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Understanding wasted time in quality processes (or why it took so long to complete that CAPA)

5 MINUTE READ

Before starting a software company, I used to run my own manufacturing plant making industrial enclosures for the power sector. My co-founder, Lakshman, ran a food processing unit making extruded snack pellets (🤷🏻‍♂️no idea what that means).

We both faced the same problem – it used to take forever to get anything done. Especially in continuous improvement processes like CAPAs.

If you study the process, you’ll understand why it’s so hard to get anything done.

 

Let’s deep dive into one non-conformance from the food industry

Here’s the background. It’s a real case we studied from Lakshman’s food processing company. There are about 20 similar non-conformances at this company every single month.

This part is a bit technical – but it doesn’t really matter so much if you follow exactly.

So, wheat flour is a key raw material in this process. The supplier (let’s call them ACME Corp) sends a shipment in big-bags (really big bags of flour – you don’t want to be lifting these by hand). The shipment is brought into the raw material warehouse and cleared by QC for production – because they’re running out. But, on the ACME test certificate, it turns out that the ash content is too high (2.0% vs. 1.4% spec).

What happens next? The extruder, the big machine that cooks the flour, gets jammed. The production head asks the quality department to check the raw material specs. Sure enough, they discover the problem – the wheat flour ash content is out-of-spec.

 

Now the quality process kicks in

A supplier non-conformance is created. Due to the huge production delay, the operations head insists that it needs to be root-caused, and CAPAs completed.

Unfortunately, the pressure is on the quality department to solve the problem and get it executed ASAP. Despite all good intentions, this NC takes 5 months to be root-caused and CAPAs executed.

It turns out that there were two problems at the core here – 1) the incoming QC cleared this shipment for production without checking the specs, 2) The supplier, ACME corp, was supplying against an old specification that had been revised 2 months ago.

These root causes lead to 4 CAPAs – (1) change the incoming raw material inspection processes, (2) Train the QC personnel on the new process, (3) Change the way specs are handed over to suppliers, (4) Change the process for suppliers to self certify their products.

That’s the summary – but where does the time get wasted

Here’s a lean takt time analysis I conducted. VA stands for value addition (or stuff your customer cares about). NVA is non-value addition (stuff you might have to do but your customer doesn’t care about).

 

Process Step

Day

Tools

Teams

VA

NVA

1

Stop production

0

 

Operator

 

2

Inform supervisor / quality

0

Phone, meeting, email/chat

Operator, supervisor, quality

 

3

Create non-conformance

1

QMS/ERP/Excel, email/chat

Supervisor, quality

 

4

Understand problem statement

2

Meeting, phone call, email/chat

Vendor, quality, production

 

5

Brainstorm disposal actions

3

Meeting, phone call, email/chat

Engineering, vendor, quality, production

 

6

Coordinate teams for disposal actions

7

Meeting, phone call, email/chat

Quality, supervisor, production

 

7

Clarify questions or responses

9

Meeting, phone call, email/chat

Supervisor, engineering, production

 

8

Implement disposal actions

12

 

Supervisor, production

 

9

Follow up for disposal implementation 

17

Meeting, phone call, email/chat

Quality, production

 

10

Check & approve disposal action

17

Meeting, NC report, email/chat

Quality, production, engineering

 

11

Update the disposal details

18

NC report, QMS/ERP

Quality

 

12

Coordinate root cause meeting

31

Meeting, phone call, email/chat

Quality, engineering, production, vendor

 

13

Complete root cause analysis

39

8D or NC/CAPA report, Excel

Quality, engineering, production, vendor

 

14

Schedule corrective action meeting

47

Meeting, phone call, email/chat

Quality, management

 

15

Define corrective actions

48

Meeting

Quality, management

 

16

Update the corrective action details

48

8D or NC/CAPA report, QMS

  

17

Coordinate and assign corrective action team

54

Meeting, phone call, email/chat

Quality, engineering, production, sourcing

 

18

Clarify corrective action(s)

59

Meeting, phone call, email/chat

Quality, engineering, production, sourcing

 

19

Schedule corrective action implementation

60

Meeting, phone call, email/chat

Quality, sourcing

 

20

Follow up on corrective action implementation

69

Meeting, phone call, email/chat

Quality, sourcing

 

21

Implement corrective action(s)

93

NC Report

Sourcing, vendor

 

22

Approval of corrective action(s)

101

Meeting, phone call, email/chat

Quality, sourcing, vendor

 

23

Update status of corrective action(s)

109

8D or NC/CAPA report, QMS

Quality, management

 

24

Management review of corrective actions(s)

115

Meeting, phone call, email/chat

Quality, mgmt/leadership

 

25

Monitor corrective action efficacy

145

Reports

Quality, mgmt/leadership

 

26

Close the correction action(s)

156

QMS

Quality,

 

It is obvious that there are a lot of steps involved. A lot of teams coming together, and using multiple tools. Apart from the usual ‘, I dropped the ball’ delays, there are other legitimate reasons for the time wastage.

So what does that snapshot of time wastage look like?

By diving into all the emails, meeting notes, excel sheets, interviews, etc, we were able to approximate where the time got spent into these buckets:

It’s interesting to note that we classified the wasted time into the 8 wastes of Lean. And what it ultimately boils down to is that ~85% of the cycle time is non-value addition time. Your customer’s not paying for it.

 

So what is the solution? How do I become more efficient?

  1. First, start measuring cycle times. Even if you can’t get the details in-between, getting the cycle times will ultimately help you reduce it.

  2. Create a place where your teams can collaborate on one issue at a time. Multiple emails, systems, excel sheets and meetings add to the chaos. Asynchronous collaboration saves incredible amounts of time.
  3. Deep dive into one process end-to-end. If you can do this once a month, it will help, if not aim for once a quarter.
  4. Identify weak spots in your process. Look for lack of ownership, excessive data transfer, unaccounted delays, long meeting cadences, high friction tasks, and silos.
  5. Continuously improve your processes.
  6. Shoot for the moon – if a process takes 6 months, ask your team why it can’t be done in 6 days. If they aren’t thinking outside the box, they won’t make much progress.

 

Ben Merton is CEO of Unifize, a software platform that makes every process collaborative for manufacturing companies. He is also a contributor for various publications on business, technology and entrepreneurship, including the Wall Street Journal, the Financial Times and Business Standard. 

Need help?
Get in touch with me at [email protected]
Or https://www.linkedin.com/in/bmerton/

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