Need help finding a book on Documentation

[KHebert]

I am very new to the industry and I was hired at a company to start a quality system from 0. I have no previous background quality control/assurance. The company I work for is small but very busy so it is essentially up to me to do the research and create a quality system with minimal assitance. I am looking for a book that takes you step by step in creating document traceability, work instructions, corrective/preventative actions ect......Unfortunately for me we are to busy for me to be trained in setting up the system since there was not one in place before I was hired. If anyone could point me in the direction for a good book to get me started that would be great. Thank you in advance.

 

[John Broomfield]

Re: Need help finding a book.

KHebert,

The company you work for is delivering quality already. Indeed, it would not be in business unless it fulfilled customer requirements most of the time. So, your quest to "create a quality system" may threaten the system you already have.

Better to think of your project as working with the leaders to understand how your company works as a system so its employees engage in developing, using and improving their management system to do an even better job of fulfilling customer requirements.

Elsmar Cove is a wonderful "book" and so is this blog.

By googling "developing a process-based management system" (with and without quotes) you will find other useful resources.

John

 

[maaquilino]

Re: Need help finding a book.

Besides all the great information shared on the Cove (and searchable), there are a number of books out there on QMS and also information online that you can find by searching for specific terms: quality management system, document control, change control, CAPA, etc. If you're in a regulated environment, then what you need to have documented will be driven by what regulations you're under, so getting a copy of the standards you need to meet, for example, FDA CFR 820, ISO 9001, etc., is also a good way to get started.

I found these using a Google search:
http://my.safaribooksonline.com/book/quality-management/9781405142793

http://asq.org/learn-about-quality/total-quality-management/overview/implementing-tqm.html

http://www.amazon.com/quot-Books-Quality-Management/lm/R1JZEG2ISRQSW3

I'm sure there are some Covers who can give you some good titles off the top of their heads, but I'm not close to my library at the moment and I have too many to remember them all

 

[Wes Bucey]

For what it's worth, I think the ISO 9000 family of Quality Management Standards is definitely at the top of the list of reference materials an organization should have on hand for this primary reason:

It summarizes the quality management systems corporations look for in prospective links in their supply chains.

Organizations do not necessarily have to become registered or certified to the various International Standards which include, but are not limited to, AS9100 series for aerospace, TS16949 for automotive, ISO13485 for medical devices (all based on the ISO 9001 series.) Being compliant with the basic ISO 9001 series will position any organization to move to certification when market forces dictate certification is necessary to expand the organization's market.

One of the basic things to seek out is a Gap Analysis form to compare an organization's current operations with the minimums outlined by the Standard.

Although you write "Unfortunately for me we are to busy for me to be trained in setting up the system since there was not one in place before I was hired." this does NOT preclude your organization from hiring a consultant for a day or two to walk you through a Gap Analysis of your organization and set you on the path to congratulating yourselves for the good stuff you already do and setting up a plan to fill the gaps you detect.

Especially for small organizations, SIMPLE is often the best route to follow. Don't get tangled in the minutiae of Quality Management which confronts large organizations with thousands of employees, customers, and products, dealing with dozens of regulatory bodies in their various markets.

Tritely, but truthfully, we say, "you have to crawl before you can walk, walk before you can run." It is unrealistic to over-analyze the subject of Quality Management and expect to be running at full speed after reading one or two books. Even old veterans such as I still approach each project in a methodical step-by-step manner, mainly because the people in the organization also have to be included in the project. It is NEVER a one-man show. Folks who think so are destined for a frustrating career.

 

[Jen C]

Can I ask what field you work in?

I have worked in drugs and medical devices. When I was first starting out (in a situation not too unlike yours!), I found Documentation Systems Clear and Simple by James L. Vesper very helpful. I also really like Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations by Carol DeSain, and Documentation Practices: A complete guide to document development and management for GMP and ISO 9000 compliant industries by Carol DeSain and Charmaine Vercimak Sutton. These are all pretty old now, but I think they give good step-by-step instructions on where to start.

Of course, this is in addition to whatever standards etc. you plan to meet - these are essential references, as mentioned above!

 

[Pancho]

This booklet really helped us out when getting started:

ISO 9001 For Small Business. What to do.

 

[Wilderness Woody]

I am very new to the industry and I was hired at a company to start a quality system from 0. I have no previous background quality control/assurance. The company I work for is small but very busy so it is essentially up to me to do the research and create a quality system with minimal assitance. I am looking for a book that takes you step by step in creating document traceability, work instructions, corrective/preventative actions ect......Unfortunately for me we are to busy for me to be trained in setting up the system since there was not one in place before I was hired. If anyone could point me in the direction for a good book to get me started that would be great. Thank you in advance.

It's unlikely that a single book will deliver your blueprint in a chapter by chapter, spoon-fed manner that is useful. Developing and implementing an effective Quality Management System is not like auditing a college course and passing an exam.

I'd suggest looking for the local ASQ Chapter group and a reputable training center (corporate, technical college etc.) to gain training for yourself and key staff at your company to support the efforts. Finding local educational and consultancy support can be critical for ongoing efforts. They can make specific recommendations for reading and reference materials as well.

Choosing from available titles at ASQ can be daunting... http://asq.org/quality-press/index.html so getting to know other quality professionals in your field and area can really help provide direction and a source of discussion.

 

[KHebert]

Aerospace manufacturing is the field that I work in. We do have a good system in place but its not documented and that's what we want to work towards.

 

[John Broomfield]

Aerospace manufacturing is the field that I work in. We do have a good system in place but its not documented and that's what we want to work towards.

KHebert,

Most books about documentation are about writing procedures around the clauses in the standard. Indeed, you'll see many requests for ready-made documented procedures here.

As you've already gathered, it is better for everyone to develop and capture the system you already have.

May I take it that you and your colleagues already understand how your organization works as a system to fulfill customer requirements?

If you do it probably means that you have analyzed how the company works with its customers and suppliers to convert the needs of customers into cash in the bank. You may have captured the results of this analysis in a high-level deployment flowchart showing how the three entities interact through your organization's processes. It will show what your organization does to get work, do work and get paid.

From this you can determine the processes that are essential to your company's mission. Top management will have named subject matter experts (no necessarily managers) as owners for each of these processes.

Then you can work with each of the process owners to analyze their process (search here for SIPOC) and its interactions with other processes in the system. Using your knowledge of the system standard(s) you can agree upon any nonconformity with the process owner as you go to initiate correction. If correction is delayed beyond, say, two weeks then feed these nonconformities into your process for "stopping recurrence of nonconformity" (aka Corrective Action).

Again you can capture the results of these analyses in deployment flowcharts. After review for accuracy by the process team these flowcharts can become the documented procedures linked to essential data-gathering devices (forms) and cues on how to complete certain high risk tasks (work instructions).

Your deployment flowcharts may then be used and improved as procedures and later, perhaps, as blueprints for development of your computerized management system.

This is less about "documentation" and more about enabling everyone to understand how to determine and fulfill requirements. They can then use and improve their management system, its processes (and procedures) and their outcomes.

John