Should documents that support the operation of its processes be excluded from control?

[Integrator]

During a recent internal audit of a manufacturing operation I noted a form that I believed supported the process that was not listed in the Document Control Register.

The form was filled out by hand by the Manufacturing Manager to communicate production schedules to his staff and resided in his personal folder.

ISO 9001 4.4.2 To the extent necessary, the organisation shall:
a) maintain documented information to support the operation of its processes;

ISO 901 7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
7.5.3.2 For the control of documented information, the organisation shall address the following activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.

I thought that this approach provided predictability about when documents should be controlled and was a pretty cut and dried case. I believe forms should be controlled.

The Quality Manager rejected this and said that the Manufacturing Manager had developed it himself and that the information could be conveyed in other ways such as email etc.

Please may I have feedback on this.

Integrator

 

[Ed Panek]

From just a practical standpoint what would happen if this form went away? Would it impact customers?

 

[Jim Wynne]

Following @Ed Panek's train of thought, if the schedule were communicated via email, or if it were written on a blank piece of paper, would you still consider it in need of control? Is there a documented requirement to communicate the information involved?

 

[Bev D]

How about if it were on a white board?

Another thought is that revision controlled documents need review and approval - who is gonna review and approve schedule changes? Is the manufacturing manager scheduling poorly? In contradiction of established planners schedules? Are their schedules affecting Customer delivery commitments? If so it’s not the document that needs control it’s the manager…

 

[Bev D]

so funny story. My organization had stated to implement ‘gemba’ boards where lot status and position in the mfg process were shown on a white board. In addition, problems and solutions were posted as well as other pertinent info for the team. The team would meet daily to discuss teh process and problems encountered. And how to best respond. When a team first started a board they often changed it multiple times a week until they got a layout that worked for them. Then they might change the board once a month or so, but the info changed continuously as things happened in their area. An auditor issued us a finding for not having the boards under control. They wanted the supervisor to sign and date the board each time something changed. We fought that one at the closing meeting and got it ‘downgraded’ to an observation which we ignored.

 

[Ed Panek]

Sign and date a dry-erase board?

 

[Bev D]

Sign and date a dry-erase board?

Yup. He even threatened to make it a major since all of our white boards were like this. We asked that he never return.

 

[Tidge]

Sign and date a dry-erase board?

Yup. He even threatened to make it a major since all of our white boards were like this. We asked that he never return.

This auditor may have been reincarnated as a Quality Manager at a company I know all too well: All dry-erase markers and Sharpie markers were seized and sequestered because "The Quality Manual demands that all work be recorded in blue/black ink."

 

[qualitymanagerTT]

During a recent internal audit of a manufacturing operation I noted a form that I believed supported the process that was not listed in the Document Control Register.

The form was filled out by hand by the Manufacturing Manager to communicate production schedules to his staff and resided in his personal folder.

...

I thought that this approach provided predictability about when documents should be controlled and was a pretty cut and dried case. I believe forms should be controlled.

The Quality Manager rejected this and said that the Manufacturing Manager had developed it himself and that the information could be conveyed in other ways such as email etc.

Please may I have feedback on this.

Integrator

Where is your evidence that this form is not under control?

Which requirement is not met?

 

[Kyle.Ramson]

My thoughts on the original question, if the information contained could negatively impact quality or any of your key metrics, including OTD, if it is incorrect, then it needs to be controlled or as in this case, at least redlined with date, name and signature of person with authority, so all seeing it and following it know it is accurate and authorized.
Here is an example of why it is important. Years ago, an unsigned notice was posted at the time clock on a Friday afternoon, stating weekend production was canceled. Employees assumed it was from management since they regularly posted information in this manner. The problem was it was actually posted by an employee who didn't want to work over the weekend and didn't want to get in trouble for calling in.
The weekend production was crucial for a time-sensitive shipment for Sunday evening pickup or OTD would be negatively impacted, with a skeleton crew the material was completed on time, however mistakes were made and steps were skipped, so a week later, the shipment was rejected by the customer causing additional delays, and additional costs from shipping, rework, scrap, and most importantly customer dissatisfaction. The root cause for both errors was there was not a process in place that required postings, information, instructions or directions, that could negative impact key metrics to have a name, signature and date signed by authority. We developed a policy going forward and trained all employees and there were no further questions or concerns.
This is outside the box thinking that sometimes only comes from lessons learned, those lessons are best learned from others instead of the hard way, but it isn't always a choice how they are learned.
I will sign this "lesson learned the hard way" and hope others benefit from it.