays and give them help as soon as problems

05:50arise. Have each team member of the ISO steering team lead several point teams. Each point team

05:58should have an ISO steering team member for a leader. This allows you to coordinate the work

06:03of the different teams. Common setbacks. Poor team makeup. Make sure you include people involved in

06:12the process. For example use purchasing staff for the purchasing team. Not meeting timelines.

06:19Establish realistic timelines for the plan. Teams should be able to meet them with small changes. If

06:26the teams are not expected to meet the deadlines other tasks will take precedence. The project will

06:32drag on and lose energy. Misrepresentation of the standard. If you don't understand what's required

06:40by the standard you may waste time and resources doing things that aren't required for straight

06:46team members and miss important requirements of the standard. No central point of collection and

06:54control of new documents. If the document control system is not developed early on in the project

07:00you create confusion on what documents are final, what has been approved, what is the final revision,

07:06where's the electronic file, has it been distributed. Not establishing document templates early on in

07:14the process. If you don't format and distribute documentation templates for the procedures and

07:20work instructions you will not get consistent documents. You'll need to go back at the end of

07:25the project and redo all the documentation. Lack of communication during the project. Remember

07:32employees that are not on point teams may not be hearing much about what's going on with the

07:37project. Employees may think that the project has faded away. Communicate with newsletters,

07:42bulletin boards or meetings. Number five. Run the system for three months. Once a system is

07:51complete follow documented procedures, conduct internal audits and management reviews and make

07:57improvements to the system. Tips. Start off with an additional training for all employees. Summarise

08:05the new quality system emphasising their responsibilities. Review the timeline for

08:10running the system and conduct audits. Schedule internal audits so that you can audit the entire

08:17system two times before the registration audit. This allows you to find non-conformances and fix

08:24them before the registrar comes in. Keep corrective actions on schedule. Hold management review at

08:31least once before your audit. That's required. More is better. Common setbacks. Lack of communication

08:40with employees. Employees that have not been involved in the design and documentation of the

08:45quality system will not be aware of the requirements of the quality system. Training and communication

08:51are critical to get them involved. Lack of follow-through on corrective actions. The new

08:59system will generate numerous corrective actions. If they're not investigated and completed your

09:05system will not be ready for a registration audit. In effect of management review, management must

09:13take a close look at the data from the quality system, evaluate it and take action.

Category

Transcript

Recommended