Comments for Current Quality Blog

Comment on Oops You Did it Again – Revising Standard Operating Procedures by Sandra Gauvin

Sandra Gauvin — Sat, 13 Nov 2010 22:34:55 +0000

Vanessa,
I agree that many SOP’s contain too much information, much of which is non-value added and put a company at risk during an audit. The best situation is to provide the ‘how to’ details in a work instruction and training. Unfortunately, many companies use SOP’s as work instructions and either have too much information that’s difficult to maintain or the SOP’s are too vague and the training is poor…either situation can lead to issues (e.g. nonconformances, audit findings).

Comment on Oops You Did it Again – Revising Standard Operating Procedures by Vanessa Jackson

Vanessa Jackson — Sat, 13 Nov 2010 14:17:49 +0000

I think SOP’s should be just that. A standard. It should not contain far too many intricate details.. Leave that up to your work instructions or Training manuals. For example,. the exact annual training test should not be included in your SOP. I think the SOP should simply state “a qualifying test will be utilized at each session.” If this is not done then each time you change the test… then you MUST change the SOP. Rules, regulations studies etc. change with time, and so should your training materials. Now the HACCP plan must be detailed, but overall make this a very well written standard. I once had an SOP that stated”all QA doors must remain locked at end of day”. Well, how was I going to SHOW that this was done.. another form of course perhaps….so I removed it and just place signs on the door..”only authroized EE allowed”….. NEVER had one problem with an auditor over this. What do you think?

Comment on Should You Ever Reopen a Closed Non Conformance Report? by Sandra Gauvin

Sandra Gauvin — Mon, 09 Aug 2010 10:36:07 +0000

Stephen,
Let me know how you make out.

Sandra

Comment on Should You Ever Reopen a Closed Non Conformance Report? by Stephen

Stephen — Mon, 09 Aug 2010 00:05:54 +0000

Thanks Sandra.

I’ll take a look TrackWise and see how closely it aligns with possible applications here.

Stephen

Comment on Should You Ever Reopen a Closed Non Conformance Report? by Sandra Gauvin

Sandra Gauvin — Sat, 07 Aug 2010 15:27:13 +0000

Stephen,
You’re very welcome…I’m glad that you enjoy the newsletter. I’ve used TrackWise by Sparta Systems in the past to track non-conformances and more (planned deviations, corrective and preventive actions, change controls, etc.). Most biotech companies use it because it’s 21 CFR Part 11 compliant, but the company also has software for non-biotech industries…you can check out their website at http://tinyurl.com/335pjul.

Sandra

Comment on Should You Ever Reopen a Closed Non Conformance Report? by Stephen

Stephen — Fri, 06 Aug 2010 23:47:15 +0000

Thanks for your latest newsletter. I always find them informative and practical – a good combination.

Non conformances, system improvement and document control are all high on the list of challenges for most management systems I’ve seen.

Risk management also seems to be getting a lot more attention in the past year or two.

You mention the use of electronic systems for logging non-conformances. What systems have you seen that are effective for a small or medium sized business?
eg. for a (service or manufacturing) business with up to 50 staff?

- Stephen

Comment on Creating a Lean Office With 5S – No More Cubicle Clutter! by Sandra Gauvin

Sandra Gauvin — Tue, 01 Jun 2010 21:21:54 +0000

Thanks Sherry. It’s nice to see a large company like Fidelity apply continuous improvement tools and techniques in the mail room.

Comment on Creating a Lean Office With 5S – No More Cubicle Clutter! by Sherry Gordon

Sherry Gordon — Tue, 01 Jun 2010 16:19:38 +0000

Good synopsis of 5S, Sandra. Instead of seeing 5S as just for the manufacturing floor, people are finally seeing it as a tool to improve administrative processes as well. I had the opportunity to see Office 5S in action last fall when I toured Fidelity Investment’s operations in Covington, KY (near Cincinnati, OH). Their incoming mail operation was particularly impressive. Your readers might be interested in the article that I wrote about what Fidelity has done in this area, “The Lean Office: Pushing the Envelope — Efficiently (http://valuechaingroup.com/sherryblog/2009/11/02/the-lean-office-achieving-paper-pushing-proficiency.html).

Comment on Building A Quality Mindset With Your Staff (or Not) by Sherry Gordon

Sherry Gordon — Sat, 08 May 2010 12:00:07 +0000

Another issue that I’ve seen is that quality is seen as the domain of the just the quality department. Other functions don’t see quality as their responsibility, too. All functions need to have quality as part of their mindset. I had a boss who actually told me I was avoiding my responsibilities in quality and pawning them off on other departments.

Comment on Recognizing Your Personal Achievements by Roberto

Roberto — Mon, 28 Dec 2009 18:39:36 +0000

Hello Sandra,
I think it was putting online my websites http://www.topkaizen.ca, and http://www.topkaizen.com
and my first software, related to my experience(AXIS)