🔁 ISO Series Competence and Documents


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Quality that's simple

Hey Reader

How is quality responsible for competence?

Do you use the word competence in your workplace?


Was this email forwarded to you?


I don’t like calling people incompetent. I prefer certification.

Here’s the thing about ISO 9001, it tells you what to do, but not how to do it.

You have the freedom to rename, change, and modify nearly everything so that it works for you

I deleted all their Work Instructions

An example: at a client, I recently got rid of all their “work instructions.”

WHAT? WHY? (good questions)

Because the people had become so jaded to the idea of work instructions they couldn’t see their benefit.

So we talked about the benefits:

  • teaching new people
  • setting expectations
  • saving best practices
  • explaining contingency plans

They were on board with all of it, just not "work instructions".

So we made training aids (I’m betting you see where this is going).

Same stuff different format.

So what is “Documented Information”?

Anything you want it to be:

  • A training guide that explains what to do
  • a process outline
  • a checklist with some extra steps on the top (I use this a lot)
  • a video recording

(examples at the end)

Documented Information takes many different forms. The form must match the purpose and audience of the document; that is make the document user-friendly.

I push this to where my clients have multiple document templates. We have template examples, but allow each department to modify them as needed. The usefulness of the document is paramount (suitability in 7.5.3.1).

Back to the original question, how is Quality responsible for competence?

So what does documented information have to do with competence?

Everything. We cannot assess competence (7.2) without first understanding the expectations (7.5). This also overlaps with roles and responsibilities (5.3).

Quality's responsibility for competence is to build and document the process to define, assess, and train people.

ISO 7.2 requires the organization to:

a. Figure out what skills and knowledge (competence) are required

b. Assess people to know they have those skills and knowledge

c. Help people learn any missing skills and knowledge.

d. Keey records (because if you don't write it down, it didn't happen).

It's impossible to do 7.2 a) without a good basis in process documentation. The expectations must be communicated clearly and effectively, otherwise, there's no hope for people to meet them.

3 parting requests for you:

What did I miss or explain poorly? Reply with feedback so I can improve.

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Where should we go next? Reply and let me know what struggles I can help with.

Quality doesn't need to be complicated.

Let's make the world a simpler place,

Mike

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Example Work Instructions

Checklist Format

Checklists can serve both as instructions and verification of the process. These need to be designed well. Airlines extensively use checklists and serve as a good reference.


Prose Format

Upon receiving new material shipments, begin by checking the delivery schedule to confirm the shipment is expected. Carefully inspect the shipment for any visible damage to the packaging. Then, verify the Bill of Lading to ensure it matches the expected shipment details. If all checks are satisfactory, document receipt by signing off. Once accepted, move the material to the designated staging area, where it should be clearly labeled with its material ID and batch number. Finally, update the inventory system to reflect the new stock.

The prose format is difficult to read, skim, and understand.


Outline Format

I. Preparing for Material Receipt
A. Check delivery schedule for expected shipment
B. Prepare area for material inspection

II. Inspecting Shipment
A. Review packaging for damage
B. Match shipment contents with the Bill of Lading

III. Receiving and Documenting Material
A. Sign and document receipt if inspection is satisfactory
B. Move material to staging area

IV. Labeling and Recording Material
A. Label items with material ID and batch number
B. Enter material into inventory system


Video Transcript Format

Scene 1:
Narrator: “Welcome to the Receiving Material Work Instruction video. Let’s walk through the steps for handling incoming materials effectively.”

Scene 2:
Narrator: “Step one: check the delivery schedule. Make sure the shipment is expected and there is a prepared space for inspection.”

Scene 3:
Narrator: “Next, inspect the condition of the shipment. Check the packaging for any visible signs of damage. This step helps prevent issues downstream.”

Scene 4:
Narrator: “Now, verify the Bill of Lading. Confirm that it matches the expected details of your shipment.”

Scene 5:
Narrator: “If all checks are satisfactory, sign for the shipment and move the material to the staging area.”

Scene 6:
Narrator: “In the staging area, label the material with the appropriate material ID and batch number. This will help with traceability.”

Scene 7:
Narrator: “Finally, enter the material into the inventory system, updating stock levels. Thank you for watching and following the material receipt protocol!”


Slide Show Format

Slide 1:Title Slide
Receiving Material: Work Instruction

Slide 2:Step 1: Check Delivery Schedule
- Confirm shipment matches delivery schedule.
- Prepare inspection area.

Slide 3:Step 2: Inspect Shipment Condition
- Look for visible damage on packaging.
- Report any issues immediately.

Slide 4:Step 3: Verify Bill of Lading (BOL)
- Confirm shipment details match BOL.
- Address discrepancies before receipt.

Slide 5:Step 4: Document Receipt
- Sign for shipment after inspection.
- Move material to designated staging area.

Slide 6:Step 5: Label Material
- Attach labels with material ID and batch number.

Slide 7:Step 6: Enter into Inventory System
- Record receipt in inventory.

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